Prevention of Childhood Maltreatment in Families With Young Children

NCT ID: NCT04341376

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2026-01-01

Brief Summary

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.

Conditions

Child Maltreatment; Child Exposure to Intimate Partner Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Enhanced First Connections

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 Type: EXPERIMENTAL

Enhanced First Connections

Intervention Type: BEHAVIORAL

Enhanced First Connections is a short-term home visiting program that includes prenatal identification and engagement of women with an adversity or trauma history, and infant and early childhood mental health consultation.

Treatment as Usual

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Enhanced First Connections

Enhanced First Connections is a short-term home visiting program that includes prenatal identification and engagement of women with an adversity or trauma history, and infant and early childhood mental health consultation.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pregnant women
• Recruited in the second or third trimester of pregnancy
• At least one self-reported experience of adversity or trauma
• English or Spanish speaking

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bradley Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie H Parade, PhD

Role: PRINCIPAL_INVESTIGATOR

E.P. Bradley Hospital

Locations

E.P. Bradley Hospital

East Providence, Rhode Island, United States

Countries

United States

Other Identifiers

R01CE003103

Identifier Type: NIH

Identifier Source: org_study_id

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