Skip to main content
OpenTrials
Completed

NCT Number: NCT02308826

Multi-Component Early Intervention for Socially Inhibited Preschool Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Behavioral Inhibition Anxiety Anxiety Disorders Mental Disorders

Age range

45 month–64 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maryland ADHD Program

College Park, Maryland, 20742, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Turtle Program

Behavioral

Cool Little Kids

Behavioral

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2014
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.