A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
Launched by UNIVERSITY OF COLORADO, DENVER · May 15, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different programs designed to help manage anxiety in autistic students aged 8 to 14. The researchers want to find out which program is more effective at reducing anxiety and improving emotional regulation: the Facing Your Fears-School Based Program (FYF-SB) or the Zones of Regulation (ZOR). Students who are experiencing anxiety will be randomly assigned to one of these programs and will participate for 12 weeks. Throughout the study, researchers will check in before, after, and a little while after the program to see how well it worked and how satisfied everyone is with the experience.
To be eligible for the trial, students must have a diagnosis or a strong suspicion of Autism Spectrum Disorder (ASD) and show signs of anxiety. They also need to have difficulty with social interactions, as determined by a specific assessment. Caregivers of eligible students can also participate, as well as school professionals who work with autistic students and have the proper training. Participants can expect to attend sessions, receive support, and share their feedback on the programs. This trial aims to find effective ways to help autistic students cope with anxiety, benefiting them and their families.
Gender
ALL
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
About University Of Colorado, Denver
The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aurora, Colorado, United States
Patients applied
Trial Officials
Judy Reaven, Ph.D.
Principal Investigator
University of Colorado, Denver
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported