Skip to main content
OpenTrials
Completed

NCT Number: NCT01261806

Mental Health Services for Toddlers in Foster Care

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Behavior Problems Mental Disorders

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 2 -3 years of age, in foster care

Exclusion criteria

  • Not in foster care

Treatment and study plan

Attachment and Biobehavioral Catch-Up

Behavioral

Enhances nurturance, following the lead, and calming behaviors

Other names: ABC, ABC-T, Attachment and Biobehavioral Catch-up for Foster Toddlers

Developmental Education for Families

Behavioral

Attention control: Enhances parents understanding of developmental milestones

Other names: DEF, Occupational Therapy/Physical Therapy

Primary outcomes

  1. Problem behaviors

    Time frame: Annual

    Assessed through laboratory measures of child behavior problems. (Disruptive Behavior Diagnostic Observation Schedule)

Secondary outcomes

  1. Attachment

    Time frame: Once at post-intervention

    Assessed through Preschool Strange Situation

Other outcomes

  1. Cortisol production

    Time frame: Annual

    Diurnal cortisol assessed through saliva sampling at wake-up and bedtime

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2010
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.