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Clinical Trials/NCT02308826
NCT02308826
Completed
N/A

Multi-Component Early Intervention for Socially Inhibited Preschool Children

University of Maryland, College Park1 site in 1 country169 target enrollmentDecember 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Behavioral Inhibition
Sponsor
University of Maryland, College Park
Enrollment
169
Locations
1
Primary Endpoint
Change in child anxiety disorder symptoms
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This project is intended to provide a rigorous test of the Turtle Program, an early intervention program for behaviorally inhibited preschoolers. The proposed project will extend promising pilot study findings by: (a) evaluating the integrated intervention in a larger sample (n = 150) of 45-64 month children and their parents, which will allow for an examination of mediators and moderators of treatment effects; (b) comparing the Turtle Program to the best available treatment for preschool behavioral inhibition, the Cool Little Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation as both baseline moderators of treatment response and as outcome measures; (d) examining parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment assessment and extending follow-up to one year.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
June 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrea Chronis-Tuscano

Professor

University of Maryland, College Park

Eligibility Criteria

Inclusion Criteria

  • child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire

Exclusion Criteria

  • child has a diagnosis of pervasive developmental disorder, selective mutism, or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety; child does not have a custodial parent who has also consented to participate

Outcomes

Primary Outcomes

Change in child anxiety disorder symptoms

Time Frame: pre-treatment, mid-treatment (week 4), post-treatment (week 8), and 1-year follow-up

Assessed with diagnostic interviews (Anxiety Disorders Interview Schedule) with parents

Study Sites (1)

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