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

Conduct Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362946
• Other study ID #: 1R34MH085796-01A2
• Secondary ID: 1R34MH085796-01A
• Status: Completed
• Phase: N/A
• First received: January 7, 2011
• Last updated: December 10, 2015
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: December 2015
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Conduct Disorder
• Disease
• Oppositional Defiant Disorder

Intervention

Behavioral:
• Reward-Emphasized Treatment
Intensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized
• Standard Treatment
Intensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conduct Problems	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.	Weekly	No
Primary	Negative Verbalizations	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.	Weekly	No
Primary	Complaining	Counselors recorded each instance of complaining. The average number per day was computed for each week of treatment.	Weekly	No
Primary	Interruption	Counselors recorded each instance of interrupting. The average number per day was computed for each week of treatment.	Weekly	No
Primary	Noncompliance	Counselors recorded each instance of noncompliance. The average number per day was computed for each week of treatment.	Weekly	No
Primary	Rule Violations	Counselors recorded each instance of rule violations. The average number per day was computed for each week of treatment.	Weekly	No
Primary	Positive Peer Behavior	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.	Weekly	No
Primary	Minutes in Time Out	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.	Weekly	No
Primary	Number of Time Outs	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.	Weekly	No
Primary	Minutes of Physical Management	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.	Weekly	No
Secondary	IOWA Inattentive/Overactive Scale - Counselor	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.	Weekly	No
Secondary	IOWA Inattentive/Overactive Scale - Parent	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.	Weekly	No
Secondary	IOWA Oppositional-defiant Scale - Counselor	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.	Weekly	No
Secondary	IOWA Oppositional-defiant Scale - Parent	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.	Weekly	No
Secondary	WPRF Serious Conduct Problems Scale - Counselor	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.	Weekly	No
Secondary	WPRF Serious Conduct Problems Scale - Parent	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.	Weekly	No
Secondary	WPRF Rule Following Problems - Counselor	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.	Weekly	No
Secondary	WPRF Rule Following Problems - Parent	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.	Weekly	No
Secondary	WPRF Overall Problems - Counselor	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.	Weekly	No
Secondary	WPRF Overall Problems - Parent	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.	Weekly	No
Secondary	How Much Did Your Child Benefit From Treatment?	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").	End of each treatment, at weeks 4 and 8	No
Secondary	How Much Did You (the Parent) Benefit From Treatment?	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").	End of each treatment, at weeks 4 and 8	No
Secondary	How Much Did Your Child Enjoy the Treatment?	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").	End of each treatment, at weeks 4 and 8	No
Secondary	Would You Send Your Child to This Treatment Again?	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").	End of each treatment, at weeks 4 and 8	No
Secondary	Recommend Treatment?	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").	End of each treatment, at weeks 4 and 8	No
Secondary	Overall Satisfaction	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").	End of each treatment, at weeks 4 and 8	No
Secondary	Overall Effectiveness	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").	End of each treatment, at weeks 4 and 8	No
Secondary	Overall Treatment Recommendation - Counselor	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	End of all treatment, at week 8	No
Secondary	Overall Treatment Recommendation - Parent	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	End of all treatment, at week 8	No

External Links

•   Center for Children and Families - Florida International University