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Cognitive Behavioral Therapy

Facing Your Fears Therapy for ASD with Intellectual Disability (FYF:ASD/ID Trial)

N/A

Recruiting

Led By Audrey D Blakeley-Smith, Ph.d.

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Clinically significant symptoms of anxiety, defined by clinically significant anxiety elevations on the ADAMS and meeting diagnostic criteria for at least one anxiety diagnosis on the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

FYF:ASD/ID Trial 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.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this is a psychological intervention focusing on behavior and coping skills rather than medication, traditional physical side effects are not expected. However, participants may experience emotional discomfort or increased anxiety initially as they confront fears during therapy.

FYF:ASD/ID Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with anxiety based on specific tests.

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I am between 12 and 18 years old.

FYF:ASD/ID Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in number of anxiety diagnoses as measured by the Anxiety Disorders Interview Schedule: Autism Addendum (ADIS:ASA)

Anxiety Disorders

Secondary outcome measures

Abnormal behavior

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)

Other outcome measures

Therapeutic procedure

FYF:ASD/ID Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment as UsualExperimental Treatment1 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 InterventionExperimental Treatment1 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).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,737 Previous Clinical Trials

2,149,273 Total Patients Enrolled

United States Department of DefenseFED

864 Previous Clinical Trials

327,527 Total Patients Enrolled

Audrey D Blakeley-Smith, Ph.d.Principal InvestigatorUniversity of Colorado, Denver

Media Library

Facing Your Fears: ASD/ID (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05131425 — N/A

Intellectual Disability Research Study Groups: Treatment as Usual, Cognitive Behavioral Intervention

Intellectual Disability Clinical Trial 2023: Facing Your Fears: ASD/ID Highlights & Side Effects. Trial Name: NCT05131425 — N/A

Facing Your Fears: ASD/ID (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05131425 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How might I be eligible to participate in this research?

"Qualifying individuals must demonstrate mental incapacity and be in the age range of 12 to 18. A maximum of 72 participants may join this medical trial."

Answered by AI

Is this experiment seeking out participants aged 55 or older?

"The stipulated enrolment age ranges from 12 to 18 years old; based on this criteria, the minimum and maximum ages for inclusion are both specified."

Answered by AI

What is the participant capacity for this experiment?

"Indeed, clinicaltrials.gov demonstrates that this medical trial is presently seeking volunteers. This endeavor was initially posted on September 1st 2021 and has been recently updated as of November 29th 2021; 72 patients are needed from 2 distinct research sites."

Answered by AI

Are new patients being admitted to this study at the present time?

"Affirmative, clinicaltrials.gov reveals that this medical trial is actively searching for participants. The study was first announced on September 1st 2021 and has been recently updated as of November 29th 2021, aiming to enroll 72 patients from 2 centers."

Answered by AI