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Mental Health Services for Foster and Adopted Children

Specialized Mental Health Services for Foster Infants

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00056303
Enrollment
220
Registered
2003-03-11
Start date
2002-12-31
Completion date
2016-12-31
Last updated
2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder, Depression, Problem Behaviors

Keywords

Attachment, Intervention, Prevention

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 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.

Interventions

Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Months to 36 Months
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

Design outcomes

Primary

MeasureTime frameDescription
AttachmentAnnuallyThe Preschool Strange Situation is conducted annually.

Secondary

MeasureTime frameDescription
Executive FunctioningAnnuallyDisruptive 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 cortisolAnnuallyThree days of saliva sampling at wake-up and bedtime.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026