Cognitive-Behavioral Therapy for Autism

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Medical, psychiatric conditions, others

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

Compensation: Varies

Number of Visits: 18

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests cognitive-behavioral therapy (CBT) to manage disruptive behaviors such as irritability and tantrums in children with autism. The therapy is adapted to be simpler while still teaching essential skills for coping with frustration. The study also employs brain scans (fMRI) to observe how therapy affects social perception and emotion regulation. Children with autism who frequently experience anger outbursts and have an IQ between 55 and 85 might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance therapeutic approaches for children with autism.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants can be un-medicated or on a stable medication regimen. It seems you may continue your current medications if they are stable.

What prior data suggests that this cognitive-behavioral therapy is safe for children with autism?

Research has shown that cognitive-behavioral therapy (CBT) can greatly help children and teenagers with autism spectrum disorders (ASD). Studies have found that CBT improves social skills and reduces emotional and social problems. Importantly, no evidence indicates serious safety issues with CBT, as it is a well-known therapy. Parents have observed positive changes, particularly in reducing anxiety in autistic youth. This suggests that CBT is generally safe and can help manage challenging behaviors in children with ASD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive-Behavioral Therapy (CBT) for autism because it offers a tailored approach to managing frustration and anger in children. Unlike standard treatments such as medication or general behavioral interventions, CBT teaches specific coping skills to children and equips parents with strategies to handle challenging situations. This hands-on, skills-based method could provide more immediate and practical benefits, helping families navigate daily life more effectively.

What evidence suggests that cognitive-behavioral therapy is effective for disruptive behavior in children with autism?

Research shows that Cognitive-Behavioral Therapy (CBT), the focus of this trial, can greatly help children with Autism Spectrum Disorder (ASD). Studies have found that CBT improves social skills and reduces social difficulties in these children. Encouraging evidence indicates that CBT works well, especially for those with additional challenges like obsessive-compulsive disorder. Additionally, adapted versions of CBT have succeeded for young people with ASD in local communities. Overall, these findings suggest that CBT is a helpful treatment for improving behavior and managing emotions in children with autism. ^{1 2 6 7 8}

Who Is on the Research Team?

Denis Sukhodolsky, PhD

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

This trial is for children with Autism Spectrum Disorder and an IQ between 55 and 85 who show disruptive behaviors like irritability. They must be able to complete study assessments and fMRI scans, either un-medicated or on a stable medication regimen. Children with other medical or psychiatric conditions needing different treatments cannot participate.

Inclusion Criteria

You have a score of 15 or higher on the ABC Irritability Scale.

You have been diagnosed with Autism Spectrum Disorder using the DSM-5 guidelines.

Able to complete all study assessment and fMRI procedures

Exclusion Criteria

I have a health or mental condition needing different treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly sessions of Principles-Based Cognitive Behavior Therapy (PB-CBT) for irritability in autism

16 weeks

16 visits (in-person)

fMRI Assessment

Participants undergo fMRI scans to evaluate biomarkers of social perception and emotion regulation before and after CBT

2 sessions

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-Behavioral Therapy

Trial Overview The study tests Cognitive-Behavioral Therapy (CBT) tailored for children with ASD to manage irritability and disruptive behavior. It includes simpler activities while keeping CBT's core principles intact. Participants will also undergo fMRI scans before and after therapy to look for changes in brain activity related to social perception and emotion regulation.

How Is the Trial Designed?

Group I: Cognitive-Behavioral Therapy Experimental Treatment 2 Interventions

CBT is a behavioral intervention where children are taught various skills for coping with frustration and parents are taught various strategies for managing situations that can be anger-provoking for their child.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

Cognitive Behaviour Therapy (CBT) has been shown to be an effective treatment for anxiety in individuals with Asperger's syndrome, based on a review of nine studies.

There is limited data on the effectiveness of CBT for other sub-types of autism spectrum disorders (ASD), indicating a need for further research to explore its efficacy across the spectrum and to understand the mechanisms behind its success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of anxiety in autism spectrum disorders using cognitive behaviour therapy: A systematic review. Lang, R., Regester, A., Lauderdale, S., et al.[2022]

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]

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) 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]

Clinicians who participated in Workshop training conditions showed significantly increased knowledge of cognitive-behavioral therapy (CBT) and delivered the Facing Your Fears program with higher fidelity compared to those trained via a Manual, indicating that interactive training methods may enhance the quality of therapy delivery.

Despite the differences in training methods, all clinicians effectively reduced anxiety symptoms in children with autism spectrum disorder (ASD), suggesting that the Facing Your Fears program can be successfully implemented across various training formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training clinicians to deliver group CBT to manage anxiety in youth with ASD: Results of a multisite trial. Reaven, J., Moody, EJ., Grofer Klinger, L., et al.[2019]

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]

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]

Using outcome measures in psychotherapy can significantly improve treatment results, especially for patients who are likely to struggle with negative outcomes.

A meta-analysis indicates that monitoring patient feedback and providing clinicians with decision-making tools can enhance treatment effectiveness for those showing early signs of treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measures for practice. Whipple, JL., Lambert, MJ.[2015]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33888566/

Cognitive Behavioral Therapy for Autism Spectrum Disorders Conclusions: These findings indicate that CBT may significantly improve the symptoms of ASD and social-emotional problems in children or adolescents with ASD.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5858576/

Effectiveness of Cognitive Behavioral Therapy for ... These studies offer promising data on the use of CBT interventions for individuals with ASD and comorbid OCD as well as for individuals with OCD and comorbid ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165032723011904

Cognitive behavioural therapy to improve social skills in ... CBT improved social skills in children with autism compared to controls. CBT is effective in improving social impairment in children with autism.

4. molecularautism.biomedcentral.com molecularautism.biomedcentral.com/articles/10.1186/s13229-020-00341-6

Effectiveness of a modified group cognitive behavioral therapy ... Overall, this study demonstrated that community implementation of a modified group CBT program for youth with ASD is feasible and effective for ...

5. publications.aap.org publications.aap.org/pediatrics/article-abstract/147/5/e2020049880/180885/Cognitive-Behavioral-Therapy-for-Autism-Spectrum

Cognitive Behavioral Therapy for Autism Spectrum Disorders CBT might significantly improve the symptoms of ASD and social-emotional problems in children or adolescents with ASD.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01178385

Cognitive-Behavioral Treatment for Anxiety Disorders in ... Autism spectrum disorders affect as many as 1 out of 150 children and are related to significant impairment in social, adaptive, and school functioning.

7. nature.com nature.com/articles/s41598-025-88779-7

Virtual delivery of group-based cognitive behavioral ... Virtual delivery of FYF is feasible and effective for treating elevated anxiety in autistic children/youth and may improve access.

8. bmcpsychology.biomedcentral.com bmcpsychology.biomedcentral.com/articles/10.1186/s40359-021-00658-8

Cognitive behavioural therapy for anxiety in children and ... Parent reported outcomes for anxiety in autistic youth showed CBT as an efficacious treatment in comparison to control conditions. Using a ...