Behavior Therapy for Irritability in Autism (BTIA)

Yale University

Status: Enrolling

Conditions: Pervasive Developmental Disorder; Aggression; Autism Spectrum Disorder; Anger; Irritability; Disruptive Behavior; Asperger Syndrome

Treatments: Behavioral: Psychoeducation and Supportive Therapy (PST); Behavioral: Behavioral Therapy for Irritability in Autism

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04654260

W81XWH2010718 (Other Grant/Funding Number)

0102012121-5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 12 to 19 years old

Volunteers: Accepts Healthy Volunteers

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 criteria

• Presence of a medical condition that would interfere with participation in the study
• Presence of a current psychiatric disorder that requires immediate clinical attention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Behavioral Therapy for Irritability in Autism (BTIA)

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Therapy for Irritability in Autism

Psychoeducation and Supportive Therapy (PST)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychoeducation and Supportive Therapy (PST)