A Pilot Evaluation of the Pregnant Moms' Empowerment Program

University of Notre Dame

Status: Completed

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

Treatments: Behavioral: Pregnant Moms' Empowerment Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05011825

17-08-4035

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: Female

Ages: 16 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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137 participants in 2 patient groups

Pregnant Moms' Empowerment Program

Experimental group

Description:

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.

Treatment:

Behavioral: Pregnant Moms' Empowerment Program

Control

No Intervention group

Description:

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