Back to resultsCognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents (RDoC-CBT)
Primary Purpose
Disruptive Behavior, Aggression, Anger
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy for Anger and Aggression
Supportive Psychotherapy (SPT)
Sponsored by
About this trial
This is an interventional treatment trial for Disruptive Behavior focused on measuring child, cognitive behavioral therapy, CBT, aggression, disruptive behavior, treatment, frustrative non-reward, irritability
Eligibility Criteria
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.
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive-Behavioral Therapy for Anger and Aggressive Behavior
Supportive Psychotherapy (SPT)
Arm Description
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.
SPT consists of 12 sessions that are focused on discussing peer relationships and family functioning with a goal of enhancing subjective well-being
Outcomes
Primary Outcome Measures
Modified Overt Aggression Scale
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.
Modified Overt Aggression Scale
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.
Modified Overt Aggression Scale
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.
Modified Overt Aggression Scale
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.
The Clinical Global Impression - Improvement Score
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.
The Clinical Global Impression - Improvement Score
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.
The Clinical Global Impression - Improvement Score
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.
The Clinical Global Impression - Improvement Score
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.
Secondary Outcome Measures
The Child Behavior Checklist
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.
The Child Behavior Checklist
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.
The Child Behavior Checklist
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.
The Child Behavior Checklist
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.
Full Information
NCT ID
NCT01965184
First Posted
October 14, 2013
Last Updated
February 24, 2023
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01965184
Brief Title
Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents
Acronym
RDoC-CBT
Official Title
Using CBT to Examine Circuitry of Frustrative Non-reward in Aggressive Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 14, 2013 (Actual)
Primary Completion Date
August 3, 2018 (Actual)
Study Completion Date
December 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disruptive Behavior, Aggression, Anger, Irritability, Noncompliance
Keywords
child, cognitive behavioral therapy, CBT, aggression, disruptive behavior, treatment, frustrative non-reward, irritability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive-Behavioral Therapy for Anger and Aggressive Behavior
Arm Type
Experimental
Arm Description
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.
Arm Title
Supportive Psychotherapy (SPT)
Arm Type
Active Comparator
Arm Description
SPT consists of 12 sessions that are focused on discussing peer relationships and family functioning with a goal of enhancing subjective well-being
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy for Anger and Aggression
Intervention Type
Behavioral
Intervention Name(s)
Supportive Psychotherapy (SPT)
Primary Outcome Measure Information:
Title
Modified Overt Aggression Scale
Description
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.
Time Frame
basline (week 0)
Title
Modified Overt Aggression Scale
Description
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.
Time Frame
midpoint (week 6)
Title
Modified Overt Aggression Scale
Description
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.
Time Frame
endpoint (week 12)
Title
Modified Overt Aggression Scale
Description
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.
Time Frame
follow up (3 months)
Title
The Clinical Global Impression - Improvement Score
Description
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.
Time Frame
basline (week 0)
Title
The Clinical Global Impression - Improvement Score
Description
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.
Time Frame
midpoint (week 6)
Title
The Clinical Global Impression - Improvement Score
Description
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.
Time Frame
endpoint (week 12)
Title
The Clinical Global Impression - Improvement Score
Description
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.
Time Frame
follow up (3 months)
Secondary Outcome Measure Information:
Title
The Child Behavior Checklist
Description
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.
Time Frame
basline (week 0)
Title
The Child Behavior Checklist
Description
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.
Time Frame
midpoint (week 6)
Title
The Child Behavior Checklist
Description
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.
Time Frame
endpoint (week 12)
Title
The Child Behavior Checklist
Description
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.
Time Frame
follow up (3 months)
Other Pre-specified Outcome Measures:
Title
functional magnetic resonance imaging (fMRI)
Description
fMRI scanning with tasks of emotion regulation and social perception
Time Frame
baseline (week 0)
Title
Electroencephalography (EEG)
Description
EEG recordings will be collected as participants perform tasks of emotion regulation and social perception
Time Frame
baseline (week 0)
Title
functional magnetic resonance imaging (fMRI)
Description
fMRI scanning with tasks of emotion regulation and social perception
Time Frame
endpoint (week 12)
Title
Electroencephalography (EEG)
Description
EEG recordings will be collected as participants perform tasks of emotion regulation and social perception
Time Frame
endpoint (week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis G. Sukhodolsky, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Sukhodolsky, D. G. & Scahill, L. (2012). Cognitive-behavioral therapy for anger and aggression in children. New York: Guilford Press.
Results Reference
background
PubMed Identifier
19242384
Citation
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.
Results Reference
background
PubMed Identifier
20971474
Citation
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.
Results Reference
background
Links:
URL
https://medicine.yale.edu/childstudy/faculty/denis_sukhodolsky.profile
Description
Information about the study on the Yale University Child Study Center website
Learn more about this trial
Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents
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