Prevention of Childhood Maltreatment in Families With Young Children

Child Maltreatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04341376
• Other study ID #: R01CE003103
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: July 2023
• Source: Bradley Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: July 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Child Exposure to Intimate Partner Violence
• Child Maltreatment

Intervention

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.

Locations

Country	Name	City	State
United States	E.P. Bradley Hospital	East Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Bradley Hospital

Country where clinical trial is conducted

United States, 

Outcome

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