Perinatal DepressionNCT02979444
Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression
A study testing Mothers and Babies Groups in people with Perinatal Depression and PostPartum Depression, run by Northwestern University at 1 site in United States.
Trial summary
There is considerable evidence that most perinatal women at risk for postpartum depression do not engage in mental health services, even when referred by home visiting (HV) programs, primary care physicians, obstetricians, or gynecologists. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression, PostPartum Depression
- What is being tested?
- Mothers and Babies Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 874 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 13 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The investigators will enroll only pregnant women in this study, given that the Mothers and Babies Course is delivered prenatally as a postpartum depression prevention intervention. The investigators will offer participation to prenatal home visiting clients, ages 16 and older, knowing the client base for home visiting programs includes pregnant teens.
Who cannot join
- Women with high-risk medical and pregnancy conditions will be excluded since this may preclude women from regularly attending intervention sessions. The investigators will not exclude women based on race/ethnicity or based on demographic characteristics other than the ability to speak English or Spanish.
Trial locations and contacts
1 site in 1 country.
About this study
There is considerable evidence that most perinatal women at risk for postpartum depression do not engage in mental health services, even when referred by home visiting (HV) programs, primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be delivered via alternative settings-e.g., HV programs-are essential to prevent the onset of major depression and worsening of depressive symptoms among perinatal women. This Patient Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is more efficacious than usual care (i.e., home visiting without the MB enhancement). It will also examine if MB, when led by paraprofessional home visitors, is not inferior to MB delivered by mental health professionals. The results of this study will inform decision-making by HV programs regarding provision of MB to perinatal women at risk for developing major depression.
Read the detailed description
Study Aims:
Aim #1 is to conduct a superiority trial that compares the efficacy of MB delivered by paraprofessional home visitors versus usual care (i.e., home visiting without MB) on patient-reported outcomes, including depressive symptoms, quality of life, parenting practices, engagement in pleasant activities, and relationship with one's partner.
Aim #2 is to conduct a non-inferiority trial that compares the effectiveness of MB delivered by (a) mental health clinicians versus (b) paraprofessional home visitors.
Aim #3 is to evaluate whether effectiveness of the two versions of MB (clinician led vs. paraprofessional home visitor led) varies according to patient characteristics (e.g., race, ethnicity, first-time mother, and/or geographic type of home visiting (HV) program (i.e., urban vs. rural).
Aim #4 is to examine the feasibility and acceptability of MB delivered by paraprofessional home visitors and mental health clinicians.
Postpartum depression is a serious mental health disorder that poses significant health and mental health risks for mothers and their infants. Research suggests that prevalence rates of postpartum depression are higher among low-income women than among middle-or high-income women. There is also consistent evidence that low-income women are less likely to receive mental health services in the perinatal (i.e., pregnancy until child's first birthday) period than their more affluent counterparts due to a variety of factors including stigma related to mental health service use and lack of access to community-based mental health providers. Postpartum depression is a particularly serious problem for low-income women, as it has the potential to create two generations of suffering, for both mother and child. It is estimated that over 10% of low-income infants have a mother who has major depression and more than 50% have a mother with some depressive symptoms. Postpartum depression has negative consequences for maternal parenting practices. Compared with women not suffering from postpartum depression, depressed women tend to be less positive, less spontaneous, and less responsive with their infants. Postpartum depression has been linked to developmental delays among infants of depressed mothers, including social interaction difficulties, attachment insecurity, and cognitive impairments.
Home visiting (HV) programs that provide services to perinatal women are one of the largest avenues through which perinatal women come to the attention of service providers, making HV a unique and viable setting for delivering mental health services. Although professional HV models exist (e.g., Nurse-Family Partnership), most HV programs in the United States use paraprofessionals. Previously, study investigators have established the efficacy of a group-based intervention -the Mothers and Babies (MB) Course-in preventing the onset of postpartum depression and reducing depressive symptoms when led by mental health professionals. However, to date there are no interventions led by non-health or non-mental health professionals that have demonstrated efficacy in preventing the onset and worsening of postpartum depression among low-income women. This project attempts to fill this notable gap.
The investigators will conduct a cluster randomized trial in which HV clients receive either a) MB delivered by mental health professionals, b) MB delivered by paraprofessional home visitors, or c) usual home visiting services. This study design will allow the investigators to conduct a superiority trial that compares the efficacy of MB delivered by paraprofessional home visitors versus usual care. A superiority trial will allow the investigators to generate efficacy data on MB delivered by paraprofessional home visitors. The study design will also allow the investigators to conduct a non-inferiority trial that compares the effectiveness of MB delivered by mental health professionals versus paraprofessional home visitors. Should the investigators find that paraprofessional home visitors are not inferior to mental health professionals in delivering the intervention, HV programs throughout the United States will be able to implement the MB Course with paraprofessional home visitors-an approach that is considerably more efficient and cost-effective than employing mental health professionals.
This study was born out of community stakeholders' need and desire for a low-cost intervention that could prevent the onset and worsening of depression among low-income women enrolled in HV programs. Maternal depression is an enormous challenge facing HV programs. However, there is consistent evidence that low-income women exhibiting depressive symptoms-including women enrolled in HV programs-do not access mental health treatment in the community. Lack of available mental health professionals, stigma in seeking mental health services, and logistical challenges (e.g., childcare, transportation) are a few of the barriers faced by perinatal women seeking mental health services. For those clients who do access services, most perinatal women are likely to receive pharmacological treatments, despite the fact that the vast majority of perinatal women prefer non-pharmacologic interventions.
HV programs are ideal settings for delivering mental health care to perinatal women because their mission is not stigmatizing and HV programs tend to be trusted entities in the communities they serve. However, there is not yet an evidence-based intervention that can be delivered by paraprofessionals (such as home visitors), thereby limiting HV programs' capacity to meet the needs of their clients needing mental health services.
- Conditions
- Perinatal Depression, PostPartum Depression
- Being tested
- Mothers and Babies Groups
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mothers and Babies GroupsBehavioural
The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a "toolkit" of approaches they can use to improve their mood.
| Study group | Role | What they receive |
|---|---|---|
| Mothers and Babies Groups Home-Visitor | Experimental | Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Receives: Behavioral: Mothers and Babies Groups |
| Mothers and Babies Groups Clinician | Experimental | Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. Receives: Behavioral: Mothers and Babies Groups |
| Control | No intervention | Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16). The QIDS-SR16 was used to assess severity of depressive symptoms consistent with Diagnostic and Statistical Manual symptom criteria. Total scores range from 0-27; higher scores indicate greater symptomatology. The investigators anticipate a clinically meaningfully difference to be on the order of five points (as this is the difference in score on each severity level of depression) (Trivedi et al., 2004). For our non-inferiority analyses comparing MB led by home visitors vs. MB led by mental health clinicians, we will have >85% power to detect a difference difference in mean QIDS-16 scores of two points between the two active intervention arms.
Measured: Baseline and 12 and 24-week postpartum follow-up
Secondary outcomes (4)
The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum
Behavioral Activation will be measured using the Behavioral Activation Depression Scale (BADS). The BADS assesses behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation strategies. It examines changes in the following areas: activation, avoidance/ rumination, work/school impairment, and social impairment. The BADS consists of 25 items, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). The range of the scale is 0-64. For the total scale, higher scores represent increased activation. The BADS has demonstrated strong internal consistency, construct validity, and predictive validity (Kanter et al, 2007; Kanter et al., 2009).
Measured: Baseline and 12 and 24-week postpartum follow-ups
The Change in the Negative Mood Regulation Scale
Mood regulation will be measured using the 30-item Negative Mood Regulation Scale (NMRS) (Catanzaro \& Means, 1990). For each question, respondents use a 5-point scale to indicate what they believe they can do when they are disappointed or experiencing a negative mood. For our analyses, these items were averaged to create a mean NMRS score (range 1-5). Higher scores indicate a greater ability to regulate one's mood.
Measured: Baseline and 12 and 24-week postpartum follow-ups
The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum
Social support will be measured using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne \& Stewart, 1991). This brief self-administered survey includes an overall functional social support index, as well as four functional support subscales: affectionate, emotional/informational, tangible, and positive social interaction. The range is 1-5 with greater scores indicating more perceived social support.
Measured: Baseline and 12 and 24-week follow-ups
The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum
Decentering will be measured using the Experiences Questionnaire (EQ) (Fresco et al., 2007). The EQ is a 20 item self-report scale designed to measure decentering and rumination, which has demonstrated strong internal consistency in a number of studies examining effects of interventions that incorporate cognitive restructuring techniques. Response choices are on a 1-5 scale. For the purposes of our analyses, we created a mean EQ score (range 1-5), with higher scores indicating more decentering/rumination.
Measured: Baseline and 12 and 24-week follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startAug 2016
- Primary completion5 Aug 2019
- Study completion13 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 874 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darius Tandon, Northwestern University
- Investigators
- Darius Tandon, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979444
- Sponsor's protocol ID
- STU00203761
- Status last verified
- Sep 2020
- First submitted
- 29 Nov 2016
- Last updated
- 5 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Abrams LS, Dornig K, Curran L. Barriers to service use for postpartum depression symptoms among low-income ethnic minority mothers in the United States. Qual Health Res. 2009 Apr;19(4):535-51. doi: 10.1177/1049732309332794.
PubMed 19299758Catanzaro SJ, Mearns J. Measuring generalized expectancies for negative mood regulation: initial scale development and implications. J Pers Assess. 1990 Summer;54(3-4):546-63. doi: 10.1080/00223891.1990.9674019.
PubMed 2348341Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
PubMed 3651732Fresco DM, Moore MT, van Dulmen MH, Segal ZV, Ma SH, Teasdale JD, Williams JM. Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering. Behav Ther. 2007 Sep;38(3):234-46. doi: 10.1016/j.beth.2006.08.003. Epub 2007 Apr 24.
PubMed 17697849Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T, Gartlehner G, Brody S, Miller WC. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005 Feb;(119):1-8. doi: 10.1037/e439372005-001. No abstract available.
PubMed 15760246Grace SL, Evindar A, Stewart DE. The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Womens Ment Health. 2003 Nov;6(4):263-74. doi: 10.1007/s00737-003-0024-6.
PubMed 14628179Huybrechts KF, Palmsten K, Mogun H, Kowal M, Avorn J, Setoguchi-Iwata S, Hernandez-Diaz S. National trends in antidepressant medication treatment among publicly insured pregnant women. Gen Hosp Psychiatry. 2013 May-Jun;35(3):265-71. doi: 10.1016/j.genhosppsych.2012.12.010. Epub 2013 Jan 30.
PubMed 23374897Leis JA, Mendelson T, Perry DF, Tandon SD. Perceptions of mental health services among low-income, perinatal African-American women. Womens Health Issues. 2011 Jul-Aug;21(4):314-9. doi: 10.1016/j.whi.2011.03.005.
PubMed 21712144Meijer JL, Beijers C, van Pampus MG, Verbeek T, Stolk RP, Milgrom J, Bockting CL, Burger H. Predictive accuracy of Edinburgh postnatal depression scale assessment during pregnancy for the risk of developing postpartum depressive symptoms: a prospective cohort study. BJOG. 2014 Dec;121(13):1604-10. doi: 10.1111/1471-0528.12759. Epub 2014 Apr 7.
PubMed 24703235Rich-Edwards JW, Kleinman K, Abrams A, Harlow BL, McLaughlin TJ, Joffe H, Gillman MW. Sociodemographic predictors of antenatal and postpartum depressive symptoms among women in a medical group practice. J Epidemiol Community Health. 2006 Mar;60(3):221-7. doi: 10.1136/jech.2005.039370.
PubMed 16476752Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
PubMed 2035047Sohr-Preston SL, Scaramella LV. Implications of timing of maternal depressive symptoms for early cognitive and language development. Clin Child Fam Psychol Rev. 2006 Mar;9(1):65-83. doi: 10.1007/s10567-006-0004-2.
PubMed 16817009Trivedi MH, Rush AJ, Ibrahim HM, Carmody TJ, Biggs MM, Suppes T, Crismon ML, Shores-Wilson K, Toprac MG, Dennehy EB, Witte B, Kashner TM. The Inventory of Depressive Symptomatology, Clinician Rating (IDS-C) and Self-Report (IDS-SR), and the Quick Inventory of Depressive Symptomatology, Clinician Rating (QIDS-C) and Self-Report (QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation. Psychol Med. 2004 Jan;34(1):73-82. doi: 10.1017/s0033291703001107.
PubMed 14971628van Doesum KTM, Hosman CMH, Riksen-Walraven JM, Hoefnagels C. Correlates of depressed mothers' sensitivity toward their infants: the role of maternal, child, and contextual characteristics. J Am Acad Child Adolesc Psychiatry. 2007 Jun;46(6):747-756. doi: 10.1097/CHI.0b013e318040b272.
PubMed 17513987Zittel-Palamara K, Rockmaker JR, Schwabel KM, Weinstein WL, Thompson SJ. Desired assistance versus care received for postpartum depression: access to care differences by race. Arch Womens Ment Health. 2008 Jun;11(2):81-92. doi: 10.1007/s00737-008-0001-1. Epub 2008 May 8.
PubMed 18463943
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression
- ClinicalTrials.gov ID
- NCT02979444
- Acronym / sponsor ID
- STU00203761
- Conditions
- Perinatal Depression, PostPartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 874 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Posted 13 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is considerable evidence that most perinatal women at risk for postpartum depression do not engage in mental health services, even when referred by home visiting (HV) programs, primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be delivered via alternative settings-e.g., HV programs-are essential to prevent the onset of major depression and worsening of depressive symptoms among perinatal women. This Patient Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is more efficacious than usual care (i.e., home visiting without the MB enhancement). It will also examine if MB, when led by paraprofessional home visitors, is not inferior to MB delivered by mental health professionals. The results of this study will inform decision-making by HV programs regarding provision of MB to perinatal women at risk for developing major depression.
Detailed description
Study Aims:
Aim #1 is to conduct a superiority trial that compares the efficacy of MB delivered by paraprofessional home visitors versus usual care (i.e., home visiting without MB) on patient-reported outcomes, including depressive symptoms, quality of life, parenting practices, engagement in pleasant activities, and relationship with one's partner.
Aim #2 is to conduct a non-inferiority trial that compares the effectiveness of MB delivered by (a) mental health clinicians versus (b) paraprofessional home visitors.
Aim #3 is to evaluate whether effectiveness of the two versions of MB (clinician led vs. paraprofessional home visitor led) varies according to patient characteristics (e.g., race, ethnicity, first-time mother, and/or geographic type of home visiting (HV) program (i.e., urban vs. rural).
Aim #4 is to examine the feasibility and acceptability of MB delivered by paraprofessional home visitors and mental health clinicians.
Postpartum depression is a serious mental health disorder that poses significant health and mental health risks for mothers and their infants. Research suggests that prevalence rates of postpartum depression are higher among low-income women than among middle-or high-income women. There is also consistent evidence that low-income women are less likely to receive mental health services in the perinatal (i.e., pregnancy until child's first birthday) period than their more affluent counterparts due to a variety of factors including stigma related to mental health service use and lack of access to community-based mental health providers. Postpartum depression is a particularly serious problem for low-income women, as it has the potential to create two generations of suffering, for both mother and child. It is estimated that over 10% of low-income infants have a mother who has major depression and more than 50% have a mother with some depressive symptoms. Postpartum depression has negative consequences for maternal parenting practices. Compared with women not suffering from postpartum depression, depressed women tend to be less positive, less spontaneous, and less responsive with their infants. Postpartum depression has been linked to developmental delays among infants of depressed mothers, including social interaction difficulties, attachment insecurity, and cognitive impairments.
Home visiting (HV) programs that provide services to perinatal women are one of the largest avenues through which perinatal women come to the attention of service providers, making HV a unique and viable setting for delivering mental health services. Although professional HV models exist (e.g., Nurse-Family Partnership), most HV programs in the United States use paraprofessionals. Previously, study investigators have established the efficacy of a group-based intervention -the Mothers and Babies (MB) Course-in preventing the onset of postpartum depression and reducing depressive symptoms when led by mental health professionals. However, to date there are no interventions led by non-health or non-mental health professionals that have demonstrated efficacy in preventing the onset and worsening of postpartum depression among low-income women. This project attempts to fill this notable gap.
The investigators will conduct a cluster randomized trial in which HV clients receive either a) MB delivered by mental health professionals, b) MB delivered by paraprofessional home visitors, or c) usual home visiting services. This study design will allow the investigators to conduct a superiority trial that compares the efficacy of MB delivered by paraprofessional home visitors versus usual care. A superiority trial will allow the investigators to generate efficacy data on MB delivered by paraprofessional home visitors. The study design will also allow the investigators to conduct a non-inferiority trial that compares the effectiveness of MB delivered by mental health professionals versus paraprofessional home visitors. Should the investigators find that paraprofessional home visitors are not inferior to mental health professionals in delivering the intervention, HV programs throughout the United States will be able to implement the MB Course with paraprofessional home visitors-an approach that is considerably more efficient and cost-effective than employing mental health professionals.
This study was born out of community stakeholders' need and desire for a low-cost intervention that could prevent the onset and worsening of depression among low-income women enrolled in HV programs. Maternal depression is an enormous challenge facing HV programs. However, there is consistent evidence that low-income women exhibiting depressive symptoms-including women enrolled in HV programs-do not access mental health treatment in the community. Lack of available mental health professionals, stigma in seeking mental health services, and logistical challenges (e.g., childcare, transportation) are a few of the barriers faced by perinatal women seeking mental health services. For those clients who do access services, most perinatal women are likely to receive pharmacological treatments, despite the fact that the vast majority of perinatal women prefer non-pharmacologic interventions.
HV programs are ideal settings for delivering mental health care to perinatal women because their mission is not stigmatizing and HV programs tend to be trusted entities in the communities they serve. However, there is not yet an evidence-based intervention that can be delivered by paraprofessionals (such as home visitors), thereby limiting HV programs' capacity to meet the needs of their clients needing mental health services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mothers and Babies Groups Home-Visitor | Experimental | Behavioral: Mothers and Babies GroupsWomen who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. |
| Mothers and Babies Groups Clinician | Experimental | Behavioral: Mothers and Babies GroupsWomen who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum. |
| Control | No intervention | –Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The investigators will enroll only pregnant women in this study, given that the Mothers and Babies Course is delivered prenatally as a postpartum depression prevention intervention. The investigators will offer participation to prenatal home visiting clients, ages 16 and older, knowing the client base for home visiting programs includes pregnant teens.
Key exclusion criteria (1 listed)
- Women with high-risk medical and pregnancy conditions will be excluded since this may preclude women from regularly attending intervention sessions. The investigators will not exclude women based on race/ethnicity or based on demographic characteristics other than the ability to speak English or Spanish.
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 |
|---|---|---|
| Mothers and Babies GroupsThe Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a "toolkit" of approaches they can use to improve their mood. | Behavioural | Mothers and Babies Groups Clinician, Mothers and Babies Groups Home-Visitor |
Primary outcome
The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum
Time frame: Baseline and 12 and 24-week postpartum follow-up
Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16). The QIDS-SR16 was used to assess severity of depressive symptoms consistent with Diagnostic and Statistical Manual symptom criteria. Total scores range from 0-27; higher scores indicate greater symptomatology. The investigators anticipate a clinically meaningfully difference to be on the order of five points (as this is the difference in score on each severity level of depression) (Trivedi et al., 2004). For our non-inferiority analyses comparing MB led by home visitors vs. MB led by mental health clinicians, we will have >85% power to detect a difference difference in mean QIDS-16 scores of two points between the two active intervention arms.
4 secondary outcomes
The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum
Time frame: Baseline and 12 and 24-week postpartum follow-ups
The Change in the Negative Mood Regulation Scale
Time frame: Baseline and 12 and 24-week postpartum follow-ups
The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum
Time frame: Baseline and 12 and 24-week follow-ups
The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum
Time frame: Baseline and 12 and 24-week follow-ups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19299758Abrams LS, Dornig K, Curran L. Barriers to service use for postpartum depression symptoms among low-income ethnic minority mothers in the United States. Qual Health Res. 2009 Apr;19(4):535-51. doi: 10.1177/1049732309332794.
- Background: PubMed 2348341Catanzaro SJ, Mearns J. Measuring generalized expectancies for negative mood regulation: initial scale development and implications. J Pers Assess. 1990 Summer;54(3-4):546-63. doi: 10.1080/00223891.1990.9674019.
- Background: PubMed 3651732Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Background: PubMed 17697849Fresco DM, Moore MT, van Dulmen MH, Segal ZV, Ma SH, Teasdale JD, Williams JM. Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering. Behav Ther. 2007 Sep;38(3):234-46. doi: 10.1016/j.beth.2006.08.003. Epub 2007 Apr 24.
- Background: PubMed 15760246Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T, Gartlehner G, Brody S, Miller WC. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005 Feb;(119):1-8. doi: 10.1037/e439372005-001. No abstract available.
- Background: PubMed 14628179Grace SL, Evindar A, Stewart DE. The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Womens Ment Health. 2003 Nov;6(4):263-74. doi: 10.1007/s00737-003-0024-6.
- Background: PubMed 23374897Huybrechts KF, Palmsten K, Mogun H, Kowal M, Avorn J, Setoguchi-Iwata S, Hernandez-Diaz S. National trends in antidepressant medication treatment among publicly insured pregnant women. Gen Hosp Psychiatry. 2013 May-Jun;35(3):265-71. doi: 10.1016/j.genhosppsych.2012.12.010. Epub 2013 Jan 30.
- Background: PubMed 21712144Leis JA, Mendelson T, Perry DF, Tandon SD. Perceptions of mental health services among low-income, perinatal African-American women. Womens Health Issues. 2011 Jul-Aug;21(4):314-9. doi: 10.1016/j.whi.2011.03.005.
- Background: PubMed 24703235Meijer JL, Beijers C, van Pampus MG, Verbeek T, Stolk RP, Milgrom J, Bockting CL, Burger H. Predictive accuracy of Edinburgh postnatal depression scale assessment during pregnancy for the risk of developing postpartum depressive symptoms: a prospective cohort study. BJOG. 2014 Dec;121(13):1604-10. doi: 10.1111/1471-0528.12759. Epub 2014 Apr 7.
- Background: PubMed 16476752Rich-Edwards JW, Kleinman K, Abrams A, Harlow BL, McLaughlin TJ, Joffe H, Gillman MW. Sociodemographic predictors of antenatal and postpartum depressive symptoms among women in a medical group practice. J Epidemiol Community Health. 2006 Mar;60(3):221-7. doi: 10.1136/jech.2005.039370.
- Background: PubMed 2035047Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
- Background: PubMed 16817009Sohr-Preston SL, Scaramella LV. Implications of timing of maternal depressive symptoms for early cognitive and language development. Clin Child Fam Psychol Rev. 2006 Mar;9(1):65-83. doi: 10.1007/s10567-006-0004-2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Darius Tandon, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mothers and Babies Groups in people with Perinatal Depression and PostPartum Depression, run by Northwestern University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum (time frame: Baseline and 12 and 24-week postpartum follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02979444, which also lists 23 linked publications.
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 5 Oct 2020.