School-Based Interventions for Anxiety in Autism

Overseen By Katherine Pickard, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Intellectual disability, Significant behavior challenge, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two school-based programs to help manage anxiety in autistic students. It compares the effectiveness of the "Facing Your Fears-School Based" program, which involves learning about emotions and gradually facing fears, with the "Zones of Regulation," which teaches emotion regulation using color-coded zones. The trial seeks feedback on the effectiveness of these programs and the satisfaction levels of students, caregivers, and school providers. It invites autistic students aged 8-14 who experience anxiety to participate. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance anxiety management strategies for autistic students.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these school-based interventions are safe for autistic students with anxiety?

Research has shown that the Facing Your Fears-School Based (FYF-SB) program is well-supported by evidence. Several studies have proven it reduces anxiety in students with autism. Past trials demonstrated its effectiveness and safety for this group.

In contrast, the Zones of Regulation (ZOR) program lacks substantial scientific evidence for use with autistic individuals. Although widely used for social-emotional skills, some reviews advise caution due to limited research confirming its effectiveness and safety for autistic students.

In summary, the FYF-SB program is backed by strong research and is generally considered safe for autistic students. The ZOR program, while popular, has less scientific support, making its safety and effectiveness for autistic students less certain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for anxiety in autism because they offer unique, school-based approaches that differ from traditional therapy options like cognitive-behavioral therapy (CBT) or medication. "Facing Your Fears - School Based" stands out by incorporating graded exposure to fears and emotions over 12 weeks, which helps students gradually become more comfortable with their anxieties while still in their familiar school environment. On the other hand, "Zones of Regulation" introduces a creative psychoeducational approach by using colors to represent emotional states, helping students identify and regulate their emotions through practical strategies. Both programs focus on equipping students with tools for real-life situations, potentially making them more engaging and effective for young individuals with autism.

What evidence suggests that this trial's treatments could be effective for managing anxiety in autistic students?

This trial will compare the effectiveness of two programs for reducing anxiety in autistic students: Facing Your Fears-School Based (FYF-SB) and Zones of Regulation (ZOR). Research has shown that both programs can help reduce anxiety. Studies on FYF-SB, based on cognitive behavioral therapy (CBT), found that it significantly lowers anxiety levels in young participants. Evidence also supports the ZOR program, which teaches emotional control using color-coded zones and has improved emotional and behavioral outcomes in autistic students. Both programs offer structured methods to manage anxiety and enhance emotional control. ^{2 3 5 6 7}

Who Is on the Research Team?

Judy Reaven, Ph.D.

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for autistic students aged 8-14 who experience anxiety and have a medical or educational diagnosis of ASD, or suspected ASD. They must also show significant social challenges as measured by the SRS-2. It's not suitable for those outside this age range or without these specific needs.

Inclusion Criteria

I have been diagnosed or suspected to have autism spectrum disorder (ASD).

You have been diagnosed with anxiety by a student, parent, or teacher.

You have a significant difficulty with social interaction, as measured by a specific test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the Facing Your Fears-School Based Program (FYF-SB) or Zones of Regulation (ZOR) for 12 weeks

12 weeks

Weekly sessions in school

Post-Intervention Assessment

Assessments conducted to evaluate the effectiveness of the interventions

4 weeks

Assessments conducted in-person and via questionnaires

Follow-up

Participants are monitored for long-term outcomes and effectiveness of the interventions

6 months

Follow-up assessments at 6 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Facing Your Fears - School Based
• Zones of Regulation

Trial Overview

The study compares two programs: Facing Your Fears-School Based (FYF-SB) and Zones of Regulation (ZOR), to see which is better at reducing anxiety and helping with emotion regulation in autistic students. Participants will be randomly assigned to one program for 12 weeks, with evaluations before, after, and following the intervention.

How Is the Trial Designed?

Group I: Zones of Regulation Active Control 1 Intervention

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.

Group II: Facing Your Fears - School Based Active Control 1 Intervention

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).

Facing Your Fears - School Based is already approved in United States for the following indications:

Approved in United States as Facing Your Fears - School Based for:

• Anxiety management in autistic students

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

Clinicians who participated in Workshop training conditions showed significantly increased knowledge of cognitive-behavioral therapy (CBT) and delivered the Facing Your Fears program with higher fidelity compared to those trained via a Manual, indicating that interactive training methods may enhance the quality of therapy delivery.

Despite the differences in training methods, all clinicians effectively reduced anxiety symptoms in children with autism spectrum disorder (ASD), suggesting that the Facing Your Fears program can be successfully implemented across various training formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training clinicians to deliver group CBT to manage anxiety in youth with ASD: Results of a multisite trial. Reaven, J., Moody, EJ., Grofer Klinger, L., et al.[2019]

A systematic review and meta-analysis of six studies involving 165 participants found that school-based interventions can significantly reduce anxiety in children with Autism Spectrum Disorder (ASD), with a moderate effect size of -0.58.

Despite the positive findings, the review highlighted that school-based interventions are still developing, facing challenges in adapting clinical methods and anxiety measurement tools for effective use in educational settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and Treatment of Anxiety in Children with Autism Spectrum Disorder in School Settings: A Systematic Review and Meta-Analysis. Perihan, C., Bicer, A., Bocanegra, J.[2022]

The study found that the Facing Your Fears-School-Based program can positively impact school participation for autistic students, making it a valuable resource for addressing anxiety symptoms in this population.

Thirty school providers reported that the program was easy to implement and adaptable to meet the diverse needs of students, suggesting that training non-mental health providers to deliver such programs can improve access to mental health support for autistic youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using evaluative frameworks to examine the implementation outcomes of a cognitive behavioral therapy program for autistic students with anxiety within public school settings. Pickard, K., Meyer, A., Reyes, N., et al.[2022]

The Facing Your Fears: School-Based program (FYF-SB) effectively adapted cognitive behavioral therapy (CBT) for students with autism spectrum disorder (ASD), showing significant improvements in anxiety symptoms across multiple areas after the intervention.

Students benefited from CBT delivered by interdisciplinary school providers, with reductions in anxiety observed even in areas not directly targeted by the program, indicating potential for broader impacts on their overall functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Clinic to Classroom: Two Case Studies of Youth With ASD and Anxiety From the School-Based Facing Your Fears Program. Rosen, TE., Pickard, K., Ponomaryova, A., et al.[2022]

The Facing Your Fears cognitive behavioral therapy (CBT) program was successfully adapted and piloted in a school setting for 44 adolescents with autism spectrum disorder (ASD), showing feasibility and acceptability among participants, parents, and school staff.

Participants reported decreases in anxiety symptoms, indicating that school-based CBT can be an effective intervention for youth with ASD, highlighting the importance of adapting research-based therapies for practical use in educational environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability and Preliminary Treatment Outcomes in a School-Based CBT Intervention Program for Adolescents with ASD and Anxiety in Singapore. Drmic, IE., Aljunied, M., Reaven, J.[2022]

Clinicians were successfully trained to deliver the 'Facing Your Fears' therapy for managing anxiety in children with high-functioning autism, achieving excellent fidelity in implementation.

Post-treatment, 53% of children reported meaningful reductions in anxiety, indicating the therapy's initial effectiveness and potential for use in various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving transportability of a cognitive-behavioral treatment intervention for anxiety in youth with autism spectrum disorders: results from a US-Canada collaboration. Reaven, J., Blakeley-Smith, A., Beattie, TL., et al.[2021]

A study involving 81 autistic students aged 8-14 showed that those participating in the school-based Facing Your Fears cognitive behavior therapy program experienced significant reductions in anxiety compared to those receiving usual care.

Training 77 interdisciplinary school providers to deliver this program resulted in improved knowledge of cognitive behavior therapy and effective implementation of the program, suggesting that school-based mental health interventions can enhance access to care for autistic youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing school-based cognitive behavior therapy for anxiety in students with autism or suspected autism via a train-the-trainer approach: Results from a clustered randomized trial. Reaven, J., Pickard, K., Meyer, AT., et al.[2023]

Citations

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This study compares the effectiveness of two school-based programs rooted in cognitive behavioral therapy principles to reduce anxiety ...

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Emotion regulation and behavior concerns

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They highlight educator's ability to deliver empirically-supported treatments to address anxiety among students with Autism Spectrum. Disorder.