- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04654260
Behavior Therapy for Irritability in Autism (BTIA)
April 1, 2024 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
Recruiting
Conditions
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
Interventional
Enrollment (Estimated)
126
Phase
- 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
- Name: Sydeny Anderson
- Phone Number: (203) 737-7662
- Email: sydney.anderson@yale.edu
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Recruiting
- Yale Child Study Center
-
Contact:
- Denis Sukhodolsky, Ph.D.
- Phone Number: 203-785-6446
- Email: denis.sukhodolsky@yale.edu
-
Contact:
- Julia Zhong, B.A.
- Phone Number: (203) 737-7664
- Email: julia.zhong@yale.edu
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
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
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
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
Collaborators
Investigators
- Principal Investigator: Denis Sukhodolsky, Ph.D., Yale School of Medicine
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
- Sukhodolsky DG, Smith SD, McCauley SA, Ibrahim K, Piasecka JB. Behavioral Interventions for Anger, Irritability, and Aggression in Children and Adolescents. J Child Adolesc Psychopharmacol. 2016 Feb;26(1):58-64. doi: 10.1089/cap.2015.0120. Epub 2016 Jan 8.
- Scahill L, Bearss K, Lecavalier L, Smith T, Swiezy N, Aman MG, Sukhodolsky DG, McCracken C, Minshawi N, Turner K, Levato L, Saulnier C, Dziura J, Johnson C. Effect of Parent Training on Adaptive Behavior in Children With Autism Spectrum Disorder and Disruptive Behavior: Results of a Randomized Trial. J Am Acad Child Adolesc Psychiatry. 2016 Jul;55(7):602-609.e3. doi: 10.1016/j.jaac.2016.05.001. Epub 2016 May 7.
- Ibrahim K, Eilbott JA, Ventola P, He G, Pelphrey KA, McCarthy G, Sukhodolsky DG. Reduced Amygdala-Prefrontal Functional Connectivity in Children With Autism Spectrum Disorder and Co-occurring Disruptive Behavior. Biol Psychiatry Cogn Neurosci Neuroimaging. 2019 Dec;4(12):1031-1041. doi: 10.1016/j.bpsc.2019.01.009. Epub 2019 Feb 4.
- Ibrahim K, Kalvin C, Marsh CL, Anzano A, Gorynova L, Cimino K, Sukhodolsky DG. Anger Rumination is Associated with Restricted and Repetitive Behaviors in Children with Autism Spectrum Disorder. J Autism Dev Disord. 2019 Sep;49(9):3656-3668. doi: 10.1007/s10803-019-04085-y.
- Henriksen M, Skrove M, Hoftun GB, Sund ER, Lydersen S, Tseng WL, Sukhodolsky DG. Developmental Course and Risk Factors of Physical Aggression in Late Adolescence. Child Psychiatry Hum Dev. 2021 Aug;52(4):628-639. doi: 10.1007/s10578-020-01049-7.
- Kalvin CB, Gladstone TR, Jordan R, Rowley S, Marsh CL, Ibrahim K, Sukhodolsky DG. Assessing Irritability in Children with Autism Spectrum Disorder Using the Affective Reactivity Index. J Autism Dev Disord. 2021 May;51(5):1496-1507. doi: 10.1007/s10803-020-04627-9.
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)
December 10, 2020
Primary Completion (Estimated)
August 30, 2025
Study Completion (Estimated)
August 30, 2025
Study Registration Dates
First Submitted
December 2, 2020
First Submitted That Met QC Criteria
December 2, 2020
First Posted (Actual)
December 4, 2020
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
April 1, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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