Multi-Component Early Intervention for Socially Inhibited Preschool Children

University of Maryland

Status: Completed

Conditions: Behavioral Inhibition; Anxiety

Treatments: Behavioral: Turtle Program; Behavioral: Cool Little Kids

Study type: Interventional

Funder types: Other

Identifiers

NCT02308826

R01MH103253-01A1

Details and patient eligibility

About

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.

Enrollment: 169 patients

Sex: All

Ages: 45 to 64 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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169 participants in 2 patient groups

Turtle Program

Experimental group

Description:

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.

Treatment:

Behavioral: Turtle Program

Cool Little Kids

Active Comparator group

Description:

A 6-week parent psychoeducation group administered over an 8-week period.

Treatment:

Behavioral: Cool Little Kids