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CompletedNCT01261806Updated Dec 20, 2016

Mental Health Services for Toddlers in Foster Care

A Phase 1 interventional study of Attachment and Biobehavioral Catch-up and Developmental Education for Families in Behavior Problems, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 2 Years to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-20.

Sponsored by University of Delaware · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
2 Years to 3 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Behavior Problems

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03

In context

Problem Behavior

517 studies on the registry are indexed under Problem Behavior; 92 are open to participants now.

This study's enrollment of 220 is above the median of 90 across 391 interventional studies indexed under Problem Behavior.

Browse Problem Behavior studies →

Lead sponsor

University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 3 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 2 -3 years of age, in foster care

Exclusion criteria

Exclusion Criteria:

  • Not in foster care
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Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Attachment and Biobehavioral Catch-up

  • Active comparator
    Developmental Education for Families

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

    Behavioral: Developmental Education for Families

Interventions

  • BehavioralAttachment and Biobehavioral Catch-up

    Enhances nurturance, following the lead, and calming behaviors

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

  • BehavioralDevelopmental Education for Families

    Attention control: Enhances parents understanding of developmental milestones

    Also known as: DEF, Occupational Therapy/Physical Therapy

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What researchers measure

Primary outcomes

  1. Problem behaviors

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

    Time frame: Annual

Secondary outcomes

  1. Attachment

    Assessed through Preschool Strange Situation

    Time frame: Once at post-intervention

Other outcomes

  1. Cortisol production

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

    Time frame: Annual

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Study locations

1 site
  • University of Delaware
    Newark, Delaware 19716, United States
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References and documents

Publications

  • 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. PubMed 30230658 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01261806
Lead sponsor
University of Delaware
Responsible party
Mary Dozier (UNIDEL-Amy E dupont Professor, Psychology, University of Delaware) — Principal investigator
First posted
Dec 16, 2010
Start date
Apr 2010
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Dec 20, 2016

Study contacts

Mary Dozier, Ph.D.
principal investigator · University of Delaware

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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