Mental Health Services for Foster and Adopted Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mary Dozier, University of Delaware
ClinicalTrials.gov Identifier:
NCT00056303
First received: March 10, 2003
Last updated: December 15, 2013
Last verified: December 2013
  Purpose

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
Depression
Behavioral: Attachment and Biobehavioral Catch-up
Behavioral: Developmental Education for Families
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Delaware:

Primary Outcome Measures:
  • Attachment [ Time Frame: Annually ] [ Designated as safety issue: No ]
    The Preschool Strange Situation is conducted annually.


Secondary Outcome Measures:
  • Problem behaviors [ Time Frame: Annually ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Three days of saliva sampling at wake-up and bedtime.


Enrollment: 220
Study Start Date: December 2002
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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.

  Eligibility

Ages Eligible for Study:   20 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00056303

Locations
United States, Delaware
University of Delaware
Newark, Delaware, United States, 19716
Sponsors and Collaborators
University of Delaware
Investigators
Principal Investigator: Mary Dozier, Ph.D. University of Delaware
  More Information

No publications provided

Responsible Party: Mary Dozier, UNIDEL-Amy E dupont Professor, Psychology, University of Delaware
ClinicalTrials.gov Identifier: NCT00056303     History of Changes
Other Study ID Numbers: R01 MH52135, R01MH052135, DSIR 84-CTCT
Study First Received: March 10, 2003
Last Updated: December 15, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Delaware:
Attachment
Intervention
Prevention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Behavioral Symptoms
Mood Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014