Comparing two school programs to help autistic students with anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of two school-based interventions, Facing Your Fears-School Based (FYF-SB) and Zones of Regulation (ZOR), in managing anxiety and improving emotion regulation among autistic students aged 8-14. Participants will be randomly assigned to one of the programs for a duration of 12 weeks, with assessments conducted before, after, and at follow-up to evaluate outcomes. The study also seeks to gather feedback on the feasibility and satisfaction of both programs from students, caregivers, and school providers. By implementing these interventions in schools, the trial addresses the critical need for accessible mental health support for autistic youth, particularly those from underserved backgrounds.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Judy Reaven, Ph.D. — University of Colorado, Denver
• Study coordinator: Judy Reaven, Ph.D.
• Email: judy.reaven@cuanschutz.edu
• Phone: 303-724-7646

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.