Mental Health Services for Toddlers in Foster Care

Phase 1

Completed

• Conditions: Behavior Problems
• Interventions: Behavioral: Attachment and Biobehavioral Catch-up; Behavioral: Developmental Education for Families

• Registration Number: NCT01261806
• Lead Sponsor: University of Delaware

Brief Summary

Toddlers (2- to 3-year-old children) in foster care often have difficulty regulating behavior and biology, and are at risk for a host of mental health problems. Critical issues for toddlers straddle the challenges of infancy and preschool years. In particular, toddlers in foster care face significant challenges in forming new attachment relationships and developing behavioral and biological regulatory capabilities. This project will assess the effectiveness of an intervention that targets these issues. Attachment and Biobehavioral Catch-up for Toddlers in Foster Care (ABC-T) was developed to help parents: provide nurturing care so that children develop secure, trusting relationships; and supporting children when they become overwhelmed that enhance children's ability to regulate behavior and biology. This intervention's effectiveness will be assessed in a randomized clinical trial.

Detailed Description

This study assesses the efficacy of a 10-session intervention for young children in the foster care system. Children are randomly assigned to the experimental condition (ABC-T) or to a treatment control (DEF). In the Attachment and Biobehavioral Catch-up for Toddlers (ABC-T) condition, children's foster parents receive an intervention that focuses on nurturance, following children's lead, and helping children settle when they become overwhelmed. In the Developmental Education for Families (DEF) intervention, children's foster parents receive an intervention that focuses on enhancing children's cognitive and motor skills. Both of the interventions are provided in families' homes for 10 sessions of about 60 minutes duration. Outcomes include attachment (assessed in the Preschool Strange Situation), cortisol production (assessed diurnally), child behavior problems (assessed through laboratory procedures that stress children), and through psychiatric interviews.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• 2 -3 years of age, in foster care

Exclusion Criteria

• Not in foster care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attachment and Biobehavioral Catch-up	Attachment and Biobehavioral Catch-up	Attachment and Biobehavioral Catch-up: 10 session intervention in foster families' homes designed to enhance parental nurturance, synchrony, and provide skills such that parents can help children calm down when overwhelmed.
Developmental Education for Families	Developmental Education for Families	10 session intervention in foster families' homes that targets cognitive and motor skills of children

Primary Outcome Measures

Name	Time	Method
Problem behaviors	Annual	Assessed through laboratory measures of child behavior problems. (Disruptive Behavior Diagnostic Observation Schedule)

Secondary Outcome Measures

Name	Time	Method
Attachment	Once at post-intervention	Assessed through Preschool Strange Situation

Trial Locations

Locations (1)

University of Delaware; 🇺🇸 Newark, Delaware, United States