Facing Your Fears Therapy for ASD with Intellectual Disability

(FYF:ASD/ID Trial)

Recruiting at1 trial location

Overseen by Audrey D Blakeley-Smith, Ph.d.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Trial Summary

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.

Treatment Details

Interventions

• Facing Your Fears: ASD/ID (Cognitive Behavioral Therapy)

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+

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

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences