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

Tracking Information

First Received Date ^ICMJE

January 7, 2011

Last Updated Date

March 12, 2013

Start Date ^ICMJE

January 2012

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Improvement Rating Scale [ Time Frame: Every two weeks ] [ Designated as safety issue: No ]

Parent and counselor ratings of improvement in problem areas.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01362946 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Designing a Novel Behavioral Treatment Protocol for Children Characterized by Conduct Problems and Callous-unemotional Traits

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Conduct Disorder
Oppositional Defiant Disorder

Intervention ^ICMJE

Behavioral: Summer treatment program
Intensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized
Behavioral: Summer Treatment Program
Intensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized.

Study Arm (s)

Experimental: Reward-Emphasized treatment
Intervention: Behavioral: Summer treatment program
Active Comparator: Standard treatment
Intervention: Behavioral: Summer Treatment Program

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2012

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01362946

Other Study ID Numbers ^ICMJE

1R34MH085796-01A2

Has Data Monitoring Committee

Yes

Responsible Party

Florida International University

Study Sponsor ^ICMJE

Florida International University

Collaborators ^ICMJE

National Institute of Mental Health (NIMH)

Investigators ^ICMJE

Principal Investigator:

Daniel A Waschbusch, Ph.D.

Florida International University

Information Provided By

Florida International University

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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