Multi-Component Early Intervention for Socially Inhibited Preschool Children

Not Applicable

Completed

• Conditions: Behavioral Inhibition; Anxiety
• Interventions: Behavioral: Turtle Program; Behavioral: Cool Little Kids

• Registration Number: NCT02308826
• Lead Sponsor: University of Maryland, College Park

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-04
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Turtle Program	Turtle Program	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.
Cool Little Kids	Cool Little Kids	A 6-week parent psychoeducation group administered over an 8-week period.

Primary Outcome Measures

Name	Time	Method
Change in child anxiety disorder symptoms	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

Trial Locations

Locations (1)

Maryland ADHD Program; 🇺🇸 College Park, Maryland, United States