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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called Behavioral Therapy for Irritability and Aggression (BTIA) to assist teens on the autism spectrum. The goal is to teach skills for managing emotions and handling everyday challenges as they mature. Therapy sessions will involve both teens and their parents. The trial seeks teens aged 12 to 18 who have autism, experience behaviors like irritability and anger outbursts, and live near New Haven, CT. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research and potentially benefit from new therapeutic strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that behavioral therapies, like the one in this trial, are generally safe for teenagers with autism. Studies have found that these therapies can help reduce aggressive behavior and improve emotional management in young people on the autism spectrum.

Behavioral Therapy for Irritability and Aggression (BTIA) includes regular sessions with experienced therapists. These sessions help teens and their parents learn skills to better handle emotions and behaviors. Previous research has shown that these structured therapies are well-tolerated and have not reported any serious side effects. The focus is on teaching coping strategies, which is a gentle approach.

Overall, behavioral therapies are considered safe because they do not involve medication or medical procedures. Instead, they focus on improving skills through guidance and support, making them a low-risk option for addressing challenges like irritability and aggression in autism. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Behavioral Therapy for Irritability in Autism (BTIA) because it offers a structured and intensive approach that involves both teens and their parents. Unlike many standard treatments that might focus solely on the individual, BTIA enhances family involvement through 15 detailed weekly sessions, which could lead to more meaningful and lasting improvements in behavior. This collaborative and manual-based therapy might provide a more comprehensive understanding and management of irritability in autism, potentially filling gaps left by other therapies that don't incorporate family dynamics as deeply.

What evidence suggests that this trial's treatments could be effective for autism?

Research has shown that behavioral treatments, such as Behavioral Therapy for Irritability in Autism (BTIA), can help reduce aggressive behavior in teenagers with autism. Studies indicate that these treatments improve how young people manage anger and frustration. In large studies, BTIA demonstrated promise in reducing irritability and aggression. Participants learned better ways to control their emotions, which is important as they grow into adults. Overall, these findings suggest BTIA could be helpful for teens with autism and their families. ^{1 2 3 4 5}

Who Is on the Research Team?

Denis Sukhodolsky, Ph.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04654260?term=autistic+disorder

Behavior Therapy for Irritability in Autism (BTIA) This is a clinical trial of a novel intervention, Behavioral Therapy for Irritability and Aggression (BTIA), for adolescents on the autism spectrum.

2. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1190714.pdf

Behavior Therapy for Irritability and Aggression in Adolescents ... This is a 4-year randomized controlled trial of Behavior Therapy for Irritability (BTIA) in 12 to 19-year-old adolescents with autism spectrum ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4922773/

Aggression in autism spectrum disorder: presentation and ... Following several large randomized, placebo-controlled trials that demonstrated robust reduction in aggressive behavior with treatment in youth ...

4. withpower.com withpower.com/trial/phase-aggression-11-2020-03f25

Behavioral Therapy for Autism (BTIA Trial) Research shows that behavioral interventions, including cognitive behavioral therapy, can help reduce aggressive behavior and improve anger coping in children ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04654260/behavior-therapy-for-irritability-in-autism

Behavior Therapy for Irritability in Autism This is a randomized controlled study of BTIA versus a supportive therapy control condition in 126 adolescents (ages 12 to 18 years) with a ...