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

NCT06732310 | Enrolling By Invitation Phase 2 DMC

• 2 other identifiers: 22-05-7238R01HD114597
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Child Abuse; Intimate Partner Violence; Secondary Prevention; Parenting

Keywords

child abuse; child maltreatment; intimate partner violence; domestic violence; secondary prevention; parenting

Outcome Measures

Primary Outcomes (7)

• DCS Records - Maltreatment Classification System

  DCS records will be coded using the Maltreatment Classification System (MCS; Barnett et al., 1993). The MCS utilizes operational criteria for determining the occurrence of subtypes of maltreatment. Subtype categories include sexual abuse, physical abuse, physical neglect, and emotional maltreatment.

  RET baseline (T5), 6 month follow-up (T8). 12 month follow-up

• Maternal Maltreatment Classification Interview

  MCS ratings will be supplemented by information obtained during the Maternal Maltreatment Classification Interview (MMCI; Cicchetti et al., 2002), a structured interview based on the MCS. It will be audiotaped and coded by two independent raters utilizing the same operational criteria as the MCS.

  RET baseline (T5), 6 month follow-up (T8)

• Maltreatment risk/Propensity

  Mothers will complete the Child Abuse Potential Inventory (CAPI; Milner, 1986) and the Adult Adolescent Parenting Inventory (AAPI; Bavolek \& Keene, 2001), both of which assess maltreatment propensity. A composite variable of maltreatment propensity/risk will be created by combining these indicators.

  PMEP baseline [T1], PMEP immediate post-test [T2], PMEP 3 month post-partum follow-up [T3], PMEP 12 month post-partum follow-up [T4], RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]

• Intimate partner violence

  others will complete the Revised Conflict Tactics Scale (CTS2) (Straus, Hamby, Boney-McCoy, \& Sugarman, 1996; Straus, 1979), which assesses the severity of psychological, physical, and sexual violence in a dating, cohabiting, or marital relationship. This measure has the advantage of being able to be flexibly coded to gain information about IPV severity, frequency, and chronicity.

  PMEP baseline [T1], PMEP immediate post-test [T2], PMEP 3 month post-partum follow-up [T3], PMEP 12 month post-partum follow-up [T4], RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]

• Maternal Sensitivity - perinatal period

  Maternal sensitivity will be assessed in several observational contexts. At T3 and T4, mother-child dyads will participate in a 5-minute free play activity that will be coded using an established coding framework (Braungart-Rieker et al., 2014).

  PMEP 3 month post-partum follow-up [T3], PMEP 12 month post-partum follow-up [T4]

• Maternal Sensitive Guidance - early childhood

  From T5-T8, maternal sensitive guidance will be assessed by following the Autobiographical Emotional Events Dialogue procedure (AEED; Koren-Kari e, Oppenheim, Haimovich, \& Etzion-Carasso, 2003b).

  RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]

• Maternal Sensitivity - DPICS - early childhood

  Participants will also complete a 10-minute free play paradigm using an abbreviated Dyadic Parent-Child Interaction Coding System (DPICS; Eyeberg, et al., 2013). This free play will be coded for positive, neutral and negative patterns of parent-child communication.

  RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]

Secondary Outcomes (6)

• Positive Parenting Behavior

  RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)

• Maternal emotional style

  RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)

• Child Emotion Regulation

  RET baseline (T5), RET immediate post-test (T6), 3 month follow-up (T7), 6 month follow-up (T8)

• Child Temperament - infancy

  PMEP 12 month postpartum follow-up (T4)

• Child Temperament - early childhood

  RET baseline (T5), RET immediate post-test (T6), RET 3 month follow-up (T7), RET 6 month follow-up (T8)

Other Outcomes (8)

• Maternal Trauma History

  PMEP baseline [T1], RET baseline [T5]

• Maternal Child Maltreatment History

  RET baseline [T5]

• Maternal Social Support

  PMEP baseline [T1], PMEP immediate post-test [T2], PMEP 3 month post-partum follow-up [T3], PMEP 12 month post-partum follow-up [T4], RET baseline [T5], RET immediate post-test [T6], RET 3 month follow-up [T7], RET 6 month follow-up [T8]

Study Arms (4)

PMEP + ECM

EXPERIMENTAL

In pregnancy: PMEP In early childhood: enhanced case management

Behavioral: Pregnant Moms' Empowerment Program; Behavioral: Enhanced Case Management

Pregnancy - Active Control + RET

EXPERIMENTAL

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.

Behavioral: Reminiscing and Emotion Training; Behavioral: Pregnancy - Active Control

PMEP + RET

EXPERIMENTAL

In pregnancy: PMEP In early childhood: Reminiscing and Emotion Training Program

Behavioral: Pregnant Moms' Empowerment Program; Behavioral: Reminiscing and Emotion Training

Pregnancy - Active Control + ECM

ACTIVE COMPARATOR

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.

Behavioral: Pregnancy - Active Control; Behavioral: Enhanced Case Management

Interventions

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.

PMEP + RET; Pregnancy - Active Control + RET

Pregnancy - Active Control BEHAVIORAL

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

Also known as: AC

Pregnancy - Active Control + ECM; Pregnancy - Active Control + RET

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.

Also known as: ECM

PMEP + ECM; Pregnancy - Active Control + ECM

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.

Also known as: PMEP

PMEP + ECM; PMEP + RET

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

The sample will be composed of n=230 women and children drawn from an ongoing randomized clinical trial (RCT) of the PMEP (R01HD098092); during Year 1 of the current study, we will recruit an additional n=70 pregnant, IPV-exposed women and implement the PMEP RCT protocol with them, for a total sample of N=300 families. In order to be eligible for the PMEP trial arm, women must be: 18 years or older, pregnant (between 10 and 30 weeks), English speaking, and exposed to IPV in the past year. To be eligible for re-enrollment in the RET trial arm, women must have previously participated in the PMEP trial arm. Women who have a significant mental health disorder or cognitive impairment that precludes their ability to understand or participate in the intervention will be excluded. Mothers who have experienced miscarriage, infant death, or who no longer have custody of the child with whom they were pregnant with when they participated in the PMEP trial arm will be excluded from the intervention given that the RET trial arm requires active participation from both parent and child; if, however, women have a child born after their participation in PMEP and who is in the study age range, they and their child may participate.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Notre Dame: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of Notre Dame

Notre Dame, Indiana, 46556, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Interventions

exopolysaccharide, Pseudomonas

Study Officials

• Laura E Miller-Graff, PhD

  University of Notre Dame

  PRINCIPAL INVESTIGATOR

• Kathryn H Howell, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Kristin Valentino, PhD

  University of Notre Dame

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In pregnancy: 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. Women who are not randomized to PMEP participate in a contact-equivalent, non-directive social support group. In early childhood: 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. 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.

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 13, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): March 30, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)