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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
101
Yale University
New Haven, Connecticut, United States
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.
Time frame: basline (week 0)
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.
Time frame: midpoint (week 6)
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.
Time frame: endpoint (week 12)
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.
Time frame: follow up (3 months)
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.
Time frame: basline (week 0)
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.
Time frame: midpoint (week 6)
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.
Time frame: endpoint (week 12)
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.
Time frame: follow up (3 months)
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.
Time frame: basline (week 0)
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.
Time frame: midpoint (week 6)
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.
Time frame: endpoint (week 12)
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.
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Time frame: follow up (3 months)