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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a program called Enhanced First Connections in preventing child abuse and domestic violence. The program involves home visits for expectant mothers who have experienced adversity or trauma. It seeks to prevent child maltreatment and violence exposure, promote family involvement in long-term support, and enhance parenting skills and relationships. Pregnant women in their second or third trimester who have faced adversity or trauma and speak English or Spanish may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to significant research that could improve support programs for families in need.

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 prior data suggests that the Enhanced First Connections program is safe?

Research has shown that programs like Enhanced First Connections, which focus on early childhood support, lead to positive safety outcomes. Studies indicate that similar programs can reduce child abuse and neglect, suggesting general safety. Enhanced First Connections includes home visits and mental health support to assist families with a history of trauma.

Although specific safety data for Enhanced First Connections is unavailable, similar programs have been used safely. Participants often feel more supported and connected to community resources, reducing stress and improving family relationships—especially crucial for those with past trauma.

While specific data on Enhanced First Connections is limited, the safe use of similar programs suggests it is likely a safe and beneficial program for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Enhanced First Connections because it offers a proactive and personalized approach to preventing child abuse and domestic violence exposure. Unlike typical care options that might not be as targeted, this program focuses on early identification of families at risk and provides tailored support through home visits. By directly linking families to community resources and addressing mental health needs early on, Enhanced First Connections aims to create a stronger safety net for vulnerable families, potentially leading to better long-term outcomes.

What evidence suggests that Enhanced First Connections is effective for preventing child abuse and domestic violence exposure?

Research has shown that programs like Enhanced First Connections, a treatment option in this trial, focus on early help and home visits, effectively preventing child abuse and domestic violence. Studies have found that these programs improve family communication and problem-solving, reducing partner violence and harm to children. Evidence also suggests that involving families in supportive services lowers risks for mothers and encourages positive parenting. For families with a history of trauma, these programs significantly connect them to community resources and support networks. Overall, these interventions create safer and more supportive environments for both children and mothers. ^{5 6 7 8 9}

Who Is on the Research Team?

Stephanie H Parade, PhD

Principal Investigator

E.P. Bradley Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10913357/

Effectiveness of Violence Prevention Interventions Regardless of the level of intervention, violence prevention programs need to be supported by evidence of their efficacy (,World Health Organization, 2022).

2. stacks.cdc.gov stacks.cdc.gov/view/cdc/119299/cdc_119299_DS3.pdf

Appendix Preventing Adverse Childhood Experiences Appendix Table 1. Examples of Recent CDC-Supported Etiological Research Findings Focused on Adverse Childhood Experiences. (ACEs). Focus area. Research aims.

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK401349/

IMPRoving Outcomes for children exposed to domestic ... - NCBI Domestic violence and abuse (DVA) is threatening behaviour, violence or abuse between adults who are relatives, partners or ex-partners.1 It is a breach of ...

4. thelancet.com thelancet.com/journals/lanpub/article/PIIS2468-2667(24)00048-3/fulltext

Interventions that prevent or respond to intimate partner ... Key mechanisms for reducing IPV and VAC in primary prevention interventions included improved communication, conflict resolution, reflection on harmful gender ...

5. journals.copmadrid.org journals.copmadrid.org/pi/art/pi2025a6

Effectiveness Evaluation of a Violence Prevention ... This two-arm randomized controlled trial examined the effectiveness of the parenting program, the ACT Action Program - Raising Safe Kids, on parenting ...

6. acf.gov acf.gov/cb/data-research

Data & Research DART is responsible for collecting, processing, analyzing, and disseminating program data including AFCARS, NYTD, Family First Prevention Data, and NCANDS.

7. cdc.gov cdc.gov/violence-prevention/media/pdf/resources-for-action/CV-Prevention-Resource-for-Action_508.pdf

Community Violence Prevention Resource for Action Policies and programs that improve the social and economic conditions of youth, young adults, families, and communities can have the largest impacts on health.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190740920305405

Pathways to prevention: Early Head Start outcomes in the ... Short term impacts of early childhood programs can lead to reduced child maltreatment. · Children who benefited from Early Head Start's positive effects on ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12144326/

Child Protection Responses to Domestic Violence Exposure Childhood exposure to domestic violence (CEDV) poses significant risks to children's safety and wellbeing, yet its prevalence and impact on ...