Facing Your Fears Therapy for ASD with Intellectual Disability

(FYF:ASD/ID Trial)

Not currently recruiting at 1 trial location

Overseen By Judy Reaven, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Thought disorder, High irritability, Attendance issues

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

Compensation: Varies

Number of Visits: 1

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help adolescents with autism spectrum disorder (ASD) and intellectual disability (ID) who experience significant anxiety. Researchers are testing a therapy called "Facing Your Fears," designed to reduce anxiety and improve coping skills in teens with ASD/ID. Participants will be randomly assigned to either start this therapy immediately or continue their usual treatment before switching to the therapy. The study seeks teens aged 12-18 with ASD/ID who have noticeable anxiety symptoms. As an unphased trial, it offers participants the opportunity to access potentially beneficial therapy tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cognitive behavioral intervention is safe for adolescents with ASD and intellectual disability?

Research shows that the Facing Your Fears (FYF) therapy has been adapted and tested for teenagers with Autism Spectrum Disorder and Intellectual Disability (ASD/ID). Earlier studies, including one with 23 teens, found that this cognitive behavioral therapy (CBT) approach significantly improved anxiety and mood symptoms. Importantly, these studies did not report any serious side effects, indicating that the treatment is well-tolerated by this group.

This therapy teaches teens how to manage their emotions and develop coping skills tailored to their individual needs. It emphasizes building confidence through strategies like "graded exposure" (gradually facing fears) and encouraging positive self-talk.

Overall, research supports the safety of the FYF program, as it has been specifically designed and tested for this group without any major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Facing Your Fears: ASD/ID therapy because it offers a specialized cognitive-behavioral intervention tailored for individuals with Autism Spectrum Disorder (ASD) and intellectual disabilities. Unlike traditional treatments that might not specifically address the unique sensory and regulatory needs of this population, this therapy focuses on developing emotion regulation skills and somatic management techniques. Additionally, it incorporates individualized cognitive strategies and graded exposure, helping participants gradually face their fears. This personalized approach could provide more effective support compared to the standard care options, which often include medications and general behavioral therapies.

What evidence suggests that Facing Your Fears: ASD/ID could be an effective treatment for anxiety in adolescents with ASD and intellectual disability?

Research has shown that the Facing Your Fears (FYF) program, specially adapted for teenagers with Autism Spectrum Disorder (ASD) and intellectual disability (ID), can greatly reduce anxiety. An earlier study with 23 teens demonstrated noticeable improvements in anxiety and mood. In this trial, participants will join different arms, including a Cognitive Behavioral Intervention arm that uses the FYF program. Studies have found that programs like FYF, which use cognitive-behavioral therapy (CBT), effectively lower anxiety in autistic youth. The program helps build skills such as managing emotions, thinking positively, and gradually facing fears. These techniques have proven effective in managing anxiety in this group. ^{1 6 7 8 9}

Who Is on the Research Team?

Audrey D Blakeley-Smith, Ph.d.

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-18 with Autism Spectrum Disorder (ASD) and Intellectual Disability (ID), having an IQ score of 40-70 and significant anxiety symptoms. They must have a confirmed ASD diagnosis, but can't join if they miss more than three sessions, have a primary non-anxiety mental health condition, or exhibit severe irritability.

Inclusion Criteria

Cognitive and adaptive behavior abilities in the ID range as determined by a Brief IQ standard score between 40 - 70 on the Stanford Binet-Fifth Edition (SB-5) and a Total Adaptive Composite below 70 on the Adaptive Behavior Assessment System, 3rd Edition (ABAS-3)

I have been diagnosed with ASD based on specific tests and evaluations.

I have been diagnosed with anxiety based on specific tests.

Exclusion Criteria

My primary mental health issue is not related to anxiety, but another condition.

If you have a high score on the Irritability sub-scale of the Aberrant Behavior Checklist-Community (ABC-C), it means you have more problem behaviors than usual for your age group, and you may not be able to join the group treatment.

Families cannot attend at least 11 out of 14 sessions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either FYF:ASD/ID or TAU for 14 weeks

14 weeks

Weekly sessions

Crossover Treatment

Participants initially in TAU crossover to receive FYF:ASD/ID

14 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Facing Your Fears: ASD/ID

Trial Overview The study tests 'Facing Your Fears: ASD/ID', a cognitive behavioral therapy adapted for teens with ASD/ID against the usual treatment. It's a randomized control trial where participants are assigned to either the new intervention or standard care to compare effectiveness in reducing anxiety.

How Is the Trial Designed?

Group I: Treatment as Usual Experimental Treatment 1 Intervention

The TAU condition will serve as the control condition and participants' medication use and outside therapies will be tracked monthly. Following completion of the 16-week wait period, the TAU group will be invited to enroll in FYF:ASD/ID.

Group II: Cognitive Behavioral Intervention Experimental Treatment 1 Intervention

The experimental condition is a CBT intervention which focuses on developing 1) emotion regulation skills, 2) somatic management skills individually tailored for sensory and regulatory needs; 3) cognitive strategies such as individualized helpful thoughts and mantras (I can do it); and 4) graded exposure (e.g., facing fears).

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A study involving 49 children with Autism Spectrum Disorder (ASD) showed that Cognitive Behavioural Therapy (CBT) significantly reduced anxiety, with 30% of participants free from their primary anxiety diagnoses after treatment.

While there were no significant differences in primary outcomes between the treatment and waitlist groups, secondary outcomes indicated meaningful improvements, suggesting that CBT is a feasible and potentially effective intervention for anxiety in children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Based Cognitive Behavioural Therapy for Anxiety in Children with Autism Spectrum Disorder: A Randomised Controlled Trial in a General Child Psychiatric Hospital Setting. Kilburn, TR., Sørensen, MJ., Thastum, M., et al.[2023]

The Facing Your Fears-Adolescent Version (FYF-A) program, a modified cognitive behavior therapy (CBT) for adolescents with high-functioning autism spectrum disorders, showed significant reductions in anxiety severity and interference after treatment in a study of 24 participants aged 13-18.

Nearly 46% of participants met criteria for a positive treatment response on their primary anxiety diagnosis post-intervention, with low anxiety levels maintained at a 3-month follow-up, indicating the potential effectiveness of this tailored CBT approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facing your fears in adolescence: cognitive-behavioral therapy for high-functioning autism spectrum disorders and anxiety. Reaven, J., Blakeley-Smith, A., Leuthe, E., et al.[2022]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3471403/

Facing Your Fears in Adolescence: Cognitive-Behavioral ... The purpose of the present study was to develop an intervention for treating anxiety in adolescents with ASD based on a CBT program designed for school-aged ...

2. medschool.cuanschutz.edu medschool.cuanschutz.edu/jfk-partners/clinical-services/facing-your-fears-program/research--evidence-base--and-publications

Research, Evidence Base, and Publications Six treatment trials on FYF have been published, including a pilot study for autistic adolescents, a telehealth adaptation of FYF, a randomized trial, and a ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1750946724001387

Facing Your Fears in autistic youth with co-occurring ... Adapted cognitive-behavioural interventions, such as Facing Your Fears (FYF), are effective in reducing anxiety in autistic youth.

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1569435/full

Facing your fears in schools: using the ADIS/ASA to ... School-based CBT programs, like Facing Your Fears in Schools (FYF-S), have shown effectiveness in reducing anxiety in autistic students and may ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12329307/

Facing your fears in schools: using the ADIS/ASA to ... School-based CBT programs, like Facing Your Fears in Schools (FYF-S), have shown effectiveness in reducing anxiety in autistic students and may ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23091719/

Facing your fears in adolescence - PubMed - NIH The purpose of the present study was to develop an intervention for treating anxiety in adolescents with ASD based on a CBT program designed for school-aged ...

7. researchautism.org researchautism.org/research-item/facing-your-fears-supporting-teens-with-autism-spectrum-disorders-and-intellectual-disabilities/

Facing Your Fears: Supporting Teens with Autism ... This pilot study will have two major aims: (1) To obtain feedback from key stakeholders on the specific modifications made to our evidenced based program Facing ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04666493?term=AREA%5BConditionSearch%5D(Covid-19%20AND%20%22Developmental%20Disabilities%22)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=6

Adapting Anxiety Intervention for Youth With Autism ... This study will examine if a virtual delivery of a group Cognitive Behavioural Therapy (CBT) program, specifically using "Facing Your Fears" (FYF) curriculum, ...

9. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05131425/facing-your-fears-adolescents-with-asd-and-intellectual-disability

Facing Your Fears: Adolescents With ASD and Intellectual ... The current investigators adapted a cognitive behavioral treatment (CBT) manualized intervention, Facing Your Fears, for adolescents with ASD/ID ...