Mental Health Services for Foster and Adopted Children

Depression Clinical Trial

Official title:

Specialized Mental Health Services for Foster Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056303
• Other study ID #: R01MH052135
• Secondary ID: R01MH052135DSIR
• Status: Completed
• Phase: Phase 1
• First received: March 10, 2003
• Last updated: December 19, 2016
• Start date: December 2002
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Months to 36 Months

Eligibility

Inclusion Criteria:

• Toddler placed into foster care

• Resident of Delaware and surrounding counties in Pennsylvania and Maryland

Exclusion Criteria:

• Significant medical problems

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Depression
• Problem Behavior
• Problem Behaviors

Intervention

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.
• Developmental Education for Families
Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
University of Delaware	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attachment	The Preschool Strange Situation is conducted annually.	Annually	No
Secondary	Executive Functioning	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.	Annually	No
Secondary	Diurnal production of cortisol	Three days of saliva sampling at wake-up and bedtime.	Annually	No