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Behavior Therapy for Irritability in Autism (BTIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04654260
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : March 2, 2021
Sponsor:
Collaborator:
Department of Defense - Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Irritability Disruptive Behavior Anger Aggression Asperger Syndrome Pervasive Developmental Disorder Behavioral: Behavioral Therapy for Irritability in Autism Behavioral: Psychoeducation and Supportive Therapy (PST) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is randomized controlled trial of behavior therapy for irritability versus a supportive therapy control condition
Masking: Single (Outcomes Assessor)
Masking Description: Primary outcomes will be assessed by an independent evaluator who will be "blinded" to subject's treatment assignment
Primary Purpose: Treatment
Official Title: Behavior Therapy for Irritability and Aggression in Adolescents With Autism
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04654260


Contacts
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Contact: Rebecca Jordan (203) 737-7664 rebecca.jordan@yale.edu
Contact: Sonia Rowley (203)-737-7662 sonia.rowley@yale.edu

Locations
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United States, Connecticut
Yale Child Study Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Denis Sukhodolsky, Ph.D.    203-785-6446    denis.sukhodolsky@yale.edu   
Contact: Rebecca Jordan, B.A.    (203) 737-7664    rebecca.jordan@yale.edu   
Sponsors and Collaborators
Yale University
Department of Defense - Congressionally Directed Medical Research Programs
Investigators
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Principal Investigator: Denis Sukhodolsky, Ph.D. Yale School of Medicine
Additional Information:
Publications:

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04654260    
Other Study ID Numbers: 0102012121-5
W81XWH2010718 ( Other Grant/Funding Number: DoD, Congressionally Directed Medical Research Programs )
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
Access Criteria: Data generated with funds from this grant will be freely available on the NIH/NDAR database

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
autism
adolescents
behavior therapy
treatment
disruptive behavior
irritability
anger
aggression
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Aggression
Developmental Disabilities
Problem Behavior
Asperger Syndrome
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Behavioral Symptoms