A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
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; a
| Condition(s) | Autism Spectrum Disorder, Anxiety Disorders, Emotion Regulation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 mee |
| Ages | 7 Years to 15 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Colorado, Denver |
| Locations | Aurora, Colorado, United States |
| Start date | 2023-08-25 |
| NCT ID | NCT05863520 |
| Official listing | https://clinicaltrials.gov/study/NCT05863520 |