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NCT05863520 · ClinicalTrials.gov registry record · NA
A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
A NA study of Autism Spectrum Disorder and Anxiety Disorders, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT05863520: Recruiting NA study of Autism Spectrum Disorder and Anxiety Disorders, sponsored by University of Colorado, Denver.
NCT05863520 is a NA study of Autism Spectrum Disorder and Anxiety Disorders that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 200 participants, above the 134-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (49% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05863520, a NA study of Autism Spectrum Disorder and Anxiety Disorders, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
The PARS-ASD is a clinician administered semi-structured interview to assess anxiety symptoms and severity. The PARS-ASD will be administered by an independent evaluator (IE) masked to condition. It includes: a Symptom Checklist and five Severity Items. The Symptom Checklist covers social anxiety, separation anxiety, generalized anxiety, panic, specific phobia, and other anxiety symptoms. The severity of symptoms is examined by assessing the frequency and pervasiveness of anxiety, as well as the
Conditions Studied
Interventions
- BEHAVIORAL Zones of Regulation
- BEHAVIORAL Facing Your Fears - School Based
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-08-25 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
What NCT05863520 shows while recruiting
NCT05863520 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 134-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (49% higher).
The record links to 3 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Zones of Regulation is the first listed.
NCT05863520 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05863520 about?
NCT05863520 is a clinical study titled "A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students". 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 e...
What is the current status of trial NCT05863520?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2023-08-25. Estimated completion is 2026-03-31.
What conditions does trial NCT05863520 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Anxiety Disorders, Emotion Regulation.
What interventions are being tested in trial NCT05863520?
The interventions under investigation include: Zones of Regulation (BEHAVIORAL), Facing Your Fears - School Based (BEHAVIORAL).
Who is sponsoring clinical trial NCT05863520?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05863520 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05863520's enrollment target sits among peer trials
200 39th of 224 higher than 184 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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