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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01965184
First Posted: October 18, 2013
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Denis Sukhodolsky, Yale University
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Denis Sukhodolsky, Yale University:

Primary Outcome Measures:
  • The Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: basline (week 0) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    fMRI scanning with tasks of emotion regulation and social perception

  • Electroencephalography (EEG) [ Time Frame: baseline (week 0) ]
    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) ]
    fMRI scanning with tasks of emotion regulation and social perception

  • Electroencephalography (EEG) [ Time Frame: endpoint (week 12) ]
    EEG recordings will be collected as participants perform tasks of emotion regulation and social perception


Enrollment: 101
Actual Study Start Date: November 14, 2013
Estimated Study Completion Date: December 1, 2017
Primary Completion Date: August 3, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965184


Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
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 ( U.S. NIH Grant/Contract )
First Submitted: October 14, 2013
First Posted: October 18, 2013
Last Update Posted: October 25, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Aggression
Problem Behavior
Behavioral Symptoms