A Multi-Method Early Intervention Program for Inhibited and Anxious Preschoolers

Not Applicable

Completed

• Conditions: Behavioral Inhibition; Anxiety
• Interventions: Behavioral: Turtle Program; Behavioral: Parent Psychoeducation

• Registration Number: NCT03486860
• Lead Sponsor: University of Maryland, College Park

Brief Summary

This project aims to develop and evaluate a novel early intervention program that targets the specific risk factors implicated in the development and persistence of shyness, social reticence, and withdrawal in children. The project includes a program development phase, Phase I (pilot test of full study procedures using developed treatment protocol), and Phase II (randomized controlled trial/RCT). Outcomes that will be assessed include change in child behavioral inhibition and parenting, using parent and teacher reports and observational data. Families are assessed at three time points: baseline, post-treatment (or at approximately 8 weeks for the control group), and 2 month follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Primary Completion: 2012-11-30
• Study Completion: 2012-11-30
• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire; child has a biological parent with at least 50% physical custody who consents to participate

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Exclusion Criteria

• Child has a diagnosis of pervasive developmental disorder or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Turtle Program	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.
Waitlist Control	Parent Psychoeducation	Untreated comparison group during the study, received parent psychoeducation intervention after the active treatment group.

Primary Outcome Measures

Name	Time	Method
Change in child anxiety disorder symptoms	Pre-treatment (baseline), post-treatment (week 8), and 2-month follow-up	Assessed with diagnostic interviews (Preschool Age Psychiatric Assessment) with parents

Trial Locations

Locations (1)

University of Maryland; 🇺🇸 College Park, Maryland, United States