AutismNCT02914951
Cognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability
A study testing Cognitive-Behavioral Therapy and Functional magnetic resonance imaging (fMRI) in people with Autism and Intellectual Disability, run by Yale University at 1 site in United States.
Trial summary
In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Autism, Intellectual Disability
- What is being tested?
- Cognitive-Behavioral Therapy and Functional magnetic resonance imaging (fMRI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-5 diagnosis of Autism Spectrum Disorder
- Presence of disruptive behaviors such as irritability and anger outbursts
- IQ between 55 and 85
- ABC Irritability Scale score greater than or equal to 15
- Un-medicated or on stable medication regimen
- Able to complete all study assessment and fMRI procedures
Who cannot join
- Medical or psychiatric condition that would require alternative treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yale Child Study Center
New Haven, Connecticut, 06520
About this study
Official title: Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents (An Open Pilot Study in Autism Spectrum Disorder)
In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. The purpose of this study is to investigate cognitive-behavioral therapy (CBT) for disruptive behavior in children with autism spectrum disorders and intellectual disability. This pilot study will include children with ASD and IQ between 55 and 85 in an open study of CBT. CBT is modified in this study to reduce complexity of activities during therapy sessions but retains all key elements and principles of CBT. Assessments of irritability and disruptive behavior will include clinical interviews, parent ratings and child self-report measures. Study participants will be asked to complete functional magnetic resonance imaging (fMRI) to evaluate biomarkers of social perception and emotion regulation before and after CBT.
Read the detailed description
Children with ASD share common symptoms in the core domains of social reciprocity, communication, and repetitive behaviors. In addition to the core symptoms, 50 to 70 percent of children with ASD often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, aggression and self-injury.
In this open pilot study expands clinical research on CBT for irritability to children with autism and mild cognitive impairment. CBT consists of individual weekly sessions dedicated to teaching children to recognize situations that may lead to frustration and to build coping skills for dealing with frustration in socially appropriate ways. Recent research as well as clinical reports suggest that children with mild intellectual disabilities (IQ between 55 and 85) can also benefit from CBT. The intervention is modified to reduce complexity of activities during therapy sessions but retains key elements and principles of CBT. Thus, the modified version of CBT is referred to as "Principles-Based Cognitive Behavior Therapy for Irritability in Autism" or PB-CBT for short. Subjects in this study will receive a comprehensive evaluation of ASD and associated psychopathology. Irritability and related disruptive behaviors will be rated on weekly basis to utilize a single-subject approach to data analysis. Children will be asked to participate in functional magnetic resonance imaging (fMRI) with tasks of social perception and emotion regulation before and after CBT. The purpose of the fMRI portion of the study is to evaluate feasibility of fMRI as an outcome measure in studies of behavioral interventions for children with ASD and intellectual disability.
- Conditions
- Autism, Intellectual Disability
- Being tested
- Cognitive-Behavioral Therapy, Functional magnetic resonance imaging (fMRI)
- Keywords
- Autism, Irritability, Disruptive Behavior, Aggression, Behavior Therapy, Cognitive Behavioral Therapy, Intellectual Disability, Cognitive Impairment
- Medical subject headings
- Autistic Disorder, Intellectual Disability, Problem Behavior, Aggression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral TherapyBehavioural
CBT is a behavioral intervention that consists of 12 60- to 90-minute-long weekly sessions. A modified, principles-based form of CBT will be used in this study to reduce complexity of activities during therapy sessions while retaining all key elements and principles of CBT.
Functional magnetic resonance imaging (fMRI)Other
Functional magnetic resonance imaging (fMRI). There will be two fMRI visits, 60 to 90 minute each, one before and the other after CBT. fMRI is a technique that uses magnetism to measure activity of the brain as participants perform simple tasks such as pressing the button in response to pictures. During this study, children will be asked to look at pictures of objects and press or not press the button in response to specific instruction. Participants will also look at pictures of faces and light-point displays depicted biological motion. fMRI is used as an outcome measure to explore if change in irritability is associated with change in brain responses to these tasks during fMRI.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | CBT is a behavioral intervention where children are taught various skills for coping with frustration and parents are taught various strategies for managing situations that can be anger-provoking for their child. Receives: Behavioral: Cognitive-Behavioral Therapy; Other: Functional magnetic resonance imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Overt Aggression Scale (MOAS)
Modified Overt Aggression Scale (MOAS) is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior
Measured: Weekly - up to 20 weeks
Aberrant Behavior Checklist - Irritability Scale (ABC-I)
The ABC-I is a 15-item parent rating of irritability that has been commonly used in clinical trials in children with ASD.
Measured: Weekly - up to 20 weeks
Secondary outcomes (2)
Home Situations Questionnaire (HSQ)
HSQ is a parent-rated measure of noncompliance in children with ASD
Measured: baseline
Home Situations Questionnaire (HSQ)
HSQ is a parent-rated measure of noncompliance in children with ASD
Measured: endpoint (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Behavior therapy for irritability and disruptive behavior for children with autism and intellectual disability
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Sukhodolsky, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914951
- Sponsor's protocol ID
- 0102012121-D
- Other IDs
- No NIH funding
- Status last verified
- May 2026
- First submitted
- 20 Sep 2016
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26745682Sukhodolsky DG, Vander Wyk BC, Eilbott JA, McCauley SA, Ibrahim K, Crowley MJ, Pelphrey KA. Neural Mechanisms of Cognitive-Behavioral Therapy for Aggression in Children and Adolescents: Design of a Randomized Controlled Trial Within the National Institute for Mental Health Research Domain Criteria Construct of Frustrative Non-Reward. J Child Adolesc Psychopharmacol. 2016 Feb;26(1):38-48. doi: 10.1089/cap.2015.0164. Epub 2016 Jan 19.
PubMed 26784537
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents (An Open Pilot Study in Autism Spectrum Disorder)
- ClinicalTrials.gov ID
- NCT02914951
- Acronym / sponsor ID
- 0102012121-D
- Conditions
- Autism, Intellectual Disability
- Keywords
- Autism, Irritability, Disruptive Behavior, Aggression, Behavior Therapy, Cognitive Behavioral Therapy, Intellectual Disability, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. The purpose of this study is to investigate cognitive-behavioral therapy (CBT) for disruptive behavior in children with autism spectrum disorders and intellectual disability. This pilot study will include children with ASD and IQ between 55 and 85 in an open study of CBT. CBT is modified in this study to reduce complexity of activities during therapy sessions but retains all key elements and principles of CBT. Assessments of irritability and disruptive behavior will include clinical interviews, parent ratings and child self-report measures. Study participants will be asked to complete functional magnetic resonance imaging (fMRI) to evaluate biomarkers of social perception and emotion regulation before and after CBT.
Detailed description
Children with ASD share common symptoms in the core domains of social reciprocity, communication, and repetitive behaviors. In addition to the core symptoms, 50 to 70 percent of children with ASD often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, aggression and self-injury.
In this open pilot study expands clinical research on CBT for irritability to children with autism and mild cognitive impairment. CBT consists of individual weekly sessions dedicated to teaching children to recognize situations that may lead to frustration and to build coping skills for dealing with frustration in socially appropriate ways. Recent research as well as clinical reports suggest that children with mild intellectual disabilities (IQ between 55 and 85) can also benefit from CBT. The intervention is modified to reduce complexity of activities during therapy sessions but retains key elements and principles of CBT. Thus, the modified version of CBT is referred to as "Principles-Based Cognitive Behavior Therapy for Irritability in Autism" or PB-CBT for short. Subjects in this study will receive a comprehensive evaluation of ASD and associated psychopathology. Irritability and related disruptive behaviors will be rated on weekly basis to utilize a single-subject approach to data analysis. Children will be asked to participate in functional magnetic resonance imaging (fMRI) with tasks of social perception and emotion regulation before and after CBT. The purpose of the fMRI portion of the study is to evaluate feasibility of fMRI as an outcome measure in studies of behavioral interventions for children with ASD and intellectual disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Behavior therapy for irritability and disruptive behavior for children with autism and intellectual disability
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Behavioral: Cognitive-Behavioral Therapy, Other: Functional magnetic resonance imaging (fMRI)CBT is a behavioral intervention where children are taught various skills for coping with frustration and parents are taught various strategies for managing situations that can be anger-provoking for their child. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- DSM-5 diagnosis of Autism Spectrum Disorder
- Presence of disruptive behaviors such as irritability and anger outbursts
- IQ between 55 and 85
- ABC Irritability Scale score greater than or equal to 15
- Un-medicated or on stable medication regimen
Key exclusion criteria (1 listed)
- Medical or psychiatric condition that would require alternative treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral TherapyCBT is a behavioral intervention that consists of 12 60- to 90-minute-long weekly sessions. A modified, principles-based form of CBT will be used in this study to reduce complexity of activities during therapy sessions while retaining all key elements and principles of CBT. | Behavioural | Cognitive-Behavioral Therapy |
| Functional magnetic resonance imaging (fMRI)Functional magnetic resonance imaging (fMRI). There will be two fMRI visits, 60 to 90 minute each, one before and the other after CBT. fMRI is a technique that uses magnetism to measure activity of the brain as participants perform simple tasks such as pressing the button in response to pictures. During this study, children will be asked to look at pictures of objects and press or not press the button in response to specific instruction. Participants will also look at pictures of faces and light-point displays depicted biological motion. fMRI is used as an outcome measure to explore if change in irritability is associated with change in brain responses to these tasks during fMRI. | Other | Cognitive-Behavioral Therapy |
Primary outcome
Modified Overt Aggression Scale (MOAS)
Time frame: Weekly - up to 20 weeks
Modified Overt Aggression Scale (MOAS) is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior
Aberrant Behavior Checklist - Irritability Scale (ABC-I)
Time frame: Weekly - up to 20 weeks
The ABC-I is a 15-item parent rating of irritability that has been commonly used in clinical trials in children with ASD.
2 secondary outcomes
Home Situations Questionnaire (HSQ)
Time frame: baseline
Home Situations Questionnaire (HSQ)
Time frame: endpoint (16 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 26745682Sukhodolsky 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.
- Results publication: PubMed 26784537Sukhodolsky DG, Vander Wyk BC, Eilbott JA, McCauley SA, Ibrahim K, Crowley MJ, Pelphrey KA. Neural Mechanisms of Cognitive-Behavioral Therapy for Aggression in Children and Adolescents: Design of a Randomized Controlled Trial Within the National Institute for Mental Health Research Domain Criteria Construct of Frustrative Non-Reward. J Child Adolesc Psychopharmacol. 2016 Feb;26(1):38-48. doi: 10.1089/cap.2015.0164. Epub 2016 Jan 19.
- Behavior therapy studies for children with autism spectrum disorder at Sukhodolsky labLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Denis Sukhodolsky, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy and Functional magnetic resonance imaging (fMRI) in people with Autism and Intellectual Disability, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Overt Aggression Scale (MOAS) (time frame: Weekly - up to 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914951, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.