- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01965184
Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents (RDoC-CBT)
November 15, 2023 updated by: Yale University
Using CBT to Examine Circuitry of Frustrative Non-reward in Aggressive Children
This is a randomized controlled study of cognitive-behavioral therapy (CBT) for disruptive behavior such as irritability, anger and aggression in children and adolescents.
CBT will be compared to Supportive Psychotherapy (SPT) and participants of this study will be randomly assigned (like the flip of a coin) to receive CBT or SPT.
Participants will be also asked to complete functional magnetic resonance imaging (fMRI) and electrophysiological (EEG) tasks (recordings/images of brain activity) before and after treatment.
Study Overview
Status
Completed
Conditions
Detailed Description
Cognitive-behavioral therapy (CBT) is a behavioral intervention that consists of 12 weekly sessions.
During CBT 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.
This study is conducted to examine whether reduction of behavioral problems including anger outbursts, irritability, aggression and noncompliance after CBT may be paralleled by changes in areas of the brain responsible for emotion regulation and social perception.
Study Type
Interventional
Enrollment (Actual)
101
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 Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University
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-
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
8 years to 16 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Boys and girls, 8 to 16 years of age.
- T-Score > 65 on the parent-rated Aggressive Behavior Scale of the Child Behavior Checklist (CBCL).
- Unmedicated or on stable medication for aggression, ADHD, anxiety, or depression for at least 6 weeks, with no planned changes for duration of study.
- Children can speak English sufficiently enough to participate in CBT and study assessments.
- Children should have 1) no metal medical implants, 2) a body weight of less than 250 lbs. and 3) no claustrophobia. [These are necessitated by the safety requirements of the fMRI.]
- Children should be able to meet fMRI data quality requirements at baseline [to enable pre- to post-treatment comparison.]
- Families can commute to the Yale Child Study Center in New Haven, CT for weekly visits.
Exclusion Criteria:
- IQ below 85.
- Children across various DSM diagnoses will be eligible for participation. However, significant levels of psychopathology that require immediate clinical attention such as severe depression or psychosis will be exclusionary because it will require alternative treatments.
- Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder, brain injury based on medical history which can interfere with participation in the study.
- Concurrent psychotherapy can continue, but CBT for aggression is exclusionary. Subjects will be asked not to initiate any new child psychotherapy during the study.
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: Cognitive-Behavioral Therapy for Anger and Aggressive Behavior
CBT is a behavioral intervention that consists of 12 weekly sessions.
During CBT 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.
|
|
Active Comparator: Supportive Psychotherapy (SPT)
SPT consists of 12 sessions that are focused on discussing peer relationships and family functioning with a goal of enhancing subjective well-being
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Overt Aggression Scale
Time Frame: basline (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.
|
basline (week 0)
|
Modified Overt Aggression Scale
Time Frame: midpoint (week 6)
|
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 6)
|
Modified Overt Aggression Scale
Time Frame: endpoint (week 12)
|
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 12)
|
Modified Overt Aggression Scale
Time Frame: follow up (3 months)
|
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.
|
follow up (3 months)
|
The Clinical Global Impression - Improvement Score
Time Frame: basline (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.
|
basline (week 0)
|
The Clinical Global Impression - Improvement Score
Time Frame: midpoint (week 6)
|
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 6)
|
The Clinical Global Impression - Improvement Score
Time Frame: endpoint (week 12)
|
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 12)
|
The Clinical Global Impression - Improvement Score
Time Frame: follow up (3 months)
|
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.
|
follow up (3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Child Behavior Checklist
Time Frame: basline (week 0)
|
The Child Behavior Checklist is a parent rating of child psychopathology that has two factor-analytically derived scales of disruptive behavior.
Child Behavior Checklist Aggressive Behavior Scale consists of 18 items, rated as 0, 1 or 2, with a scale raw score range from 0 (minimum) to 36 (maximum) with higher scores reflecting worse outcome.
Raw scores are also converted to T-scores with possible range from 0 to 100 with higher scores reflecting worse outcomes and T-scores of 65 and higher reflecting clinically significant range.
|
basline (week 0)
|
The Child Behavior Checklist
Time Frame: midpoint (week 6)
|
The Child Behavior Checklist is a parent rating of child psychopathology that has two factor-analytically derived scales of disruptive behavior.
Child Behavior Checklist Aggressive Behavior Scale consists of 18 items, rated as 0, 1 or 2, with a scale raw score range from 0 (minimum) to 36 (maximum) with higher scores reflecting worse outcome.
Raw scores are also converted to T-scores with possible range from 0 to 100 with higher scores reflecting worse outcomes and T-scores of 65 and higher reflecting clinically significant range.
|
midpoint (week 6)
|
The Child Behavior Checklist
Time Frame: endpoint (week 12)
|
The Child Behavior Checklist is a parent rating of child psychopathology that has two factor-analytically derived scales of disruptive behavior.
Child Behavior Checklist Aggressive Behavior Scale consists of 18 items, rated as 0, 1 or 2, with a scale raw score range from 0 (minimum) to 36 (maximum) with higher scores reflecting worse outcome.
Raw scores are also converted to T-scores with possible range from 0 to 100 with higher scores reflecting worse outcomes and T-scores of 65 and higher reflecting clinically significant range.
|
endpoint (week 12)
|
The Child Behavior Checklist
Time Frame: follow up (3 months)
|
The Child Behavior Checklist is a parent rating of child psychopathology that has two factor-analytically derived scales of disruptive behavior.
Child Behavior Checklist Aggressive Behavior Scale consists of 18 items, rated as 0, 1 or 2, with a scale raw score range from 0 (minimum) to 36 (maximum) with higher scores reflecting worse outcome.
Raw scores are also converted to T-scores with possible range from 0 to 100 with higher scores reflecting worse outcomes and T-scores of 65 and higher reflecting clinically significant range.
|
follow up (3 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
functional magnetic resonance imaging (fMRI)
Time Frame: baseline (week 0)
|
fMRI scanning with tasks of emotion regulation and social perception
|
baseline (week 0)
|
functional magnetic resonance imaging (fMRI)
Time Frame: endpoint (week 12)
|
fMRI scanning with tasks of emotion regulation and social perception
|
endpoint (week 12)
|
Electroencephalography (EEG)
Time Frame: baseline (week 0)
|
EEG recordings will be collected as participants perform tasks of emotion regulation and social perception
|
baseline (week 0)
|
Electroencephalography (EEG)
Time Frame: endpoint (week 12)
|
EEG recordings will be collected as participants perform tasks of emotion regulation and social perception
|
endpoint (week 12)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Denis G. Sukhodolsky, Ph.D., Yale University
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, Vitulano LA, Carroll DH, McGuire J, Leckman JF, Scahill L. Randomized trial of anger control training for adolescents with Tourette's syndrome and disruptive behavior. J Am Acad Child Adolesc Psychiatry. 2009 Apr;48(4):413-421. doi: 10.1097/CHI.0b013e3181985050.
- Sukhodolsky, D. G. & Scahill, L. (2012). Cognitive-behavioral therapy for anger and aggression in children. New York: Guilford Press.
- Perlman SB, Pelphrey KA. Developing connections for affective regulation: age-related changes in emotional brain connectivity. J Exp Child Psychol. 2011 Mar;108(3):607-20. doi: 10.1016/j.jecp.2010.08.006. Epub 2010 Oct 23.
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)
November 14, 2013
Primary Completion (Actual)
August 3, 2018
Study Completion (Actual)
November 3, 2018
Study Registration Dates
First Submitted
October 14, 2013
First Submitted That Met QC Criteria
October 14, 2013
First Posted (Estimated)
October 18, 2013
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0102012121-C
- R01MH101514 (U.S. NIH Grant/Contract)
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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