Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents

Aggression Clinical Trial

— RDoC-CBT  

Official title:

Using CBT to Examine Circuitry of Frustrative Non-reward in Aggressive Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965184
• Other study ID #: 0102012121-C
• Secondary ID: R01MH101514
• Status: Completed
• Phase: N/A
• Start date: November 14, 2013
• Est. completion date: November 3, 2018

Study information

• Verified date: November 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

1. Boys and girls, 8 to 16 years of age.

2. T-Score > 65 on the parent-rated Aggressive Behavior Scale of the Child Behavior Checklist (CBCL).

3. Unmedicated or on stable medication for aggression, ADHD, anxiety, or depression for at least 6 weeks, with no planned changes for duration of study.

4. Children can speak English sufficiently enough to participate in CBT and study assessments.

5. 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.]

6. Children should be able to meet fMRI data quality requirements at baseline [to enable pre- to post-treatment comparison.]

7. Families can commute to the Yale Child Study Center in New Haven, CT for weekly visits.

Exclusion Criteria:

1. IQ below 85.

2. 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.

3. 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.

4. Concurrent psychotherapy can continue, but CBT for aggression is exclusionary. Subjects will be asked not to initiate any new child psychotherapy during the study.

Related Conditions & MeSH terms

• Aggression
• Anger
• Disruptive Behavior
• Irritability
• Noncompliance
• Problem Behavior

Intervention

Behavioral:
• Cognitive-Behavioral Therapy for Anger and Aggression

• Supportive Psychotherapy (SPT)

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View Citation

Sukhodolsky, D. G. & Scahill, L. (2012). Cognitive-behavioral therapy for anger and aggression in children. New York: Guilford Press.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	functional magnetic resonance imaging (fMRI)	fMRI scanning with tasks of emotion regulation and social perception	baseline (week 0)
Other	Electroencephalography (EEG)	EEG recordings will be collected as participants perform tasks of emotion regulation and social perception	baseline (week 0)
Other	functional magnetic resonance imaging (fMRI)	fMRI scanning with tasks of emotion regulation and social perception	endpoint (week 12)
Other	Electroencephalography (EEG)	EEG recordings will be collected as participants perform tasks of emotion regulation and social perception	endpoint (week 12)
Primary	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.	basline (week 0)
Primary	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.	midpoint (week 6)
Primary	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.	endpoint (week 12)
Primary	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.	follow up (3 months)
Primary	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.	basline (week 0)
Primary	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.	midpoint (week 6)
Primary	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.	endpoint (week 12)
Primary	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.	follow up (3 months)
Secondary	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.	basline (week 0)
Secondary	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.	midpoint (week 6)
Secondary	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.	endpoint (week 12)
Secondary	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.	follow up (3 months)

External Links

•   Information about the study on the Yale University Child Study Center website