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

Study Overview
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Brief Summary
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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.

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

Conditions
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Behavioral Inhibition, Anxiety

Intervention / Treatment
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* Behavioral: Parent Psychoeducation
* Behavioral: Turtle Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 42 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Turtle Program<br>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<br>* 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.<br>|
| Other: Waitlist Control<br>Untreated comparison group during the study, received parent psychoeducation intervention after the active treatment group. | Behavioral: Parent Psychoeducation<br>* 6-session parent psychoeducation group on child anxiety, following their children's lead, and encouraging approach behaviors.<br>|

What is the study measuring?
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Primary Outcome Measures

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