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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Florida International University

Current Primary Outcome:

  • 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, def

    Original Primary Outcome: Improvement Rating Scale [ Time Frame: Every two weeks ]

    Parent and counselor ratings of improvement in problem areas.


    Current Secondary Outcome:

    • 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&

      Original Secondary Outcome: Inattentive/Impulsive Overactive With Aggression (IOWA) Rating Scale [ Time Frame: Every two weeks ]

      Counselor and parent ratings of disruptive behavior


      Information By: Florida International University

      Dates:
      Date Received: January 7, 2011
      Date Started: January 2012
      Date Completion:
      Last Updated: December 10, 2015
      Last Verified: December 2015