Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents

NCT01965184 | Completed DMC

• 2 other identifiers: 0102012121-CR01MH101514
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Disruptive Behavior; Aggression; Anger; Irritability; Noncompliance

Keywords

child; cognitive behavioral therapy; CBT; aggression; disruptive behavior; treatment; frustrative non-reward; irritability

Outcome Measures

Primary Outcomes (8)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• The Child Behavior Checklist

  basline (week 0)

• The Child Behavior Checklist

  midpoint (week 6)

• The Child Behavior Checklist

  endpoint (week 12)

• The Child Behavior Checklist

  follow up (3 months)

Other Outcomes (4)

• functional magnetic resonance imaging (fMRI)

  baseline (week 0)

• Electroencephalography (EEG)

  baseline (week 0)

• functional magnetic resonance imaging (fMRI)

  endpoint (week 12)

Study Arms (2)

Cognitive-Behavioral Therapy for Anger and Aggressive Behavior

EXPERIMENTAL

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.

Behavioral: Cognitive-Behavioral Therapy for Anger and Aggression

Supportive Psychotherapy (SPT)

ACTIVE COMPARATOR

SPT consists of 12 sessions that are focused on discussing peer relationships and family functioning with a goal of enhancing subjective well-being

Behavioral: Supportive Psychotherapy (SPT)

Interventions

Cognitive-Behavioral Therapy for Anger and Aggression BEHAVIORAL

Cognitive-Behavioral Therapy for Anger and Aggressive Behavior

Supportive Psychotherapy (SPT) BEHAVIORAL

Supportive Psychotherapy (SPT)

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• IQ below 85.
• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Related Publications (3)

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

  BACKGROUND

• 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.

  PMID: 19242384 BACKGROUND

• 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.

  PMID: 20971474 BACKGROUND

MeSH Terms

Conditions

Problem Behavior; Aggression; Patient Compliance

Interventions

Cognitive Behavioral Therapy; mycophenolic adenine dinucleotide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Aberrant Motor Behavior in Dementia; Social Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Denis G. Sukhodolsky, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 18, 2013
• Study Start: November 14, 2013
• Primary Completion: August 3, 2018
• Study Completion: November 3, 2018
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)