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Clinical Trials/NCT05011825
NCT05011825
Completed
Not Applicable

A Pilot Evaluation of the Pregnant Moms' Empowerment Program

University of Notre Dame2 sites in 1 country137 target enrollmentMarch 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Violence
Sponsor
University of Notre Dame
Enrollment
137
Locations
2
Primary Endpoint
Connors Davidson Resilience Scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2017
End Date
February 15, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Connors Davidson Resilience Scale

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

Resilience

Center for Epidemiological Studies Depression Scale

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

Depression

Conflict Tactics Scales - Revised

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

Intimate Partner Violence

Karitane Parenting Inventory

Time Frame: Change from baseline assessment to 12 months postpartum

Parenting Confidence

PTSD Checklist - 5

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

Posttraumatic Stress

Infant Behavior Questionnaire

Time Frame: Differences between groups at 12 months post partum

Infant Temperament

Infant Development

Time Frame: Differences between groups at 3 months postpartum

Bayley Scales of Infant Development

Adult Adolescent Parenting Inventory

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

Parenting Attitudes

Pregnancy Risk and Monitoring System (PRAMS)

Time Frame: Differences between groups at 12 months postpartum

Labor, Delivery and Breastfeeding

Maternal Sensitivity and Infant Affect Regulation

Time Frame: Differences between groups at 12 months postpartum

Coded free play data

Secondary Outcomes

  • Rotter Locus of Control Scale(Change from baseline to 12 months postpartum)
  • Lubben Social Network Scale(Change from baseline to posttest 3.5-5 years postpartum)
  • Child behavior checklist(3.5-5 years postpartum)

Study Sites (2)

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