No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
7 – 15
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for autistic students aged 8 to 14 who experience anxiety. Participants will join one of two programs that aim to help reduce their anxiety over 12 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have a diagnosis of Autism Spectrum Disorder
I have anxiety according to myself, my parent, or my teacher
I have trouble with social interactions
You may not be able to join if
I have a known intellectual disability
I have serious behavior or mental health issues that stop me from joining group activities
My parent or caregiver does not allow me to participate
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 s…
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.
Trial Locations
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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, par…
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
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