Behavioral Therapy for Autism

(BTIA Trial)

Overseen By Sydeny Anderson

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Medical condition, Psychiatric disorder, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 57

Duration: 15 weeks

126 Participants Needed

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.

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
• Psychoeducation and Supportive Therapy (PST)

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.

Behavioral Therapy for Irritability in Autism is already approved in United States for the following indications:

Approved in United States as Behavioral Therapy for Irritability and Aggression (BTIA) for:

• Irritability and aggression in autism spectrum disorder

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Findings from Research

A study involving 51 school-aged children with autism spectrum disorders showed that an attention-based cognitive behavioral treatment effectively reduced temper tantrums and arguing, indicating improved anger regulation skills.

While the treatment enhanced some adaptive coping strategies, it did not significantly affect other aggressive behaviors or overall quality of life, suggesting that while the intervention is beneficial, its effects may be limited to specific behaviors.

NCBI (Pubmed)

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. Clifford, P., Gevers, C., Jonkman, KM., et al.[2023]

This meta-analysis of 101 studies found that both pharmacological and nonpharmacological interventions significantly reduce irritability in youth with conditions like autism spectrum disorder (ASD) and ADHD, with a large overall effect size of 1.62.

Antipsychotic medications were the most effective treatment option, showing the largest effect size (1.85) for reducing irritability, especially in youth with ASD, who had an even larger effect size of 1.89.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis: Pharmacological and Nonpharmacological Interventions for Persistent Nonepisodic Irritability. Breaux, R., Baweja, R., Eadeh, HM., et al.[2023]

A review of 95 studies found that interventions like Parent-Implemented Intervention and Emotion Regulation Training are highly effective in reducing challenging behaviors in children and adolescents with autism, emphasizing the importance of teaching emotion-regulation skills.

The review highlights the need for more rigorous studies that include measures of emotion dysregulation, suggesting that addressing this aspect could improve outcomes in managing challenging behaviors.

NCBI (Pubmed)

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. Nuske, HJ., Young, AV., Khan, F., et al.[2023]

A review of 95 studies found that effective interventions for reducing challenging behavior in children with autism include Parent-Implemented Interventions, Emotion Regulation Training, and Antecedent-Based Interventions, highlighting the importance of teaching emotion regulation skills.

Most studies focused on challenging behavior rather than emotion dysregulation, indicating a need for future research to include emotion dysregulation as a key outcome to better understand and address these behaviors.

NCBI (Pubmed)

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. Nuske, HJ., Young, AV., Khan, FY., et al.[2023]

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]

Children with autism spectrum disorders often experience high levels of irritability and aggression, with studies indicating that up to 20% exhibit severe symptoms like tantrums and self-injury.

The review will focus on medications that are FDA-approved and demonstrate the best safety and efficacy profiles for treating irritability in these children, covering various drug categories including antipsychotics and antidepressants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

A survey of 901 Board Certified Behavior Analysts revealed that most professionals have little knowledge of Naturalistic Developmental Behavior Interventions, despite strong evidence supporting their effectiveness for children on the autism spectrum.

The findings suggest a need for increased training and updated certification requirements to align with current research, as many professionals do not believe these interventions are effective or appropriate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keeping up with the evidence base: Survey of behavior professionals about Naturalistic Developmental Behavioral Interventions. Hampton, LH., Sandbank, MP.[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]