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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six-month follow up (week 42)

Awards & highlights

BTIA Trial Summary

This trial is testing a new behavioral therapy to help adolescents on the autism spectrum with irritability and aggression. The goal is to see if it can help them develop skills to cope with frustration and the challenges of transitioning to adulthood.

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.Check my eligibility

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).See study design

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.

BTIA Trial 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.

BTIA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Irritability subscale - Aberrant Behavioral Checklist

Modified Overt Aggression Scale (MOAS)

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

Secondary outcome measures

Vineland Adaptive Behavior Scales - Communication Domain Score

Other outcome measures

Erythrocyte Indices

Social Responsiveness Scale-2 (SRS-2)

BTIA 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 / 1Eligibility criteria met

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Who is running the clinical trial?

Congressionally Directed Medical Research ProgramsFED

47 Previous Clinical Trials

6,452 Total Patients Enrolled

2 Trials studying Autism Spectrum Disorder

180 Patients Enrolled for Autism Spectrum Disorder

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,738,195 Total Patients Enrolled

26 Trials studying Autism Spectrum Disorder

2,261 Patients Enrolled for Autism Spectrum Disorder

Denis Sukhodolsky, Ph.D.Principal InvestigatorYale School of Medicine

3 Previous Clinical Trials

24 Total Patients Enrolled

3 Trials studying Autism Spectrum Disorder

24 Patients Enrolled for Autism Spectrum Disorder

Media Library

Behavioral Therapy for Irritability in Autism Clinical Trial Eligibility Overview. Trial Name: NCT04654260 — N/A

Autism Spectrum Disorder Research Study Groups: Behavioral Therapy for Irritability in Autism (BTIA), Psychoeducation and Supportive Therapy (PST)

Autism Spectrum Disorder Clinical Trial 2023: Behavioral Therapy for Irritability in Autism Highlights & Side Effects. Trial Name: NCT04654260 — N/A

Behavioral Therapy for Irritability in Autism 2023 Treatment Timeline for Medical Study. Trial Name: NCT04654260 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment available for this clinical research endeavor?

"According to clinicaltrials.gov, this medical trial is currently in progress and actively recruiting patients for the study which began on December 10th 2020 with an update posted on May 18th 2022."

Answered by AI

How many individuals are committing to participating in this clinical trial?

"Affirmative. Data on clinicaltrials.gov indicate that the medical trial, which was initially advertised on December 10th 2020, is currently enrolling participants. 126 individuals across 1 facility are sought out for this research endeavour."

Answered by AI

Who is eligible to participate in this medical experiment?

"To be eligible for the trial, adolescents aged 12 to 18 with aggression must apply. A total of 126 participants will be accepted into this clinical study."

Answered by AI