What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) is generally considered a safe and effective treatment for managing anxiety and developing coping skills in individuals with intellectual disabilities, including those with ASD/ID. Common side effects are minimal but can include temporary increases in anxiety or emotional discomfort as individuals confront challenging thoughts and situations. Additionally, some individuals may experience frustration or fatigue from the effort required to engage in therapy sessions and practice new skills. Overall, the benefits of CBT in improving anxiety and coping skills typically outweigh these mild and transient side effects.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments using Cognitive Behavioral Therapy (CBT) techniques for Intellectual Disability (ID) or Autism Spectrum Disorder with Intellectual Disability (ASD/ID). However, CBT is a well-established, non-pharmacological approach that has been adapted and studied for managing anxiety and developing coping skills in adolescents with ASD/ID, as seen in the 'Facing Your Fears' (FYF:ASD/ID) trial. This trial aims to reduce anxiety and improve emotion regulation and problem behavior through structured CBT interventions.

What other types of research exist?

Promising alternatives to FYF:ASD/ID for adolescents with ASD/ID include: 1) Dialectical Behavior Therapy (DBT), which has shown feasibility and acceptability in autistic adults without ID and may be adapted for adolescents with ID; 2) Mindfulness-Based Interventions, which have demonstrated effectiveness in improving quality of life and coping skills in children with autism; and 3) Participant Modeling, a technique involving gradual exposure and modeling by caregivers, which has been effective in reducing fears in children with intellectual disabilities.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Anxiety Disorders

Secondary study objectives

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 study objectives

Therapeutic procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy (CBT) is a common treatment for Intellectual Disability (ID) that focuses on identifying and changing negative thought patterns and behaviors. In the context of the 'Facing Your Fears' (FYF:ASD/ID) trial, CBT techniques are adapted to help adolescents with ID and Autism Spectrum Disorder (ASD) manage anxiety and develop coping skills. The mechanisms of action include cognitive restructuring to challenge and modify unhelpful thoughts, exposure therapy to gradually face and reduce fear responses, and skills training to enhance emotional regulation and problem-solving abilities. These mechanisms are crucial for ID patients as they provide structured, evidence-based strategies to improve mental health and functional outcomes, thereby supporting a smoother transition to adulthood and better family functioning.