Clinical trial NCT01362946: 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
Overall status: COMPLETED
Phase: NA
Conditions: Conduct Disorder
Oppositional Defiant Disorder
Keywords: Conduct problems
callous-unemotional traits
disruptive behavior disorders
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2011-06-01
Enrollment: 48
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Conduct Problems
timeFrame: Weekly
measure: Negative Verbalizations
timeFrame: Weekly
measure: Complaining
timeFrame: Weekly
measure: Interruption
timeFrame: Weekly
measure: Noncompliance
timeFrame: Weekly
measure: Rule Violations
timeFrame: Weekly
measure: Positive Peer Behavior
timeFrame: Weekly
measure: Minutes in Time Out
timeFrame: Weekly
measure: Number of Time Outs
timeFrame: Weekly
measure: Minutes of Physical Management
timeFrame: Weekly
Secondary outcomes:
measure: IOWA Inattentive/Overactive Scale - Counselor
timeFrame: Weekly
measure: IOWA Inattentive/Overactive Scale - Parent
timeFrame: Weekly
measure: IOWA Oppositional-defiant Scale - Counselor
timeFrame: Weekly
measure: IOWA Oppositional-defiant Scale - Parent
timeFrame: Weekly
measure: WPRF Serious Conduct Problems Scale - Counselor
timeFrame: Weekly
measure: WPRF Serious Conduct Problems Scale - Parent
timeFrame: Weekly
measure: WPRF Rule Following Problems - Counselor
timeFrame: Weekly
measure: WPRF Rule Following Problems - Parent
timeFrame: Weekly
measure: WPRF Overall Problems - Counselor
timeFrame: Weekly
measure: WPRF Overall Problems - Parent
timeFrame: Weekly
measure: How Much Did Your Child Benefit From Treatment?
timeFrame: End of each treatment, at weeks 4 and 8
measure: How Much Did You (the Parent) Benefit From Treatment?
timeFrame: End of each treatment, at weeks 4 and 8
measure: How Much Did Your Child Enjoy the Treatment?
timeFrame: End of each treatment, at weeks 4 and 8
measure: Would You Send Your Child to This Treatment Again?
timeFrame: End of each treatment, at weeks 4 and 8
measure: Recommend Treatment?
timeFrame: End of each treatment, at weeks 4 and 8
measure: Overall Satisfaction
timeFrame: End of each treatment, at weeks 4 and 8
measure: Overall Effectiveness
timeFrame: End of each treatment, at weeks 4 and 8
measure: Overall Treatment Recommendation - Counselor
timeFrame: End of all treatment, at week 8
measure: Overall Treatment Recommendation - Parent
timeFrame: End of all treatment, at week 8
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Daniel A Waschbusch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: