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

University of Colorado, Denver · with University of North Carolina, Chapel Hill, Emory University · NCT05863520

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 7–15 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
200
US sites recruiting
1
Study start
August 25, 2023
Record last updated
April 4, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Zones of Regulation; Facing Your Fears - School Based

Conditions: Autism Spectrum Disorder; Anxiety Disorders; Emotion Regulation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria: There are 3 groups of participants: students, caregivers and interdisciplinary school providers:

Inclusion criteria for students ages 8-14:

  • known medical diagnosis of ASD OR educational identification of ASD OR suspected ASD
  • clinical anxiety according to either student, parent or teacher report
  • clinically significant impairment (T-score above 70) in reciprocal social behavior according to the Social Responsiveness Scale - Second Edition (SRS-2).

Exclusion criteria for students

  • known intellectual disability
  • significant behavior or psychiatric challenge that prevents them from participation in small group activities
  • lack of parent or caregiver permission for participation

Inclusion Criteria for Caregivers of students 8-14

  • legal guardian of a student who meets inclusion criteria defined above

Inclusion criteria for Interdisciplinary school providers (ISPs).

  • degreed professionals in one of the following: education (special or general education), school psychology, counseling, social work, speech/language pathology, occupational or physical therapy OR paraprofessional who assist ISPs
  • working with autistic students with anxiety
  • be able to complete study requirements including attending the training workshops, delivering at least 80% of the program they were randomized to, and participating in 80% of bi-monthly consultation sessions with the research team.

Exclusion criteria ISPs

  • if they are unable to participate in the trainings, deliver the program they are assigned to, or participate in any of the consultation visits
  • if they do not work with students with autism and anxiety

Recruiting US locations

  • University of Colorado Anschutz Medical Campus

    Aurora, CO 80045

    Site contact: Judy Reaven, PhD · 303-724-7646 · judy.reaven@cuanschutz.edu

Study contacts (from the official record)

  • Judy Reaven, Ph.D. · 303-724-7646 · judy.reaven@cuanschutz.edu
  • Katherine Pickard, Ph.D. · 303-724-7646 · Katherine.e.pickard@emory.edu
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A Comparison of Two School Based Interventions to Manage Anxiety… (NCT05863520) | Bored Studies