Mental Health Services for Toddlers in Foster Care

December 19, 2016 updated by: Mary Dozier, University of Delaware
Toddlers (2- to 3-year-old children) in foster care often have difficulty regulating behavior and biology, and are at risk for a host of mental health problems. Critical issues for toddlers straddle the challenges of infancy and preschool years. In particular, toddlers in foster care face significant challenges in forming new attachment relationships and developing behavioral and biological regulatory capabilities. This project will assess the effectiveness of an intervention that targets these issues. Attachment and Biobehavioral Catch-up for Toddlers in Foster Care (ABC-T) was developed to help parents: provide nurturing care so that children develop secure, trusting relationships; and supporting children when they become overwhelmed that enhance children's ability to regulate behavior and biology. This intervention's effectiveness will be assessed in a randomized clinical trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study assesses the efficacy of a 10-session intervention for young children in the foster care system. Children are randomly assigned to the experimental condition (ABC-T) or to a treatment control (DEF). In the Attachment and Biobehavioral Catch-up for Toddlers (ABC-T) condition, children's foster parents receive an intervention that focuses on nurturance, following children's lead, and helping children settle when they become overwhelmed. In the Developmental Education for Families (DEF) intervention, children's foster parents receive an intervention that focuses on enhancing children's cognitive and motor skills. Both of the interventions are provided in families' homes for 10 sessions of about 60 minutes duration. Outcomes include attachment (assessed in the Preschool Strange Situation), cortisol production (assessed diurnally), child behavior problems (assessed through laboratory procedures that stress children), and through psychiatric interviews.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19716
        • University of Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 2 -3 years of age, in foster care

Exclusion Criteria:

  • Not in foster care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Attachment and Biobehavioral Catch-up
Attachment and Biobehavioral Catch-up: 10 session intervention in foster families' homes designed to enhance parental nurturance, synchrony, and provide skills such that parents can help children calm down when overwhelmed.
Behavioral: Attachment and Biobehavioral Catch-up
Enhances nurturance, following the lead, and calming behaviors
Other Names:
  • ABC
  • ABC-T
  • Attachment and Biobehavioral Catch-up for Foster Toddlers
Active Comparator: Developmental Education for Families
10 session intervention in foster families' homes that targets cognitive and motor skills of children
Behavioral: Developmental Education for Families
Attention control: Enhances parents understanding of developmental milestones
Other Names:
  • DEF
  • Occupational Therapy/Physical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Problem behaviors
Time Frame: Annual
Assessed through laboratory measures of child behavior problems. (Disruptive Behavior Diagnostic Observation Schedule)
Annual

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attachment
Time Frame: Once at post-intervention
Assessed through Preschool Strange Situation
Once at post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortisol production
Time Frame: Annual
Diurnal cortisol assessed through saliva sampling at wake-up and bedtime
Annual

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Delaware

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (Estimate)

December 16, 2010

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIH R01 MH052135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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