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Mental Health Services for Foster and Adopted Children

NCT ID: NCT00056303

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Problem Behaviors Attention Deficit Hyperactivity Disorder Depression

Keywords

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Attachment Intervention Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Attachment and Biobehavioral Catch-up

Intervention Type BEHAVIORAL

Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.

Developmental Education for Families

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

Group Type ACTIVE_COMPARATOR

Developmental Education for Families

Intervention Type BEHAVIORAL

Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.

Interventions

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Attachment and Biobehavioral Catch-up

Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.

Intervention Type BEHAVIORAL

Developmental Education for Families

Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Significant medical problems
Minimum Eligible Age

20 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Delaware

OTHER

Sponsor Role lead

Responsible Party

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Mary Dozier

UNIDEL-Amy E dupont Professor, Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Dozier, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

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University of Delaware

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH052135

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 84-CTCT

Identifier Type: -

Identifier Source: secondary_id

R01MH052135

Identifier Type: NIH

Identifier Source: org_study_id

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