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Mental Health Services for Foster and Adopted Children

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mary Dozier, University of Delaware Identifier:
First received: March 10, 2003
Last updated: December 19, 2016
Last verified: December 2016
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 Intervention Phase
Problem Behaviors
Attention Deficit Hyperactivity Disorder
Behavioral: Attachment and Biobehavioral Catch-up
Behavioral: Developmental Education for Families
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Specialized Mental Health Services for Foster Infants

Resource links provided by NLM:

Further study details as provided by Mary Dozier, University of Delaware:

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

Secondary Outcome Measures:
  • 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.

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

Enrollment: 220
Study Start Date: December 2002
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00056303     History of Changes
Other Study ID Numbers: R01MH052135 ( US NIH Grant/Contract Award Number )
Study First Received: March 10, 2003
Last Updated: December 19, 2016
Individual Participant Data  
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 processed this record on May 25, 2017