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Prevention of Childhood Maltreatment in Families With Young Children

Embedding Mental Health Consultation Within Prenatal Home Visiting to Prevent Child Maltreatment and Violence Exposure

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04341376
Enrollment
200
Registered
2020-04-10
Start date
2021-01-22
Completion date
2026-01-01
Last updated
2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Exposure to Intimate Partner Violence, Child Maltreatment

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.

Interventions

BEHAVIORALEnhanced 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.

Sponsors

Bradley Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

\- Does not meet all inclusion criteria above

Design outcomes

Primary

MeasureTime frameDescription
Child Maltreatment Status6-months postpartumChild protection record review
Child Exposure to Intimate Partner Violence6-months postpartumChild protection record review
Maternal Report of Intimate Partner Violence6-months postpartumMaternal report: Conflict Tactics Scales

Secondary

MeasureTime frameDescription
Maternal anxiety symptoms6-months postpartumMaternal report: Generalized Anxiety Disorder 7-item scale
Maternal PTSD symptoms6-months postpartumMaternal report: Short Post-Traumatic Stress Disorder Rating Interview
Maternal alcohol use6-months postpartumMaternal report: Alcohol Use Disorders Test
Maternal substance use6-months postpartumMaternal report: Drug Abuse Screening Test
Maternal parenting stress6-months postpartumMaternal report: Parenting Stress Index
Family engagement in evidence based home visiting programs6-months postpartumHome visiting record review
Maternal hostility6-months postpartumObservation of free play interaction coded using Emotional Availability Scales
Maternal non-responsiveness6-months postpartumMaternal report: Maternal Responsiveness Questionnaire
Home environment6-months postpartumHome Observation for Measurement of the Environment
Mother-infant relationship6-months postpartumMaternal report: Postpartum Bonding Questionnaire
Maternal sensitivity6-months postpartumObservation of free play interaction coded using Parent Caregiver Involvement Scales and Emotional Availability Scales
Contextual stress exposure6-months postpartumMaternal report: Contextual Stress Interview
Maternal depressive symptoms6-months postpartumMaternal report: Patient Health Questionnaire-9

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026