Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents (RDoC-CBT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Denis Sukhodolsky, Yale University
ClinicalTrials.gov Identifier:
NCT01965184
First received: October 14, 2013
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This is a randomized controlled study of cognitive-behavioral therapy (CBT) for disruptive behavior such as 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. CBT is a behavioral intervention that consists of 12 one-hour long, 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.


Condition Intervention
Disruptive Behavior
Aggression
Anger
Irritability
Noncompliance
Behavioral: Cognitive-Behavioral Therapy for Aggression
Behavioral: Supportive Psychotherapy (SPT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using CBT to Examine Circuitry of Frustrative Non-reward in Aggressive Children

Further study details as provided by Yale University:

Primary Outcome Measures:
  • The Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: basline (week 0) ] [ Designated as safety issue: No ]
    The Clinical Global Impression - Improvement (CGI-I) Score assigned by an independent evaluator (IE) who will be blind to treatment assignment is the categorical primary outcome measure of aggressive behavior

  • Modified Overt Aggression Scale (MOAS) [ Time Frame: basline (week 0) ] [ Designated as safety issue: No ]
    Modified Overt Aggression Scale (MOAS)is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior

  • The Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: midpoint (week 6) ] [ Designated as safety issue: No ]
    The Clinical Global Impression - Improvement (CGI-I) Score assigned by an independent evaluator (IE) who will be blind to treatment assignment is the categorical primary outcome measure of aggressive behavior

  • The Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: endpoint (week 12) ] [ Designated as safety issue: No ]
    The Clinical Global Impression - Improvement (CGI-I) Score assigned by an independent evaluator (IE) who will be blind to treatment assignment is the categorical primary outcome measure of aggressive behavior

  • The Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: follow up (3 months) ] [ Designated as safety issue: No ]
    The Clinical Global Impression - Improvement (CGI-I) Score assigned by an independent evaluator (IE) who will be blind to treatment assignment is the categorical primary outcome measure of aggressive behavior

  • Modified Overt Aggression Scale (MOAS) [ Time Frame: midpoint (week 6) ] [ Designated as safety issue: No ]
    Modified Overt Aggression Scale (MOAS)is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior

  • Modified Overt Aggression Scale (MOAS) [ Time Frame: endpoint (week 12) ] [ Designated as safety issue: No ]
    Modified Overt Aggression Scale (MOAS)is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior

  • Modified Overt Aggression Scale (MOAS) [ Time Frame: follow up (3 months) ] [ Designated as safety issue: No ]
    Modified Overt Aggression Scale (MOAS)is a 16-item scale that reflects the frequency and severity of incidents of aggressive behavior


Secondary Outcome Measures:
  • The Child Behavior Checklist (CBCL) [ Time Frame: basline (week 0) ] [ Designated as safety issue: No ]
    The Child Behavior Checklist is a parent rating of child psychopathology that has two factor-analytically derived scales of disruptive behavior

  • The Child Behavior Checklist (CBCL) [ Time Frame: midpoint (week 6) ] [ Designated as safety issue: No ]
    The Child Behavior Checklist is a parent rating of child psychopathology that has two factor-analytically derived scales of disruptive behavior

  • The Child Behavior Checklist (CBCL) [ Time Frame: endpoint (week 12) ] [ Designated as safety issue: No ]
    The Child Behavior Checklist is a parent rating of child psychopathology that has two factor-analytically derived scales of disruptive behavior

  • The Child Behavior Checklist (CBCL) [ Time Frame: follow up (3 months) ] [ Designated as safety issue: No ]
    The Child Behavior Checklist is a parent rating of child psychopathology that has two factor-analytically derived scales of disruptive behavior


Other Outcome Measures:
  • functional magnetic resonance imaging (fMRI) [ Time Frame: baseline (week 0) ] [ Designated as safety issue: No ]
    fMRI scanning with tasks of emotion regulation and social perception

  • Electroencephalography (EEG) [ Time Frame: baseline (week 0) ] [ Designated as safety issue: No ]
    EEG recordings will be collected as participants perform tasks of emotion regulation and social perception

  • functional magnetic resonance imaging (fMRI) [ Time Frame: endpoint (week 12) ] [ Designated as safety issue: No ]
    fMRI scanning with tasks of emotion regulation and social perception

  • Electroencephalography (EEG) [ Time Frame: endpoint (week 12) ] [ Designated as safety issue: No ]
    EEG recordings will be collected as participants perform tasks of emotion regulation and social perception


Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-Behavioral Therapy (CBT) for Aggressive Behavior
CBT is a behavioral intervention that consists of 12 one-hour long, 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 Aggression
Active Comparator: Supportive Psychotherapy (SPT)
SPT consists of 12 one-hour sessions that are focused on discussing peer relationships and family functioning with a goal of enhancing subjective well-being
Behavioral: Supportive Psychotherapy (SPT)

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965184

Contacts
Contact: Spencer McCauley, B.S. (203) 737-7664 spencer.mccauley@yale.edu

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Spencer McCauley, B.S.    203-737-7664    spencer.mccauley@yale.edu   
Principal Investigator: Denis G. Sukhodolsky, Ph.D.         
Principal Investigator: Kevin A. Pelphrey, Ph.D.         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Denis G. Sukhodolsky, Ph.D. Yale University
Principal Investigator: Kevin A Pelphrey, Ph.D. Yale University
  More Information

Additional Information:
Publications:
Responsible Party: Denis Sukhodolsky, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01965184     History of Changes
Other Study ID Numbers: 0102012121C, R01MH101514
Study First Received: October 14, 2013
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
child
cognitive behavioral therapy
CBT
aggression
disruptive behavior
treatment
frustrative non-reward

Additional relevant MeSH terms:
Aggression
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 28, 2014