Behavior Therapy for Irritability in Autism

NCT04654260 | Active Not Recruiting

• 2 other identifiers: 0102012121-5W81XWH2010718
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

autism; adolescents; behavior therapy; treatment; disruptive behavior; irritability; anger; aggression

Outcome Measures

Primary Outcomes (12)

• Modified Overt Aggression Scale (MOAS)

  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)

  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)

  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)

  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)

  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)

  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)

  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)

  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

  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

  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

  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

  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 Outcomes (3)

• Vineland Adaptive Behavior Scales - Communication Domain Score

  baseline (week 0)

• Vineland Adaptive Behavior Scales - Communication Domain Score

  endpoint (week 16)

• Vineland Adaptive Behavior Scales - Communication Domain Score

  six-month follow up (week 42)

Other Outcomes (8)

• Affective Reactivity Index (ARI)

  baseline (week 0)

• Affective Reactivity Index (ARI)

  midpoint (week 8)

• Affective Reactivity Index (ARI)

  endpoint (week 16)

Study Arms (2)

Behavioral Therapy for Irritability in Autism (BTIA)

EXPERIMENTAL

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

Psychoeducation and Supportive Therapy (PST)

ACTIVE COMPARATOR

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)

Interventions

Behavioral Therapy for Irritability in Autism 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.

Behavioral Therapy for Irritability in Autism (BTIA)

Psychoeducation and Supportive Therapy (PST) 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.

Psychoeducation and Supportive Therapy (PST)

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Presence of a medical condition that would interfere with participation in the study
• Presence of a current psychiatric disorder that requires immediate clinical attention

Sponsors & Collaborators

• Yale University: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

Related Publications (6)

• 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.

  PMID: 26745682 BACKGROUND

• 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.

  PMID: 27343887 BACKGROUND

• 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.

  PMID: 30979647 BACKGROUND

• 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.

  PMID: 31144231 BACKGROUND

• 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.

  PMID: 32852728 BACKGROUND

• 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.

  PMID: 32734421 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Problem Behavior; Aggression; Asperger Syndrome; Child Development Disorders, Pervasive; Autistic Disorder

Interventions

Behavior Therapy; Palliative Care

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior; Aberrant Motor Behavior in Dementia; Social Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Denis Sukhodolsky, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcomes will be assessed by an independent evaluator who will be "blinded" to subject's treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 4, 2020
• Study Start: December 10, 2020
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

US (1)