Behavior Therapy for Irritability in Autism (BTIA)

June 10, 2026 updated by: Yale University

Behavior Therapy for Irritability and Aggression in Adolescents With Autism

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Child Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modified Overt Aggression Scale (MOAS)
Time Frame: baseline (week 0)
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.
baseline (week 0)
Modified Overt Aggression Scale (MOAS)
Time Frame: midpoint (week 8)
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.
midpoint (week 8)
Modified Overt Aggression Scale (MOAS)
Time Frame: endpoint (week 16)
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.
endpoint (week 16)
Modified Overt Aggression Scale (MOAS)
Time Frame: 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.
six-month follow up (week 42)
The Clinical Global Impression - Improvement Score (CGI-I)
Time Frame: baseline (week 0)
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.
baseline (week 0)
The Clinical Global Impression - Improvement Score (CGI-I)
Time Frame: midpoint (week 8)
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.
midpoint (week 8)
The Clinical Global Impression - Improvement Score (CGI-I)
Time Frame: endpoint (week 16)
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.
endpoint (week 16)
The Clinical Global Impression - Improvement Score (CGI-I)
Time Frame: 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.
six-month follow up (week 42)
Irritability subscale - Aberrant Behavioral Checklist
Time Frame: baseline (week 0)
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.
baseline (week 0)
Irritability subscale - Aberrant Behavioral Checklist
Time Frame: midpoint (week 8)
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.
midpoint (week 8)
Irritability subscale - Aberrant Behavioral Checklist
Time Frame: endpoint (week 16)
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.
endpoint (week 16)
Irritability subscale - Aberrant Behavioral Checklist
Time Frame: 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.
six-month follow up (week 42)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vineland Adaptive Behavior Scales - Communication Domain Score
Time Frame: baseline (week 0)
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.
baseline (week 0)
Vineland Adaptive Behavior Scales - Communication Domain Score
Time Frame: endpoint (week 16)
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.
endpoint (week 16)
Vineland Adaptive Behavior Scales - Communication Domain Score
Time Frame: 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.
six-month follow up (week 42)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Affective Reactivity Index (ARI)
Time Frame: baseline (week 0)
Affective Reactivity Index (ARI) is an 7-item measure of anger and irritability in children and adolescents which is reliable in ASD. Items are scored of a 0, 1 or 3 scale and first 6 items are summed for a total score, with a possible range from 0 to 12, higher scores reflecting greater levels of irritability
baseline (week 0)
Affective Reactivity Index (ARI)
Time Frame: midpoint (week 8)
Affective Reactivity Index (ARI) is an 7-item measure of anger and irritability in children and adolescents which is reliable in ASD. Items are scored of a 0, 1 or 3 scale and first 6 items are summed for a total score, with a possible range from 0 to 12, higher scores reflecting greater levels of irritability
midpoint (week 8)
Affective Reactivity Index (ARI)
Time Frame: endpoint (week 16)
Affective Reactivity Index (ARI) is an 7-item measure of anger and irritability in children and adolescents which is reliable in ASD. Items are scored of a 0, 1 or 3 scale and first 6 items are summed for a total score, with a possible range from 0 to 12, higher scores reflecting greater levels of irritability
endpoint (week 16)
Affective Reactivity Index (ARI)
Time Frame: six-month follow up (week 42)
Affective Reactivity Index (ARI) is an 7-item measure of anger and irritability in children and adolescents which is reliable in ASD. Items are scored of a 0, 1 or 3 scale and first 6 items are summed for a total score, with a possible range from 0 to 12, higher scores reflecting greater levels of irritability
six-month follow up (week 42)
Social Responsiveness Scale-2 (SRS-2)
Time Frame: baseline (week 0)
Social Responsiveness Scale-2 (SRS-2) is a 65-item, parent-report scale that measures social disability. Items assess the individual's social awareness, social cognition, social communication, social motivation, and restricted interest and repetitive behaviors on a scale from 0 to 3. The raw scores are converted to T-scores (mean = 50, SD = 10; range 30 to 90), and higher scores indicate greater impairment.
baseline (week 0)
Social Responsiveness Scale-2 (SRS-2)
Time Frame: midpoint (week 8)
Social Responsiveness Scale-2 (SRS-2) is a 65-item, parent-report scale that measures social disability. Items assess the individual's social awareness, social cognition, social communication, social motivation, and restricted interest and repetitive behaviors on a scale from 0 to 3. The raw scores are converted to T-scores (mean = 50, SD = 10; range 30 to 90), and higher scores indicate greater impairment.
midpoint (week 8)
Social Responsiveness Scale-2 (SRS-2)
Time Frame: endpoint (week 16)
Social Responsiveness Scale-2 (SRS-2) is a 65-item, parent-report scale that measures social disability. Items assess the individual's social awareness, social cognition, social communication, social motivation, and restricted interest and repetitive behaviors on a scale from 0 to 3. The raw scores are converted to T-scores (mean = 50, SD = 10; range 30 to 90), and higher scores indicate greater impairment.
endpoint (week 16)
Social Responsiveness Scale-2 (SRS-2)
Time Frame: six-month follow up (week 42)
Social Responsiveness Scale-2 (SRS-2) is a 65-item, parent-report scale that measures social disability. Items assess the individual's social awareness, social cognition, social communication, social motivation, and restricted interest and repetitive behaviors on a scale from 0 to 3. The raw scores are converted to T-scores (mean = 50, SD = 10; range 30 to 90), and higher scores indicate greater impairment.
six-month follow up (week 42)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Congressionally Directed Medical Research Programs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Denis Sukhodolsky, Ph.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0102012121-5
  • W81XWH2010718 (Other Grant/Funding Number: DoD, Congressionally Directed Medical Research Programs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Research data from this study will be shared via the National Database for Autism Research and NIH Data Repositories (https://nda.nih.gov/) consistent with the Yale University Policy. The data management for this study will be conducted using the OnCore system at YCCI (https://medicine.yale.edu/ycci/oncore/), which enables translation of data to de-identified data sets that can be placed online using GUID technology as specified in Federal guidelines. At the time of permission/consent/assent, participants and their parents will be informed of the data-sharing plan. Raw data generated by the project will be quality-certified by our research team (including fidelity to research procedures, proper file format, artifact removal, and de-identifying, resulting in artifact-free raw data) prior to submission to NDAR for usability. Consistent with the NDAR data sharing policy, data will be submitted, at the individual level, on all enrolled subjects.

IPD Sharing Time Frame

Analyzed data will be submitted at the time of publication, and publications resulting from these data will be associated with NDAR entries using the NDAR Study Feature.

IPD Sharing Access Criteria

Data generated with funds from this grant will be freely available on the NIH/NDAR database

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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