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

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ClinicalTrials.gov Identifier: NCT01362946
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : January 15, 2016
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Florida International University

Tracking Information
First Submitted Date  ICMJE January 7, 2011
First Posted Date  ICMJE June 1, 2011
Results First Submitted Date  ICMJE March 3, 2015
Results First Posted Date  ICMJE January 15, 2016
Last Update Posted Date January 15, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2015)
  • Conduct Problems [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    Counselors recorded each instance of complaining. The average number per day was computed for each week of treatment.
  • Interruption [ Time Frame: Weekly ]
    Counselors recorded each instance of interrupting. The average number per day was computed for each week of treatment.
  • Noncompliance [ Time Frame: Weekly ]
    Counselors recorded each instance of noncompliance. The average number per day was computed for each week of treatment.
  • Rule Violations [ Time Frame: Weekly ]
    Counselors recorded each instance of rule violations. The average number per day was computed for each week of treatment.
  • Positive Peer Behavior [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2011)
Improvement Rating Scale [ Time Frame: Every two weeks ]
Parent and counselor ratings of improvement in problem areas.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2015)
  • IOWA Inattentive/Overactive Scale - Counselor [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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 [ Time Frame: Weekly ]
    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? [ Time Frame: End of each treatment, at weeks 4 and 8 ]
    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? [ Time Frame: End of each treatment, at weeks 4 and 8 ]
    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? [ Time Frame: End of each treatment, at weeks 4 and 8 ]
    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? [ Time Frame: End of each treatment, at weeks 4 and 8 ]
    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? [ Time Frame: End of each treatment, at weeks 4 and 8 ]
    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 [ Time Frame: End of each treatment, at weeks 4 and 8 ]
    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 [ Time Frame: End of each treatment, at weeks 4 and 8 ]
    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 [ Time Frame: End of all treatment, at week 8 ]
    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 [ Time Frame: End of all treatment, at week 8 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2011)
Inattentive/Impulsive Overactive With Aggression (IOWA) Rating Scale [ Time Frame: Every two weeks ]
Counselor and parent ratings of disruptive behavior
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Conduct Disorder
  • Oppositional Defiant Disorder
Intervention  ICMJE
  • Behavioral: Reward-Emphasized Treatment
    Intensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized
  • Behavioral: Standard Treatment
    Intensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized.
Study Arms  ICMJE
  • Experimental: Reward-Emphasized treatment
    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.
    Intervention: Behavioral: Reward-Emphasized Treatment
  • Active Comparator: Standard treatment
    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: Behavioral: Standard Treatment
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
Actual Enrollment  ICMJE
 (submitted: May 27, 2011)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01362946
Other Study ID Numbers  ICMJE 1R34MH085796-01A2( U.S. NIH Grant/Contract )
1R34MH085796-01A2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account Florida International University
Verification Date December 2015

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