Behavioral Therapy for Autism

(BTIA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Denis Sukhodolsky, Ph.D.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Yale University

Disqualifiers: Medical condition, Psychiatric disorder, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests a new therapy called BTIA, which helps teens with autism manage their emotions and behaviors. The therapy involves regular sessions where therapists teach both the teens and their parents how to handle frustration and improve daily functioning. The study aims to see if BTIA can reduce disruptive behaviors and help these teens function better in their everyday lives.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it requires participants to be either medication-free or on stable medication. This means you should not change your current medications during the trial.

What data supports the effectiveness of the treatment Behavioral Therapy for Irritability in Autism?

Research shows that behavioral interventions, including cognitive behavioral therapy, can help reduce aggressive behavior and improve anger coping in children with autism. These treatments can decrease temper tantrums and arguing, and increase adaptive coping strategies, although they may not impact all areas of aggression and coping. ^{1 2 3 4 5}

Is behavioral therapy for autism safe for humans?

Behavioral therapies for autism, such as those focusing on emotion regulation and challenging behaviors, have been studied extensively and are generally considered safe. These therapies often involve strategies like parent-implemented interventions, emotion regulation training, and cognitive behavioral techniques, which have shown high-quality evidence of safety in multiple studies. ^{2 3 4 6 7}

How is Behavioral Therapy for Irritability in Autism different from other treatments for irritability in autism?

This treatment is unique because it focuses on exposure-based cognitive behavioral therapy, which helps children become more aware of their emotions and develop self-regulation skills to reduce temper tantrums and arguing. Unlike some other treatments, it emphasizes mindfulness and dialectical behavior therapy techniques to improve coping strategies, although it may not impact all areas of aggression or quality of life. ^{1 2 3 4 8}

Research Team

Denis Sukhodolsky, Ph.D.

Principal Investigator

Yale University

Eligibility Criteria

This trial is for boys and girls aged 12-18 with autism spectrum disorder who live near New Haven, CT. They should have disruptive behaviors like irritability or anger outbursts but no severe psychiatric disorders needing immediate treatment. Participants can be medication-free or on a stable regimen without planned changes.

Inclusion Criteria

You have a tendency to act out in angry or disruptive ways, such as getting easily irritated or having outbursts.

You must be able to speak and understand the language used in the therapy sessions.

I have been diagnosed with autism spectrum disorder.

Exclusion Criteria

Presence of a medical condition that would interfere with participation in the study

I am currently dealing with a psychiatric condition that needs immediate treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Behavioral Therapy for Irritability and Aggression (BTIA) or Psychoeducation and Supportive Therapy (PST) in 15 weekly, ninety-minute sessions

15 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at week 42

Treatment Details

Interventions

• Behavioral Therapy for Irritability in Autism (Behavioral Intervention)
• Psychoeducation and Supportive Therapy (PST) (Behavioral Intervention)

Trial Overview The study tests Behavioral Therapy for Irritability and Aggression (BTIA) in adolescents with autism to improve emotion regulation and transition into adulthood skills. It compares BTIA's effectiveness against Psychoeducation and Supportive Therapy (PST).

Participant Groups

Group I: Behavioral Therapy for Irritability in Autism (BTIA) Experimental Treatment 1 Intervention

BTIA consists of 15 ninety-minute weekly sessions that will be conducted with the teens and their parents by experienced therapists using a structured, detailed manual.

Group II: Psychoeducation and Supportive Therapy (PST) Active Control 1 Intervention

PST consist of 15 weekly, ninety-minute sessions focused on learning about and discussing issues of diagnosis, treatment and educational services with an experienced therapist could be helpful to children on the autism spectrum and their families.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Colonel Mark G. Hartell

Congressionally Directed Medical Research Programs

Director, Congressionally Directed Medical Research Programs since 2022

PhD in Analytical Chemistry from Auburn University, MS in Biophysical Chemistry from Ohio State University, BS in Chemistry from State University of New York at Oswego

Dr. Sarah Goldman

Congressionally Directed Medical Research Programs

Chief Medical Officer since 2023

MD

Findings from Research

A review of 213 studies involving 358 individuals with autism found that behavioral interventions are generally effective in reducing problem behaviors, with some interventions showing significantly better results than others.

Interventions that were preceded by a functional analysis were notably more effective, highlighting the importance of understanding the specific behaviors before applying treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of behavioral interventions for reducing problem behavior in persons with autism: an updated quantitative synthesis of single-subject research. Heyvaert, M., Saenen, L., Campbell, JM., et al.[2019]

The pilot study involving 11 children aged 5-7 with Autism Spectrum Disorders (ASD) showed that developmentally modified Cognitive Behavioral Therapy (CBT) effectively reduced anger and anxiety, as evidenced by improved parent-reported emotion regulation and shorter outbursts after treatment.

Parents also reported increased confidence in their child's ability to manage emotions, suggesting that parent training alongside CBT may enhance overall effectiveness, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving emotion regulation with CBT in young children with high functioning autism spectrum disorders: a pilot study. Scarpa, A., Reyes, NM.[2022]

References

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

The effectiveness of an attention-based intervention for school-aged autistic children with anger regulating problems: A randomized controlled trial. [2023]

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

Systematic Review and Meta-analysis: Pharmacological and Nonpharmacological Interventions for Persistent Nonepisodic Irritability. [2023]

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

Systematic Review: Emotion Dysregulation and Challenging Behavior Interventions for Children andAdolescents with Autism with Graded Key Evidence-Based Strategy Recommendations. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Systematic review: emotion dysregulation and challenging behavior interventions for children and adolescents on the autism spectrum with graded key evidence-based strategy recommendations. [2023]

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

Efficacy of behavioral interventions for reducing problem behavior in persons with autism: an updated quantitative synthesis of single-subject research. [2019]

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

Managing irritability and aggression in autism spectrum disorders in children and adolescents. [2010]

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

Improving emotion regulation with CBT in young children with high functioning autism spectrum disorders: a pilot study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Keeping up with the evidence base: Survey of behavior professionals about Naturalistic Developmental Behavioral Interventions. [2022]