Comparing School-Based Anxiety Programs for Autistic Students
This study is comparing two school-based programs, Zones of Regulation (ZOR) and Facing Your Fears - School Based (FYF-SB), to help autistic students manage anxiety. Both programs use strategies based on cognitive behavioral therapy (CBT), which helps people understand and change their thoughts and behaviors. The study aims to see which program is more effective at reducing anxiety and improving emotion regulation in autistic students aged 7 to 15. Researchers will also look at how practical and satisfying these programs are for students, caregivers, and school staff. The study is currently unclear about its recruitment status and plans to enroll 200 participants.
- Study design
- This is an interventional study comparing two programs. Autistic students will be randomly assigned to either the Zones of Regulation or Facing Your Fears - School Based program.
- What's involved
- Participants will take part in one of the programs for 12 weeks. Anxiety levels will be measured at the beginning, within 4 weeks after the program, and 6 months later.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after completing the intervention to measure anxiety levels.
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A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
At a glance
Conditions
NCT05863520
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Colorado Anschutz Medical Campus
Aurora, Coloradostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Judy Reaven, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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Inclusion
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What this trial measures
- Change from Baseline in anxiety on the clinician-administered Pediatric Anxiety Rating Scale - Autism Spectrum Disorder (PARS-ASD)Baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention
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 extent to which the child avoids anxiety provoking situations (e.g., behavioral manifestations of anxiety).
- Change from Baseline in parent reported anxiety on the Screening for Childhood Anxiety and Related Emotional Disorders (SCARED)baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention
The SCARED is a 41-item inventory of statements that assesses five types of anxiety experienced by children and adolescents, to be completed separately by caregivers and students. A total score, as well as cutoffs for specific domains of anxiety (e.g., social, generalized) are obtained. A total score of 25 or higher is clinically significant. Scores range from 0-82 and higher scores indicate a worse outcome.
- Change from Baseline in child reported anxiety on the Screening for Childhood Anxiety and Related Emotional Disorders (SCARED)baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention
The SCARED is a 41-item inventory of statements that assesses five types of anxiety experienced by children and adolescents, to be completed separately by caregivers and students. A total score, as well as cutoffs for specific domains of anxiety (e.g., social, generalized) are obtained. A total score of 25 or higher is clinically significant. Scores range from 0-82 and higher scores indicate a worse outcome.