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

6 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Cognitive-Behavioral Therapy for Autism?

Research shows that Cognitive-Behavioral Therapy (CBT) is effective in improving symptoms and functioning in conditions like schizophrenia and mood disorders, suggesting it may also help with autism. For example, a study found improvements in symptom severity and psychosocial functioning in patients with schizophrenia who received CBT. ^{1 2 3 4 5}

Is Cognitive-Behavioral Therapy (CBT) safe for people with autism?

Cognitive-Behavioral Therapy (CBT) has been used safely in children and adolescents with autism spectrum disorders, particularly for reducing anxiety. Studies show high program satisfaction and no significant safety concerns have been reported. ^{6 7 8 9 10}

How is Cognitive-Behavioral Therapy (CBT) different from other treatments for autism?

Cognitive-Behavioral Therapy (CBT) is unique for autism as it is specifically adapted to help high-functioning children with autism manage anxiety and obsessive-compulsive disorders. Unlike other treatments, CBT can be delivered in a family-based, internet-delivered format, making it more accessible and engaging for autistic youth and their families. ^{6 11 12 13 14}

What is the purpose of this trial?

In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. The purpose of this study is to investigate cognitive-behavioral therapy (CBT) for disruptive behavior in children with autism spectrum disorders and intellectual disability. This pilot study will include children with ASD and IQ between 55 and 85 in an open study of CBT. CBT is modified in this study to reduce complexity of activities during therapy sessions but retains all key elements and principles of CBT. Assessments of irritability and disruptive behavior will include clinical interviews, parent ratings and child self-report measures. Study participants will be asked to complete functional magnetic resonance imaging (fMRI) to evaluate biomarkers of social perception and emotion regulation before and after CBT.

Research Team

Denis Sukhodolsky, PhD

Principal Investigator

Associate Professor

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive therapy for persistent psychosis in schizophrenia: a case-controlled clinical trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive and behavioral changes related to symptom improvement among patients with a mood disorder receiving intensive cognitive-behavioral therapy. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Improving cognitive therapy for depression with functional analytic psychotherapy: Theory and case study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Similar changes in cognitions following cognitive-behavioral therapy or escitalopram for major depressive disorder: Implications for mechanisms of change. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Outcome measures for practice. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for children with autism: review and considerations for future research. [2021]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

CBT for anxiety disorders in children with and without autism spectrum disorders. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for early adolescents with autism spectrum disorders and clinical anxiety: a randomized, controlled trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive behavioural therapy with people who have autistic spectrum disorders: A systematic review and meta-analysis. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Development and pilot testing of internet-delivered, family-based cognitive behavioral therapy for anxiety and obsessive-compulsive disorders in autistic youth. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Improving Cognitive Behaviour Therapy for Autistic Individuals: A Delphi Survey with Practitioners. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Treatment of anxiety in autism spectrum disorders using cognitive behaviour therapy: A systematic review. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Training clinicians to deliver group CBT to manage anxiety in youth with ASD: Results of a multisite trial. [2019]