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

Phase 2

Waitlist Available

Led By Laura E Miller-Graff, PhD

Research Sponsored by University of Notre Dame

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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]

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Child Abuse
Domestic Violence
Secondary Prevention
Parenting

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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]

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DCS Records - Maltreatment Classification System

Intimate partner violence

Maltreatment risk/Propensity

+4 more

Secondary study objectives

Child Adjustment

Child Emotion Regulation

Child Temperament - early childhood

+3 more

Other study objectives

Child Verbal Ability

Child victimization

Maternal Child Maltreatment History

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Pregnancy - Active Control + RETExperimental Treatment2 Interventions

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.

Group II: PMEP + RETExperimental Treatment2 Interventions

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

Group III: PMEP + ECMExperimental Treatment2 Interventions

In pregnancy: PMEP In early childhood: enhanced case management

Group IV: Pregnancy - Active Control + ECMActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pregnant Moms' Empowerment Program

2017

N/A

~140

0 / 2Eligibility criteria met