NCT05863520 A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
| NCT ID | NCT05863520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-08-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-08-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Judy Reaven, Ph.D.
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT05863520 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 15 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05863520 currently recruiting?
Yes, NCT05863520 is actively recruiting participants. Contact the research team at judy.reaven@cuanschutz.edu for enrollment information.
Where is the NCT05863520 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05863520 clinical trial?
NCT05863520 is sponsored by University of Colorado, Denver. The principal investigator is Judy Reaven, Ph.D. at University of Colorado, Denver. The trial plans to enroll 200 participants.