Multi-Component Early Intervention for Socially Inhibited Preschool Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 169
- Locations
- 1
- Primary Endpoint
- Change in child anxiety disorder symptoms
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Months to 64 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Turtle Program (Behavioral)
Cool Little Kids
A 6-week parent psychoeducation group administered over an 8-week period.
Intervention: Cool Little Kids (Behavioral)
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrea Chronis-Tuscano
Professor
University of Maryland, College Park