Behavior Therapy for Irritability in Autism

Not Applicable

Recruiting

• Conditions: Anger; Irritability; Autism Spectrum Disorder; Disruptive Behavior; Asperger Syndrome; Pervasive Developmental Disorder; Aggression
• Interventions: Behavioral: Behavioral Therapy for Irritability in Autism; Behavioral: Psychoeducation and Supportive Therapy (PST)

• Registration Number: NCT04654260
• Lead Sponsor: Yale University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-04
• Study Start: 2020-12-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Therapy for Irritability in Autism (BTIA)	Behavioral Therapy for Irritability in Autism	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.
Psychoeducation and Supportive Therapy (PST)	Psychoeducation and Supportive Therapy (PST)	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.

Primary Outcome Measures

Name	Time	Method
The Clinical Global Impression - Improvement Score (CGI-I)	six-month follow up (week 42)	The Clinical Global Impression - Improvement Score assigned by an independent evaluator (IE) who will be blind to treatment assignment is the categorical primary outcome measure of aggressive behavior. The CGI-I reflects the IE's assessment of overall change from baseline rated on a scale from 1 to 7 where 1 is very much improved, 2 is much improved, 3 is minimally improved, 4 is no change, 5 is minimally worse, 6 is much worth, and 7 is very much worse. Higher scores reflect worse outcome. By convention, ratings of very much improved (1) or much improved (2) define positive response; all other scores are classified as a negative response.
Irritability subscale - Aberrant Behavioral Checklist	six-month follow up (week 42)	The 15-item Irritability subscale includes questions about aggression, tantrums, agitation, and unstable mood that are rated on a 4-point scale with the following anchor points: 0 = not at all a problem; 1 = the behavior is a problem but slight in degree; 2 = the problem is moderately serious; 3 = the problem is severe in degree. The total Irritability subscale score ranges from 0 to 45, with higher scores indicating greater severity.
Modified Overt Aggression Scale (MOAS)	six-month follow up (week 42)	Modified Overt Aggression Scale is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior. Scores can range from 0 (minimum) to 300 (maximum) with higher scores reflecting worse outcome.

Secondary Outcome Measures

Name	Time	Method
Vineland Adaptive Behavior Scales - Communication Domain Score	six-month follow up (week 42)	Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is a measure of competence in communication, daily living skills, and socialization which is administered in a semi-structured parent interview format. Items assess the individual's behavior in these domains and are rated according to the frequency with which behaviors are performed without help or prompting (i.e., "Never," "Sometimes" or "Usually"). The raw scores are converted to standard scores (mean = 100, SD = 15; range 40 to 160), and higher scores indicate better adaptive functioning.

Trial Locations

Locations (1)

Yale Child Study Center; 🇺🇸 New Haven, Connecticut, United States