Mental Health Services for Foster and Adopted Children

Phase 1

Completed

• Conditions: Attention Deficit Hyperactivity Disorder; Depression; Problem Behaviors
• Interventions: Behavioral: Developmental Education for Families; Behavioral: Attachment and Biobehavioral Catch-up

• Registration Number: NCT00056303
• Lead Sponsor: University of Delaware

Brief Summary

This study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.

Detailed Description

Infants and toddlers who are placed into foster or adoptive care often exhibit a number of behavioral, emotional, and physiological problems. In the absence of specialized services, problems in the relationship between caregiver and child may develop; problems in the child's functioning often persist and are exacerbated. This study will attempt to alleviate the attachment and regulatory difficulties that affect many young children placed into care.

Children are randomly assigned to either an experimental group or to a treatment control group for 3 years. The experimental group focuses on relational issues; the control group focuses on cognitive development. Caregivers receiving the relational intervention are trained to provide nurturing care, and to help children learn to develop adequate regulatory skills. Caregivers in the treatment control group receive training designed to enhance children's cognitive development. Caregivers in both groups will receive 10 home visits. Observations of children and parents are used to assess participants.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2003-03-10
• Study First Submitted QC: 2003-03-10
• Study First Posted: 2003-03-11
• 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

• Toddler placed into foster care
• Resident of Delaware and surrounding counties in Pennsylvania and Maryland

Exclusion Criteria

• Significant medical problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Developmental Education for Families	Developmental Education for Families	Developmental Education for Families targets providing cognitive stimulation to their children.
Attachment and Biobehavioral Catch-up	Attachment and Biobehavioral Catch-up	Attachment and Biobehavioral Catch-up targets nurturance, synchrony, and non-frightening behavior, as well as providing caregivers with help calming toddlers.

Primary Outcome Measures

Name	Time	Method
Attachment	Annually	The Preschool Strange Situation is conducted annually.

Secondary Outcome Measures

Name	Time	Method
Executive Functioning	Annually	Disruptive Behaviors-Diagnostic Observation Schedule (DB-DOS) is used to assess problem behaviors. The DB-DOS consists of a series of challenging tasks that ask the child to inhibit prepotent behaviors and regulate emotions.
Diurnal production of cortisol	Annually	Three days of saliva sampling at wake-up and bedtime.

Trial Locations

Locations (1)

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