NCT05011825

A Pilot Evaluation of the Pregnant Moms' Empowerment Program

Completed NA Last updated 8 November 2023

What this trial tests

NA trial testing Pregnant Moms' Empowerment Program in Violence in 137 participants. Completed in 15 February 2021.

Timeline

15 March 2017

Primary endpoint
15 February 2021

15 February 2021

Quick facts

Lead sponsor	University of Notre Dame
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	137
Start date	15 March 2017
Primary completion	15 February 2021
Estimated completion	15 February 2021
Sites	2 locations across United States

Drugs / interventions tested

• Pregnant Moms' Empowerment Program

Conditions studied

• Violence — all drugs for Violence →
• Depression — all drugs for Depression →
• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →
• Parenting — all drugs for Parenting →

Sponsor

University of Notre Dame

Who can join

Adults 16 to 55, female only, with Violence or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Breastfeeding interventions for preventing postpartum depression.
   Lenells M, Uphoff E, Marshall D, Wilson E, et al · · 2025 · cited 1× · PMID 39963955 · DOI 10.1002/14651858.cd014833.pub2