A cluster randomized controlled trial comparing the effectiveness of two school-based interventions for autistic youth with anxiety.
Katherine Pickard, Brenna Maddox, Richard Boles...
https://pubmed.ncbi.nlm.nih.gov/38166851/Actively Recruiting
Led by University of Colorado, Denver · Updated on 2025-04-04
200
Participants Needed
1
Research Sites
12 weeks
Total Duration
Researchers are comparing two school-based programs, Facing Your Fears-School Based FYF-SB and Zones of Regulation ZOR, to see which is more effective at reducing anxiety and improving emotion regulation in autistic students aged 8 to 14 years. This study focuses on autistic youth who experience anxiety and aims to help schools better support their mental health, especially students from underserved communities. The trial will also assess how well each program is accepted by students, caregivers, and school providers. The study involves 200 autistic students with anxiety who will be randomly assigned to one of the two programs for 12 weeks. FYF-SB uses cognitive-behavioral therapy CBT strategies focused on anxiety reduction through psychoeducation and gradual exposure to fears. ZOR teaches students to recognize and manage emotions by categorizing feelings into four zones using color codes and providing strategies to regulate emotions. Trained school providers will deliver the programs to small groups of students in their schools. Participants will be evaluated before and after the intervention, with a follow-up six months later. Assessments include anxiety and emotion regulation measures completed by students, caregivers, teachers, and independent evaluators. The study will also track school attendance, disciplinary actions, academic participation, and satisfaction with the programs. Researchers will examine treatment effects and gather feedback through surveys and interviews to understand how feasible and acceptable each program is in school settings.
CONDITIONS
A Comparison of Two School Based Interventions to Manage Anxiety in Autistic Students
J
Judy Reaven, Ph.D.
K
Katherine Pickard, Ph.D.
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University of Colorado, Denver
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Facing Your Fears - School Based | Zones of Regulation |
|---|---|---|
| What it is | A school-based group cognitive behavioral therapy program tailored for autistic students, designed to help manage anxiety through skills and strategies appropriate for school settings. | A school-based intervention using cognitive behavioral and metacognitive strategies to build awareness of emotions, develop regulation skills, support prosocial behavior, and promote overall wellness in autistic students. |
| Role in the trial | One of two interventions randomly assigned to eligible students; tested for effectiveness in reducing anxiety at school. | The comparative intervention in the trial; eligible students are randomly assigned to this group for measuring outcomes against the alternative program. |
| Primary use | Aims to reduce anxiety symptoms and support social adjustment in autistic youth participating in small school-based groups. | Designed to improve emotional awareness, regulation, and prosocial skills, with a focus on wellness and adaptive behavior in school. |
| How it is given or performed | Delivered in group format during the school day, with trained school providers leading sessions following a structured CBT curriculum for autistic youth. | Delivered in a school setting by trained interdisciplinary school staff, using activities and lessons that encourage emotional identification, regulation strategies, and social skills practice. |
| Evidence status | Being studied in randomized trials for effectiveness in reducing anxiety in autistic school-aged children. Recent RCTs support measurable anxiety improvement for participants. | Widely used for emotional and behavioral regulation among students. Recent RCTs in autistic populations support improvements in emotional regulation and adaptive skills, although direct reduction in anxiety symptoms is under ongoing investigation. |
| Important limitations | Benefits and effectiveness may depend on individual school resources, fidelity of program delivery, and participant engagement. Real-world implementation outside research settings may vary. | Outcomes may be influenced by the school's capacity to support ongoing training, the experience of providers, and student participation willingness. Generalizability to all autistic students may be limited. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants attend a 12-week school-based group program to manage anxiety. They receive either the Facing Your Fears - School Based (FYF-SB) program, which includes psychoeducation and graded exposure, or the Zones of Regulation (ZOR) program, which focuses on emotion regulation strategies.
Weekly group sessions during the 12-week program
Duration - 6 months after intervention completion
Participants complete assessments on anxiety, emotion regulation, and functional outcomes up to 6 months after the intervention to evaluate lasting effects of the programs.
Assessments at post-intervention and at 6 months follow-up
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Katherine Pickard, Brenna Maddox, Richard Boles...
https://pubmed.ncbi.nlm.nih.gov/38166851/University of Colorado, Denver
Lead Sponsor
University of North Carolina, Chapel Hill
Collaborating Sponsor