Facing Your Fears Therapy for ASD with Intellectual Disability

(FYF:ASD/ID Trial)

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

73 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Facing Your Fears: ASD/ID?

Research shows that the Facing Your Fears therapy, which is a type of cognitive-behavioral therapy (CBT), has been effective in reducing anxiety in children with autism spectrum disorder (ASD). In various studies, children experienced meaningful reductions in anxiety symptoms, and the program was well-received by both clinicians and participants. ^{1 2 3 4 5}

Is Facing Your Fears Therapy safe for humans?

The Facing Your Fears Therapy has been used in various studies with children and adolescents with autism spectrum disorders and anxiety, and it has been found to be acceptable and feasible, with no major safety concerns reported. ^{1 3 5 6 7}

How is the Facing Your Fears Therapy for ASD with Intellectual Disability treatment different from other treatments?

The Facing Your Fears Therapy for ASD with Intellectual Disability is unique because it specifically targets anxiety in individuals with both autism spectrum disorder (ASD) and intellectual disability, a combination that is often overlooked in standard treatments. This therapy is designed to be accessible and effective for this specific population, which may not benefit from traditional anxiety treatments. ^{8 9 10 11 12}

What is the purpose of this trial?

This trial tests a program called 'Facing Your Fears' for teenagers with autism and intellectual disabilities. It aims to help them manage anxiety by teaching coping skills. The 'Facing Your Fears' program has been previously adapted and tested for adolescents with high-functioning autism spectrum disorders and anxiety, showing encouraging initial results.

Research Team

Audrey D Blakeley-Smith, Ph.d.

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. 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]

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

Adaptation of One-Session Treatment for Specific Phobias for Children with Autism Spectrum Disorder Using a Non-concurrent Multiple Baseline Design: A Preliminary Investigation. [2021]

3. 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]

4. United States 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. [2023]

5. 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]

6. 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]

7. Egypt pubmed.ncbi.nlm.nih.gov

Facing your fears in adolescence: cognitive-behavioral therapy for high-functioning autism spectrum disorders and anxiety. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Therapeutic response of patients with adult Still's disease to biologic agents: multicenter results in Japan. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Treatment of adult Still's disease with dexamethasone, an alternative to prednisolone. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Treatment pattern and changes in oral glucocorticoid dose after tocilizumab treatment in patients with adult Still's disease: An analysis of a Japanese claims database. [2023]

11. Italy pubmed.ncbi.nlm.nih.gov

Infliximab in the treatment of adult Still's disease refractory to conventional therapy. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Effectiveness of subcutaneous tocilizumab in refractory adult Still's disease: report of three cases and a review of the literature. [2021]