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.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05863520

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

Recruiting
NAAges 7–15InterventionalTreatment
University of Colorado, Denver
~200 participants
Updated 2025-04-04 on ClinicalTrials.gov
What's tested:Zones of RegulationFacing Your Fears - School Based

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in anxiety on the clinician-administered Pediatric Anxiety Rating Scale - Autism Spectrum Disorder (PARS-ASD)
Measured over Baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention
+2 more outcomes measured
Autism Spectrum Disorder
Anxiety Disorders
Emotion Regulation

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.

  • Judy Reaven, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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).
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

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
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
  • 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.