Mental Health Services for Toddlers in Foster Care

Behavior Problems Clinical Trial

Official title:

Mental Health Services for Toddlers in Foster Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261806
• Other study ID #: NIH R01 MH052135
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2010
• Last updated: December 19, 2016
• Start date: April 2010
• 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: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 3 Years

Eligibility

Inclusion Criteria:

• 2 -3 years of age, in foster care

Exclusion Criteria:

• Not in foster care

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

• Behavior Problems
• Problem Behavior

Intervention

Behavioral:
• Attachment and Biobehavioral Catch-up
Enhances nurturance, following the lead, and calming behaviors
• Developmental Education for Families
Attention control: Enhances parents understanding of developmental milestones

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cortisol production	Diurnal cortisol assessed through saliva sampling at wake-up and bedtime	Annual	No
Primary	Problem behaviors	Assessed through laboratory measures of child behavior problems. (Disruptive Behavior Diagnostic Observation Schedule)	Annual	No
Secondary	Attachment	Assessed through Preschool Strange Situation	Once at post-intervention	No