Clinical trial NCT01261806: Mental Health Services for Toddlers in Foster Care
Official title: Mental Health Services for Toddlers in Foster Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Behavior Problems
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 220
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 criteria: Inclusion Criteria:

* 2 -3 years of age, in foster care

Exclusion Criteria:

* Not in foster care

Primary outcomes:
measure: Problem behaviors
timeFrame: Annual
Secondary outcomes:
measure: Attachment
timeFrame: Once at post-intervention
Other outcomes:
measure: Cortisol production
timeFrame: Annual
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Mary Dozier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raby KL, Freedman E, Yarger HA, Lind T, Dozier M. Enhancing the language development of toddlers in foster care by promoting foster parents' sensitivity: Results from a randomized controlled trial. Dev Sci. 2019 Mar;22(2):e12753. doi: 10.1111/desc.12753. Epub 2018 Oct 3.