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Behavioral Treatment for Children With Conduct Problems and Callous-Unemotional Traits

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Florida International University
ClinicalTrials.gov Identifier:
NCT01362946
First received: January 7, 2011
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to modify behavior therapy so that it is optimized for children with conduct problems and callous-unemotional traits by emphasizing reward components and de-emphasizing punishment components.


Condition Intervention
Conduct Disorder
Oppositional Defiant Disorder
 Behavioral: Summer treatment program
Behavioral: Summer Treatment Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Designing a Novel Behavioral Treatment Protocol for Children Characterized by Conduct Problems and Callous-unemotional Traits

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Florida International University:

Primary Outcome Measures:
  • Improvement Rating Scale [ Time Frame: Every two weeks ] [ Designated as safety issue: No ]
    Parent and counselor ratings of improvement in problem areas.


Secondary Outcome Measures:
  • Inattentive/Impulsive Overactive With Aggression (IOWA) Rating Scale [ Time Frame: Every two weeks ] [ Designated as safety issue: No ]
    Counselor and parent ratings of disruptive behavior


Enrollment: 48
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reward-Emphasized treatment Behavioral: Summer treatment program
Intensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized
Active Comparator: Standard treatment Behavioral: Summer Treatment Program
Intensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of oppositional defiant disorder or conduct disorder
  • Ages 7 to 12 years old

Exclusion Criteria:

  • Full scale IQ of less than 70
  • medical conditions that contra-indicate participation in treatment
  • current or past clinical diagnosis of pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder
  • lack of functional impairment
  • current or past seizures or other neurological disorders
  • current or past treatment with non-stimulant psychoactive medication
  • current treatment with stimulant medication and unwilling or unable to change stimulant medication during treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362946

Locations
United States, Florida
Florida International University
Miami, Florida, United States, 33199
Sponsors and Collaborators
Florida International University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Daniel A Waschbusch, Ph.D. Florida International University
  More Information

Additional Information:
Center for Children and Families - Florida International University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT01362946     History of Changes
Other Study ID Numbers: 1R34MH085796-01A2
Study First Received: January 7, 2011
Last Updated: March 12, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Florida International University:
Conduct problems
callous-unemotional traits
disruptive behavior disorders

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Conduct Disorder
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013