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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Page 1 of 1 (1 locations)

1

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students | DecenTrialz