This trial is active, not recruiting.

Condition behavior problems
Treatments attachment and biobehavioral catch-up, developmental education for families
Phase phase 1
Sponsor University of Delaware
Start date April 2010
End date December 2015
Trial size 220 participants
Trial identifier NCT01261806, NIH R01 MH052135


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose prevention
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.
attachment and biobehavioral catch-up ABC
(Active Comparator)
10 session intervention in foster families' homes that targets cognitive and motor skills of children
developmental education for families DEF

Primary Outcomes

Problem behaviors
time frame: Annual

Secondary Outcomes

time frame: Once at post-intervention

Eligibility Criteria

Male or female participants from 2 years up to 3 years old.

Inclusion Criteria: - 2 -3 years of age, in foster care Exclusion Criteria: - Not in foster care

Additional Information

Official title Mental Health Services for Toddlers in Foster Care
Principal investigator Mary Dozier, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by University of Delaware.