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

Primary Purpose

Conduct Disorder, Oppositional Defiant Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reward-Emphasized Treatment
Standard Treatment
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conduct Disorder focused on measuring Conduct problems, callous-unemotional traits, disruptive behavior disorders

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Florida International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reward-Emphasized treatment

Standard treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Complaining
Counselors recorded each instance of complaining. The average number per day was computed for each week of treatment.
Interruption
Counselors recorded each instance of interrupting. The average number per day was computed for each week of treatment.
Noncompliance
Counselors recorded each instance of noncompliance. The average number per day was computed for each week of treatment.
Rule Violations
Counselors recorded each instance of rule violations. The average number per day was computed for each week of treatment.
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.
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.
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.
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.

Secondary Outcome Measures

IOWA Inattentive/Overactive Scale - Counselor
At the end of each treatment week counselors rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). Items were summed to compute a scale score with a theoretical range of 0 to 15.
IOWA Inattentive/Overactive Scale - Parent
At the end of each treatment week parents rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). Items were summed to compute a scale score with a theoretical range of 0 to 15.
IOWA Oppositional-defiant Scale - Counselor
At the end of each treatment week counselors rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). Items were summed to compute a scale score with a theoretical range of 0 to 15.
IOWA Oppositional-defiant Scale - Parent
At the end of each treatment week parents rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). Items were summed to compute a scale score with a theoretical range of 0 to 15.
WPRF Serious Conduct Problems Scale - Counselor
At the end of each treatment week counselors rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
WPRF Serious Conduct Problems Scale - Parent
At the end of each treatment week parents rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
WPRF Rule Following Problems - Counselor
At the end of each treatment week counselors rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
WPRF Rule Following Problems - Parent
At the end of each treatment week parents rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
WPRF Overall Problems - Counselor
At the end of each treatment week counselors rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
WPRF Overall Problems - Parent
At the end of each treatment week parents rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
How Much Did Your Child Benefit From Treatment?
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "How much did your child benefit from this treatment?". This item was rated using a Likert scale that ranged from 0 ("not at all") to 3 ("very much").
How Much Did You (the Parent) Benefit From Treatment?
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "How much did you benefit from this treatment?". This item was rated using a Likert scale that ranged from 0 ("not at all") to 3 ("very much").
How Much Did Your Child Enjoy the Treatment?
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "How much did your child this treatment?". This item was rated using a Likert scale that ranged from 0 ("not at all") to 3 ("very much").
Would You Send Your Child to This Treatment Again?
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "Would you send your child to this treatment if you could do it over again?". This item was rated using a Likert scale that ranged from 0 ("no definitely") to 4 ("yes definitely").
Recommend Treatment?
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "Would you recommend this treatment to other parents?". This item was rated using a Likert scale that ranged from 0 ("no definitely") to 4 ("yes definitely").
Overall Satisfaction
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "Please rate your overall satisfaction with this treatment as compared with other treatment services your child has received". This item was rated using a Likert scale that ranged from 0 ("much less satisfied with this program") to 4 ("much more satisfied with this program").
Overall Effectiveness
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "Please rate how effective this treatment was in changing your child as compared with other treatment services your child has received". This item was rated using a Likert scale that ranged from 0 ("this treatment much less effective") to 4 ("this treatment much more effective").
Overall Treatment Recommendation - Counselor
At end end of both treatment blocks, counselors sorted children into one of four treatment response groups: (1) responded best to standard behavior therapy; (2) responded best to modified behavior therapy; (3) responded well to both treatments; (4) did not respond to either treatment
Overall Treatment Recommendation - Parent
At end end of both treatment blocks, parents selected which treatment they though was best for their child - standard behavioral treatment or modified behavioral treatment

Full Information

First Posted
January 7, 2011
Last Updated
December 10, 2015
Sponsor
Florida International University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01362946
Brief Title
Behavioral Treatment for Children With Conduct Problems and Callous-Unemotional Traits
Official Title
Designing a Novel Behavioral Treatment Protocol for Children Characterized by Conduct Problems and Callous-unemotional Traits
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Several studies have demonstrated that standard behavioral treatments do not appear to be sufficient for children with conduct problems (CP) and callous-unemotional (CU) traits. Other research suggests that children with CPCU are less responsive to punishments as evaluated using controlled laboratory tasks. Based on these two sets of findings, it was hypothesized that behavioral treatment modified to emphasize reward and de-emphasize punishments would be advantageous when used to treat children with CPCU. This hypothesis was tested in a treatment development study that had three phases. During phase 1, which occurred in 2010, the intervention was planned and treatment procedures and manuals were developed. During phase 2, which occurred in 2011, a pilot study was conducted in which the intervention was tested in an iterative manner in a group of 12 children with conduct problems and callous-unemotional traits. In phase 3, a larger trial was conducted using a cross over design, with one-half of participants getting standard behavioral treatment for four weeks followed by modified behavioral treatment for four weeks and remaining participants receiving treatments in the reverse order.Treatments were evaluated using parent ratings, counselor ratings, and frequency counts of behavior during treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conduct Disorder, Oppositional Defiant Disorder
Keywords
Conduct problems, callous-unemotional traits, disruptive behavior disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reward-Emphasized treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reward-Emphasized Treatment
Intervention Description
Intensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized
Intervention Type
Behavioral
Intervention Name(s)
Standard Treatment
Intervention Description
Intensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized.
Primary Outcome Measure Information:
Title
Conduct Problems
Description
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.
Time Frame
Weekly
Title
Negative Verbalizations
Description
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.
Time Frame
Weekly
Title
Complaining
Description
Counselors recorded each instance of complaining. The average number per day was computed for each week of treatment.
Time Frame
Weekly
Title
Interruption
Description
Counselors recorded each instance of interrupting. The average number per day was computed for each week of treatment.
Time Frame
Weekly
Title
Noncompliance
Description
Counselors recorded each instance of noncompliance. The average number per day was computed for each week of treatment.
Time Frame
Weekly
Title
Rule Violations
Description
Counselors recorded each instance of rule violations. The average number per day was computed for each week of treatment.
Time Frame
Weekly
Title
Positive Peer Behavior
Description
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.
Time Frame
Weekly
Title
Minutes in Time Out
Description
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.
Time Frame
Weekly
Title
Number of Time Outs
Description
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.
Time Frame
Weekly
Title
Minutes of Physical Management
Description
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.
Time Frame
Weekly
Secondary Outcome Measure Information:
Title
IOWA Inattentive/Overactive Scale - Counselor
Description
At the end of each treatment week counselors rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). Items were summed to compute a scale score with a theoretical range of 0 to 15.
Time Frame
Weekly
Title
IOWA Inattentive/Overactive Scale - Parent
Description
At the end of each treatment week parents rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). Items were summed to compute a scale score with a theoretical range of 0 to 15.
Time Frame
Weekly
Title
IOWA Oppositional-defiant Scale - Counselor
Description
At the end of each treatment week counselors rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). Items were summed to compute a scale score with a theoretical range of 0 to 15.
Time Frame
Weekly
Title
IOWA Oppositional-defiant Scale - Parent
Description
At the end of each treatment week parents rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 ("not at all") to 3 ("very much"). Items were summed to compute a scale score with a theoretical range of 0 to 15.
Time Frame
Weekly
Title
WPRF Serious Conduct Problems Scale - Counselor
Description
At the end of each treatment week counselors rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
Time Frame
Weekly
Title
WPRF Serious Conduct Problems Scale - Parent
Description
At the end of each treatment week parents rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
Time Frame
Weekly
Title
WPRF Rule Following Problems - Counselor
Description
At the end of each treatment week counselors rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
Time Frame
Weekly
Title
WPRF Rule Following Problems - Parent
Description
At the end of each treatment week parents rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
Time Frame
Weekly
Title
WPRF Overall Problems - Counselor
Description
At the end of each treatment week counselors rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
Time Frame
Weekly
Title
WPRF Overall Problems - Parent
Description
At the end of each treatment week parents rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 ("no problem") to 7 ("serious problem"). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems.
Time Frame
Weekly
Title
How Much Did Your Child Benefit From Treatment?
Description
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "How much did your child benefit from this treatment?". This item was rated using a Likert scale that ranged from 0 ("not at all") to 3 ("very much").
Time Frame
End of each treatment, at weeks 4 and 8
Title
How Much Did You (the Parent) Benefit From Treatment?
Description
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "How much did you benefit from this treatment?". This item was rated using a Likert scale that ranged from 0 ("not at all") to 3 ("very much").
Time Frame
End of each treatment, at weeks 4 and 8
Title
How Much Did Your Child Enjoy the Treatment?
Description
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "How much did your child this treatment?". This item was rated using a Likert scale that ranged from 0 ("not at all") to 3 ("very much").
Time Frame
End of each treatment, at weeks 4 and 8
Title
Would You Send Your Child to This Treatment Again?
Description
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "Would you send your child to this treatment if you could do it over again?". This item was rated using a Likert scale that ranged from 0 ("no definitely") to 4 ("yes definitely").
Time Frame
End of each treatment, at weeks 4 and 8
Title
Recommend Treatment?
Description
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "Would you recommend this treatment to other parents?". This item was rated using a Likert scale that ranged from 0 ("no definitely") to 4 ("yes definitely").
Time Frame
End of each treatment, at weeks 4 and 8
Title
Overall Satisfaction
Description
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "Please rate your overall satisfaction with this treatment as compared with other treatment services your child has received". This item was rated using a Likert scale that ranged from 0 ("much less satisfied with this program") to 4 ("much more satisfied with this program").
Time Frame
End of each treatment, at weeks 4 and 8
Title
Overall Effectiveness
Description
At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: "Please rate how effective this treatment was in changing your child as compared with other treatment services your child has received". This item was rated using a Likert scale that ranged from 0 ("this treatment much less effective") to 4 ("this treatment much more effective").
Time Frame
End of each treatment, at weeks 4 and 8
Title
Overall Treatment Recommendation - Counselor
Description
At end end of both treatment blocks, counselors sorted children into one of four treatment response groups: (1) responded best to standard behavior therapy; (2) responded best to modified behavior therapy; (3) responded well to both treatments; (4) did not respond to either treatment
Time Frame
End of all treatment, at week 8
Title
Overall Treatment Recommendation - Parent
Description
At end end of both treatment blocks, parents selected which treatment they though was best for their child - standard behavioral treatment or modified behavioral treatment
Time Frame
End of all treatment, at week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel A Waschbusch, Ph.D.
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States

12. IPD Sharing Statement

Links:
URL
http://casgroup.fiu.edu/ccf/index.php
Description
Center for Children and Families - Florida International University

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

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