Enhanced First Connections for Preventing Child Abuse and Domestic Violence Exposure

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Bradley Hospital

Disqualifiers: Not pregnant, First trimester, others

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

Compensation: Varies

Number of Visits: 4

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will examine the efficacy of Enhanced First Connections, which is a short-term perinatal home visiting program that includes infant and early childhood mental health consultation. Mothers with a history of adversity or trauma will be the focus of this research. Hypothesized outcomes of Enhanced First Connections include the prevention of child maltreatment (child abuse and neglect), prevention of child exposure to adult intimate partner violence, increases in family engagement in longer-term evidence based home visiting programs, increases in family engagement in specialized support services to address maternal adversity and trauma, reductions in maternal risk factors, and the promotion of positive parenting and the parent-child relationship.

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 Enhanced First Connections for preventing child abuse and domestic violence exposure?

Research on similar home-visiting programs, like Family Connects and the Family Nurse Partnership, shows that these programs can improve parenting behaviors and reduce risks of child maltreatment by providing support and education to new parents. These findings suggest that Enhanced First Connections might also be effective in preventing child abuse and domestic violence exposure. ^{1 2 3 4 5}

How does the Enhanced First Connections treatment differ from other treatments for preventing child abuse and domestic violence exposure?

Enhanced First Connections is unique because it focuses on early home visitation to support families right after childbirth, aiming to improve parenting behaviors and mental health, which can prevent child abuse. Unlike other treatments, it provides universal support to all families in a community, not just those identified as high-risk, through short-term nurse visits. ^{2 3 6 7 8}

Research Team

Stephanie H Parade, PhD

Principal Investigator

E.P. Bradley Hospital

Eligibility Criteria

This trial is for English or Spanish-speaking pregnant women in their second or third trimester, eligible for WIC, and who have faced adversity or trauma. Women not meeting these criteria cannot participate.

Inclusion Criteria

You have experienced at least one traumatic event in your life.

Eligible for the Supplemental Nutrition Program for Women, Infants, and Children (WIC)

You are pregnant.

Exclusion Criteria

Does not meet all inclusion criteria above

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enhanced First Connections

Participants receive between four and eight home visits for risk assessment and response, including mental health consultation

4-8 weeks

4-8 home visits

Follow-up

Participants are monitored for outcomes such as child maltreatment prevention and maternal mental health at 6 months postpartum

6 months postpartum

Treatment Details

Interventions

• Enhanced First Connections

Trial Overview The study tests Enhanced First Connections, a home visiting program aiming to prevent child maltreatment and domestic violence exposure by supporting mothers with histories of adversity through mental health consultation.

Participant Groups

Group I: Enhanced First Connections Experimental Treatment 1 Intervention

Enhanced First Connections is a short-term risk assessment and response home visiting referral program. The goal of Enhanced First Connections is to identify family needs and link families to community resources, including evidence based home visiting models. Enhanced First Connections includes prenatal identification and engagement of women with an adversity or trauma history, and infant and early childhood mental health consultation. Women who enroll in Enhanced First Connections are expected to receive between four and eight home visits before being referred to other community resources.

Group II: Treatment as Usual Active Control 1 Intervention

Women who receive Treatment as Usual will follow the usual course of clinical care throughout their pregnancy and into the postpartum period, and will be eligible for the typical array of community services that may be offered to them.

Who Is Running the Clinical Trial?

Bradley Hospital

Lead Sponsor

Trials

22

Recruited

1,900+

Findings from Research

In a study of 595 children, those who underwent investigations for suspected child maltreatment did not show significant improvements in key risk factors like social support, family functioning, or child behavior by age 8, compared to those who were not investigated.

The findings suggest that Child Protection Services investigations may not effectively address or improve the underlying risk factors associated with child maltreatment, indicating a potential gap in secondary prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Household, family, and child risk factors after an investigation for suspected child maltreatment: a missed opportunity for prevention. Campbell, KA., Cook, LJ., LaFleur, BJ., et al.[2021]

The Promoting First Relationships® (PFR) program, a 10-week home visiting intervention, significantly improved parents' understanding of their toddlers' social-emotional needs and increased parental sensitivity compared to a resource and referral service, based on a study of 247 families.

Children in the PFR group were less likely to be placed into foster care (6% vs. 13%) within a year after the intervention, indicating that PFR may effectively prevent child removals in families involved with child protective services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting First Relationships®: Randomized Trial of a 10-Week Home Visiting Program With Families Referred to Child Protective Services. Oxford, ML., Spieker, SJ., Lohr, MJ., et al.[2019]

In a study involving 413 mothers, the use of interactive software in the e-Parenting Program (ePP) improved working alliance ratings at 6 months compared to standard services, indicating better engagement with the program.

However, despite the software's good acceptability, there were no significant differences in child maltreatment or risk factors between the ePP and other conditions at either the 6 or 12-month follow-ups, suggesting limited efficacy in preventing maltreatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology to Augment Early Home Visitation for Child Maltreatment Prevention: A Pragmatic Randomized Trial. Ondersma, SJ., Martin, J., Fortson, B., et al.[2018]

References

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

Household, family, and child risk factors after an investigation for suspected child maltreatment: a missed opportunity for prevention. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The effects of a universal short-term home visiting program: Two-year impact on parenting behavior and parent mental health. [2023]

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

Impact of a Child Abuse Primary Prevention Strategy for New Mothers. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Randomized trial of a statewide home visiting program: impact in preventing child abuse and neglect. [2022]

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

Nurse-led home-visitation programme for first-time mothers in reducing maltreatment and improving child health and development (BB:2-6): longer-term outcomes from a randomised cohort using data linkage. [2022]

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

Promoting First Relationships®: Randomized Trial of a 10-Week Home Visiting Program With Families Referred to Child Protective Services. [2019]

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

Trauma adapted family connections: reducing developmental and complex trauma symptomatology to prevent child abuse and neglect. [2012]

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

Technology to Augment Early Home Visitation for Child Maltreatment Prevention: A Pragmatic Randomized Trial. [2018]