Behavior Therapy for Irritability in Autism

Last updated: May 12, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Autism Spectrum Disorder (Asd)

Learning Disorders

Treatment

Behavioral Therapy for Irritability in Autism

Psychoeducation and Supportive Therapy (PST)

Clinical Study ID

NCT04654260
0102012121-5
W81XWH2010718
  • Ages 12-19
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a clinical trial of a novel intervention, Behavioral Therapy for Irritability and Aggression (BTIA), for adolescents on the autism spectrum. The main goals of BTIA are to help adolescents develop emotion regulation skills to handle frustration and to strengthen skills for navigating the challenging and diverse experiences associated with the transition to adulthood. The study will test whether BTIA can be helpful to adolescents on the autism spectrum and to their families.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Boys and girls, ages 12 to 18 years inclusive

  • Diagnosis of autism spectrum disorder

  • Presence of disruptive behaviors such as irritability and anger outbursts

  • No planned changes in the intensity of current treatment(s)

  • Medication free or on stable medication

  • Sufficient language for participation in verbal therapy

  • Lives within driving distance from New Haven, CT

Exclusion

Exclusion Criteria:

  • Presence of a medical condition that would interfere with participation in the study

  • Presence of a current psychiatric disorder that requires immediate clinicalattention

Study Design

Total Participants: 126
Treatment Group(s): 2
Primary Treatment: Behavioral Therapy for Irritability in Autism
Phase:
Study Start date:
December 10, 2020
Estimated Completion Date:
February 28, 2026

Study Description

This is a randomized controlled study of BTIA versus a supportive therapy control condition in 126 adolescents (ages 12 to 18 years) with a diagnosis of autism spectrum disorder and significant levels of disruptive behaviors such as aggression, anger outbursts, and oppositional behavior. BTIA consists of 15 ninety-minute weekly sessions that will be conducted with the teens and their parents by therapists using a structured, detailed manual. The effects of BTIA on the reduction of behavioral problems will be rated by an experienced clinician who does not know which treatment each participant is receiving (a "blinded" evaluator). Study participants will receive a thorough diagnostic assessment of autism spectrum disorder and other forms of psychopathology that may co-occur with ASD. In addition to testing the effects of BTIA on disruptive behavior, the changes in adaptive functioning, or children's ability to function competently in their everyday environment, will be examined before and after treatment.

Connect with a study center

  • Yale Child Study Center

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

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