Multi-Component Early Intervention for Socially Inhibited Preschool Children

Study Overview
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Brief Summary
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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.

Conditions
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Behavioral Inhibition, Anxiety

Intervention / Treatment
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* Behavioral: Turtle Program
* Behavioral: Cool Little Kids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Months
Maximum Age: 64 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Turtle Program<br>The Turtle Program involves a child social and emotional skills group (Social Skills Facilitated Play) and a modification of Parent-Child Interaction Therapy in which parents are provided in-vivo coaching in following their children's lead and encouraging approach behaviors within the peer context. The child group provides a forum of same-age peers to learn to develop social and emotion regulation skills. The Turtle Program is administered over an 8-week period. | Behavioral: Turtle Program<br> <br> |
| Active Comparator: Cool Little Kids<br>A 6-week parent psychoeducation group administered over an 8-week period. | Behavioral: Cool Little Kids<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child anxiety disorder symptoms | Assessed with diagnostic interviews (Anxiety Disorders Interview Schedule) with parents | pre-treatment, mid-treatment (week 4), post-treatment (week 8), and 1-year follow-up |