Prevention of Childhood Maltreatment in Families With Young Children
Embedding Mental Health Consultation Within Prenatal Home Visiting to Prevent Child Maltreatment and Violence Exposure
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2020
CompletedFirst Posted
Study publicly available on registry
April 10, 2020
CompletedStudy Start
First participant enrolled
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedJanuary 23, 2025
January 1, 2025
4.9 years
April 6, 2020
January 21, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Child Maltreatment Status
Child protection record review
6-months postpartum
Child Exposure to Intimate Partner Violence
Child protection record review
6-months postpartum
Maternal Report of Intimate Partner Violence
Maternal report: Conflict Tactics Scales
6-months postpartum
Secondary Outcomes (13)
Family engagement in evidence based home visiting programs
6-months postpartum
Contextual stress exposure
6-months postpartum
Maternal depressive symptoms
6-months postpartum
Maternal anxiety symptoms
6-months postpartum
Maternal PTSD symptoms
6-months postpartum
- +8 more secondary outcomes
Study Arms (2)
Enhanced First Connections
EXPERIMENTALEnhanced 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.
Treatment as Usual
NO INTERVENTIONWomen 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bradley Hospitallead
Study Sites (1)
E.P. Bradley Hospital
East Providence, Rhode Island, 02915, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie H Parade, PhD
E.P. Bradley Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2020
First Posted
April 10, 2020
Study Start
January 22, 2021
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
January 23, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- A de-identified dataset will be made available within 30 months following completion of the project or at the time of the publication of manuscripts that present the main aims of the study
- Access Criteria
- A public use de-identified dataset that does not include sensitive or potentially identifiable information will be made broadly available. For datasets that include sensitive or potentially identifiable information, data-use agreements will be put in place with appropriate restrictions prior to the provision of data.
Final datasets generated from questionnaire, interview, and observational assessments will be cleaned and merged using SPSS syntax to generate a final dataset for analysis. A public use de-identified dataset that does not include sensitive or potentially identifiable information will be made available. For datasets that include sensitive or potentially identifiable information, data-use agreements will be put in place with appropriate restrictions prior to the provision of data. To ensure that released data have appropriate documentation, a data dictionary will accompany all de-identified datasets that includes data collection methods, measures and variable construction, and potential limitations of use.