Status:
RECRUITING
A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Emory University
Conditions:
Autism Spectrum Disorder
Anxiety Disorders
Eligibility:
All Genders
7-15 years
Phase:
NA
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 Facin...
Detailed Description
Background and Significance: Anxiety is very common for autistic youth and can significantly limit functioning and full participation across settings. In school, anxiety may negatively impact students...
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
Key Trial Info
Start Date :
August 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05863520
Start Date
August 25 2023
End Date
March 31 2026
Last Update
April 4 2025
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045