A Pilot Evaluation of the Pregnant Moms' Empowerment Program

NCT05011825 | Completed

• 1 other identifier: 17-08-4035
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Violence; Depression; Posttraumatic Stress Disorder; Parenting; Infant Development; Child Behavior

Outcome Measures

Primary Outcomes (30)

• Center for Epidemiological Studies Depression Scale

  Depression

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

• Center for Epidemiological Studies Depression Scale

  Depression

  Change from baseline assessment to 3 months postpartum

• Center for Epidemiological Studies Depression Scale

  Depression

  Change from baseline assessment to 12 months postpartum

• Center for Epidemiological Studies Depression Scale

  Depression

  Change from baseline assessment to 3.5-5 years postpartum

• PTSD Checklist - 5

  Posttraumatic Stress

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

• PTSD Checklist - 5

  Posttraumatic Stress

  Change from baseline assessment to 3 months postpartum

• PTSD Checklist - 5

  Posttraumatic Stress

  Change from baseline assessment to 12 months postpartum

• PTSD Checklist - 5

  Posttraumatic Stress

  Change from baseline assessment to 3.5-5 years postpartum

• Connors Davidson Resilience Scale

  Resilience

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

• Connors Davidson Resilience Scale

  Resilience

  Change from baseline assessment to 3 months postpartum

• Connors Davidson Resilience Scale

  Resilience

  Change from baseline assessment to 12 months postpartum

• Connors Davidson Resilience Scale

  Resilience

  Change from baseline assessment to 3.5-5 years postpartum

• Conflict Tactics Scales - Revised

  Intimate Partner Violence

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

• Conflict Tactics Scales - Revised

  Intimate Partner Violence

  Change from baseline assessment to 3 months postpartum

• Conflict Tactics Scales - Revised

  Intimate Partner Violence

  Change from baseline assessment to 12 months postpartum

• Conflict Tactics Scales - Revised

  Intimate Partner Violence

  Change from baseline assessment to 3.5-5 years postpartum

• Adult Adolescent Parenting Inventory

  Parenting Attitudes

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

• Adult Adolescent Parenting Inventory

  Parenting Attitudes

  Change from baseline assessment to 3 months postpartum

• Adult Adolescent Parenting Inventory

  Parenting Attitudes

  Change from baseline assessment to 12 months postpartum

• Adult Adolescent Parenting Inventory

  Parenting Attitudes

  Change from baseline assessment to 3.5-5 years postpartum

• Karitane Parenting Inventory

  Parenting Confidence

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

• Karitane Parenting Inventory

  Parenting Confidence

  Change from baseline assessment to 3 months postpartum

• Karitane Parenting Inventory

  Parenting Confidence

  Change from baseline assessment to 12 months postpartum

• Pregnancy Risk and Monitoring System (PRAMS)

  Labor, Delivery and Breastfeeding

  Differences between groups at 3 months postpartum

• Pregnancy Risk and Monitoring System (PRAMS)

  Labor, Delivery and Breastfeeding

  Differences between groups at 12 months postpartum

• Infant Development

  Bayley Scales of Infant Development

  Difference between groups at 12 months post partum

• Infant Development

  Bayley Scales of Infant Development

  Differences between groups at 3 months postpartum

• Infant Behavior Questionnaire

  Infant Temperament

  Differences between groups at 12 months post partum

• Maternal Sensitivity and Infant Affect Regulation

  Coded free play data

  Differences between groups at 3 months postpartum

• Maternal Sensitivity and Infant Affect Regulation

  Coded free play data

  Differences between groups at 12 months postpartum

Secondary Outcomes (8)

• Lubben Social Network Scale

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

• Lubben Social Network Scale

  Change from baseline to 3 months postpartum

• Lubben Social Network Scale

  Change from baseline to posttest 12 months postpartum

• Lubben Social Network Scale

  Change from baseline to posttest 3.5-5 years postpartum

• Rotter Locus of Control Scale

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

Other Outcomes (2)

• Breastfeeding Behavior Scale

  Differences between groups at 12 months post partum

• Postpartum Depression Scale

  3 months postpartum

Study Arms (2)

Pregnant Moms' Empowerment Program

EXPERIMENTAL

The PMEP is a 5-session program, delivered prenatally. The first three sessions address violence and mental health and the final two sessions address labor/delivery, infant health and early parenting.

Behavioral: Pregnant Moms' Empowerment Program

Control

NO INTERVENTION

Control group participants received information about community resources, but did not receive any study-related intervention.

Interventions

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.

Pregnant Moms' Empowerment Program

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• insufficient fluency in English to participate in interviews/groups

Sponsors & Collaborators

• University of Notre Dame: lead
• University of Memphis: collaborator

Study Sites (2)

University of NotreDame

Notre Dame, Indiana, 46556, United States

Location

University of Memphis

Memphis, Tennessee, 38152, United States

Location

Related Publications (1)

• Howell KH, Gilliam HC, Carney JR, Maloney CA, Miller-Graff LE. Long-term effects of the Pregnant Moms' Empowerment Program (PMEP) on intimate partner violence revictimization, maternal mental health, and child internalizing and externalizing problems. J Consult Clin Psychol. 2025 Sep;93(9):642-651. doi: 10.1037/ccp0000976.

  PMID: 40875361 DERIVED

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic; Child Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 18, 2021
• Study Start: March 15, 2017
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)