MedDataX Logo

Mental Health Services for Toddlers in Foster Care

NCT ID: NCT01261806

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Behavior Problems

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Attachment and Biobehavioral Catch-up

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.

Group Type EXPERIMENTAL

Attachment and Biobehavioral Catch-up

Intervention Type BEHAVIORAL

Enhances nurturance, following the lead, and calming behaviors

Developmental Education for Families

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

Group Type ACTIVE_COMPARATOR

Developmental Education for Families

Intervention Type BEHAVIORAL

Attention control: Enhances parents understanding of developmental milestones

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Attachment and Biobehavioral Catch-up

Enhances nurturance, following the lead, and calming behaviors

Intervention Type BEHAVIORAL

Developmental Education for Families

Attention control: Enhances parents understanding of developmental milestones

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABC ABC-T Attachment and Biobehavioral Catch-up for Foster Toddlers DEF Occupational Therapy/Physical Therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 2 -3 years of age, in foster care

Exclusion Criteria

* Not in foster care
Minimum Eligible Age

2 Years

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Delaware

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mary Dozier

UNIDEL-Amy E dupont Professor, Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mary Dozier, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Delaware

Newark, Delaware, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30230658 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIH R01 MH052135

Identifier Type: -

Identifier Source: org_study_id