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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 15
Healthy Volunteers: t
View:

• 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).

⁃ \- legal guardian of a student who meets inclusion criteria defined above

• 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.

Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Contact Information
Primary
Judy Reaven, Ph.D.
judy.reaven@cuanschutz.edu
303-724-7646
Backup
Katherine Pickard, Ph.D.
Katherine.e.pickard@emory.edu
303-724-7646
Time Frame
Start Date: 2023-08-25
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of North Carolina, Chapel Hill, Emory University, Patient-Centered Outcomes Research Institute
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov