Conduct DisorderNCT01362946
Behavioral Treatment for Children With Conduct Problems and Callous-Unemotional Traits
A study testing Reward-Emphasized Treatment and Standard Treatment in people with Conduct Disorder and Oppositional Defiant Disorder, run by Florida International University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Conduct Disorder, Oppositional Defiant Disorder
- What is being tested?
- Reward-Emphasized Treatment and Standard Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: Designing a Novel Behavioral Treatment Protocol for Children Characterized by Conduct Problems and Callous-unemotional Traits
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.
Read the 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
- Being tested
- Reward-Emphasized Treatment, Standard Treatment
- Keywords
- Conduct problems, callous-unemotional traits, disruptive behavior disorders
- Medical subject headings
- Conduct Disorder, Oppositional Defiant Disorder, Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reward-Emphasized TreatmentBehavioural
Intensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized
Standard TreatmentBehavioural
Intensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized.
| Study group | Role | What they receive |
|---|---|---|
| Reward-Emphasized treatment | Experimental | 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. Receives: Behavioral: Reward-Emphasized Treatment |
| Standard treatment | Active comparator | 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. Receives: Behavioral: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly
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.
Measured: Weekly
Complaining
Counselors recorded each instance of complaining. The average number per day was computed for each week of treatment.
Measured: Weekly
Interruption
Counselors recorded each instance of interrupting. The average number per day was computed for each week of treatment.
Measured: Weekly
Noncompliance
Counselors recorded each instance of noncompliance. The average number per day was computed for each week of treatment.
Measured: Weekly
Rule Violations
Counselors recorded each instance of rule violations. The average number per day was computed for each week of treatment.
Measured: Weekly
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.
Measured: Weekly
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.
Measured: Weekly
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.
Measured: Weekly
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.
Measured: Weekly
Secondary outcomes (19)
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.
Measured: Weekly
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.
Measured: Weekly
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.
Measured: Weekly
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.
Measured: Weekly
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.
Measured: Weekly
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.
Measured: Weekly
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.
Measured: Weekly
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.
Measured: Weekly
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.
Measured: Weekly
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.
Measured: Weekly
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").
Measured: End of each treatment, at weeks 4 and 8
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").
Measured: End of each treatment, at weeks 4 and 8
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").
Measured: End of each treatment, at weeks 4 and 8
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").
Measured: End of each treatment, at weeks 4 and 8
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").
Measured: End of each treatment, at weeks 4 and 8
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").
Measured: End of each treatment, at weeks 4 and 8
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").
Measured: End of each treatment, at weeks 4 and 8
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
Measured: End of all treatment, at week 8
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
Measured: End of all treatment, at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Daniel A Waschbusch, Ph.D., Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362946
- Sponsor's protocol ID
- 1R34MH085796-01A2
- Other IDs
- 1R34MH085796-01A2
- Status last verified
- Dec 2015
- First submitted
- 7 Jan 2011
- Last updated
- 15 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing a Novel Behavioral Treatment Protocol for Children Characterized by Conduct Problems and Callous-unemotional Traits
- ClinicalTrials.gov ID
- NCT01362946
- Acronym / sponsor ID
- 1R34MH085796-01A2
- Conditions
- Conduct Disorder, Oppositional Defiant Disorder
- Keywords
- Conduct problems, callous-unemotional traits, disruptive behavior disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Posted 15 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reward-Emphasized treatment | Experimental | Behavioral: Reward-Emphasized TreatmentThis 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. |
| Standard treatment | Active comparator | Behavioral: Standard TreatmentThis 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reward-Emphasized TreatmentIntensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized | Behavioural | Reward-Emphasized treatment |
| Standard TreatmentIntensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized. | Behavioural | Standard treatment |
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, defined as helping, sharing and ignoring teasing. 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.
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 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.
19 secondary outcomes
IOWA Inattentive/Overactive Scale - Counselor
Time frame: Weekly
IOWA Inattentive/Overactive Scale - Parent
Time frame: Weekly
IOWA Oppositional-defiant Scale - Counselor
Time frame: Weekly
IOWA Oppositional-defiant Scale - Parent
Time frame: Weekly
WPRF Serious Conduct Problems Scale - Counselor
Time frame: Weekly
WPRF Serious Conduct Problems Scale - Parent
Time frame: Weekly
WPRF Rule Following Problems - Counselor
Time frame: Weekly
WPRF Rule Following Problems - Parent
Time frame: Weekly
WPRF Overall Problems - Counselor
Time frame: Weekly
WPRF Overall Problems - Parent
Time frame: Weekly
How Much Did Your Child Benefit From Treatment?
Time frame: End of each treatment, at weeks 4 and 8
How Much Did You (the Parent) Benefit From Treatment?
Time frame: End of each treatment, at weeks 4 and 8
How Much Did Your Child Enjoy the Treatment?
Time frame: End of each treatment, at weeks 4 and 8
Would You Send Your Child to This Treatment Again?
Time frame: End of each treatment, at weeks 4 and 8
Recommend Treatment?
Time frame: End of each treatment, at weeks 4 and 8
Overall Satisfaction
Time frame: End of each treatment, at weeks 4 and 8
Overall Effectiveness
Time frame: End of each treatment, at weeks 4 and 8
Overall Treatment Recommendation - Counselor
Time frame: End of all treatment, at week 8
Overall Treatment Recommendation - Parent
Time frame: End of all treatment, at week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel A Waschbusch, Ph.D. principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reward-Emphasized Treatment and Standard Treatment in people with Conduct Disorder and Oppositional Defiant Disorder, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conduct Problems (time frame: Weekly). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016.