Facing Your Fears: ASD/ID for Idiocy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Idiocy+4 More
Facing Your Fears: ASD/ID - Behavioral
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether a cognitive behavioral treatment is more effective in reducing anxiety for adolescents with ASD and intellectual disability than treatment as usual.

Eligible Conditions
  • Idiocy
  • Autism Spectrum Disorders
  • Anxiety
  • Autism Spectrum Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 3 Secondary · Reporting Duration: Baseline (i.e., within 6 weeks' start of the treatment or TAU condition), Post treatment (i.e., within 6 weeks of the completion of the14-week treatment or TAU condition), and follow-up (six months following the completion of the treatment condition)

Week 6
Change in number of anxiety diagnoses as measured by the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA)
Abnormal behavior
Anxiety Disorders
Change in the Dysphoria subscale as assessed by the Emotion Dysregulation Inventory (EDI)
Change in the Reactivity subscale as assessed by the Emotion Dysregulation Inventory (EDI)
Clinical improvement in anxiety as measured by the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA)
Therapeutic procedure
Exploratory Aim: Exploratory analyses will be conducted to evaluate the effect of treatment participation on teens' independent use of somatic management, emotion regulation, and cognitive strategies using goal attainment scaling(e.g., GAS)
Reduction in number of anxiety diagnoses as measured by the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA)

Trial Safety

Trial Design

1 Treatment Group

Cognitive Behavioral Intervention
1 of 1
Experimental Treatment

72 Total Participants · 1 Treatment Group

Primary Treatment: Facing Your Fears: ASD/ID · No Placebo Group · N/A

Cognitive Behavioral Intervention
Behavioral
Experimental Group · 1 Intervention: Facing Your Fears: ASD/ID · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (i.e., within 6 weeks' start of the treatment or tau condition), post treatment (i.e., within 6 weeks of the completion of the14-week treatment or tau condition), and follow-up (six months following the completion of the treatment condition)

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,568 Previous Clinical Trials
1,923,337 Total Patients Enrolled
United States Department of DefenseFED
767 Previous Clinical Trials
202,333 Total Patients Enrolled
Audrey D Blakeley-Smith, Ph.d.Principal InvestigatorUniversity of Colorado, Denver

Eligibility Criteria

Age < 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
People who meet the diagnostic criteria for at least one anxiety disorder as defined by clinically significant anxiety elevations on the ADAMS and meeting diagnostic criteria for autism on the ADIS:ASA, experience clinically significant symptoms of anxiety.
, was found in 9% of boys and 1% of girls in the study The study found that a confirmed diagnosis of ASD, as based on a score above ASD cutoff on the Autism Diagnostic Observation Schedule-Second Edition and DSM-5 clinical evaluation, was found in 9% of boys and 1% of girls.
People who have an IQ score of between 40 and 70 on the Stanford Binet-Fifth Edition (SB-5) and a Total Adaptive Composite score below 70 on the Adaptive Behavior Assessment System, 3rd Edition (ABAS-3) have cognitive and adaptive behavior abilities in the ID range.
A person's chronological age is between 12 and 18 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: October 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Georgia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Colorado100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References