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Mental Health Services for Toddlers in Foster Care

Primary Purpose

Behavior Problems

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Attachment and Biobehavioral Catch-up
Developmental Education for Families
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Behavior Problems

Eligibility Criteria

2 Years - 3 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 2 -3 years of age, in foster care

Exclusion Criteria:

  • Not in foster care

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Attachment and Biobehavioral Catch-up

Developmental Education for Families

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Attachment
Assessed through Preschool Strange Situation

Full Information

First Posted
December 14, 2010
Last Updated
December 19, 2016
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT01261806
Brief Title
Mental Health Services for Toddlers in Foster Care
Official Title
Mental Health Services for Toddlers in Foster Care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problems

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attachment and Biobehavioral Catch-up
Arm Type
Experimental
Arm Description
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.
Arm Title
Developmental Education for Families
Arm Type
Active Comparator
Arm Description
10 session intervention in foster families' homes that targets cognitive and motor skills of children
Intervention Type
Behavioral
Intervention Name(s)
Attachment and Biobehavioral Catch-up
Other Intervention Name(s)
ABC, ABC-T, Attachment and Biobehavioral Catch-up for Foster Toddlers
Intervention Description
Enhances nurturance, following the lead, and calming behaviors
Intervention Type
Behavioral
Intervention Name(s)
Developmental Education for Families
Other Intervention Name(s)
DEF, Occupational Therapy/Physical Therapy
Intervention Description
Attention control: Enhances parents understanding of developmental milestones
Primary Outcome Measure Information:
Title
Problem behaviors
Description
Assessed through laboratory measures of child behavior problems. (Disruptive Behavior Diagnostic Observation Schedule)
Time Frame
Annual
Secondary Outcome Measure Information:
Title
Attachment
Description
Assessed through Preschool Strange Situation
Time Frame
Once at post-intervention
Other Pre-specified Outcome Measures:
Title
Cortisol production
Description
Diurnal cortisol assessed through saliva sampling at wake-up and bedtime
Time Frame
Annual

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 2 -3 years of age, in foster care Exclusion Criteria: Not in foster care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Dozier, Ph.D.
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19716
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30230658
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.
Results Reference
derived

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Mental Health Services for Toddlers in Foster Care

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