Maternal Psychological DistressNCT05718479
Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity
A study testing Trauma Informed Prenatal Intervention (TPI) and Prenatal Education Topics in people with Maternal Psychological Distress and Perinatal Depression, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention (TPI) in pregnant Black women with childhood adversity. 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 Psychological Distress, Perinatal Depression, Self-Regulation, Emotion
- What is being tested?
- Trauma Informed Prenatal Intervention (TPI) and Prenatal Education Topics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- receiving prenatal care at University of Illinois Health \& Hospital System
- age >/= 18 years
- English-speaking
- 10-24 weeks gestation
- able to attend four sessions
- owner of a smart phone and access to internet
- Exclusion Criteria: inability to reliably or safely participate in the study due to self-reported serious or persistent mental health disorder (e.g., schizophrenia or bipolar disorder), which could also interfere with study adherence.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Health & Hospital System
Chicago, Illinois, 60608
About this study
Official title: Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity: A Pilot Randomized Controlled Trial of Motivational Interviewing and Mental Wellness Skills
The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention (TPI) in pregnant Black women with childhood adversity. TPI participants will receive four weekly individual virtual sessions of motivational interviewing to promote self-efficacy and mental wellness skills to enhance self-awareness and self-regulation. TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities.
- With the assistance of a trained facilitator, participants will be guided to identify a specific goal related to the behavior they want to change.
- Behavior change goals will be individualized to create a change plan that reinforces resilience-based coping, accountability, and self-care rewards.
- Participants will learn to apply mental wellness skills to enhance regulation and to facilitate awareness of internal cues related to desire, motivation, and individual responses to stress.
Researchers will compare usual prenatal care plus TPI versus usual prenatal care plus prenatal education to see if TPI reduces psychological (e.g., depression, anxiety, and perceived stress), and socio-emotional (e.g., mood, resilience, social support), and prenatal health behaviors.
Read the detailed description
The goal of this research to reduce the impact of maternal adverse childhood experiences (ACEs) on perinatal mental and psychosocial health by providing the necessary tools for the development of healthy coping practices. The purpose of this proposal is to conduct Phase II preliminary testing of an individually randomized pilot trial (N=40) examining feasibility, acceptability, and compare initial estimates of the effects of the primary outcome of depression and secondary outcomes of psychological (e.g., stress and anxiety) and socio-emotional (e.g., mood, resilience, social support) functioning and prenatal health behaviors of those allocated to either a trauma-informed prenatal intervention (TPI) (n=15) or the control group, e.g., prenatal education arm, (n=15). Forty adult, pregnant women receiving prenatal care at one large Federally Qualified Health Center will be enrolled between 10-24 weeks gestation. TPI participants will receive four weekly (30-60 minute) individual online sessions of motivational interviewing to facilitate behavior change and mental wellness skills to promote self-regulation. Control group participants will receive four weekly (30-60 minutes) individual online sessions of prenatal education. Patient-reported outcome measures will be interview-administered at baseline, 4- and 12-weeks post-randomization, and 6-weeks postpartum. A trauma-informed approach within prenatal care services may help reduce maternal distress and its consequences, and, subsequently, lessen the risk for the negative impact of ACEs on maternal and child health. Findings from this study will inform a larger efficacy trial of TPI to improve perinatal mental health among pregnant women.
- Being tested
- Trauma Informed Prenatal Intervention (TPI), Prenatal Education Topics
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Informed Prenatal Intervention (TPI)Behavioural
TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities. In the experimental group, a research staff member will meet with participants and help them to identify a health behavior they want to change, explore the pros and cons of making a change, create a behavior change plan, and learn several mindfulness meditation techniques. The facilitator will check-in with the participants about their behavior change plan in the subsequent sessions regarding progress made, barriers encountered, and changes in the plan and/or goal going forward. Participants will be instructed to implement an at-home mental wellness skills and provided with a tracking log to report the frequency and dose of daily/weekly practice.
Prenatal Education TopicsOther
In the control group, a research staff member will provide participants with four different weekly prenatal education topics, including information on prenatal care, labor and delivery, postpartum care, and newborn care.
| Study group | Role | What they receive |
|---|---|---|
| Trauma Informed Prenatal Intervention (TPI) | Experimental | The experimental arm consists of four weekly, individual (30-60 minute) sessions via Zoom with a trained behavioral health scientist and therapist facilitating motivational interviewing focused on behavior change and mental wellness skills. Receives: Behavioral: Trauma Informed Prenatal Intervention (TPI) |
| Prenatal Education Topics | Active comparator | The active comparator arm consists of four weekly, individual (30-45 minute) sessions via Zoom with a research staff member delivering prenatal education topics consisting of lecture (power point slides) and video. Receives: Other: Prenatal Education Topics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Edinburgh Postnatal Depression Scale at 2-months post-intervention
The Edinburgh Postnatal Depression Scale (range: 0-30) is a 10-item scale is a pregnancy and/or postpartum depression screen that assesses different emotions in the past seven days in which a higher score indicates a worse outcome.
Measured: 6-weeks postnatal
Secondary outcomes (7)
Change in Generalized Anxiety Disorder Scale at 2-months post-intervention
Generalized Anxiety Disorder Scale (range: 0-21) is a 7-item scale that assesses the frequency of excessive, uncontrollable worry in the past two-weeks in which a higher score indicates a worse outcome regarding life events or activities in which a higher score signifies a worse outcome.
Measured: 6-weeks postnatal
Change in Perceived Stress Scale at 2-months post-intervention
The Perceived Stress Scale (range: 0-40) is a 10-item scale that assesses the frequency of stressful thoughts and feelings in the last one month in which a higher score indicates a worse outcome.
Measured: 6-weeks postnatal
Change in Behavioral Activation Scale at 2-months post-intervention
The Behavioral Activation Scale (range: 0-54) is a 9-item scale that assesses avoidance or engagement in goal-directed activity and pleasant behaviors during the past one week in which a higher score indicates a better outcome.
Measured: 6-weeks postnatal
Negative Mood Regulation Short Form Scale at 2-months post-intervention
The Negative Mood Regulation Scale (range: 15-75) is a 15-item scale that assesses the capacity for calming and soothing emotions when one is upset in which a higher score indicates a better outcome.
Measured: 6-weeks postnatal
Connor Davidson Resilience Scale at 2-months post-intervention
The 10-item CD-RS assesses resilience over the last month. Responses are scored on a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all the time), with high scores representing greater ability to bounce back from adversity.
Measured: 6-weeks postpartum
Prenatal Health Behaviors at 2-months post-intervention
The Prenatal Health Behaviors Scale (range: 0-96) is a 24-item scale that assesses the frequency of the use of prenatal health behaviors, including smoking, alcohol, drugs, food, vitamins, physical activity, sleep, etc in which a higher score signifies a worse outcome.
Measured: 6-weeks postnatal
Multidimensional Scale of Perceived Social Support at 2-months post-intervention
The 12-item MSPSS assesses social support from family, friends, and a significant other. Responses are scored on a 7-point Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree), with high scores representing greater perceived social support.
Measured: 6-weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start14 Feb 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maternal Psychological DistressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention consists of four weekly individual sessions. In Step One, participants identify ways of coping with stress and create a behavior change plan with measurable goals. An initial 1-hour semi-structured interview provides an opportunity to self-assess motivation to change a health behavior. Step Two facilitates a behavior plan assisting participants to identify a measurable goal, barriers to achieving their goal, strategies to mitigate triggers, social supports, and progress rewards. Sessions 2-4 include a 10-minute check-in to assess the status of targeted behaviors, troubleshoot potential barriers, modify the plan, and reinforce progress followed up with 20-minutes of practicing mindfulness. In Step Three, participants will learn and practice mental wellness skills (e.g., tracking, resourcing, grounding, gesturing), which can be applied to changing a behavior.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Ellen Goldstein, University of Illinois at Chicago
- Investigators
- Ellen Goldstein, PhD, MFT, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718479
- Sponsor's protocol ID
- 2022-1175
- Other IDs
- U54MD012523
- Status last verified
- Mar 2025
- First submitted
- 1 Dec 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goldstein E, Keita M, Koomson C, Tintle N, Adlam K, Farah E, Koenig MD. A Pilot Randomized Controlled Trial of a Multimodal Wellness Intervention for Perinatal Mental Health. J Midwifery Womens Health. 2025 May-Jun;70(3):442-451. doi: 10.1111/jmwh.13754. Epub 2025 Apr 10.
PubMed 40207735Itani MS, Shankar M, Goldstein E. Exploring trauma-informed prenatal care preferences through diverse pregnant voices. BMC Health Serv Res. 2025 Mar 27;25(1):452. doi: 10.1186/s12913-025-12519-w.
PubMed 40148939
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity: A Pilot Randomized Controlled Trial of Motivational Interviewing and Mental Wellness Skills
- ClinicalTrials.gov ID
- NCT05718479
- Acronym / sponsor ID
- 2022-1175
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 8 Feb 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.
The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention (TPI) in pregnant Black women with childhood adversity. TPI participants will receive four weekly individual virtual sessions of motivational interviewing to promote self-efficacy and mental wellness skills to enhance self-awareness and self-regulation. TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities.
- With the assistance of a trained facilitator, participants will be guided to identify a specific goal related to the behavior they want to change.
- Behavior change goals will be individualized to create a change plan that reinforces resilience-based coping, accountability, and self-care rewards.
- Participants will learn to apply mental wellness skills to enhance regulation and to facilitate awareness of internal cues related to desire, motivation, and individual responses to stress.
Researchers will compare usual prenatal care plus TPI versus usual prenatal care plus prenatal education to see if TPI reduces psychological (e.g., depression, anxiety, and perceived stress), and socio-emotional (e.g., mood, resilience, social support), and prenatal health behaviors.
Detailed description
The goal of this research to reduce the impact of maternal adverse childhood experiences (ACEs) on perinatal mental and psychosocial health by providing the necessary tools for the development of healthy coping practices. The purpose of this proposal is to conduct Phase II preliminary testing of an individually randomized pilot trial (N=40) examining feasibility, acceptability, and compare initial estimates of the effects of the primary outcome of depression and secondary outcomes of psychological (e.g., stress and anxiety) and socio-emotional (e.g., mood, resilience, social support) functioning and prenatal health behaviors of those allocated to either a trauma-informed prenatal intervention (TPI) (n=15) or the control group, e.g., prenatal education arm, (n=15). Forty adult, pregnant women receiving prenatal care at one large Federally Qualified Health Center will be enrolled between 10-24 weeks gestation. TPI participants will receive four weekly (30-60 minute) individual online sessions of motivational interviewing to facilitate behavior change and mental wellness skills to promote self-regulation. Control group participants will receive four weekly (30-60 minutes) individual online sessions of prenatal education. Patient-reported outcome measures will be interview-administered at baseline, 4- and 12-weeks post-randomization, and 6-weeks postpartum. A trauma-informed approach within prenatal care services may help reduce maternal distress and its consequences, and, subsequently, lessen the risk for the negative impact of ACEs on maternal and child health. Findings from this study will inform a larger efficacy trial of TPI to improve perinatal mental health among pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention consists of four weekly individual sessions. In Step One, participants identify ways of coping with stress and create a behavior change plan with measurable goals. An initial 1-hour semi-structured interview provides an opportunity to self-assess motivation to change a health behavior. Step Two facilitates a behavior plan assisting participants to identify a measurable goal, barriers to achieving their goal, strategies to mitigate triggers, social supports, and progress rewards. Sessions 2-4 include a 10-minute check-in to assess the status of targeted behaviors, troubleshoot potential barriers, modify the plan, and reinforce progress followed up with 20-minutes of practicing mindfulness. In Step Three, participants will learn and practice mental wellness skills (e.g., tracking, resourcing, grounding, gesturing), which can be applied to changing a behavior.
| Arm | Type | Receives |
|---|---|---|
| Trauma Informed Prenatal Intervention (TPI) | Experimental | Behavioral: Trauma Informed Prenatal Intervention (TPI)The experimental arm consists of four weekly, individual (30-60 minute) sessions via Zoom with a trained behavioral health scientist and therapist facilitating motivational interviewing focused on behavior change and mental wellness skills. |
| Prenatal Education Topics | Active comparator | Other: Prenatal Education TopicsThe active comparator arm consists of four weekly, individual (30-45 minute) sessions via Zoom with a research staff member delivering prenatal education topics consisting of lecture (power point slides) and video. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- receiving prenatal care at University of Illinois Health \& Hospital System
- age >/= 18 years
- English-speaking
- 10-24 weeks gestation
- able to attend four sessions
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Trauma Informed Prenatal Intervention (TPI)TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities. In the experimental group, a research staff member will meet with participants and help them to identify a health behavior they want to change, explore the pros and cons of making a change, create a behavior change plan, and learn several mindfulness meditation techniques. The facilitator will check-in with the participants about their behavior change plan in the subsequent sessions regarding progress made, barriers encountered, and changes in the plan and/or goal going forward. Participants will be instructed to implement an at-home mental wellness skills and provided with a tracking log to report the frequency and dose of daily/weekly practice. | Behavioural | Trauma Informed Prenatal Intervention (TPI) |
| Prenatal Education TopicsIn the control group, a research staff member will provide participants with four different weekly prenatal education topics, including information on prenatal care, labor and delivery, postpartum care, and newborn care. | Other | Prenatal Education Topics |
Primary outcome
Change in Edinburgh Postnatal Depression Scale at 2-months post-intervention
Time frame: 6-weeks postnatal
The Edinburgh Postnatal Depression Scale (range: 0-30) is a 10-item scale is a pregnancy and/or postpartum depression screen that assesses different emotions in the past seven days in which a higher score indicates a worse outcome.
7 secondary outcomes
Change in Generalized Anxiety Disorder Scale at 2-months post-intervention
Time frame: 6-weeks postnatal
Change in Perceived Stress Scale at 2-months post-intervention
Time frame: 6-weeks postnatal
Change in Behavioral Activation Scale at 2-months post-intervention
Time frame: 6-weeks postnatal
Negative Mood Regulation Short Form Scale at 2-months post-intervention
Time frame: 6-weeks postnatal
Connor Davidson Resilience Scale at 2-months post-intervention
Time frame: 6-weeks postpartum
Prenatal Health Behaviors at 2-months post-intervention
Time frame: 6-weeks postnatal
Multidimensional Scale of Perceived Social Support at 2-months post-intervention
Time frame: 6-weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 40207735Goldstein E, Keita M, Koomson C, Tintle N, Adlam K, Farah E, Koenig MD. A Pilot Randomized Controlled Trial of a Multimodal Wellness Intervention for Perinatal Mental Health. J Midwifery Womens Health. 2025 May-Jun;70(3):442-451. doi: 10.1111/jmwh.13754. Epub 2025 Apr 10.
- Derived from this study: PubMed 40148939Itani MS, Shankar M, Goldstein E. Exploring trauma-informed prenatal care preferences through diverse pregnant voices. BMC Health Serv Res. 2025 Mar 27;25(1):452. doi: 10.1186/s12913-025-12519-w.
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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.
Ellen Goldstein, PhD, MFT principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Informed Prenatal Intervention (TPI) and Prenatal Education Topics in people with Maternal Psychological Distress and Perinatal Depression, run by University of Illinois at Chicago 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 7 inclusion and 0 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 20 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Edinburgh Postnatal Depression Scale at 2-months post-intervention (time frame: 6-weeks postnatal). 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 NCT05718479, which also lists 2 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 20 Mar 2025.