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Mental Health Services for Foster and Adopted Children

Primary Purpose

Problem Behaviors, Attention Deficit Hyperactivity Disorder, Depression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Attachment and Biobehavioral Catch-up
Developmental Education for Families
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Problem Behaviors focused on measuring Attachment, Intervention, Prevention

Eligibility Criteria

20 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Toddler placed into foster care Resident of Delaware and surrounding counties in Pennsylvania and Maryland Exclusion Criteria: Significant medical problems

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Attachment and Biobehavioral Catch-up

Developmental Education for Families

Arm Description

Attachment and Biobehavioral Catch-up targets nurturance, synchrony, and non-frightening behavior, as well as providing caregivers with help calming toddlers.

Developmental Education for Families targets providing cognitive stimulation to their children.

Outcomes

Primary Outcome Measures

Attachment
The Preschool Strange Situation is conducted annually.

Secondary Outcome Measures

Executive Functioning
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
Three days of saliva sampling at wake-up and bedtime.

Full Information

First Posted
March 10, 2003
Last Updated
December 19, 2016
Sponsor
University of Delaware
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00056303
Brief Title
Mental Health Services for Foster and Adopted Children
Official Title
Specialized Mental Health Services for Foster Infants
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problem Behaviors, Attention Deficit Hyperactivity Disorder, Depression
Keywords
Attachment, Intervention, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attachment and Biobehavioral Catch-up
Arm Type
Experimental
Arm Description
Attachment and Biobehavioral Catch-up targets nurturance, synchrony, and non-frightening behavior, as well as providing caregivers with help calming toddlers.
Arm Title
Developmental Education for Families
Arm Type
Active Comparator
Arm Description
Developmental Education for Families targets providing cognitive stimulation to their children.
Intervention Type
Behavioral
Intervention Name(s)
Attachment and Biobehavioral Catch-up
Intervention Description
Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.
Intervention Type
Behavioral
Intervention Name(s)
Developmental Education for Families
Intervention Description
Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.
Primary Outcome Measure Information:
Title
Attachment
Description
The Preschool Strange Situation is conducted annually.
Time Frame
Annually
Secondary Outcome Measure Information:
Title
Executive Functioning
Description
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.
Time Frame
Annually
Title
Diurnal production of cortisol
Description
Three days of saliva sampling at wake-up and bedtime.
Time Frame
Annually

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Toddler placed into foster care Resident of Delaware and surrounding counties in Pennsylvania and Maryland Exclusion Criteria: Significant medical problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Dozier, Ph.D.
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mental Health Services for Foster and Adopted Children

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