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Behavioral Therapy for Irritability in 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
Sufficient language for participation in verbal therapy
Diagnosis of autism spectrum disorder
Must not have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upsix-month follow up (week 42)
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Autism Spectrum Disorder
  • Disruptive Behavior
  • Anger
  • Autism
  • Irritability
  • Aggression
  • Asperger Syndrome
  • Pervasive Developmental Disorder

BTIA Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You are able to speak and understand the language used in the therapy sessions.
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You have been diagnosed with autism spectrum disorder.
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You have frequent angry outbursts or get extremely irritable.
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You cannot change the intensity of your current treatment during the study.

BTIA Trial Timeline

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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Congressionally Directed Medical Research ProgramsFED
41 Previous Clinical Trials
6,447 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
180 Patients Enrolled for Autism Spectrum Disorder
Yale UniversityLead Sponsor
1,806 Previous Clinical Trials
2,711,555 Total Patients Enrolled
25 Trials studying Autism Spectrum Disorder
2,226 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

Does the participant criteria for this trial encompass those above 80 years of age?

"This clinical trial welcomes patients in the 12-18 year old age bracket."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~23 spots leftby Aug 2024