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

NCT ID: NCT01362946

Last Updated: 2016-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-08-31

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.

Conditions

Conduct Disorder; Oppositional Defiant Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Reward-Emphasized Treatment

Intervention Type: BEHAVIORAL

Intensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized

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.

Group Type: ACTIVE_COMPARATOR

Standard Treatment

Intervention Type: BEHAVIORAL

Intensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized.

Interventions

Reward-Emphasized Treatment

Intensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized

Intervention Type: BEHAVIORAL

Standard Treatment

Intensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel A Waschbusch, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Locations

Florida International University

Miami, Florida, United States

Countries

United States

Other Identifiers

1R34MH085796-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R34MH085796-01A2

Identifier Type: NIH

Identifier Source: org_study_id

View Link