CBT for Autism

(CYAN Trial)

Recruiting at 2 trial locations

Overseen By Wood

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Severe psychotic symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 29

Duration: 16 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of cognitive behavioral therapy (CBT) with usual clinical care for children with autism who face emotional challenges like irritability and anxiety. Clinicians will either receive expert consultation to enhance their CBT skills or access self-instruction resources to supplement their usual care. The goal is to determine which approach better helps children manage their emotions and core autism symptoms. This trial may suit children aged 6-14 with a current autism diagnosis who are newly seeking outpatient services and have significant emotional difficulties. As an unphased trial, it offers families a unique opportunity to contribute to understanding and improving emotional care for children with autism.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. However, it mentions that severe comorbid conditions requiring ongoing medication adjustments may exclude someone from participating.

What prior data suggests that CBT is safe for children with autism?

Research has shown that cognitive behavioral therapy (CBT) is generally safe for children with autism. Studies have found that CBT can significantly improve social skills and reduce anxiety in these children. For example, one study found that children who received CBT had better social skills than those who did not. Another study showed that CBT helped with autism symptoms and emotional issues.

While CBT is considered safe, some children might feel uncomfortable as they adjust to new strategies and routines. However, no serious side effects have been reported. Overall, CBT is regarded as safe and well-tolerated for children with autism. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CBT for autism because it offers a structured and personalized approach to help children with autism manage anxiety through community mental health clinicians. Unlike traditional therapies, this method provides clinicians with one-on-one online training and expert consultation in the BIACA program, allowing for practice-based feedback and tailored guidance. Additionally, the use of online resources, including demonstration videos and session materials, enhances the accessibility and scalability of the treatment, potentially improving outcomes for children with autism compared to standard care.

What evidence suggests that CBT might be an effective treatment for autism?

Research shows that Cognitive Behavioral Therapy (CBT) can greatly help children with autism manage social and emotional difficulties. Studies have found that CBT improves social skills and reduces social challenges in these children. It also effectively addresses issues like anxiety and obsessive-compulsive disorder (OCD) in children with autism. In this trial, one group of community mental health clinicians will receive Consultation-Based Training on BIACA, a CBT program, to enhance their practice. Another group will continue with Usual Care, supplemented by self-instruction resources for CBT for autism. Community programs using CBT have proven successful and practical for young people with autism. Overall, CBT has shown promise in enhancing thinking, language, and core symptoms in children with autism. ^{1 2 6 7 8}

Who Is on the Research Team?

Wood

Principal Investigator

University of California

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

The parent-reported Social Responsive Scale-2 Total T-Score will be > 60

Clinician participants will regularly treat youth with ASD within a recognized field of practice

I will refer at least 2 new families to participate in the study.

Exclusion Criteria

I have severe health conditions besides my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive behavioral therapy (CBT) or usual clinical care for emotional dysregulation and core autism symptoms, with weekly live consultation or self-instruction resources

16 weeks

Weekly sessions

Mid-treatment Assessment

Mid-treatment assessments are conducted to evaluate progress

1 week

Post-treatment Assessment

Immediate post-treatment assessments are conducted to evaluate outcomes

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

Follow-up assessments at approximately week 29

What Are the Treatments Tested in This Trial?

Interventions

• CBT

Trial Overview

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.

How Is the Trial Designed?

Group I: Consultation-Based Training on BIACA Experimental Treatment 1 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 Autism Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+

United States Naval Medical Center, San Diego

Collaborator

Trials

110

Recruited

24,200+

California Autism Professional Training and Information Network

Collaborator

Trials

1

Recruited

100+

Westside Regional Center

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

Clinicians are significantly more likely to intend to use cognitive-behavioral therapy (CBT) for non-autistic adults compared to autistic adults, indicating a gap in treatment accessibility for autistic individuals.

The most important factor influencing clinicians' intentions to provide CBT to autistic adults is their attitudes towards this treatment, suggesting that improving clinician attitudes could enhance the adoption of CBT for autistic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Influencing the Use of Cognitive-Behavioral Therapy with Autistic Adults: A Survey of Community Mental Health Clinicians. Maddox, BB., Crabbe, SR., Fishman, JM., et al.[2023]

Cognitive behavioral therapy (CBT) shows potential effectiveness for reducing anxiety and core symptoms in high-functioning children with autism, but current studies have methodological weaknesses that limit definitive conclusions.

There is a need for more rigorous research to better evaluate CBT's effectiveness, focusing on specific cognitive strategies and adaptations tailored for children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for children with autism: review and considerations for future research. Danial, JT., Wood, JJ.[2021]

A study involving 49 children with Autism Spectrum Disorder (ASD) showed that Cognitive Behavioural Therapy (CBT) significantly reduced anxiety, with 30% of participants free from their primary anxiety diagnoses after treatment.

While there were no significant differences in primary outcomes between the treatment and waitlist groups, secondary outcomes indicated meaningful improvements, suggesting that CBT is a feasible and potentially effective intervention for anxiety in children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Based Cognitive Behavioural Therapy for Anxiety in Children with Autism Spectrum Disorder: A Randomised Controlled Trial in a General Child Psychiatric Hospital Setting. Kilburn, TR., Sørensen, MJ., Thastum, M., et al.[2023]

Cognitive Behavioral Therapy (CBT) shows varying effectiveness for individuals with autistic spectrum disorders (ASDs), with significant medium effect sizes reported for informant and clinician assessments, particularly for affective disorders and ASD symptoms.

Despite some positive outcomes, the overall effect sizes for self-reported measures were small to medium and non-significant, indicating a need for more definitive trials to establish CBT as a validated treatment for ASDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive behavioural therapy with people who have autistic spectrum disorders: A systematic review and meta-analysis. Weston, L., Hodgekins, J., Langdon, PE.[2022]

Children with autism are at a higher risk for experiencing trauma, necessitating tailored treatment approaches.

The proposed treatment model combines elements from cognitive behavior therapy and trauma-focused therapy, including behavior assessment, emotion regulation training, and exposure therapy, aiming to effectively address trauma in children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autism Spectrum Disorder and the Experience of Traumatic Events: Review of the Current Literature to Inform Modifications to a Treatment Model for Children with Autism. Stack, A., Lucyshyn, J.[2021]

A study involving six adolescents and young adults with high-functioning autism showed that an adapted cognitive-behavioral therapy (CBT) protocol effectively reduced anxiety symptoms and improved adaptive functioning, with improvements maintained at a one-month follow-up.

While clinician-rated measures indicated significant reductions in anxiety severity, parent- and self-reported anxiety showed mixed results, suggesting that spontaneous changes during the baseline period may have influenced these ratings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of anxiety in older adolescents and young adults with autism spectrum disorders: A pilot study. Ehrenreich-May, J., Simpson, G., Stewart, LM., et al.[2021]

A modified Cognitive Behavioral Therapy (CBT) program for adolescents with autism spectrum disorders (ASD) significantly reduced anxiety symptoms, with 79% of participants showing positive treatment responses compared to only 28.6% in the waitlist group.

The CBT program also positively impacted autism symptom severity according to parent reports, indicating that the treatment was effective not only for anxiety but also for some aspects of autism, although further modifications to the program may be needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial. Wood, JJ., Ehrenreich-May, J., Alessandri, M., et al.[2022]

The review identified two probably efficacious cognitive-behavioral therapy (CBT) programs for treating anxiety disorders in children and youth with autism spectrum disorders (ASD), but no well-established programs were found.

The study highlights the need for further research to refine and establish the efficacy of CBT formats specifically designed for ASD populations, as current evidence shows variability in effectiveness among different program types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the effectiveness of psychotherapy for anxiety disorders in children and adolescents with ASD. Hunsche, MC., Kerns, CM.[2020]

Cognitive Behavioral Therapy (CBT) for anxiety in children with autism spectrum disorders (ASD) showed promising results, with 40 participants aged 7-11 years demonstrating improved daily living skills after immediate treatment compared to a waitlist group.

Parents of children receiving CBT reported less involvement in their children's daily routines, which correlated with reduced anxiety severity, suggesting that CBT may enhance independence in children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cognitive behavioral therapy on daily living skills in children with high-functioning autism and concurrent anxiety disorders. Drahota, A., Wood, JJ., Sze, KM., et al.[2021]

A study involving 50 CBT practitioners identified six key barriers to effective cognitive behavior therapy for autistic individuals, including issues related to service provision and practitioner training.

Consensus among practitioners highlighted the need for enhanced training on autism and co-occurring conditions, as well as improvements in service delivery, to better support autistic individuals receiving CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Cognitive Behaviour Therapy for Autistic Individuals: A Delphi Survey with Practitioners. Spain, D., Milner, V., Mason, D., et al.[2023]

Cognitive Behavioral Therapy (CBT) significantly reduces anxiety in autistic youth, showing a large effect size for clinician-rated symptoms (g = 0.88) based on a systematic review of 19 randomized controlled trials involving 833 participants.

While CBT was effective immediately after treatment, the benefits did not persist at follow-up, and the efficacy varied depending on who reported the symptoms, highlighting the need for future studies to ensure sustained treatment effects and address reporting biases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for anxiety in children and young people on the autism spectrum: a systematic review and meta-analysis. Sharma, S., Hucker, A., Matthews, T., et al.[2021]

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frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.691148/full

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