Multi-Component Early Intervention for Socially Inhibited Preschool Children

NCT02308826 | Completed

• 1 other identifier: R01MH103253-01A1
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavioral Inhibition; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in child anxiety disorder symptoms

  Assessed with diagnostic interviews (Anxiety Disorders Interview Schedule) with parents

  pre-treatment, mid-treatment (week 4), post-treatment (week 8), and 1-year follow-up

Study Arms (2)

Turtle Program

EXPERIMENTAL

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.

Behavioral: Turtle Program

Cool Little Kids

ACTIVE COMPARATOR

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

Behavioral: Cool Little Kids

Interventions

Turtle Program BEHAVIORAL

Turtle Program

Cool Little Kids BEHAVIORAL

Cool Little Kids

Eligibility Criteria

• Age: 45 Months - 64 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, College Park: lead

Study Sites (1)

Maryland ADHD Program

College Park, Maryland, 20742, United States

Location

Related Publications (4)

• Fleece H, Wagner NJ, Chronis-Tuscano A, Smith KA, Novick DR, Druskin LR, Shakiba N, Danko CM, Rubin KH. Can behaviorally inhibited preschoolers make friends? Dev Psychol. 2024 Jul;60(7):1203-1213. doi: 10.1037/dev0001742. Epub 2024 Apr 22.

  PMID: 38647467 DERIVED

• Novick DR, Meyer CT, Wagner NJ, Rubin KH, Danko CM, Dougherty LR, Druskin LR, Smith KA, Chronis-Tuscano A. Testing reciprocal associations between child anxiety and parenting across early interventions for inhibited preschoolers. J Child Psychol Psychiatry. 2023 Dec;64(12):1665-1678. doi: 10.1111/jcpp.13879. Epub 2023 Aug 29.

  PMID: 37644651 DERIVED

• Wagner NJ, Shakiba N, Bui HNT, Sem K, Novick DR, Danko CM, Dougherty LR, Chronis-Tuscano A, Rubin KH. Examining the Relations Between Children's Vagal Flexibility Across Social Stressor Tasks and Parent- and Clinician-Rated Anxiety Using Baseline Data from an Early Intervention for Inhibited Preschoolers. Res Child Adolesc Psychopathol. 2023 Aug;51(8):1213-1224. doi: 10.1007/s10802-023-01050-3. Epub 2023 Mar 24.

  PMID: 36961596 DERIVED

• Chronis-Tuscano A, Novick DR, Danko CM, Smith KA, Wagner NJ, Wang CH, Druskin L, Dougherty LR, Rubin KH. Early intervention for inhibited young children: a randomized controlled trial comparing the Turtle Program and Cool Little Kids. J Child Psychol Psychiatry. 2022 Mar;63(3):273-281. doi: 10.1111/jcpp.13475. Epub 2021 Jun 29.

  PMID: 34184792 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Andrea Chronis-Tuscano, Ph.D.

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Kenneth Rubin, Ph.D.

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

US (1)