Comparing two school programs to help autistic students with anxiety
A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
This study is testing two school programs to see which one helps autistic kids aged 8-14 manage anxiety and improve their emotions better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 7 Years to 15 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05863520 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two school-based interventions, Facing Your Fears-School Based (FYF-SB) and Zones of Regulation (ZOR), in managing anxiety and improving emotion regulation among autistic students aged 8-14. Participants will be randomly assigned to one of the programs for a duration of 12 weeks, with assessments conducted before, after, and at follow-up to evaluate outcomes. The study also seeks to gather feedback on the feasibility and satisfaction of both programs from students, caregivers, and school providers. By implementing these interventions in schools, the trial addresses the critical need for accessible mental health support for autistic youth, particularly those from underserved backgrounds.
Who should consider this trial
Good fit: Ideal candidates for this study are autistic students aged 8-14 who experience clinical anxiety and have significant social behavior impairments.
Not a fit: Patients with known intellectual disabilities or significant behavioral challenges that hinder participation in group activities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective, school-based mental health interventions that significantly reduce anxiety and improve emotional regulation in autistic students.
How similar studies have performed: Other studies have shown success with school-based cognitive-behavioral interventions for anxiety in children, indicating that this approach is both promising and necessary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Judy Reaven, Ph.D. — University of Colorado, Denver
- Study coordinator: Judy Reaven, Ph.D.
- Email: judy.reaven@cuanschutz.edu
- Phone: 303-724-7646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.