A Pilot Evaluation of the Pregnant Moms' Empowerment Program

Not Applicable

Completed

• Conditions: Violence; Posttraumatic Stress Disorder; Infant Development; Depression; Parenting; Child Behavior
• Interventions: Behavioral: Pregnant Moms' Empowerment Program

• Registration Number: NCT05011825
• Lead Sponsor: University of Notre Dame

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-15
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 137

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant Moms' Empowerment Program	Pregnant Moms' Empowerment Program	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.

Primary Outcome Measures

Name	Time	Method
Center for Epidemiological Studies Depression Scale	Change from baseline assessment to 3.5-5 years postpartum	Depression
Conflict Tactics Scales - Revised	Change from baseline assessment to 3.5-5 years postpartum	Intimate Partner Violence
Karitane Parenting Inventory	Change from baseline assessment to 12 months postpartum	Parenting Confidence
Connors Davidson Resilience Scale	Change from baseline assessment to 3.5-5 years postpartum	Resilience
PTSD Checklist - 5	Change from baseline assessment to 3.5-5 years postpartum	Posttraumatic Stress
Infant Behavior Questionnaire	Differences between groups at 12 months post partum	Infant Temperament
Infant Development	Differences between groups at 3 months postpartum	Bayley Scales of Infant Development
Adult Adolescent Parenting Inventory	Change from baseline assessment to 3.5-5 years postpartum	Parenting Attitudes
Pregnancy Risk and Monitoring System (PRAMS)	Differences between groups at 12 months postpartum	Labor, Delivery and Breastfeeding
Maternal Sensitivity and Infant Affect Regulation	Differences between groups at 12 months postpartum	Coded free play data

Secondary Outcome Measures

Name	Time	Method
Rotter Locus of Control Scale	Change from baseline to 12 months postpartum	Locus of Control
Lubben Social Network Scale	Change from baseline to posttest 3.5-5 years postpartum	Social Support
Child behavior checklist	3.5-5 years postpartum	Child adjustment

Trial Locations

Locations (2)

University of NotreDame; 🇺🇸 Notre Dame, Indiana, United States

University of Memphis; 🇺🇸 Memphis, Tennessee, United States