What side effects are associated with this type of intervention?

Behavioral therapies like CBT and DBT, which focus on emotion regulation and coping skills development, are generally well-tolerated with minimal side effects. Common side effects may include temporary increases in anxiety or emotional discomfort as individuals confront challenging thoughts and behaviors. Pharmacological treatments, such as low-dose antipsychotics or mood stabilizers, which may be used adjunctively, can have side effects including weight gain, drowsiness, and metabolic changes. It is important to monitor these side effects closely in collaboration with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved two medications specifically for the treatment of irritability associated with Autism Spectrum Disorder: risperidone and aripiprazole. These medications are used to manage symptoms such as aggression, self-injury, and severe tantrums. While these drugs do not directly address emotion regulation and coping skills development, they help reduce the behavioral symptoms that can interfere with these therapeutic goals.

What other types of research exist?

Promising novel alternatives to BTIA for treating irritability and aggression in ASD patients include: 1) Dance/Movement Therapy, which has shown trends towards reducing negative symptoms in ASD, although further research is needed to confirm its efficacy. 2) Telehealth-based Applied Behavior Analysis (ABA), which can provide remote training and intervention, making it accessible to a broader population. 3) Music Therapy, which may enhance focus, attention, and interaction, potentially aiding in emotion regulation and coping skills development.

← Back to Search

Behavioral Therapy for Autism (BTIA Trial)

N/A

Recruiting

Led By Denis Sukhodolsky, Ph.D.

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of autism spectrum disorder

Be younger than 65 years old

Must not have

Presence of a current psychiatric disorder that requires immediate clinical attention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six-month follow up (week 42)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Since the interventions are behavioral therapies, there may not be physical side effects like with medications. However, participants might experience emotional discomfort or stress during therapy sessions as they work through challenging behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with autism spectrum disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six-month follow up (week 42)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six-month follow up (week 42)

This trial's timeline: 3 weeks for screening, Varies for treatment, and six-month follow up (week 42) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Irritability subscale - Aberrant Behavioral Checklist

Modified Overt Aggression Scale (MOAS)

The Clinical Global Impression - Improvement Score (CGI-I)

Secondary study objectives

Vineland Adaptive Behavior Scales - Communication Domain Score

Other study objectives

Erythrocyte Indices

Social Responsiveness Scale-2 (SRS-2)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral Therapy for Irritability in Autism (BTIA)Experimental Treatment1 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 Control1 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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD), such as Behavioral Therapy for Irritability and Aggression (BTIA), focus on improving emotion regulation and coping skills. These therapies help patients manage frustration and navigate social interactions more effectively, which is crucial for reducing irritability and aggression. By enhancing these skills, patients experience better overall functioning and quality of life. Parent training is often included to provide consistent support, further promoting positive outcomes.

What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.Neurologic treatment strategies in autism: an overview of medical intervention strategies.