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Mental Health Services for Foster and Adopted Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00056303
First Posted: March 11, 2003
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mary Dozier, University of Delaware
March 10, 2003
March 11, 2003
December 20, 2016
December 2002
December 2016   (Final data collection date for primary outcome measure)
Attachment [ Time Frame: Annually ]
The Preschool Strange Situation is conducted annually.
Not Provided
Complete list of historical versions of study NCT00056303 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Mental Health Services for Foster and Adopted Children
Specialized Mental Health Services for Foster Infants
This study will determine the effectiveness of a relationship-based intervention in improving the interaction between caregivers and young children placed in their care.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
  • Problem Behaviors
  • Attention Deficit Hyperactivity Disorder
  • Depression
  • 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.
  • Behavioral: Developmental Education for Families
    Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.
  • 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.
    Intervention: Behavioral: Attachment and Biobehavioral Catch-up
  • Active Comparator: Developmental Education for Families
    Developmental Education for Families targets providing cognitive stimulation to their children.
    Intervention: Behavioral: Developmental Education for Families
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
December 2016
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Significant medical problems
Sexes Eligible for Study: All
20 Months to 36 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00056303
R01MH052135( U.S. NIH Grant/Contract )
R01MH052135 ( U.S. NIH Grant/Contract )
DSIR 84-CTCT
Yes
Not Provided
Plan to Share IPD: No
Mary Dozier, University of Delaware
University of Delaware
National Institute of Mental Health (NIMH)
Principal Investigator: Mary Dozier, Ph.D. University of Delaware
University of Delaware
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP