Mental Health Services for Foster and Adopted Children

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by:

University of Delaware

ClinicalTrials.gov Identifier:

NCT00056303

First received: March 10, 2003

Last updated: November 7, 2011

Last verified: November 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 10, 2003
Last Updated Date	November 7, 2011
Start Date ^ICMJE	December 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00056303 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Mental Health Services for Foster and Adopted Children
Official Title ^ICMJE	Specialized Mental Health Services for Foster Infants
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.
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 education. Caregivers receiving the relational intervention are trained to interpret children's behaviors appropriately, to provide nurturing care, and to respond sensitively to their children's behavioral and emotional cues. Caregivers in the treatment control group receive training designed to enhance children's intellectual development. Caregivers in both groups will receive 10 home visits. Observations of children and behavior checklists are used to assess participants.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Mental Health Services Foster Home Care Adoption Family Relationships
Intervention ^ICMJE	Behavioral: Attachment and Biobehavioral Catch-up
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	200
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Infant placed into foster care Resident of Delaware and surrounding counties in Pennsylvania and Maryland Exclusion Criteria: Significant medical problems
Gender	Both
Ages	up to 20 Months
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00056303
Other Study ID Numbers ^ICMJE	R01 MH52135, R01MH052135, DSIR 84-CTCT
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	University of Delaware
Collaborators ^ICMJE	National Institute of Mental Health (NIMH)
Investigators ^ICMJE	Not Provided
Information Provided By	University of Delaware
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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