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Mental Health Services for Foster and Adopted Children

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ClinicalTrials.gov Identifier: NCT00056303
Recruitment Status : Completed
First Posted : March 11, 2003
Last Update Posted : December 20, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Problem Behaviors Attention Deficit Hyperactivity Disorder Depression Behavioral: Attachment and Biobehavioral Catch-up Behavioral: Developmental Education for Families Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Specialized Mental Health Services for Foster Infants
Study Start Date : December 2002
Primary Completion Date : December 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: Developmental Education for Families
Developmental Education for Families targets providing cognitive stimulation to their children.
Behavioral: Developmental Education for Families
Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.

Outcome Measures

Primary Outcome Measures :
  1. Attachment [ Time Frame: Annually ]
    The Preschool Strange Situation is conducted annually.

Secondary Outcome Measures :
  1. Executive Functioning [ Time Frame: 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.

  2. Diurnal production of cortisol [ Time Frame: Annually ]
    Three days of saliva sampling at wake-up and bedtime.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Significant medical problems
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056303

United States, Delaware
University of Delaware
Newark, Delaware, United States, 19716
Sponsors and Collaborators
University of Delaware
National Institute of Mental Health (NIMH)
Principal Investigator: Mary Dozier, Ph.D. University of Delaware
More Information

Responsible Party: Mary Dozier, UNIDEL-Amy E dupont Professor, Psychology, University of Delaware
ClinicalTrials.gov Identifier: NCT00056303     History of Changes
Other Study ID Numbers: R01MH052135 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2003    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mary Dozier, University of Delaware:

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Behavioral Symptoms