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

This study has been completed.
Sponsor:
Collaborator:
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
  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:


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
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: NCT01362946

Locations
United States, Florida
Florida International University
Miami, Florida, United States, 33199
Sponsors and Collaborators
Florida International University
Investigators
Principal Investigator: Daniel A Waschbusch, Ph.D. Florida International University
  More Information

Additional Information:
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 August 19, 2014