Mental Health Services for Toddlers in Foster Care

NCT01261806 | Completed Phase 1 DMC

• 1 other identifier: NIH R01 MH052135
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavior Problems

Outcome Measures

Primary Outcomes (1)

• Problem behaviors

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

  Annual

Secondary Outcomes (1)

• Attachment

  Once at post-intervention

Other Outcomes (1)

• Cortisol production

  Annual

Study Arms (2)

Attachment and Biobehavioral Catch-up

EXPERIMENTAL

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

Developmental Education for Families

ACTIVE COMPARATOR

10 session intervention in foster families' homes that targets cognitive and motor skills of children

Behavioral: Developmental Education for Families

Interventions

Attachment and Biobehavioral Catch-up BEHAVIORAL

Enhances nurturance, following the lead, and calming behaviors

Also known as: ABC, ABC-T, Attachment and Biobehavioral Catch-up for Foster Toddlers

Attachment and Biobehavioral Catch-up

Developmental Education for Families BEHAVIORAL

Attention control: Enhances parents understanding of developmental milestones

Also known as: DEF, Occupational Therapy/Physical Therapy

Developmental Education for Families

Eligibility Criteria

• Age: 2 Years - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years of age, in foster care

You may not qualify if:

• Not in foster care

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

Related Publications (1)

• 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.

  PMID: 30230658 DERIVED

MeSH Terms

Conditions

Mental Disorders

Interventions

butyl phosphorotrithioate; Occupational Therapy; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Mary Dozier, Ph.D.

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UNIDEL-Amy E dupont Professor, Psychology

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 16, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)