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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03486860
Enrollment
51
Registered
2018-04-03
Start date
2010-02-01
Completion date
2012-11-30
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Behavioral Inhibition

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.

Interventions

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

BEHAVIORALTurtle 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.

Sponsors

University of Maryland, College Park
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
42 Months to 60 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in child anxiety disorder symptomsPre-treatment (baseline), post-treatment (week 8), and 2-month follow-upAssessed with diagnostic interviews (Preschool Age Psychiatric Assessment) with parents

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026