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A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students

NCT05863520 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-04-04

No results posted yet for this study

Summary

The goal of this clinical trial is to compare two school based interventions to manage anxiety in autistic students. The main question\[s\] it aims to answer are: 1) Compare the effectiveness of Facing Your Fears-School Based Program (FYF-SB) with Zones of Regulation (ZOR) on anxiety reduction and emotion regulation; and 2) examine the feasibility and satisfaction of FYF-SB and ZOR, according to students, caregivers and school providers. Autistic students with anxiety between 8-14 years will be randomized to either FYF-SB and ZOR. They will participate in one of the programs for 12 weeks and pre, post and follow-up measures will occur.

Conditions

  • Autism Spectrum Disorder
  • Anxiety Disorders
  • Emotion Regulation

Interventions

BEHAVIORAL

Zones of Regulation

ZOR is rooted in CBT principles and uses a metacognitive framework to increase awareness of feelings and to build regulation, prosocial skills, and overall wellness.

BEHAVIORAL

Facing Your Fears - School Based

FYF-SB is a CBT program for managing anxiety in autistic youth.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Judy Reaven, Ph.D. · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-25
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05863520 on ClinicalTrials.gov