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NCT01261806 · ClinicalTrials.gov registry record · Phase 1

Mental Health Services for Toddlers in Foster Care

A Phase 1 study, sponsored by University of Delaware.

Completed
Registry status
Phase 1
Development phase
220
Enrollment target

NCT01261806: Completed Phase 1 study, sponsored by University of Delaware.

NCT01261806 is a Phase 1 study that has completed, run by University of Delaware. The registered enrollment target is 220 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (267% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01261806, a Phase 1 study, has completed, sponsored by University of Delaware.

COMPLETED
Registry status
Phase 1
Development phase
220 participants
Enrollment target

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.

Primary Outcome

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

Interventions

  • BEHAVIORAL Attachment and Biobehavioral Catch-up
  • BEHAVIORAL Developmental Education for Families

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2010-04
Est. Completion 2016-12
Phase Phase 1
University of Delaware

106 total trials

What the finished NCT01261806 record still lists

NCT01261806 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (267% higher).

The record links to 0 conditions, and to 2 interventions - of which Attachment and Biobehavioral Catch-up is the first listed.

NCT01261806 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01261806 about?

NCT01261806 is a clinical study titled "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 significan...

What is the current status of trial NCT01261806?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2010-04. Estimated completion is 2016-12.

What interventions are being tested in trial NCT01261806?

The interventions under investigation include: Attachment and Biobehavioral Catch-up (BEHAVIORAL), Developmental Education for Families (BEHAVIORAL).

Who is sponsoring clinical trial NCT01261806?

This trial is sponsored by University of Delaware, which has 106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01261806's enrollment target sits among peer trials

220 230th of 2000 higher than 1,763 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01261806, the US trial registry maintained by the National Library of Medicine. NCT01261806 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.