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Clinical Trials/NCT04341376
NCT04341376
Active, not recruiting
Not Applicable

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

Bradley Hospital1 site in 1 country200 target enrollmentJanuary 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child Maltreatment
Sponsor
Bradley Hospital
Enrollment
200
Locations
1
Primary Endpoint
Maternal Report of Intimate Partner Violence
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 22, 2021
End Date
January 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Exclusion Criteria

  • Does not meet all inclusion criteria above

Outcomes

Primary Outcomes

Maternal Report of Intimate Partner Violence

Time Frame: 6-months postpartum

Maternal report: Conflict Tactics Scales

Child Maltreatment Status

Time Frame: 6-months postpartum

Child protection record review

Child Exposure to Intimate Partner Violence

Time Frame: 6-months postpartum

Child protection record review

Secondary Outcomes

  • Maternal PTSD symptoms(6-months postpartum)
  • Maternal sensitivity(6-months postpartum)
  • Maternal hostility(6-months postpartum)
  • Maternal depressive symptoms(6-months postpartum)
  • Maternal non-responsiveness(6-months postpartum)
  • Home environment(6-months postpartum)
  • Mother-infant relationship(6-months postpartum)
  • Family engagement in evidence based home visiting programs(6-months postpartum)
  • Contextual stress exposure(6-months postpartum)
  • Maternal anxiety symptoms(6-months postpartum)
  • Maternal alcohol use(6-months postpartum)
  • Maternal parenting stress(6-months postpartum)
  • Maternal substance use(6-months postpartum)

Study Sites (1)

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