Maternal HealthNCT05763537
Understanding the Role of Doulas in Supporting People With PMADs
A study testing Standard Doula Care Plus PMAD Intervention and Standard Doula Care in people with Maternal Health and Pregnancy, run by University of Montana at 1 site in United States.
Trial summary
Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Health, Pregnancy, Delivery, Obstetric
- What is being tested?
- Standard Doula Care Plus PMAD Intervention and Standard Doula Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be over the age of 18
- Currently pregnant and between 13 and 26 gestational weeks at the time of enrollment
- Live in a HRSA-designated rural area of Montana
Who cannot join
- They are under the age of 18
- Not currently pregnant
- Not between 13-26 gestational weeks at the time of enrollment
- If they do not live in a HRSA-designated rural are of Montana.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Montana
Missoula, Montana, 59812
Jessica L Liddell, PhD, 4357576780, jessica.liddell@mso.umt.edu
About this study
Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.
Read the detailed description
Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention. A subsection of 20 participants who receive care from doulas in the PMAD training will also be eligible to participate in a qualitative interview at 6 months postpartum. The interview guide will be developed based on prior research with doulas, the PI's current research exploring doula-care in Montana, and feedback from the CAB. Example questions are expected to include: "What were your experiences working with a doula?" "What would have made your experience better?" and "What worked and what didn't work?"
Interviewers will all be graduate students who have completed research methods courses and will be trained by the PI, who has extensive experience in conducting qualitative research and in conducting qualitative interviews.
The following procedures will be followed:
- Once participants have indicated that they are interested in participating in the study, the PI will contact them to set up a time to discuss the study with them, and if they are interested and meet eligibility criteria, enroll them in the study. Participants will be randomly assigned to either receive standard care from a doula, the doula PMAD intervention, or perinatal care as usual.
- Before enrollment in the study, participants will be provided with a copy of the consent form, and the information on the consent form will be read to the participants.
- Once the participants have provided informed consent, they will be given the pre-test survey via REDCap and will take the survey again at 1 month postpartum and 3 months postpartum.
- All participants will be connected to a doula and receive either care as usual from a doula or a doula trained in the intervention by the PI and will engage in care with them throughout their pregnancy, during childbirth, and for 3 months postpartum. The exact components of the doula care provided will be developed in aim 2 based on the findings of study 1.
- Participants will be provided compensation (in the form of a gift card) after the completion of each survey (pre-test, 1 month postpartum, 3 and 6 months postpartum).
- At the completion of the study, participants will be thanked for their time and participation. For those who agreed to do member checks, participants will be re-contacted after analysis for member checks.
Participants who are randomized into the intervention arm of the study will also be randomly selected to participate in cross-sectional, semi-structured interviews.
Participant recruitment is described in the recruitment and retention plan. Participants will be interviewed about experience in the intervention.
The following steps will be followed:
- Once participants have indicated that they are interested in participating in the interview portion of the study, the PI will contact them to set up a time for an interview and about their preferred interview site. They will have the option to do a phone interview if they are not available for an in-person interview or if they are not comfortable with an in-person interview for privacy reasons. The first interview will take place before they begin care with their doula.
- Interview sessions will be scheduled at a pre-determined time at locations desired by the participants. If the interview takes place in person, Covid-19 protocols will be followed and include the completion of a Covid-19 symptom questionnaire by both the participant and the interviewer, the wearing of face masks during the interview, and social distancing.
- Before beginning the interview, participants will be provided with a copy of the consent form, and the information on the consent form will be read to the participants. This process is further described in the Protection of Human Subjects document.
- Once the participants have provided informed consent and provided consent to having the interview audio-recorded, the interviewer will begin recording the interview. A semi-structured interview guide will be used to guide the interview.
- Audio-recorded interviews will follow semi-structured interview guides and last 60-90 minutes.
- Following the interview, participants will be asked whether they are willing to be contacted to do a follow-up interview at 3 months postpartum.
- Participants will be provided their compensation.
- Participants will be thanked for their time and participation.
- For those who agreed to do a second and third interviews at 3 and 6 months postpartum, the same process will be followed to conduct their second interview.
- Conditions
- Maternal Health, Pregnancy, Delivery, Obstetric, Self Efficacy, Social Support, Mental Health
- Being tested
- Standard Doula Care Plus PMAD Intervention, Standard Doula Care
- Medical subject headings
- Psychological Well-Being, Substance-Related Disorders, Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Doula Care Plus PMAD InterventionBehavioural
Doulas trained in the DONA training, and the PMAD-focused training will provide care to perinatal people.
Standard Doula CareBehavioural
Doulas trained in the DONA training will provide care to perinatal people.
| Study group | Role | What they receive |
|---|---|---|
| Standard Doula Care Plus the PMAD Intervention | Experimental | Participants in this arm will receive standard perinatal doula care provided by doulas trained in the DONA International doula training in addition to PMAD-specific care from their doulas. Receives: Behavioral: Standard Doula Care Plus PMAD Intervention |
| Standard Doula Care | Active comparator | Participants in this arm will receive standard perinatal doula care provided by doulas trained in the DONA International doula training. Receives: Behavioral: Standard Doula Care |
| Standard Maternal Care | No intervention | In this arm participants will receive standard perinatal medical care and will not receive care from a doula. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Childbirth Self-Efficacy Inventory (CBSEI)
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
Measured: At study enrollment
Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 1 month postpartum
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
Measured: 1-month postpartum
Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 3 months postpartum
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
Measured: At 3-months
Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 6 months postpartum
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
Measured: At 6-months postpartum.
The General Self-Efficacy Scale (SGSE)
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Measured: At study enrollment
Change in the General Self-Efficacy Scale (SGSE) at 1-month postpartum
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Measured: 1-month postpartum
Change in the General Self-Efficacy Scale (SGSE) at 3-months postpartum
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Measured: At 3-months postpartum
Change in the General Self-Efficacy Scale (SGSE) at 6-months postpartum
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Measured: At 6-months postpartum.
Edinburgh Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Measured: At study enrollment
Change in the Edinburgh Depression Scale at 1-month postpartum
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Measured: At 1-month postpartum
Change in the Edinburgh Depression Scale at 3-months postpartum
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Measured: At 3-months postpartum.
Change in Edinburgh Depression Scale at 6-months postpartum
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Measured: At 6-months postpartum.
Patient Health Questionnaire (PHQ)-9
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Measured: At study enrollment
Change in Patient Health Questionnaire at 1-month postpartum (PHQ)-9
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Measured: At 1-month postpartum
Change in Patient Health Questionnaire at 3-months postpartum (PHQ)-9
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Measured: At 3-months postpartum.
Change in Patient Health Questionnaire at 6-months postpartum (PHQ)-9
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Measured: At 6-months postpartum.
Generalized Anxiety Disorder (GAD)-7
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
Measured: At study enrollment
Change in Generalized Anxiety Disorder (GAD)-7 at 1-month postpartum
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
Measured: At 1-month postpartum
Change in Generalized Anxiety Disorder (GAD)-7 at 3-months postpartum
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
Measured: At 3-months postpartum.
Change in Generalized Anxiety Disorder (GAD)-7 at 6 months postpartum
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
Measured: At 6-months postpartum.
Multi-Dimensional Scale of Perceived Social Support (MSPSS)
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
Measured: At study enrollment
Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 1-month postpartum
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
Measured: At 1-month postpartum
Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 3-months postpartum
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
Measured: At 3-months postpartum.
Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 6-months postpartum
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
Measured: At 6-months postpartum.
Social Support Questionnaire (SSQ)- Short Form
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Measured: At study enrollment
Change in Social Support Questionnaire (SSQ)- Short Form at 1-month postpartum
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Measured: At 1-month postpartum
Change in Social Support Questionnaire (SSQ)- Short Form at 3-months postpartum
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Measured: At 3-months postpartum.
Change in Social Support Questionnaire (SSQ)- Short Form at 6-months postpartum
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Measured: At 6-months postpartum.
Birth Companion Support Questionnaire
The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).
Measured: 1-month postpartum
Change in Birth Companion Support Questionnaire at 3-months postpartum
The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).
Measured: At 3-months
Change in Birth Companion Support Questionnaire at 6-months postpartum
The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).
Measured: At 6-months postpartum
The Perceived Wellness Scale
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
Measured: At study enrollment
Change in the Perceived Wellness Scale at 1-month postpartum
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
Measured: 1-month postpartum
Change in the Perceived Wellness Scale at 3-months postpartum
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
Measured: 3-months postpartum
Change in the Perceived Wellness Scale at 6-months postpartum
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
Measured: At 6-months postpartum.
City Birth Trauma Scale City Birth Trauma Scale
The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).
Measured: At 1-month postpartum
Change in the City Birth Trauma Scale at 3-months postpartum City Birth Trauma Scale
The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).
Measured: At 3-months postpartum
Change in the City Birth Trauma Scale at 6-months postpartum City Birth Trauma Scale
The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).
Measured: At 6-months postpartum
Secondary outcomes (13)
Alcohol Use Disorders Identification Test (AUDIT) Alcohol Use Disorders Identification Test (AUDIT)
The Alcohol Use Disorders Identification Test(AUDIT) is a 10-item self-report measure that identifies alcohol consumption, drinking behaviors, and alcohol-related problems among adults. As described in a review by Reinert and Allen (2007): Over a broad range of diverse samples and settings the AUDIT has demonstrated a high degree of internal consistency. In a reliability generalization analysis of studies that appeared in 2000 or before, Shields and Caruso (2003) calculated a median reliability of 0.81, with a range of 0.59 to 0.91. Psychometric properties of the AUDIT, such as test-retest reliability and internal consistency, are high.
Measured: At study enrollment
Change in the Alcohol Use Disorders Identification Test (AUDIT) at 1-month postpartum Alcohol Use Disorders Identification Test (AUDIT)
The Alcohol Use Disorders Identification Test(AUDIT) is a 10-item self-report measure that identifies alcohol consumption, drinking behaviors, and alcohol-related problems among adults. As described in a review by Reinert and Allen (2007): Over a broad range of diverse samples and settings the AUDIT has demonstrated a high degree of internal consistency. In a reliability generalization analysis of studies that appeared in 2000 or before, Shields and Caruso (2003) calculated a median reliability of 0.81, with a range of 0.59 to 0.91. Psychometric properties of the AUDIT, such as test-retest reliability and internal consistency, are high.
Measured: At 1-month postpartum
Change in the Alcohol Use Disorders Identification Test (AUDIT) at 3-months postpartum Alcohol Use Disorders Identification Test (AUDIT)
The Alcohol Use Disorders Identification Test(AUDIT) is a 10-item self-report measure that identifies alcohol consumption, drinking behaviors, and alcohol-related problems among adults. As described in a review by Reinert and Allen (2007): Over a broad range of diverse samples and settings the AUDIT has demonstrated a high degree of internal consistency. In a reliability generalization analysis of studies that appeared in 2000 or before, Shields and Caruso (2003) calculated a median reliability of 0.81, with a range of 0.59 to 0.91. Psychometric properties of the AUDIT, such as test-retest reliability and internal consistency, are high.
Measured: 3-months postpartum
Change in the Alcohol Use Disorders Identification Test (AUDIT) at 6-months postpartum Alcohol Use Disorders Identification Test (AUDIT)
The Alcohol Use Disorders Identification Test(AUDIT) is a 10-item self-report measure that identifies alcohol consumption, drinking behaviors, and alcohol-related problems among adults. As described in a review by Reinert and Allen (2007): Over a broad range of diverse samples and settings the AUDIT has demonstrated a high degree of internal consistency. In a reliability generalization analysis of studies that appeared in 2000 or before, Shields and Caruso (2003) calculated a median reliability of 0.81, with a range of 0.59 to 0.91. Psychometric properties of the AUDIT, such as test-retest reliability and internal consistency, are high.
Measured: At 6-months postpartum
Drug Abuse Screening Test (DAST)
The Drug Abuse Screening Test (DAST) is a 10- item self-report form used to assess drug use with adults. The following evaluation of the scale is provided by Skinner (1982): The internal consistency reliability estimate was substantial at .92, and a factor analysis of item intercorrelations suggested an unidimensional scale. With respect to response style biases, the DAST was only moderately correlated with social desirability and denial. Concurrent validity was examined by correlating the DAST with background variables, frequency of drug use during the past 12 months, and indices of psychopathology.
Measured: At study enrollment
Change in the Drug Abuse Screening Test (DAST) at 1-month postpartum
The Drug Abuse Screening Test (DAST) is a 10- item self-report form used to assess drug use with adults. The following evaluation of the scale is provided by Skinner (1982): The internal consistency reliability estimate was substantial at .92, and a factor analysis of item intercorrelations suggested an unidimensional scale. With respect to response style biases, the DAST was only moderately correlated with social desirability and denial. Concurrent validity was examined by correlating the DAST with background variables, frequency of drug use during the past 12 months, and indices of psychopathology.
Measured: At 1-month postpartum
Change in the Drug Abuse Screening Test (DAST) at 3-months postpartum
The Drug Abuse Screening Test (DAST) is a 10- item self-report form used to assess drug use with adults. The following evaluation of the scale is provided by Skinner (1982): The internal consistency reliability estimate was substantial at .92, and a factor analysis of item intercorrelations suggested an unidimensional scale. With respect to response style biases, the DAST was only moderately correlated with social desirability and denial. Concurrent validity was examined by correlating the DAST with background variables, frequency of drug use during the past 12 months, and indices of psychopathology.
Measured: At 3-months postpartum
Change in the Drug Abuse Screening Test (DAST) at 6-months postpartum
The Drug Abuse Screening Test (DAST) is a 10- item self-report form used to assess drug use with adults. The following evaluation of the scale is provided by Skinner (1982): The internal consistency reliability estimate was substantial at .92, and a factor analysis of item intercorrelations suggested an unidimensional scale. With respect to response style biases, the DAST was only moderately correlated with social desirability and denial. Concurrent validity was examined by correlating the DAST with background variables, frequency of drug use during the past 12 months, and indices of psychopathology.
Measured: At 6-months postpartum.
CDC Health-Related Quality of Life (HRQOL)- 4 scale
The CDC Health-Related Quality of Life (HRQOL)-4 is a 4-item self-report measure of personal health and wellbeing. A large body of research indicates the HRQOL's construct and criterion validity (CDC, 2000) and high retest reliability (.75 or higher) (Andresen et al., 2003).
Measured: At study enrollment
Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 1-month postpartum
The CDC Health-Related Quality of Life (HRQOL)-4 is a 4-item self-report measure of personal health and wellbeing. A large body of research indicates the HRQOL's construct and criterion validity (CDC, 2000) and high retest reliability (.75 or higher) (Andresen et al., 2003).
Measured: At 1-month postpartum
Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 3-months postpartum
The CDC Health-Related Quality of Life (HRQOL)-4 is a 4-item self-report measure of personal health and wellbeing. A large body of research indicates the HRQOL's construct and criterion validity (CDC, 2000) and high retest reliability (.75 or higher) (Andresen et al., 2003).
Measured: At 3-months postpartum.
Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 6-months postpartum
The CDC Health-Related Quality of Life (HRQOL)-4 is a 4-item self-report measure of personal health and wellbeing. A large body of research indicates the HRQOL's construct and criterion validity (CDC, 2000) and high retest reliability (.75 or higher) (Andresen et al., 2003).
Measured: At 6-months postpartum
Pregnancy Risk Assessment Monitoring (PRAMS)
The core PRAMS questionnaire is a 52-item survey asking questions about behaviors and experiences during pregnancy, labor and the postpartum time period.
Measured: 1 time during the study period, at 1-month postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start26 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763537
- Sponsor's protocol ID
- 162-22
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of Doulas in Supporting People With PMADs
- ClinicalTrials.gov ID
- NCT05763537
- Acronym / sponsor ID
- 162-22
- Conditions
- Maternal Health, Pregnancy, Delivery, Obstetric, Self Efficacy, Social Support, Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.
Detailed description
Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention. A subsection of 20 participants who receive care from doulas in the PMAD training will also be eligible to participate in a qualitative interview at 6 months postpartum. The interview guide will be developed based on prior research with doulas, the PI's current research exploring doula-care in Montana, and feedback from the CAB. Example questions are expected to include: "What were your experiences working with a doula?" "What would have made your experience better?" and "What worked and what didn't work?"
Interviewers will all be graduate students who have completed research methods courses and will be trained by the PI, who has extensive experience in conducting qualitative research and in conducting qualitative interviews.
The following procedures will be followed:
- Once participants have indicated that they are interested in participating in the study, the PI will contact them to set up a time to discuss the study with them, and if they are interested and meet eligibility criteria, enroll them in the study. Participants will be randomly assigned to either receive standard care from a doula, the doula PMAD intervention, or perinatal care as usual.
- Before enrollment in the study, participants will be provided with a copy of the consent form, and the information on the consent form will be read to the participants.
- Once the participants have provided informed consent, they will be given the pre-test survey via REDCap and will take the survey again at 1 month postpartum and 3 months postpartum.
- All participants will be connected to a doula and receive either care as usual from a doula or a doula trained in the intervention by the PI and will engage in care with them throughout their pregnancy, during childbirth, and for 3 months postpartum. The exact components of the doula care provided will be developed in aim 2 based on the findings of study 1.
- Participants will be provided compensation (in the form of a gift card) after the completion of each survey (pre-test, 1 month postpartum, 3 and 6 months postpartum).
- At the completion of the study, participants will be thanked for their time and participation. For those who agreed to do member checks, participants will be re-contacted after analysis for member checks.
Participants who are randomized into the intervention arm of the study will also be randomly selected to participate in cross-sectional, semi-structured interviews.
Participant recruitment is described in the recruitment and retention plan. Participants will be interviewed about experience in the intervention.
The following steps will be followed:
- Once participants have indicated that they are interested in participating in the interview portion of the study, the PI will contact them to set up a time for an interview and about their preferred interview site. They will have the option to do a phone interview if they are not available for an in-person interview or if they are not comfortable with an in-person interview for privacy reasons. The first interview will take place before they begin care with their doula.
- Interview sessions will be scheduled at a pre-determined time at locations desired by the participants. If the interview takes place in person, Covid-19 protocols will be followed and include the completion of a Covid-19 symptom questionnaire by both the participant and the interviewer, the wearing of face masks during the interview, and social distancing.
- Before beginning the interview, participants will be provided with a copy of the consent form, and the information on the consent form will be read to the participants. This process is further described in the Protection of Human Subjects document.
- Once the participants have provided informed consent and provided consent to having the interview audio-recorded, the interviewer will begin recording the interview. A semi-structured interview guide will be used to guide the interview.
- Audio-recorded interviews will follow semi-structured interview guides and last 60-90 minutes.
- Following the interview, participants will be asked whether they are willing to be contacted to do a follow-up interview at 3 months postpartum.
- Participants will be provided their compensation.
- Participants will be thanked for their time and participation.
- For those who agreed to do a second and third interviews at 3 and 6 months postpartum, the same process will be followed to conduct their second interview.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Doula Care Plus the PMAD Intervention | Experimental | Behavioral: Standard Doula Care Plus PMAD InterventionParticipants in this arm will receive standard perinatal doula care provided by doulas trained in the DONA International doula training in addition to PMAD-specific care from their doulas. |
| Standard Doula Care | Active comparator | Behavioral: Standard Doula CareParticipants in this arm will receive standard perinatal doula care provided by doulas trained in the DONA International doula training. |
| Standard Maternal Care | No intervention | –In this arm participants will receive standard perinatal medical care and will not receive care from a doula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be over the age of 18
- Currently pregnant and between 13 and 26 gestational weeks at the time of enrollment
- Live in a HRSA-designated rural area of Montana
Key exclusion criteria (4 listed)
- They are under the age of 18
- Not currently pregnant
- Not between 13-26 gestational weeks at the time of enrollment
- If they do not live in a HRSA-designated rural are of Montana.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Doula Care Plus PMAD InterventionDoulas trained in the DONA training, and the PMAD-focused training will provide care to perinatal people. | Behavioural | Standard Doula Care Plus the PMAD Intervention |
| Standard Doula CareDoulas trained in the DONA training will provide care to perinatal people. | Behavioural | Standard Doula Care |
Primary outcome
The Childbirth Self-Efficacy Inventory (CBSEI)
Time frame: At study enrollment
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 1 month postpartum
Time frame: 1-month postpartum
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 3 months postpartum
Time frame: At 3-months
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 6 months postpartum
Time frame: At 6-months postpartum.
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
The General Self-Efficacy Scale (SGSE)
Time frame: At study enrollment
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Change in the General Self-Efficacy Scale (SGSE) at 1-month postpartum
Time frame: 1-month postpartum
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Change in the General Self-Efficacy Scale (SGSE) at 3-months postpartum
Time frame: At 3-months postpartum
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Change in the General Self-Efficacy Scale (SGSE) at 6-months postpartum
Time frame: At 6-months postpartum.
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Edinburgh Depression Scale
Time frame: At study enrollment
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Change in the Edinburgh Depression Scale at 1-month postpartum
Time frame: At 1-month postpartum
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Change in the Edinburgh Depression Scale at 3-months postpartum
Time frame: At 3-months postpartum.
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Change in Edinburgh Depression Scale at 6-months postpartum
Time frame: At 6-months postpartum.
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Patient Health Questionnaire (PHQ)-9
Time frame: At study enrollment
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Change in Patient Health Questionnaire at 1-month postpartum (PHQ)-9
Time frame: At 1-month postpartum
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Change in Patient Health Questionnaire at 3-months postpartum (PHQ)-9
Time frame: At 3-months postpartum.
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Change in Patient Health Questionnaire at 6-months postpartum (PHQ)-9
Time frame: At 6-months postpartum.
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Generalized Anxiety Disorder (GAD)-7
Time frame: At study enrollment
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
Change in Generalized Anxiety Disorder (GAD)-7 at 1-month postpartum
Time frame: At 1-month postpartum
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
Change in Generalized Anxiety Disorder (GAD)-7 at 3-months postpartum
Time frame: At 3-months postpartum.
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
Change in Generalized Anxiety Disorder (GAD)-7 at 6 months postpartum
Time frame: At 6-months postpartum.
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
Multi-Dimensional Scale of Perceived Social Support (MSPSS)
Time frame: At study enrollment
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 1-month postpartum
Time frame: At 1-month postpartum
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 3-months postpartum
Time frame: At 3-months postpartum.
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 6-months postpartum
Time frame: At 6-months postpartum.
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
Social Support Questionnaire (SSQ)- Short Form
Time frame: At study enrollment
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Change in Social Support Questionnaire (SSQ)- Short Form at 1-month postpartum
Time frame: At 1-month postpartum
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Change in Social Support Questionnaire (SSQ)- Short Form at 3-months postpartum
Time frame: At 3-months postpartum.
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Change in Social Support Questionnaire (SSQ)- Short Form at 6-months postpartum
Time frame: At 6-months postpartum.
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Birth Companion Support Questionnaire
Time frame: 1-month postpartum
The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).
Change in Birth Companion Support Questionnaire at 3-months postpartum
Time frame: At 3-months
The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).
Change in Birth Companion Support Questionnaire at 6-months postpartum
Time frame: At 6-months postpartum
The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).
The Perceived Wellness Scale
Time frame: At study enrollment
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
Change in the Perceived Wellness Scale at 1-month postpartum
Time frame: 1-month postpartum
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
Change in the Perceived Wellness Scale at 3-months postpartum
Time frame: 3-months postpartum
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
Change in the Perceived Wellness Scale at 6-months postpartum
Time frame: At 6-months postpartum.
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
City Birth Trauma Scale City Birth Trauma Scale
Time frame: At 1-month postpartum
The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).
Change in the City Birth Trauma Scale at 3-months postpartum City Birth Trauma Scale
Time frame: At 3-months postpartum
The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).
Change in the City Birth Trauma Scale at 6-months postpartum City Birth Trauma Scale
Time frame: At 6-months postpartum
The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).
13 secondary outcomes
Alcohol Use Disorders Identification Test (AUDIT) Alcohol Use Disorders Identification Test (AUDIT)
Time frame: At study enrollment
Change in the Alcohol Use Disorders Identification Test (AUDIT) at 1-month postpartum Alcohol Use Disorders Identification Test (AUDIT)
Time frame: At 1-month postpartum
Change in the Alcohol Use Disorders Identification Test (AUDIT) at 3-months postpartum Alcohol Use Disorders Identification Test (AUDIT)
Time frame: 3-months postpartum
Change in the Alcohol Use Disorders Identification Test (AUDIT) at 6-months postpartum Alcohol Use Disorders Identification Test (AUDIT)
Time frame: At 6-months postpartum
Drug Abuse Screening Test (DAST)
Time frame: At study enrollment
Change in the Drug Abuse Screening Test (DAST) at 1-month postpartum
Time frame: At 1-month postpartum
Change in the Drug Abuse Screening Test (DAST) at 3-months postpartum
Time frame: At 3-months postpartum
Change in the Drug Abuse Screening Test (DAST) at 6-months postpartum
Time frame: At 6-months postpartum.
CDC Health-Related Quality of Life (HRQOL)- 4 scale
Time frame: At study enrollment
Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 1-month postpartum
Time frame: At 1-month postpartum
Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 3-months postpartum
Time frame: At 3-months postpartum.
Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 6-months postpartum
Time frame: At 6-months postpartum
Pregnancy Risk Assessment Monitoring (PRAMS)
Time frame: 1 time during the study period, at 1-month postpartum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Doula Care Plus PMAD Intervention and Standard Doula Care in people with Maternal Health and Pregnancy, run by University of Montana at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica L Liddell, PhD (4357576780, jessica.liddell@mso.umt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Childbirth Self-Efficacy Inventory (CBSEI) (time frame: At study enrollment). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.