What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) is generally considered a safe and effective treatment for Autism Spectrum Disorder (ASD), particularly for managing comorbid conditions like anxiety and emotional dysregulation. The side effects of CBT are minimal and typically include temporary emotional discomfort as individuals confront challenging thoughts and behaviors. In some cases, individuals may experience increased anxiety or stress during the initial stages of therapy. Pharmacological treatments for ASD, such as SSRIs or antipsychotics, may have more pronounced side effects, including weight gain, sedation, and gastrointestinal issues. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to the individual's needs.

What prior FDA approvals exist?

The FDA has not approved any medications specifically for the core symptoms of Autism Spectrum Disorder (ASD). However, certain medications are used off-label to manage associated symptoms such as irritability, anxiety, and hyperactivity. Cognitive Behavioral Therapy (CBT), which focuses on modifying dysfunctional emotions, behaviors, and thoughts, is being studied for its effectiveness in treating emotional dysregulation in children with ASD. While CBT is not a medication, it is a well-supported therapeutic approach for managing behavioral and emotional issues in ASD.

What other types of research exist?

One promising alternative to Cognitive Behavioral Therapy for Autism Spectrum Disorder patients is Acceptance-Based Behavior Therapy (ABBT). This therapy has shown viability in treating generalized anxiety disorder, which often co-occurs with ASD. Additionally, interventions targeting sensory challenges and emotional dysregulation, such as those involving sensory integration therapy and emotional regulation strategies, are also emerging as potential alternatives.

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CBT for Autism (CYAN Trial)

N/A

Recruiting

Led By Wood

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

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

Must have

Youth participants will be boys or girls between 6 and 14 years of age with a documented clinical diagnosis of ASD

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up sessions 1 [approximately week 1], 5 [approx. week 5], 9 [approx. week 9], and 13 [approx. week 13]

Awards & highlights

CYAN Trial Summary

This trial is testing whether cognitive behavioral therapy is more effective than usual care for treating children with autism and emotional dysregulation.

Who is the study for?

This trial is for children aged 6-14 with autism and emotional challenges like irritability or anxiety. They must have a clinical diagnosis of ASD, meet certain criteria on the Social Responsive Scale-2 and Vineland Adaptive Behavior Scales, and be referred by specific agencies. Clinicians treating these youths should specialize in fields such as psychology or social work.Check my eligibility

What is being tested?

The study compares cognitive behavioral therapy (CBT) designed for emotional dysregulation in autistic children to usual care supplemented by CBT self-instruction. It involves 100 youths treated by clinicians who receive either live expert consultation or use open-access digital/print materials.See study design

What are the potential side effects?

Since this trial focuses on behavioral interventions rather than medication, traditional side effects are not a primary concern; however, participants may experience discomfort or stress related to engaging with new therapeutic practices.

CYAN Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 6 and 14 years old and have been diagnosed with ASD.

CYAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ sessions 1 [approximately week 1], 5 [approx. week 5], 9 [approx. week 9], and 13 [approx. week 13]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~sessions 1 [approximately week 1], 5 [approx. week 5], 9 [approx. week 9], and 13 [approx. week 13]

This trial's timeline: 3 weeks for screening, Varies for treatment, and sessions 1 [approximately week 1], 5 [approx. week 5], 9 [approx. week 9], and 13 [approx. week 13] 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 Brief Problem Monitor (BPM)

Secondary outcome measures

Change in Social Responsiveness Scale II (SRS-II)

Change in Youth Top Problems (YTP) Rating Scale

Consumer Satisfaction Parent Questionnaire

Other outcome measures

Change in BIACA Therapist Quiz

Mixed-methods feedback on training and consultation in BIACA

The Modular EBPs for Youth with Autism Fidelity Scale (MEYA-FS; McLeod et al., 2022)

+1 more

CYAN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Consultation-Based Training on BIACAExperimental Treatment1 Intervention

Community mental health clinicians will be given online one-on-one training and consultation in the BIACA (Behavioral Interventions for Anxiety in Children with Autism; e.g., Wood et al., 2020) CBT program. Clinicians will be provided with weekly 30-minute video-conference-based consultation sessions with an expert in BIACA. These consultation sessions are manual-driven and utilize a Practice-Based Coaching format, in which a trained consultant meets weekly with clinicians to provide practice-based feedback (cf. McLeod et al., 2018). Consultation meetings include agenda setting, case material review, planning for the next treatment session, and a meeting summary. Relevant online training materials (e.g., demonstration videos of CBT sessions; corresponding written session materials) developed in the context of a NIMH R34 grant available on meya.ucla.edu (1R34MH110591) will also be provided to clinicians for each upcoming therapy session.

Group II: Usual Care Augmented by Self-Instruction Resources for CBT for AutismActive Control1 Intervention

Community mental health clinicians in this arm will provide any therapy, counseling, and/or behavioral treatment procedures they deem appropriate for each participating child. Clinicians randomized to this arm will be given immediate access to CBT-for-autism self-instruction materials that are already freely available to any clinician at meya.ucla.edu (see Consultation-Based Training on BIACA arm, above), to supplement their usual clinical care, if they so choose, until they complete their Usual Care/Self-Instruction participation and are offered direct training and weekly consultation in BIACA.

0 / 1Eligibility 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) for Autism Spectrum Disorder (ASD) focuses on modifying dysfunctional emotions, behaviors, and thoughts by teaching coping skills and strategies to manage anxiety, irritability, and other emotional dysregulations. Other common treatments include the Early Start Denver Model (ESDM), which combines Applied Behavior Analysis (ABA) with developmental and relationship-based approaches to improve language, cognitive, and adaptive functioning. The Social Communication/Emotional Regulation/Transactional Support (SCERTS) program addresses social communication deficits and interfering behaviors. These treatments are crucial for ASD patients as they help improve social communication, emotional regulation, and adaptive behaviors, leading to increased competence and independence.

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