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

NCT01362946 | Completed Results DMC

• 1 other identifier: 1R34MH085796-01A2
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Conduct Disorder; Oppositional Defiant Disorder

Keywords

Conduct problems; callous-unemotional traits; disruptive behavior disorders

Outcome Measures

Primary Outcomes (10)

• Conduct Problems

  Counselors recorded each instance of conduct problems, defined as lying, stealing, intentional destruction of property, and intentional aggression. The average number per day was computed for each week of treatment.

  Weekly

• Negative Verbalizations

  Counselors recorded each instance of negative verbalizations, defined as verbal abuse to staff, teasing peers, and swearing. The average number per day was computed for each week of treatment.

  Weekly

• Complaining

  Counselors recorded each instance of complaining. The average number per day was computed for each week of treatment.

  Weekly

• Interruption

  Counselors recorded each instance of interrupting. The average number per day was computed for each week of treatment.

  Weekly

• Noncompliance

  Counselors recorded each instance of noncompliance. The average number per day was computed for each week of treatment.

  Weekly

• Rule Violations

  Counselors recorded each instance of rule violations. The average number per day was computed for each week of treatment.

  Weekly

• Positive Peer Behavior

  Counselors recorded each instance of positive behavior with peers, defined as helping, sharing and ignoring teasing. The average number per day was computed for each week of treatment.

  Weekly

• Minutes in Time Out

  Counselors recorded the total number of minutes children were in Time Out due to intentional aggression, intentional destruction of property, or repeated noncompliance. The average number per day was computed for each week of treatment.

  Weekly

• Number of Time Outs

  Counselors recorded the total number of Time Outs children served due to intentional aggression, intentional destruction of property, or repeated noncompliance. The average number per day was computed for each week of treatment.

  Weekly

• Minutes of Physical Management

  Counselors recorded the total number of minutes children had to be physically managed due to behavior dangerous to themselves or others. The average number per day was computed for each week of treatment.

  Weekly

Secondary Outcomes (19)

• IOWA Inattentive/Overactive Scale - Counselor

  Weekly

• IOWA Inattentive/Overactive Scale - Parent

  Weekly

• IOWA Oppositional-defiant Scale - Counselor

  Weekly

• IOWA Oppositional-defiant Scale - Parent

  Weekly

• WPRF Serious Conduct Problems Scale - Counselor

  Weekly

Study Arms (2)

Reward-Emphasized treatment

EXPERIMENTAL

This treatment consisted of behavior therapy modified to match the unique learning styles of children with CPCU. This was accomplished by emphasizing rewards and de-emphasizing punishments. This treatment was administered using a summer treatment program.

Behavioral: Reward-Emphasized Treatment

Standard treatment

ACTIVE COMPARATOR

This treatment consisted of standard behavior therapy, in which reward and punishment components were used in a balanced manner, as is typically done in outpatient settings. This treatment was administered using a summer treatment program.

Behavioral: Standard Treatment

Interventions

Reward-Emphasized Treatment BEHAVIORAL

Intensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized

Reward-Emphasized treatment

Standard Treatment BEHAVIORAL

Intensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized.

Standard treatment

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of oppositional defiant disorder or conduct disorder
• Ages 7 to 12 years old
• t-score of 65 or above on CU scale of Antisocial Process Screening Device as rated by parents or teacher
• at least parent/caregiver fluent in English
• able to participate in vigorous outdoor activities
• parent/caregiver agreement to keep psychoactive medication treatment constant throughout the study

You may not qualify if:

• Full scale intelligence quotient (IQ) of less than 75
• 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

Sponsors & Collaborators

• Florida International University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Conduct Disorder; Oppositional Defiant Disorder; Attention Deficit and Disruptive Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Dan Waschbusch
• Organization: Penn State Hershey Medical Center

dwaschbusch@hmc.psu.edu

7175318514

Study Officials

• Daniel A Waschbusch, Ph.D.

  Florida International University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: June 1, 2011
• Study Start: January 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 15, 2016
• Results First Posted: January 15, 2016

Record last verified: 2015-12

Locations

US (1)