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

University of Maryland

Status: Completed

Conditions: Behavioral Inhibition; Anxiety

Treatments: Behavioral: Turtle Program; Behavioral: Parent Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT03486860

R34MH083832

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 42 to 60 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Turtle Program

Experimental group

Description:

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.

Treatment:

Behavioral: Turtle Program

Waitlist Control

Other group

Description:

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

Treatment:

Behavioral: Parent Psychoeducation