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Completed

NCT Number: NCT05011825

A Pilot Evaluation of the Pregnant Moms' Empowerment Program

This project will use a longitudinal design with assessments at baseline (T1), post-treatment (T2), 3 month post-partum (T3), 1 year postpartum (T4) and 3.5-5 years postpartum to examine whether the PMEP improves participants': a) mental health (depression, PTSD) and resilience, b) parenting skills, c) birth, infant, and toddler developmental outcomes, and d) lowers re-victimization rates. We hypothesize significantly improved outcomes in the intervention group compared to the control group at post-treatment and at all follow-ups. The pilot will use a quasi-randomized design, with participants assigned to alternating treatment and control blocks. Analyses will be conducted using intent to treat and per protocol methods. Following group assignment, all women will be scheduled for a baseline interview at a time convenient for the participant. Participant interviews will take approximately 1.5 hours. Mothers will be compensated with a gift card in the amount of 40 USD for each interview. In addition to the core evaluation metrics, mothers' demographic information will be obtained (age, relationship status, employment, education, number of children, income). Following the baseline interview, the PMEP will be provided to the treatment group; participants will receive 2-hours of contact time per week for 5 weeks (2-hour sessions, held once weekly). Women will receive reminder calls the day of each session to identify and resolve any barriers to attendance (e.g., transportation). Taxi fare will be supported for women who are unable to obtain transportation if the bus is not feasible. Following the completion of the PMEP groups or - for the control group - after 5-6 weeks has passed, all participants will complete a second interview. This interview will include all of the core measures of hypothesized treatment change, thereby permitting a comparison between women in the treatment and control groups over time. All women will be invited in a third time when their infant is 3 months old and again when their infant is 1 year of age to evaluate parenting and infant outcomes. Women will participate in a brief phone assessment when their children are between 3.5 and 5 years of age that includes all primary study outcomes.

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Key information

Age range

16 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of NotreDame, Notre Dame, Indiana, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 16 years of age
  • experienced IPV in the past year
  • currently pregnant (<33 weeks)
  • English speaking

Exclusion criteria

  • insufficient fluency in English to participate in interviews/groups

Treatment and study plan

Pregnant Moms' Empowerment Program

Behavioral

The first session introduces women to the group, seeks to build an alliance and sense of group cohesion, and provides safety planning. The second session addresses intergenerational patterns of violence and how such violence contributes to psychopathology in both the prenatal and postnatal period, focusing on violence prevention. Information regarding cognitive restructuring, behavioral activation, and coping styles is provided in session three, as well as the role of healthy relationships and social supports in promoting resilience. This session begins with discussion on health in pregnancy, labor/delivery, and coordinating care across providers. This session also provides psychoeducation related to post-delivery parenting, including infant safety, care and breastfeeding. In the final session, group leaders assist mothers with identification, sensitivity, and responsiveness to infant cues.

Primary outcomes

  1. Center for Epidemiological Studies Depression Scale

    Time frame: Change from baseline assessment to post-test (5-6 weeks later)

    Depression

  2. Center for Epidemiological Studies Depression Scale

    Time frame: Change from baseline assessment to 3 months postpartum

    Depression

  3. Center for Epidemiological Studies Depression Scale

    Time frame: Change from baseline assessment to 12 months postpartum

    Depression

  4. Center for Epidemiological Studies Depression Scale

    Time frame: Change from baseline assessment to 3.5-5 years postpartum

    Depression

  5. PTSD Checklist - 5

    Time frame: Change from baseline assessment to post-test (5-6 weeks later)

    Posttraumatic Stress

  6. PTSD Checklist - 5

    Time frame: Change from baseline assessment to 3 months postpartum

    Posttraumatic Stress

  7. PTSD Checklist - 5

    Time frame: Change from baseline assessment to 12 months postpartum

    Posttraumatic Stress

  8. PTSD Checklist - 5

    Time frame: Change from baseline assessment to 3.5-5 years postpartum

    Posttraumatic Stress

  9. Connors Davidson Resilience Scale

    Time frame: Change from baseline assessment to post-test (5-6 weeks later)

    Resilience

  10. Connors Davidson Resilience Scale

    Time frame: Change from baseline assessment to 3 months postpartum

    Resilience

  11. Connors Davidson Resilience Scale

    Time frame: Change from baseline assessment to 12 months postpartum

    Resilience

  12. Connors Davidson Resilience Scale

    Time frame: Change from baseline assessment to 3.5-5 years postpartum

    Resilience

  13. Conflict Tactics Scales - Revised

    Time frame: Change from baseline assessment to post-test (5-6 weeks later)

    Intimate Partner Violence

  14. Conflict Tactics Scales - Revised

    Time frame: Change from baseline assessment to 3 months postpartum

    Intimate Partner Violence

  15. Conflict Tactics Scales - Revised

    Time frame: Change from baseline assessment to 12 months postpartum

    Intimate Partner Violence

  16. Conflict Tactics Scales - Revised

    Time frame: Change from baseline assessment to 3.5-5 years postpartum

    Intimate Partner Violence

  17. Adult Adolescent Parenting Inventory

    Time frame: Change from baseline assessment to post-test (5-6 weeks later)

    Parenting Attitudes

  18. Adult Adolescent Parenting Inventory

    Time frame: Change from baseline assessment to 3 months postpartum

    Parenting Attitudes

  19. Adult Adolescent Parenting Inventory

    Time frame: Change from baseline assessment to 12 months postpartum

    Parenting Attitudes

  20. Adult Adolescent Parenting Inventory

    Time frame: Change from baseline assessment to 3.5-5 years postpartum

    Parenting Attitudes

  21. Karitane Parenting Inventory

    Time frame: Change from baseline assessment to post-test (5-6 weeks later)

    Parenting Confidence

  22. Karitane Parenting Inventory

    Time frame: Change from baseline assessment to 3 months postpartum

    Parenting Confidence

  23. Karitane Parenting Inventory

    Time frame: Change from baseline assessment to 12 months postpartum

    Parenting Confidence

  24. Pregnancy Risk and Monitoring System (PRAMS)

    Time frame: Differences between groups at 3 months postpartum

    Labor, Delivery and Breastfeeding

  25. Pregnancy Risk and Monitoring System (PRAMS)

    Time frame: Differences between groups at 12 months postpartum

    Labor, Delivery and Breastfeeding

  26. Infant Development

    Time frame: Difference between groups at 12 months post partum

    Bayley Scales of Infant Development

  27. Infant Development

    Time frame: Differences between groups at 3 months postpartum

    Bayley Scales of Infant Development

  28. Infant Behavior Questionnaire

    Time frame: Differences between groups at 12 months post partum

    Infant Temperament

  29. Maternal Sensitivity and Infant Affect Regulation

    Time frame: Differences between groups at 3 months postpartum

    Coded free play data

  30. Maternal Sensitivity and Infant Affect Regulation

    Time frame: Differences between groups at 12 months postpartum

    Coded free play data

Secondary outcomes

  1. Lubben Social Network Scale

    Time frame: Change from baseline to posttest (5-6 weeks later)

    Social Support

  2. Lubben Social Network Scale

    Time frame: Change from baseline to 3 months postpartum

    Social Support

  3. Lubben Social Network Scale

    Time frame: Change from baseline to posttest 12 months postpartum

    Social Support

  4. Lubben Social Network Scale

    Time frame: Change from baseline to posttest 3.5-5 years postpartum

    Social Support

  5. Rotter Locus of Control Scale

    Time frame: Change from baseline to post-test (5-6 weeks later)

    Locus of Control

  6. Rotter Locus of Control Scale

    Time frame: Change from baseline to 3 months postpartum

    Locus of Control

  7. Rotter Locus of Control Scale

    Time frame: Change from baseline to 12 months postpartum

    Locus of Control

  8. Child behavior checklist

    Time frame: 3.5-5 years postpartum

    Child adjustment

Other outcomes

  1. Breastfeeding Behavior Scale

    Time frame: Differences between groups at 12 months post partum

    Breastfeeding attitudes

  2. Postpartum Depression Scale

    Time frame: 3 months postpartum

    Postpartum depression

Sponsors and collaborators

Lead sponsor

University of Notre Dame

Other

Collaborators

  • University of Memphis

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 18, 2021
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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