NCT05863520Recruiting
A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
Source: ClinicalTrials.gov · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 14 Mar 2023
- Start date
- 25 Aug 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Autism
- NCT number
- NCT05863520
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 25 Aug 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- significant behavior or psychiatric challenge that prevents them from participation in small group activities
Other
- known intellectual disability
- lack of parent or caregiver permission for participation
- 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
Who the study is looking for
- 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).
- \- legal guardian of a student who meets inclusion criteria defined above
- 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.
Age in the registry: 7 years to 15 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.