Prevention of Childhood Maltreatment in Families With Young Children

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Child Maltreatment; Child Exposure to Intimate Partner Violence
• Intervention / Treatment: Behavioral: Enhanced First Connections

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • East Providence, Rhode Island, United States, 02915
      • E.P. Bradley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant women
• Recruited in the second or third trimester of pregnancy
• Eligible for the Supplemental Nutrition Program for Women, Infants, and Children (WIC)
• At least one self-reported experience of adversity or trauma
• English or Spanish speaking

Exclusion Criteria:

- Does not meet all inclusion criteria above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family engagement in evidence based home visiting programs	Home visiting record review	6-months postpartum
Contextual stress exposure	Maternal report: Contextual Stress Interview	6-months postpartum
Maternal depressive symptoms	Maternal report: Patient Health Questionnaire-9	6-months postpartum
Maternal anxiety symptoms	Maternal report: Generalized Anxiety Disorder 7-item scale	6-months postpartum
Maternal PTSD symptoms	Maternal report: Short Post-Traumatic Stress Disorder Rating Interview	6-months postpartum
Maternal alcohol use	Maternal report: Alcohol Use Disorders Test	6-months postpartum
Maternal substance use	Maternal report: Drug Abuse Screening Test	6-months postpartum
Maternal parenting stress	Maternal report: Parenting Stress Index	6-months postpartum
Maternal sensitivity	Observation of free play interaction coded using Parent Caregiver Involvement Scales and Emotional Availability Scales	6-months postpartum
Maternal hostility	Observation of free play interaction coded using Emotional Availability Scales	6-months postpartum
Maternal non-responsiveness	Maternal report: Maternal Responsiveness Questionnaire	6-months postpartum
Home environment	Home Observation for Measurement of the Environment	6-months postpartum
Mother-infant relationship	Maternal report: Postpartum Bonding Questionnaire	6-months postpartum

Collaborators and Investigators

• Sponsor: Bradley Hospital
• Investigators: Principal Investigator: Stephanie H Parade, PhD, E.P. Bradley Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: R01CE003103 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No