A cluster randomized controlled trial comparing the effectiveness of two school-based interventions for autistic youth with anxiety.
Katherine Pickard, Brenna Maddox, Richard Boles...
https://pubmed.ncbi.nlm.nih.gov/38166851Actively Recruiting
Phase Not Applicable
Age: 7Years - 15Years
All Genders
Healthy Volunteers
ID05863520
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
12 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
Researchers are comparing two school-based programs, Facing Your Fears-School Based (FYF-SB) and Zones of Regulation (ZOR), to see which is more effective at reducing anxiety and improving emotion regulation in autistic students aged 8 to 14 years. This study focuses on autistic youth who experience anxiety and aims to help schools better support their mental health, especially students from underserved communities. The trial will also assess how well each program is accepted by students, caregivers, and school providers. The study involves 200 autistic students with anxiety who will be randomly assigned to one of the two programs for 12 weeks. FYF-SB uses cognitive-behavioral therapy (CBT) strategies focused on anxiety reduction through psychoeducation and gradual exposure to fears. ZOR teaches students to recognize and manage emotions by categorizing feelings into four "zones" using color codes and providing strategies to regulate emotions. Trained school providers will deliver the programs to small groups of students in their schools. Participants will be evaluated before and after the intervention, with a follow-up six months later. Assessments include anxiety and emotion regulation measures completed by students, caregivers, teachers, and independent evaluators. The study will also track school attendance, disciplinary actions, academic participation, and satisfaction with the programs. Researchers will examine treatment effects and gather feedback through surveys and interviews to understand how feasible and acceptable each program is in school settings.
CONDITIONS
Brief 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
You may qualify if you...
- Students aged 8 to 14 years with a medical diagnosis, educational identification, or suspicion of autism spectrum disorder (ASD)
- Clinical anxiety reported by student, parent, or teacher
- Significant social impairment with a T-score above 70 on the Social Responsiveness Scale - Second Edition (SRS-2)
- Caregivers who are legal guardians of eligible students
- Interdisciplinary school providers with degrees or paraprofessionals working with autistic students with anxiety
- Providers able to attend training, deliver at least 80% of their assigned program, and participate in 80% of consultation sessions
You will not qualify if you...
- Students with known intellectual disability
- Students with behavior or psychiatric challenges preventing participation in small groups
- Students without parent or caregiver permission
- School providers unable to participate in training, deliver the assigned program, or attend consultations
- Providers 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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants attend a 12-week school-based group program to manage anxiety. They receive either the Facing Your Fears - School Based (FYF-SB) program, which includes psychoeducation and graded exposure, or the Zones of Regulation (ZOR) program, which focuses on emotion regulation strategies.
Weekly group sessions during the 12-week program
Follow-up
Duration - 6 months after intervention completion
Participants complete assessments on anxiety, emotion regulation, and functional outcomes up to 6 months after the intervention to evaluate lasting effects of the programs.
Assessments at post-intervention and at 6 months follow-up
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
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Research Team
J
Judy Reaven, Ph.D.
K
Katherine Pickard, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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