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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05863520
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
7 Years - 15 Years
Healthy Volunteers
Accepted

Interventions

  • Zones of Regulation — BEHAVIORAL
    ZOR is rooted in CBT principles and uses a metacognitive framework to increase awareness of feelings and to build regulation, prosocial skills, and overall wellness.
  • Facing Your Fears - School Based — BEHAVIORAL
    FYF-SB is a CBT program for managing anxiety in autistic youth.

Study Details

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.

Key Dates

Start date
Aug 25, 2023
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Facing Your Fears - School Based
    Facing Your Fears-School Based (FYF-SB) is a 12 week school based group program comprised of psychoeducation (somatic management, development of positive self-statements and strategies for managing emotions), and graded exposure (facing fears a little at a time).
  • Active Comparator: Zones of Regulation
    Zones of Regulation (ZOR) focuses on four different emotional states called "zones." Each zone is represented by different colors that represent different levels of emotions or arousal. ZOR includes psychoeducation about emotions and emotional states (e.g., reading facial expressions, identifying triggers for emotion dysregulations, using emotion regulation tools) and problem-solving strategies. In ZOR, students are also taught emotion regulation strategies (e.g., "calming", "cognitive" and "sensory" strategies) to stay in a specific zone and/or to move from one zone to another.

Primary Outcome Measure

Change from Baseline in anxiety on the clinician-administered Pediatric Anxiety Rating Scale - Autism Spectrum Disorder (PARS-ASD) [ Time Frame: Baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Judy Reaven, PhD
[email protected]
303-724-7646
Audrey Blakeley-Smith, PhD
[email protected]
303-724-7630

Find similar trials in Aurora, CO

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
University of Colorado Anschutz Medical Campus· Aurora, CO

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