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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


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
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