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Clinical Trials/NCT01362946
NCT01362946
Completed
Not Applicable

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

Florida International University1 site in 1 country48 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Conduct Disorder
Sponsor
Florida International University
Enrollment
48
Locations
1
Primary Endpoint
Conduct Problems
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
August 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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 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.

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.

Secondary Outcomes

  • WPRF Rule Following Problems - Parent(Weekly)
  • WPRF Overall Problems - Counselor(Weekly)
  • WPRF Overall Problems - Parent(Weekly)
  • How Much Did Your Child Benefit From Treatment?(End of each treatment, at weeks 4 and 8)
  • How Much Did You (the Parent) Benefit From Treatment?(End of each treatment, at weeks 4 and 8)
  • How Much Did Your Child Enjoy the Treatment?(End of each treatment, at weeks 4 and 8)
  • Would You Send Your Child to This Treatment Again?(End of each treatment, at weeks 4 and 8)
  • Recommend Treatment?(End of each treatment, at weeks 4 and 8)
  • Overall Satisfaction(End of each treatment, at weeks 4 and 8)
  • Overall Effectiveness(End of each treatment, at weeks 4 and 8)
  • Overall Treatment Recommendation - Counselor(End of all treatment, at week 8)
  • Overall Treatment Recommendation - Parent(End of all treatment, at week 8)
  • 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)
  • WPRF Serious Conduct Problems Scale - Parent(Weekly)
  • WPRF Rule Following Problems - Counselor(Weekly)

Study Sites (1)

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