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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-01

Study Completion Date

2012-11-30

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.

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Detailed Description

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Conditions

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Behavioral Inhibition Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Turtle Program

Intervention Type 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.

Waitlist Control

Untreated comparison group during the study, received parent psychoeducation intervention after the active treatment group.

Group Type OTHER

Parent Psychoeducation

Intervention Type BEHAVIORAL

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

Interventions

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Parent Psychoeducation

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

42 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes