Clinical Trial

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

Enrolling by Invitation Phase 2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-12-09.
Trial Details
NCT Number NCT06732310
Lead Sponsor University of Notre Dame
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Child Abuse, Intimate Partner Violence, Secondary Prevention, Parenting
Enrollment 600 participants
Start Date 2024-11-07
Primary Completion 2029-03-30 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-23