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ENROLLING BY INVITATION
NCT06732310
PHASE2

The Unique and Combined Effects of Prenatal and Early Childhood Programming on Child Maltreatment: Examining Mechanisms of Change

Sponsor: University of Notre Dame

View on ClinicalTrials.gov

Summary

Child maltreatment and child exposure to adult intimate partner violence (IPV) often co-occur and are detrimental to the mental and physical health of children, yet few prevention programs address these intersecting forms of adversity using dual-generation approaches. The proposed study is a rigorous randomized controlled trial that uses a 2x2 factorial design to evaluate the potential synergistic benefits of delivering programming prenatally and during early childhood in order to support the mother-child relationship and ultimately prevent child maltreatment. If effective in preventing child maltreatment, these programs have the potential for high public health impact given that they are both cost-effective and readily scalable.

Key Details

Gender

All

Age Range

3 Years - Any

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2024-11-07

Completion Date

2029-08-31

Last Updated

2024-12-13

Healthy Volunteers

No

Interventions

BEHAVIORAL

Pregnant Moms' Empowerment Program

Women who receive the PMEP complete a structured set of sessions delivered over the course of 5 weeks, each session lasts 2 hours in duration: (1) becoming a group \& safety planning, (2) identifying and understanding sources of stress, (3) strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting.

BEHAVIORAL

Reminiscing and Emotion Training

Each of the 5 RET sessions are 1 hour in duration. The program is manualized and each session includes teaching/review of skills, instructions/activity with rationale, reminiscing practice, and immediate video feedback by a family coach.

BEHAVIORAL

Pregnancy - Active Control

Women who are not randomized to the PMEP participate in a contact-equivalent, nondirective social support group.

BEHAVIORAL

Enhanced Case Management

Families randomized to this attentional control condition will receive enhanced case management. They will be mailed a kit containing 5 packets to be opened weekly. Each packet includes a family activity and a newsletter with parenting materials (e.g., Adventures in Parenting curriculum developed by NICHD) that were selected to not overlap with RET content (e.g., reading together, fitness, etc.). Using mothers' responses regarding access to resources on the Family Resource Scale (Dunst \& Leet, 1987), which is completed during the baseline visit, mothers will also receive referrals to community resources for items rated as inadequate.

Locations (2)

University of Notre Dame

Notre Dame, Indiana, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States