Recruiting

Anxiety Interventions

Sponsor:

University of Colorado, Denver

Code:

NCT05863520

Conditions

Autism Spectrum Disorder

Anxiety Disorders

Emotion Regulation

Eligibility Criteria

Sex: All

Age: 7 - 15

Healthy Volunteers: Accepted

Interventions

Zones of Regulation

Facing Your Fears - School Based

Study Details

Brief 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.

Conditions

Autism Spectrum Disorder

Anxiety Disorders

Emotion Regulation

Study ID

NCT05863520

Start date

Aug 25, 2023

Status verified date

Apr, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 15

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Zones of Regulation

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

FYF-SB is a CBT program for managing anxiety in autistic youth.

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 ]
  • Change from Baseline in parent reported anxiety on the Screening for Childhood Anxiety and Related Emotional Disorders (SCARED) [ Time Frame: baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention ]
  • Change from Baseline in child reported anxiety on the Screening for Childhood Anxiety and Related Emotional Disorders (SCARED) [ Time Frame: baseline, within 4 weeks post-intervention; and 6 months after completion of the intervention ]

Central Contacts and Locations

Central contacts

Judy Reaven, Ph.D.

303-724-7646judy.reaven@cuanschutz.edu

Katherine Pickard, Ph.D.

303-724-7646Katherine.e.pickard@emory.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Judy Reaven, PhD

303-724-7646judy.reaven@cuanschutz.edu

Audrey Blakeley-Smith, PhD

303-724-7630audrey.blakeleysmith@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 4, 2025

Last verified

Apr, 2025

Keywords

  • intervention
  • schools
  • cognitive behavior therapy
  • group

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-04-04.