Parenting Programs for Child Abuse Prevention

Recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Notre Dame

Disqualifiers: Significant mental disorder, Cognitive impairment, Miscarriage, Infant death, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

600 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Pregnant Moms' Empowerment Program, Reminiscing and Emotion Training for child abuse prevention?

The Reminiscing and Emotion Training (RET) has been shown to reduce child welfare reinvolvement and improve emotional and behavioral adjustment in maltreated children by enhancing mothers' emotional socialization behaviors. The Pregnant Moms' Empowerment Program (PMEP) has demonstrated short-term positive effects on parenting attitudes and warm-sensitive parenting in women exposed to intimate partner violence. ^{1 2 3 4 5}

Is the Reminiscing and Emotion Training (RET) intervention safe for humans?

The studies on Reminiscing and Emotion Training (RET) do not report any safety concerns, suggesting it is generally safe for use in humans, particularly in improving parenting behaviors and child outcomes. ^{1 2 6 7 8}

How does the Parenting Programs for Child Abuse Prevention treatment differ from other treatments?

The Parenting Programs for Child Abuse Prevention treatment, which includes the Pregnant Moms' Empowerment Program and Reminiscing and Emotion Training, is unique because it focuses on improving maternal emotion socialization and parenting behaviors to prevent child abuse. This approach is distinct from other treatments as it targets enhancing sensitive guidance during reminiscing and addressing the emotional needs of mothers who have experienced intimate partner violence, aiming to reduce child maladjustment and prevent child welfare reinvolvement. ^{1 2 3 9 10}

Research Team

Laura Miller-Graff, PhD

Principal Investigator

University of Notre Dame

Kristin Valentino, PhD

Principal Investigator

University of Notre Dame

Kathryn H Howell, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for pregnant women and their young children, aiming to prevent child maltreatment and exposure to domestic violence. It's designed for those who could benefit from support in the mother-child relationship. Specific eligibility details are not provided.

Inclusion Criteria

I am a woman who speaks English.

I am pregnant and between 10 to 30 weeks along.

I have experienced intimate partner violence in the last year.

Exclusion Criteria

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

I do not have a mental health condition that affects my understanding or participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PMEP Treatment

Participants receive the Pregnant Moms' Empowerment Program (PMEP) intervention, which includes five group sessions focusing on empowerment and parenting skills.

16 months

5 group sessions (in-person)

RET Treatment

Participants engage in the Reminiscing and Emotion Training (RET) program, which includes five virtual sessions aimed at enhancing parent-child communication.

11 months

5 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at various intervals.

12 months

4 follow-up assessments

Treatment Details

Interventions

• Pregnant Moms' Empowerment Program
• Reminiscing and Emotion Training

Trial Overview The study tests if combining prenatal programs with early childhood interventions can help prevent child abuse. It uses a 2x2 factorial design, meaning participants receive either one program or both, to see which combination is most effective.

Participant Groups

Group I: Pregnancy - Active Control + RET Experimental Treatment 2 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 + RET Experimental Treatment 2 Interventions

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

Group III: PMEP + ECM Experimental Treatment 2 Interventions

In pregnancy: PMEP In early childhood: enhanced case management

Group IV: Pregnancy - Active Control + ECM Active Control 2 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.

Who Is Running the Clinical Trial?

University of Notre Dame

Lead Sponsor

Trials

36

Recruited

60,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

The Mom Power (MP) program, a 13-session intervention for high-risk mothers and their young children, showed promise in improving maternal mental health by significantly reducing depression and PTSD symptoms among participants, particularly those with pre-existing mental health diagnoses.

Participation in the MP program was associated with improved parenting competence, with a notable dose-response effect indicating that mothers who attended at least 70% of the sessions experienced greater benefits compared to those who attended fewer sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mom Power: preliminary outcomes of a group intervention to improve mental health and parenting among high-risk mothers. Muzik, M., Rosenblum, KL., Alfafara, EA., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preventing child welfare reinvolvement: The efficacy of the Reminiscing and Emotion Training intervention. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Longitudinal Effects of Reminiscing and Emotion Training on Child Maladjustment in the Context of Maltreatment and Maternal Depressive Symptoms. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluating the effects of prenatal intervention on parenting in women exposed to intimate partner violence. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Preventing child abuse: An experimental evaluation of the child parent enrichment project. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A parenting group for women dealing with child sexual abuse and substance abuse. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a reminiscing and emotion training intervention on maltreating families with preschool-aged children. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Maternal sensitive guidance during reminiscing in the context of child maltreatment: Implications for child self-regulatory processes. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Longitudinal effects of maltreatment, intimate partner violence, and Reminiscing and Emotion Training on children's diurnal cortisol regulation. [2022]

9. Austria pubmed.ncbi.nlm.nih.gov

Mom Power: preliminary outcomes of a group intervention to improve mental health and parenting among high-risk mothers. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Community-based child abuse prevention. [2019]