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

NCT03486860 | Completed

• 1 other identifier: R34MH083832
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavioral Inhibition; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Turtle Program

EXPERIMENTAL

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

Waitlist Control

OTHER

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

Behavioral: Parent Psychoeducation

Interventions

Parent Psychoeducation BEHAVIORAL

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

Waitlist Control

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.

Turtle Program

Eligibility Criteria

• Age: 42 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, College Park: lead

Study Sites (1)

University of Maryland

College Park, Maryland, 20742, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Andrea Chronis-Tuscano, Ph.D.

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Kenneth Rubin, Ph.D.

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 3, 2018
• Study Start: February 1, 2010
• Primary Completion: November 30, 2012
• Study Completion: November 30, 2012
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

US (1)