Actively Recruiting

Phase Not Applicable
Age: 7Years - 15Years
All Genders
Healthy Volunteers
NCT05863520

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

Led by University of Colorado, Denver · Updated on 2025-04-04

200

Participants Needed

1

Research Sites

135 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

U

University of North Carolina, Chapel Hill

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 7Years - 15Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Students aged 8 to 14 years
  • Known, suspected, or educationally identified diagnosis of autism spectrum disorder (ASD)
  • Clinical anxiety reported by student, parent, or teacher
  • Significant social behavior impairment based on Social Responsiveness Scale-Second Edition (SRS-2) T-score above 70
  • Caregivers are legal guardians of eligible students
  • Interdisciplinary school providers (ISPs) must be degreed professionals or paraprofessionals working with autistic students with anxiety
  • ISPs must be able to attend training, deliver at least 80% of their assigned program, and participate in 80% of bi-monthly consultations
Not Eligible

You will not qualify if you...

  • Students with known intellectual disability
  • Students with significant behavioral or psychiatric challenges preventing participation in small groups
  • Lack of parent or caregiver permission for participation
  • ISPs unable to participate in training, deliver their assigned program, or attend consultation visits
  • ISPs not working with autistic students with anxiety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

Loading map...

Research Team

J

Judy Reaven, Ph.D.

CONTACT

K

Katherine Pickard, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here