Postpartum DepressionNCT04068662
Intervention for IPV-exposed Pregnant Women
A study testing Pregnant Moms' Empowerment Program and Nondirective Support Group in people with Postpartum Depression and Posttraumatic Stress Disorder, run by University of Notre Dame at 2 sites in United States.
Trial summary
The overarching goal of the proposed project is to evaluate a randomized clinical trial of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal mental health, re-victimization, parenting sensitivity, and infant development. Read more about this study
- Who is it for?
- Ages 3 months to 55 years, women only
- Conditions the study is for
- Postpartum Depression, Posttraumatic Stress Disorder, Infant Behavior
- What is being tested?
- Pregnant Moms' Empowerment Program and Nondirective Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jul 2019to 18 Nov 2025
- 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 3 months to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- currently pregnant (primi or multiparous)
- experienced intimate partner violence within the past year
- English speaking
- age 16 or older
- between 10-30 weeks pregnant
Who cannot join
- fails to meet inclusion criteria
- unavailable or unwilling to participate in core study components, including groups
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Memphis
Memphis, Tennessee, 38152
University of Notre Dame
Notre Dame, Indiana, 46556
About this study
Official title: Intervening During the Prenatal Period With Women Exposed to Intimate Partner Violence to Improve Maternal Functioning and Infant Adjustment
The overarching goal of the proposed project is to evaluate a randomized clinical trial of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal mental health, re-victimization, parenting sensitivity, and infant development. The project also seeks to examine theoretically-grounded mechanisms of change, including social support and empowerment. Women participating in the study will receive either the PMEP or participate in a contact-equivalent active control group during pregnancy, and will be interviewed at baseline, post-intervention and with their infants at 3 months and 1 year old. The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site - Memphis, Tennessee (n=115) and South Bend, Indiana (n=115). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the Pregnant Moms' Empowerment Program. The expected duration of the study for each participant will be approximately 1.5 years, with some variation due to women enrolling at different points in their pregnancy.
The primary objective of the proposed project is to determine if the Pregnant Moms' Empowerment Program has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development compared to women's participation in a contact-equivalent active control group. This objective will be evaluated using a multi-site randomized clinical trial design. Participants (N = 230) will be equally randomized into study arms. Eligible women will include those who are: 1) currently pregnant (primi or multiparous) and between 10 and 30 weeks gestation, 2) experienced IPV within the past year, 3) English speaking and 4) age 16 or older.
The study will include 9 total visits: 4 assessments and 5 sessions for both study arms. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with post-partum assessments somewhat longer than prenatal assessments given the addition of the infant developmental assessment and parent-child observation task. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Following the final assessment, women will be invited to complete a daily diary (virtually) each day for 30 days. Each survey will take approximately 5-10 minutes to complete, and women will be compensated $2 for each completed survey. Women will also receive a $10 bonus for each set of 10 consecutive surveys. Treatment sessions will be 2 hours in duration. Women in the PMEP will complete a structured set of sessions: (1) supporting each other, support in the community, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting. Women in the active control condition will participate in facilitated discussions on a topic identified by the group. All sessions will be audio recorded so that treatment fidelity can be evaluated (for the Pregnant Moms' Empowerment Program) and so that content overlap can be assessed (for the active control condition).
Read the detailed description
The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site (n=115 at each site for a total of N=230 mothers). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the PMEP. The expected duration of the study for each participant is approximately 1.75 years, with some variation due to women enrolling at different points in their pregnancy. The primary objective of the current study is to determine if the PMEP has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development, as compared to women's participation in a contact-equivalent control group. This objective will be evaluated usin ga multi-site randomized clinical trial design. Participants (N=230) will be equally randomized into study arms. Eligible women include those who are currently pregnant, who have experienced IPV in the past year, are age 16 or older, and are currently between 10 and 30 weeks pregnant. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with postpartum assessments somewhat longer than prenatal assessments due to the addition of the infant developmental assessment. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Treatment sessions will be 2 hrs in duration. Women in the PMEP will complete a structured set of sessions: (1) safety planning, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, (5) positive parenting. Women in the AC will participate in facilitated discussions on a topic identified by the group. All sessions will be audiorecorded so that treatment fidelity can be evaluated (for PMEP) and content overlap can be identified (for AC).
- Conditions
- Postpartum Depression, Posttraumatic Stress Disorder, Infant Behavior, Violence, Parenting
- Being tested
- Pregnant Moms' Empowerment Program, Nondirective Support Group
- Keywords
- intimate partner violence, resilience, psychological
- Medical subject headings
- Depression, Postpartum, Stress Disorders, Post-Traumatic, Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant Moms' Empowerment ProgramBehavioural
The Pregnant Moms' Empowerment Program is a five session group therapy program designed for pregnant women with a recent history of exposure to intimate partner violence. One session is administered each week with a duration of 2 hours each, for a total of ten contact hours across the course of the intervention. Intervention topics includes safety planning, social support, resilience, psychoeducation about intimate partner violence, cognitive and behavioral strategies for remediating distress, infant sleep and breastfeeding, responsive parenting, and co-parenting.
Nondirective Support GroupBehavioural
Participants in the non-directive support group condition participate in groups of the same size and with the same total contact time as women in Intervention 1. In contrast to the structured, manualized content delivered as a part of the Pregnant Moms' Empowerment Program, however, group leaders in this condition facilitate open conversation on topics that women identify together as a group.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Moms' Empowerment Program | Experimental | Five session group therapy program covering safety planning, resilience and coping, infant care and parenting. Receives: Behavioral: Pregnant Moms' Empowerment Program |
| Nondirective Support Group | Active comparator | Five session nondirective support group with two co-leaders who assist in facilitating open discussion on women's self-identified discussion topics. Receives: Behavioral: Nondirective Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in posttraumatic stress symptoms from baseline to post-treatment
Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr, 2013). We hypothesize that compared to women in the active control condition, that beginning at the post-treatment assessment women in the treatment condition will have lower levels of posttraumatic stress. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes.
Measured: posttreatment
Change in posttraumatic stress symptoms from baseline to 3-months postpartum
Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr, 2013). We hypothesize that compared to women in the active control condition, women in the treatment condition will have lower levels of posttraumatic stress. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes.
Measured: 3-months postpartum
Change in posttraumatic stress symptoms from baseline to 12-months postpartum
Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr, 2013). We hypothesize that compared to women in the active control condition, women in the treatment condition will have lower levels of posttraumatic stress. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes.
Measured: 12-months postpartum
Change in depressed mood from baseline to posttreatment
Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977). We hypothesize that compared to women in the AC condition, that beginning at the post-treatment assessment (T2) women in the PMEP condition will have lower levels of depressed mood over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes.
Measured: posttreatment
Change in depressed mood from baseline to 3-months postpartum
Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977). We hypothesize that compared to women in the active control condition, that beginning at that women in the treatment condition will have lower levels of depressed mood over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes.
Measured: 3-months postpartum
Change in depressed mood from baseline to 12-months postpartum
Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977). We hypothesize that compared to women in the active control condition, that beginning at that women in the treatment condition will have lower levels of depressed mood over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes.
Measured: 12-months postpartum
Change in resilience from baseline to posttreatment
Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor \& Davidson, 2003), which examines one's ability to cope with adversity. We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 100. Higher scores indicate better outcomes.
Measured: posttreatment
Change in resilience from baseline to 3-months postpartum
Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor \& Davidson, 2003), which examines one's ability to cope with adversity. We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 100. Higher scores indicate better outcomes.
Measured: 3-months postpartum
Change in resilience from baseline to 12-months postpartum
Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor \& Davidson, 2003), which examines one's ability to cope with adversity. We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 100. Higher scores indicate better outcomes.
Measured: 12-months postpartum
Maternal Sensitivity at infant age 3 months
Maternal sensitivity will be assessed using observational paradigms coded by trained research assistants for sensitive parenting behaviors. At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in a fixed-order observational assessment, constituted of the Still-Face Paradigm (Tronick et al., 1978) and a 10-minute free play period. Parent sensitivity will be rated on a 5 point Likert scale from the play and reunion episodes. Coded ratings on sensitivity and intrusiveness will be combined across intervals to create a composite maternal sensitivity score. We hypothesize that compared to women in the active control condition, women in the treatment condition will show higher levels of maternal sensitivity at the 3-month postpartum assessment. Higher scores indicate better outcomes.
Measured: 3-months postpartum
Maternal Sensitivity at infant age 12 months
Maternal sensitivity will be assessed using observational paradigms coded by trained research assistants for sensitive parenting behaviors. At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in a fixed-order observational assessment, constituted of the Still-Face Paradigm (Tronick et al., 1978) and a 10-minute free play period. Parent sensitivity will be rated on a 5 point Likert scale from the play and reunion episodes. Coded ratings on sensitivity and intrusiveness will be combined across intervals to create a composite maternal sensitivity score. We hypothesize that compared to women in the active control condition, women in the treatment condition will show higher levels of maternal sensitivity at the 12-month postpartum assessment. Higher scores indicate better outcomes.
Measured: 12-months postpartum
Intimate Partner Violence at posttreatment
The Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship. We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques. Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview]. Higher scores indicate worse outcomes. The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events.
Measured: posttreatment
Intimate Partner Violence at 3-months postpartum
he Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship. We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques. Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview]. Higher scores indicate worse outcomes. The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events.
Measured: 3-months postpartum
Intimate Partner Violence at 12-months postpartum
he Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship. We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques. Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview]. Higher scores indicate worse outcomes. The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events.
Measured: 12-months postpartum
Infant Development at 3 months of age
Infant development (cognitive, language, socioemotional) will be evaluated using The Bayley Scales of Infant and Toddler Development and The Ages and Stages Questionnaire - 3, which are a standardized measures. We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show better developmental outcomes. Further, we hypothesize that infant development at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. The Bayley is a standardized measure and within each domain an average score is 100. Higher scores indicate better outcomes. On the Ages and Stages Questionnaire, scores for each subdomain (Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social) range from 0 to 60.
Measured: 3-months
Infant Development at 12 months of age
Infant development (cognitive, language, socioemotional) will be evaluated using The Bayley Scales of Infant and Toddler Development and The Ages and Stages Questionnaire - 3, which are a standardized measures. We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show better developmental outcomes. Further, we hypothesize that infant development at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. The Bayley is a standardized measure and within each domain an average score is 100. Higher scores indicate better outcomes. On the Ages and Stages Questionnaire, scores for each subdomain (Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social) range from 0 to 60.
Measured: 12-months
Infant Regulation at 3 months of age
At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in the Still-Face Paradigm (Tronick et al., 1978). Infant affect, which includes a combination of vocal and facial reactions, will be rated on a second-by-second basis across all three episodes of the SFP and free play. A 7 point Likert scale ranging from a -3 (screaming) to +3 (laughing intensely) will be used. Affect data are reduced to the proportion of time infants spend in negative and positive affect states (Braungart-Rieker et al., 2014). We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show more positive affect over time, at 3 and 12 months of age. Further, we hypothesize that infant affect at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. Higher scores indicate better outcomes.
Measured: 3-months
Infant Regulation at 12 months of age
At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in the Still-Face Paradigm (Tronick et al., 1978). Infant affect, which includes a combination of vocal and facial reactions, will be rated on a second-by-second basis across all three episodes of the SFP and free play. A 7 point Likert scale ranging from a -3 (screaming) to +3 (laughing intensely) will be used. Affect data are reduced to the proportion of time infants spend in negative and positive affect states (Braungart-Rieker et al., 2014). We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show more positive affect over time, at 3 and 12 months of age. Further, we hypothesize that infant affect at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. Higher scores indicate better outcomes.
Measured: 12-months
Secondary outcomes (6)
Change in social support from baseline to posttreatment
Women's sources of maternal support will be assessed with the Lubben Social Network Scale-Revised(Lubben \& Gironda, 2003), which examines the level of perceived support from family networks and friendship networks. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher social support over time. Further, we hypothesize that social support will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Total scores range from 0 to 90. Higher scores indicate better outcomes.
Measured: posttreatment
Change in social support from baseline to 3-months postpartum
Women's sources of maternal support will be assessed with the Lubben Social Network Scale-Revised(Lubben \& Gironda, 2003), which examines the level of perceived support from family networks and friendship networks. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher social support over time. Further, we hypothesize that social support will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Total scores range from 0 to 90. Higher scores indicate better outcomes.
Measured: 3-months postpartum
Change in social support from baseline to 12-months postpartum
Women's sources of maternal support will be assessed with the Lubben Social Network Scale-Revised(Lubben \& Gironda, 2003), which examines the level of perceived support from family networks and friendship networks. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher social support over time. Further, we hypothesize that social support will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Total scores range from 0 to 90. Higher scores indicate better outcomes.
Measured: 12-months postpartum
Change in empowerment from baseline to posttreatment
The Personal Progress Scale-Revised (Johnson, Worrell, \& Chandler, 2005) will be used to examine women's attitudes and behaviors associated with increased empowerment and well-being. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher empowerment over time. Further, we hypothesize that empowerment will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Scores range from 0 to 196; higher scores indicated better outcomes.
Measured: posttreatment
Change in empowerment from baseline to 3-months postpartum
The Personal Progress Scale-Revised (Johnson, Worrell, \& Chandler, 2005) will be used to examine women's attitudes and behaviors associated with increased empowerment and well-being. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher empowerment over time. Further, we hypothesize that empowerment will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Scores range from 0 to 196; higher scores indicated better outcomes.
Measured: 3-months postpartum
Change in empowerment from baseline to 12-months postpartum
The Personal Progress Scale-Revised (Johnson, Worrell, \& Chandler, 2005) will be used to examine women's attitudes and behaviors associated with increased empowerment and well-being. We hypothesize that compared to women in the active control condition, that women in the treatment condition will have higher empowerment over time. Further, we hypothesize that empowerment will mediate the relationship between treatment and women's mental health, revictimization, resilience, and sensitive parenting. Scores range from 0 to 196; higher scores indicated better outcomes.
Measured: 12-months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start10 Jul 2019
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies 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
- Participants are assigned to either the Pregnant Moms' Empowerment Program or an active control group. Members of the active control group participate in a non-directive support group with contact equivalent time to the Pregnant Moms' Empowerment Program (10 hrs).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- University of Memphis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068662
- Sponsor's protocol ID
- 19-03-5260
- Status last verified
- Nov 2025
- First submitted
- 20 Aug 2019
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Five years after the completion of the study we will make the data available to other researchers for the purposes of replication of published findings or inclusion of data in meta-analyses via a data-sharing agreement that will provide for: (1) a commitment to using the data only for these research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening During the Prenatal Period With Women Exposed to Intimate Partner Violence to Improve Maternal Functioning and Infant Adjustment
- ClinicalTrials.gov ID
- NCT04068662
- Acronym / sponsor ID
- 19-03-5260
- Conditions
- Postpartum Depression, Posttraumatic Stress Disorder, Infant Behavior, Violence, Parenting
- Keywords
- intimate partner violence, resilience, psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- University of Memphis
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 28 Aug 2019 (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 overarching goal of the proposed project is to evaluate a randomized clinical trial of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal mental health, re-victimization, parenting sensitivity, and infant development. The project also seeks to examine theoretically-grounded mechanisms of change, including social support and empowerment. Women participating in the study will receive either the PMEP or participate in a contact-equivalent active control group during pregnancy, and will be interviewed at baseline, post-intervention and with their infants at 3 months and 1 year old. The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site - Memphis, Tennessee (n=115) and South Bend, Indiana (n=115). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the Pregnant Moms' Empowerment Program. The expected duration of the study for each participant will be approximately 1.5 years, with some variation due to women enrolling at different points in their pregnancy.
The primary objective of the proposed project is to determine if the Pregnant Moms' Empowerment Program has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development compared to women's participation in a contact-equivalent active control group. This objective will be evaluated using a multi-site randomized clinical trial design. Participants (N = 230) will be equally randomized into study arms. Eligible women will include those who are: 1) currently pregnant (primi or multiparous) and between 10 and 30 weeks gestation, 2) experienced IPV within the past year, 3) English speaking and 4) age 16 or older.
The study will include 9 total visits: 4 assessments and 5 sessions for both study arms. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with post-partum assessments somewhat longer than prenatal assessments given the addition of the infant developmental assessment and parent-child observation task. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Following the final assessment, women will be invited to complete a daily diary (virtually) each day for 30 days. Each survey will take approximately 5-10 minutes to complete, and women will be compensated $2 for each completed survey. Women will also receive a $10 bonus for each set of 10 consecutive surveys. Treatment sessions will be 2 hours in duration. Women in the PMEP will complete a structured set of sessions: (1) supporting each other, support in the community, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting. Women in the active control condition will participate in facilitated discussions on a topic identified by the group. All sessions will be audio recorded so that treatment fidelity can be evaluated (for the Pregnant Moms' Empowerment Program) and so that content overlap can be assessed (for the active control condition).
Detailed description
The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site (n=115 at each site for a total of N=230 mothers). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the PMEP. The expected duration of the study for each participant is approximately 1.75 years, with some variation due to women enrolling at different points in their pregnancy. The primary objective of the current study is to determine if the PMEP has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development, as compared to women's participation in a contact-equivalent control group. This objective will be evaluated usin ga multi-site randomized clinical trial design. Participants (N=230) will be equally randomized into study arms. Eligible women include those who are currently pregnant, who have experienced IPV in the past year, are age 16 or older, and are currently between 10 and 30 weeks pregnant. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with postpartum assessments somewhat longer than prenatal assessments due to the addition of the infant developmental assessment. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Treatment sessions will be 2 hrs in duration. Women in the PMEP will complete a structured set of sessions: (1) safety planning, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, (5) positive parenting. Women in the AC will participate in facilitated discussions on a topic identified by the group. All sessions will be audiorecorded so that treatment fidelity can be evaluated (for PMEP) and content overlap can be identified (for AC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are assigned to either the Pregnant Moms' Empowerment Program or an active control group. Members of the active control group participate in a non-directive support group with contact equivalent time to the Pregnant Moms' Empowerment Program (10 hrs).
| Arm | Type | Receives |
|---|---|---|
| Pregnant Moms' Empowerment Program | Experimental | Behavioral: Pregnant Moms' Empowerment ProgramFive session group therapy program covering safety planning, resilience and coping, infant care and parenting. |
| Nondirective Support Group | Active comparator | Behavioral: Nondirective Support GroupFive session nondirective support group with two co-leaders who assist in facilitating open discussion on women's self-identified discussion topics. |
Who may qualify
- Ages
- 3 months to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- currently pregnant (primi or multiparous)
- experienced intimate partner violence within the past year
- English speaking
- age 16 or older
- between 10-30 weeks pregnant
Key exclusion criteria (2 listed)
- fails to meet inclusion criteria
- unavailable or unwilling to participate in core study components, including groups
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 |
|---|---|---|
| Pregnant Moms' Empowerment ProgramThe Pregnant Moms' Empowerment Program is a five session group therapy program designed for pregnant women with a recent history of exposure to intimate partner violence. One session is administered each week with a duration of 2 hours each, for a total of ten contact hours across the course of the intervention. Intervention topics includes safety planning, social support, resilience, psychoeducation about intimate partner violence, cognitive and behavioral strategies for remediating distress, infant sleep and breastfeeding, responsive parenting, and co-parenting. | Behavioural | Pregnant Moms' Empowerment Program |
| Nondirective Support GroupParticipants in the non-directive support group condition participate in groups of the same size and with the same total contact time as women in Intervention 1. In contrast to the structured, manualized content delivered as a part of the Pregnant Moms' Empowerment Program, however, group leaders in this condition facilitate open conversation on topics that women identify together as a group. | Behavioural | Nondirective Support Group |
Primary outcome
Change in posttraumatic stress symptoms from baseline to post-treatment
Time frame: posttreatment
Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr, 2013). We hypothesize that compared to women in the active control condition, that beginning at the post-treatment assessment women in the treatment condition will have lower levels of posttraumatic stress. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes.
Change in posttraumatic stress symptoms from baseline to 3-months postpartum
Time frame: 3-months postpartum
Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr, 2013). We hypothesize that compared to women in the active control condition, women in the treatment condition will have lower levels of posttraumatic stress. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes.
Change in posttraumatic stress symptoms from baseline to 12-months postpartum
Time frame: 12-months postpartum
Mothers will report on symptoms of posttraumatic stress using the PTSD Checklist for DSM-5 (Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr, 2013). We hypothesize that compared to women in the active control condition, women in the treatment condition will have lower levels of posttraumatic stress. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 80. Higher scores indicate worse outcomes.
Change in depressed mood from baseline to posttreatment
Time frame: posttreatment
Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977). We hypothesize that compared to women in the AC condition, that beginning at the post-treatment assessment (T2) women in the PMEP condition will have lower levels of depressed mood over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes.
Change in depressed mood from baseline to 3-months postpartum
Time frame: 3-months postpartum
Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977). We hypothesize that compared to women in the active control condition, that beginning at that women in the treatment condition will have lower levels of depressed mood over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes.
Change in depressed mood from baseline to 12-months postpartum
Time frame: 12-months postpartum
Mothers will report on symptoms of depressed mood using the Center for Epidemiological Studies Depression Scale (Radloff, 1977). We hypothesize that compared to women in the active control condition, that beginning at that women in the treatment condition will have lower levels of depressed mood over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 60. Higher scores indicate worse outcomes.
Change in resilience from baseline to posttreatment
Time frame: posttreatment
Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor \& Davidson, 2003), which examines one's ability to cope with adversity. We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 100. Higher scores indicate better outcomes.
Change in resilience from baseline to 3-months postpartum
Time frame: 3-months postpartum
Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor \& Davidson, 2003), which examines one's ability to cope with adversity. We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 100. Higher scores indicate better outcomes.
Change in resilience from baseline to 12-months postpartum
Time frame: 12-months postpartum
Mothers will report on resilience using the Connor-Davidson Resilience Scale (Connor \& Davidson, 2003), which examines one's ability to cope with adversity. We hypothesize that compared to women in the active control condition that women in the treatment condition will have higher levels of resilience over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items are summed to create a total score, which can range from 0 to 100. Higher scores indicate better outcomes.
Maternal Sensitivity at infant age 3 months
Time frame: 3-months postpartum
Maternal sensitivity will be assessed using observational paradigms coded by trained research assistants for sensitive parenting behaviors. At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in a fixed-order observational assessment, constituted of the Still-Face Paradigm (Tronick et al., 1978) and a 10-minute free play period. Parent sensitivity will be rated on a 5 point Likert scale from the play and reunion episodes. Coded ratings on sensitivity and intrusiveness will be combined across intervals to create a composite maternal sensitivity score. We hypothesize that compared to women in the active control condition, women in the treatment condition will show higher levels of maternal sensitivity at the 3-month postpartum assessment. Higher scores indicate better outcomes.
Maternal Sensitivity at infant age 12 months
Time frame: 12-months postpartum
Maternal sensitivity will be assessed using observational paradigms coded by trained research assistants for sensitive parenting behaviors. At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in a fixed-order observational assessment, constituted of the Still-Face Paradigm (Tronick et al., 1978) and a 10-minute free play period. Parent sensitivity will be rated on a 5 point Likert scale from the play and reunion episodes. Coded ratings on sensitivity and intrusiveness will be combined across intervals to create a composite maternal sensitivity score. We hypothesize that compared to women in the active control condition, women in the treatment condition will show higher levels of maternal sensitivity at the 12-month postpartum assessment. Higher scores indicate better outcomes.
Intimate Partner Violence at posttreatment
Time frame: posttreatment
The Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship. We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques. Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview]. Higher scores indicate worse outcomes. The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events.
Intimate Partner Violence at 3-months postpartum
Time frame: 3-months postpartum
he Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship. We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques. Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview]. Higher scores indicate worse outcomes. The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events.
Intimate Partner Violence at 12-months postpartum
Time frame: 12-months postpartum
he Revised Conflict Tactics Scale (Straus, et al, 1996) will be used to assess the severity of psychological, physical, and sexual violence experienced by women in a dating, cohabiting, or marital relationship. We hypothesize that compared to women in the active control condition that women in the treatment condition will have lower frequency of intimate partner re-victimization over time. Further, we hypothesize that this will be mediated by the effect of treatment on women's empowerment and social support. Items cluster into five scales: physical assaults, psychological aggression, sexual coercion, injury, and negotiation techniques. Respondents report frequency on a scale of 1 = once [since the last interview] to 6 = more than 20 times [since the last interview]. Higher scores indicate worse outcomes. The current study used the frequency scoring method for the CTS2, which recodes the scale to represent the midpoints of each range with a possible total range of 0 to 825 events.
Infant Development at 3 months of age
Time frame: 3-months
Infant development (cognitive, language, socioemotional) will be evaluated using The Bayley Scales of Infant and Toddler Development and The Ages and Stages Questionnaire - 3, which are a standardized measures. We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show better developmental outcomes. Further, we hypothesize that infant development at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. The Bayley is a standardized measure and within each domain an average score is 100. Higher scores indicate better outcomes. On the Ages and Stages Questionnaire, scores for each subdomain (Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social) range from 0 to 60.
Infant Development at 12 months of age
Time frame: 12-months
Infant development (cognitive, language, socioemotional) will be evaluated using The Bayley Scales of Infant and Toddler Development and The Ages and Stages Questionnaire - 3, which are a standardized measures. We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show better developmental outcomes. Further, we hypothesize that infant development at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. The Bayley is a standardized measure and within each domain an average score is 100. Higher scores indicate better outcomes. On the Ages and Stages Questionnaire, scores for each subdomain (Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social) range from 0 to 60.
Infant Regulation at 3 months of age
Time frame: 3-months
At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in the Still-Face Paradigm (Tronick et al., 1978). Infant affect, which includes a combination of vocal and facial reactions, will be rated on a second-by-second basis across all three episodes of the SFP and free play. A 7 point Likert scale ranging from a -3 (screaming) to +3 (laughing intensely) will be used. Affect data are reduced to the proportion of time infants spend in negative and positive affect states (Braungart-Rieker et al., 2014). We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show more positive affect over time, at 3 and 12 months of age. Further, we hypothesize that infant affect at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. Higher scores indicate better outcomes.
Infant Regulation at 12 months of age
Time frame: 12-months
At the 3 month and 12 month postpartum assessments, mother-infant dyads will participate in the Still-Face Paradigm (Tronick et al., 1978). Infant affect, which includes a combination of vocal and facial reactions, will be rated on a second-by-second basis across all three episodes of the SFP and free play. A 7 point Likert scale ranging from a -3 (screaming) to +3 (laughing intensely) will be used. Affect data are reduced to the proportion of time infants spend in negative and positive affect states (Braungart-Rieker et al., 2014). We hypothesize that compared to infants born to women in the active control condition, infants born to mothers in the treatment condition will show more positive affect over time, at 3 and 12 months of age. Further, we hypothesize that infant affect at 12 months will be indirectly predicted by mothers' improvement as a result of treatment at 3 months. Higher scores indicate better outcomes.
6 secondary outcomes
Change in social support from baseline to posttreatment
Time frame: posttreatment
Change in social support from baseline to 3-months postpartum
Time frame: 3-months postpartum
Change in social support from baseline to 12-months postpartum
Time frame: 12-months postpartum
Change in empowerment from baseline to posttreatment
Time frame: posttreatment
Change in empowerment from baseline to 3-months postpartum
Time frame: 3-months postpartum
Change in empowerment from baseline to 12-months postpartum
Time frame: 12-months 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 24 Nov 2025.
- Individual participant dataSharing planned: Yes. Five years after the completion of the study we will make the data available to other researchers for the purposes of replication of published findings or inclusion of data in meta-analyses via a data-sharing agreement that will provide for: (1) a commitment to using the data only for these research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregnant Moms' Empowerment Program and Nondirective Support Group in people with Postpartum Depression and Posttraumatic Stress Disorder, run by University of Notre Dame at 2 sites 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 5 inclusion and 2 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 posttraumatic stress symptoms from baseline to post-treatment (time frame: posttreatment). The study lists 18 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 24 Nov 2025.