School-Based Interventions for Anxiety in Autism

Recruiting in Palo Alto (17 mi)

Overseen by Judy Reaven, Ph.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Disqualifiers: Intellectual disability, Significant behavior challenge, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Facing Your Fears - School Based for anxiety in autism?

Research shows that the Facing Your Fears - School Based treatment helps reduce anxiety in autistic students, with significant improvements reported in school settings. The program is adaptable, easy to use by school staff, and has been effective in both the US and Singapore, with many students experiencing meaningful reductions in anxiety. ^{1 2 3 4 5}

Is the school-based Facing Your Fears program safe for autistic students with anxiety?

The school-based Facing Your Fears program has been implemented in various settings and is generally viewed as acceptable and useful by staff and parents. No specific safety concerns have been reported in the studies, suggesting it is safe for autistic students with anxiety. ^{1 2 3 5 6}

How is the treatment 'Facing Your Fears - School Based' different from other treatments for anxiety in autism?

Facing Your Fears - School Based is unique because it adapts cognitive behavioral therapy (CBT) for delivery in school settings, making it accessible to autistic students who might not otherwise receive such treatment. It is designed to be flexible and easy for various school providers to use, even those without a mental health background, which helps in reaching a broader range of students. ^{1 2 4 6 7}

Research Team

Judy Reaven, Ph.D.

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Facing Your Fears - School Based (Behavioral Intervention)
• Zones of Regulation (Behavioral Intervention)

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.

Participant Groups

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).

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Nakela L. Cook

Patient-Centered Outcomes Research Institute

Chief Executive Officer since 2020

MD, MPH

Harv Feldman

Patient-Centered Outcomes Research Institute

Chief Medical Officer

MD, MSCE

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. England 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. [2021]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Training clinicians to deliver group CBT to manage anxiety in youth with ASD: Results of a multisite trial. [2019]

5. United States 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. [2022]

6. United States 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. [2022]

7. United States 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. [2022]