Clinical trial NCT04654260: Behavior Therapy for Irritability in Autism
Official title: Behavior Therapy for Irritability and Aggression in Adolescents With Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Congressionally Directed Medical Research Programs
First posted: 2020-12-04
Enrollment: 126
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is randomized controlled trial of behavior therapy for irritability versus a supportive therapy control condition
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Modified Overt Aggression Scale (MOAS)
timeFrame: baseline (week 0)
measure: Modified Overt Aggression Scale (MOAS)
timeFrame: midpoint (week 8)
measure: Modified Overt Aggression Scale (MOAS)
timeFrame: endpoint (week 16)
measure: Modified Overt Aggression Scale (MOAS)
timeFrame: six-month follow up (week 42)
measure: The Clinical Global Impression - Improvement Score (CGI-I)
timeFrame: baseline (week 0)
measure: The Clinical Global Impression - Improvement Score (CGI-I)
timeFrame: midpoint (week 8)
measure: The Clinical Global Impression - Improvement Score (CGI-I)
timeFrame: endpoint (week 16)
measure: The Clinical Global Impression - Improvement Score (CGI-I)
timeFrame: six-month follow up (week 42)
measure: Irritability subscale - Aberrant Behavioral Checklist
timeFrame: baseline (week 0)
measure: Irritability subscale - Aberrant Behavioral Checklist
timeFrame: midpoint (week 8)
measure: Irritability subscale - Aberrant Behavioral Checklist
timeFrame: endpoint (week 16)
measure: Irritability subscale - Aberrant Behavioral Checklist
timeFrame: six-month follow up (week 42)
Secondary outcomes:
measure: Vineland Adaptive Behavior Scales - Communication Domain Score
timeFrame: baseline (week 0)
measure: Vineland Adaptive Behavior Scales - Communication Domain Score
timeFrame: endpoint (week 16)
measure: Vineland Adaptive Behavior Scales - Communication Domain Score
timeFrame: six-month follow up (week 42)
Other outcomes:
measure: Affective Reactivity Index (ARI)
timeFrame: baseline (week 0)
measure: Affective Reactivity Index (ARI)
timeFrame: midpoint (week 8)
measure: Affective Reactivity Index (ARI)
timeFrame: endpoint (week 16)
measure: Affective Reactivity Index (ARI)
timeFrame: six-month follow up (week 42)
measure: Social Responsiveness Scale-2 (SRS-2)
timeFrame: baseline (week 0)
measure: Social Responsiveness Scale-2 (SRS-2)
timeFrame: midpoint (week 8)
measure: Social Responsiveness Scale-2 (SRS-2)
timeFrame: endpoint (week 16)
measure: Social Responsiveness Scale-2 (SRS-2)
timeFrame: six-month follow up (week 42)
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Denis Sukhodolsky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.