Mental Health Services for Toddlers in Foster Care

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mary Dozier, University of Delaware
ClinicalTrials.gov Identifier:
NCT01261806
First received: December 14, 2010
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Behavior Problems
Behavioral: Attachment and Biobehavioral Catch-up
Behavioral: Developmental Education for Families
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mental Health Services for Toddlers in Foster Care

Resource links provided by NLM:


Further study details as provided by University of Delaware:

Primary Outcome Measures:
  • Problem behaviors [ Time Frame: Annual ] [ Designated as safety issue: No ]
    Assessed through laboratory measures of child behavior problems. (Disruptive Behavior Diagnostic Observation Schedule)


Secondary Outcome Measures:
  • Attachment [ Time Frame: Once at post-intervention ] [ Designated as safety issue: No ]
    Assessed through Preschool Strange Situation


Other Outcome Measures:
  • Cortisol production [ Time Frame: Annual ] [ Designated as safety issue: No ]
    Diurnal cortisol assessed through saliva sampling at wake-up and bedtime


Enrollment: 220
Study Start Date: April 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Other Names:
  • DEF
  • Occupational Therapy/Physical Therapy

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.

  Eligibility

Ages Eligible for Study:   2 Years to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 2 -3 years of age, in foster care

Exclusion Criteria:

  • Not in foster care
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261806

Locations
United States, Delaware
University of Delaware
Newark, Delaware, United States, 19716
Sponsors and Collaborators
University of Delaware
Investigators
Principal Investigator: Mary Dozier, Ph.D. University of Delaware
  More Information

No publications provided

Responsible Party: Mary Dozier, UNIDEL-Amy E dupont Professor, Psychology, University of Delaware
ClinicalTrials.gov Identifier: NCT01261806     History of Changes
Other Study ID Numbers: NIH R01 MH052135
Study First Received: December 14, 2010
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 22, 2014