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

Part of paid clinical trials in Notre Dame, Indiana.

Sponsor
University of Notre Dame
Study ID
NCT06732310
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Child Abuse
  • Intimate Partner Violence
  • Parenting
  • Secondary Prevention

Eligibility Criteria

Sex
ALL
Age
3 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pregnant Moms' Empowerment Program — BEHAVIORAL
    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.
  • Reminiscing and Emotion Training — BEHAVIORAL
    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.
  • Pregnancy - Active Control — BEHAVIORAL
    Women who are not randomized to the PMEP participate in a contact-equivalent, nondirective social support group.
  • Enhanced Case Management — BEHAVIORAL
    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.

Study Details

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 Dates

Start date
Nov 7, 2024
Status verified
Apr 2026
Primary completion
Mar 30, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: PMEP + ECM
    In pregnancy: PMEP In early childhood: enhanced case management
  • Experimental: Pregnancy - Active Control + RET
    In pregnancy: Women who are not randomized to PMEP participate in a contact-equivalent, non-directive social support group. In early-childhood: Women participant in the RET.
  • Experimental: PMEP + RET
    In pregnancy: PMEP In early childhood: Reminiscing and Emotion Training Program
  • Active Comparator: Pregnancy - Active Control + ECM
    In pregnancy: Women not randomized to PMEP will participate in a contact-equivalent, nondirective social support group. In early childhood: Families who are not randomized to the RET condition will be mailed a kit containing 5 packets to be opened weekly. Each packet includes a family activity and a newsletter with parenting materials.

Primary Outcome Measure

DCS Records - Maltreatment Classification System [ Time Frame: RET baseline (T5), 6 month follow-up (T8). 12 month follow-up ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Notre DameNotre DameIndiana46556-
University of Wisconsin - MadisonMadisonWisconsin53706-

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