Behavior Therapy for Irritability in Autism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is randomized controlled trial of behavior therapy for irritability versus a supportive therapy control condition

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Primary outcomes will be assessed by an independent evaluator who will be "blinded" to subject's treatment assignment

Study Groups

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Behavioral Therapy for Irritability in Autism (BTIA)

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 Type EXPERIMENTAL

Behavioral Therapy for Irritability in Autism

Intervention Type BEHAVIORAL

The child-focused components of BTIA are organized in modules dedicated to emotion regulation, problem solving and practice of planned steps to prevent or resolve conflicts. Each session contains a set of six to seven goals, and each goal contains a menu of techniques and activities that can be used to attain this goal. In order to administer the treatment in a flexible yet reliable manner, the therapist works collaboratively with the child and his or her parents to select activities that are perceived as relevant for attaining the session's goal. The parent-focused components of BTIA include include education about the effects of antecedents and consequences on disruptive behavior, developing strategies for reducing or altering antecedent events that may lead to disruptive reactions and helping parents to use reinforcement of competent and calm responses in potentially frustrating situations.

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.

Group Type ACTIVE_COMPARATOR

Psychoeducation and Supportive Therapy (PST)

Intervention Type BEHAVIORAL

Each PST session will start with a review of events of the past week and include queries of topics such as school, interests, hobbies, and family with an overarching goal of enhancing subjective well-being. A major objective is to enables the participant to discuss his or her concerns with a therapist toward a goal of enhancing overall psychological wellbeing. Education about autism diagnosis and services is also provided to families as part of PST.

Interventions

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Behavioral Therapy for Irritability in Autism

The child-focused components of BTIA are organized in modules dedicated to emotion regulation, problem solving and practice of planned steps to prevent or resolve conflicts. Each session contains a set of six to seven goals, and each goal contains a menu of techniques and activities that can be used to attain this goal. In order to administer the treatment in a flexible yet reliable manner, the therapist works collaboratively with the child and his or her parents to select activities that are perceived as relevant for attaining the session's goal. The parent-focused components of BTIA include include education about the effects of antecedents and consequences on disruptive behavior, developing strategies for reducing or altering antecedent events that may lead to disruptive reactions and helping parents to use reinforcement of competent and calm responses in potentially frustrating situations.

Intervention Type BEHAVIORAL

Psychoeducation and Supportive Therapy (PST)

Each PST session will start with a review of events of the past week and include queries of topics such as school, interests, hobbies, and family with an overarching goal of enhancing subjective well-being. A major objective is to enables the participant to discuss his or her concerns with a therapist toward a goal of enhancing overall psychological wellbeing. Education about autism diagnosis and services is also provided to families as part of PST.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes