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.

Study Overview

• Status: Completed
• Conditions: Depression; Parenting; Child Behavior; Posttraumatic Stress Disorder; Violence; Infant Development
• Intervention / Treatment: Behavioral: Pregnant Moms' Empowerment Program

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Notre Dame, Indiana, United States, 46556
      • University of NotreDame
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • University of Memphis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Pregnant Moms' Empowerment Program; 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.
No Intervention: Control; Control group participants received information about community resources, but did not receive any study-related intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lubben Social Network Scale	Social Support	Change from baseline to posttest (5-6 weeks later)
Lubben Social Network Scale	Social Support	Change from baseline to 3 months postpartum
Lubben Social Network Scale	Social Support	Change from baseline to posttest 12 months postpartum
Lubben Social Network Scale	Social Support	Change from baseline to posttest 3.5-5 years postpartum
Rotter Locus of Control Scale	Locus of Control	Change from baseline to post-test (5-6 weeks later)
Rotter Locus of Control Scale	Locus of Control	Change from baseline to 3 months postpartum
Rotter Locus of Control Scale	Locus of Control	Change from baseline to 12 months postpartum
Child behavior checklist	Child adjustment	3.5-5 years postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding Behavior Scale	Breastfeeding attitudes	Differences between groups at 12 months post partum
Postpartum Depression Scale	Postpartum depression	3 months postpartum

Collaborators and Investigators

• Sponsor: University of Notre Dame
• Collaborators: University of Memphis

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 17-08-4035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No