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

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.

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Key information

Conditions

Behavioral Inhibition Anxiety Anxiety Disorders Mental Disorders

Age range

42 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland

College Park, Maryland, 20742, United States

Who can participate

Healthy volunteers accepted: Yes

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; child has a biological parent with at least 50% physical custody who consents to participate

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

Treatment and study plan

Parent psychoeducation

Behavioral

6-session parent psychoeducation group on child anxiety, following their children's lead, and encouraging approach behaviors.

Turtle Program

Behavioral

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.

Primary outcomes

Change in child anxiety disorder symptoms

Time frame: Pre-treatment (baseline), post-treatment (week 8), and 2-month follow-up

Assessed with diagnostic interviews (Preschool Age Psychiatric Assessment) with parents

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Apr 3, 2018
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.

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

Completed