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Multi-Component Early Intervention for Socially Inhibited Preschool Children

NCT02308826 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Turtle Program

BEHAVIORAL

Cool Little Kids

Sponsors & Collaborators

  • University of Maryland, College Park

    lead OTHER

Principal Investigators

  • Andrea Chronis-Tuscano, Ph.D. · University of Maryland

  • Kenneth Rubin, Ph.D. · University of Maryland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Months
Max Age
64 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02308826 on ClinicalTrials.gov