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Multi-Component Early Intervention for Socially Inhibited Preschool Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02308826
Enrollment
169
Registered
2014-12-04
Start date
2014-12-31
Completion date
2019-06-30
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 is intended to provide a rigorous test of the Turtle Program, an early intervention program for behaviorally inhibited preschoolers. The proposed project will extend promising pilot study findings by: (a) evaluating the integrated intervention in a larger sample (n = 150) of 45-64 month children and their parents, which will allow for an examination of mediators and moderators of treatment effects; (b) comparing the Turtle Program to the best available treatment for preschool behavioral inhibition, the Cool Little Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation as both baseline moderators of treatment response and as outcome measures; (d) examining parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment assessment and extending follow-up to one year.

Interventions

BEHAVIORALTurtle Program
BEHAVIORALCool Little Kids

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
45 Months to 64 Months
Healthy volunteers
No

Inclusion criteria

* child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire

Exclusion criteria

* child has a diagnosis of pervasive developmental disorder, selective mutism, or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety; child does not have a custodial parent who has also consented to participate

Design outcomes

Primary

MeasureTime frameDescription
Change in child anxiety disorder symptomspre-treatment, mid-treatment (week 4), post-treatment (week 8), and 1-year follow-upAssessed with diagnostic interviews (Anxiety Disorders Interview Schedule) with parents

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026