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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362946
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : January 15, 2016
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Florida International University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Conduct Disorder
Oppositional Defiant Disorder
Interventions Behavioral: Reward-Emphasized Treatment
Behavioral: Standard Treatment
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Modified Behavior Treatment Then Standard Behavior Treatment Standard Behavior Treatment Then Modified Behavior Treatment
Hide Arm/Group Description Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
Period Title: First Behavior Modification Block
Started 24 24
Completed 24 24
Not Completed 0 0
Period Title: Second Behavior Modification Block
Started 23 [1] 24
Completed 23 24
Not Completed 0 0
[1]
1 participant withdrew after last but before this treatment period - illness unrelated to study.
Arm/Group Title Overall Sample
Hide Arm/Group Description Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<=18 years
48
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
9.29  (1.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
10
  20.8%
Male
38
  79.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Hispanic or Latino
27
  56.3%
Not Hispanic or Latino
21
  43.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
American Indian or Alaska Native
1
   2.1%
Asian
4
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  12.5%
White
34
  70.8%
More than one race
3
   6.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants
48
1.Primary Outcome
Title Conduct Problems
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: Number of conduct problems per day
Standard Behavior Therapy - week 1 0.76  (0.27)
Standard Behavior Therapy - week 2 1.08  (0.35)
Standard Behavior Therapy - week 3 0.41  (0.54)
Standard Behavior Therapy - week 4 0.92  (0.48)
Modified Behavior Therapy - week 1 0.76  (0.28)
Modified Behavior Therapy - week 2 1.26  (0.36)
Modified Behavior Therapy - week 3 1.54  (0.54)
Modified Behavior Therapy - week 4 1.42  (0.49)
2.Primary Outcome
Title Negative Verbalizations
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: Number of negative verbals per day
Standard behavior therapy - week 1 5.70  (1.31)
Standard behavior therapy - week 2 7.32  (1.53)
Standard behavior therapy - week 3 6.73  (2.41)
Standard behavior therapy - week 4 5.91  (1.98)
Modified Behavior Therapy - week 1 4.94  (1.36)
Modified Behavior Therapy - week 2 9.16  (1.58)
Modified Behavior Therapy - week 3 10.63  (2.45)
Modified Behavior Therapy - week 4 10.95  (2.01)
3.Primary Outcome
Title Complaining
Hide Description Counselors recorded each instance of complaining. The average number per day was computed for each week of treatment.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: Number of complaints per day
Standard Behavior Therapy - week 1 5.25  (1.02)
Standard Behavior Therapy - week 2 4.92  (1.25)
Standard Behavior Therapy - week 3 2.76  (1.32)
Standard Behavior Therapy - week 4 3.54  (1.21)
Modified behavior therapy - week 1 3.33  (1.00)
Modified behavior therapy - week 2 5.18  (1.25)
Modified behavior therapy - week 3 5.90  (1.32)
Modified behavior therapy - week 4 5.95  (1.24)
4.Primary Outcome
Title Interruption
Hide Description Counselors recorded each instance of interrupting. The average number per day was computed for each week of treatment.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: Number of interruptions per day
Standard Behavior Therapy - week 1 9.86  (1.32)
Standard Behavior Therapy - week 2 14.81  (2.02)
Standard Behavior Therapy - week 3 13.43  (2.51)
Standard Behavior Therapy - week 4 12.61  (2.27)
Modified Behavior Therapy - week 1 10.21  (1.41)
Modified Behavior Therapy - week 2 14.32  (2.06)
Modified Behavior Therapy - week 3 19.32  (2.54)
Modified Behavior Therapy - week 4 19.66  (2.28)
5.Primary Outcome
Title Noncompliance
Hide Description Counselors recorded each instance of noncompliance. The average number per day was computed for each week of treatment.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: Number of noncompliance per day
Standard Behavior Therapy - week 1 3.82  (0.89)
Standard Behavior Therapy - week 2 4.29  (0.97)
Standard Behavior Therapy - week 3 3.52  (0.84)
Standard Behavior Therapy - week 4 2.99  (0.85)
Modified Behavior Therapy - week 1 3.35  (0.90)
Modified Behavior Therapy - week 2 5.16  (0.97)
Modified Behavior Therapy - week 3 4.26  (0.87)
Modified Behavior Therapy - week 4 4.28  (0.87)
6.Primary Outcome
Title Rule Violations
Hide Description Counselors recorded each instance of rule violations. The average number per day was computed for each week of treatment.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: Number of rule violations per day
Standard Behavior Therapy - week 1 36.65  (6.08)
Standard Behavior Therapy - week 2 40.84  (6.10)
Standard Behavior Therapy - week 3 33.93  (6.80)
Standard Behavior Therapy - week 4 35.31  (7.26)
Modified Behavior Therapy - week 1 27.28  (6.13)
Modified Behavior Therapy - week 2 41.89  (6.06)
Modified Behavior Therapy - week 3 46.99  (6.86)
Modified Behavior Therapy - week 4 49.56  (7.21)
7.Primary Outcome
Title Positive Peer Behavior
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: Number of positive peer behave per day
Standard Behavior Therapy - week 1 4.91  (0.48)
Standard Behavior Therapy - week 2 4.51  (0.48)
Standard Behavior Therapy - week 3 4.84  (0.58)
Standard Behavior Therapy - week 4 4.33  (0.49)
Modified Behavior Therapy - week 1 5.42  (0.49)
Modified Behavior Therapy - week 2 7.08  (0.51)
Modified Behavior Therapy - week 3 6.72  (0.59)
Modified Behavior Therapy - week 4 9.72  (0.52)
8.Primary Outcome
Title Minutes in Time Out
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: Minutes in Time Out per day
Standard Behavior Therapy - week 1 10.62  (3.03)
Standard Behavior Therapy - week 2 14.77  (3.68)
Standard Behavior Therapy - week 3 9.50  (3.33)
Standard Behavior Therapy - week 4 10.17  (3.45)
Modified Behavior Therapy - week 1 6.57  (3.06)
Modified Behavior Therapy - week 2 12.15  (3.72)
Modified Behavior Therapy - week 3 10.76  (3.45)
Modified Behavior Therapy - week 4 10.67  (3.52)
9.Primary Outcome
Title Number of Time Outs
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: Number of Time Outs per day
Standard Behavior Therapy - week 1 0.69  (0.25)
Standard Behavior Therapy - week 2 1.00  (0.26)
Standard Behavior Therapy - week 3 1.15  (0.28)
Standard Behavior Therapy - week 4 0.76  (0.27)
Modified Behavior Therapy - week 1 0.82  (0.27)
Modified Behavior Therapy - week 2 1.09  (0.26)
Modified Behavior Therapy - week 3 0.98  (0.28)
Modified Behavior Therapy - week 4 1.27  (0.28)
10.Primary Outcome
Title Minutes of Physical Management
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: Minutes of Physical Manage per day
Standard Behavior Therapy - week 1 0.09  (0.30)
Standard Behavior Therapy - week 2 0.21  (0.16)
Standard Behavior Therapy - week 3 0.29  (0.17)
Standard Behavior Therapy - week 4 0.31  (0.17)
Modified Behavior Therapy - week 1 0.54  (0.30)
Modified Behavior Therapy - week 2 0.30  (0.16)
Modified Behavior Therapy - week 3 0.28  (0.17)
Modified Behavior Therapy - week 4 0.21  (0.17)
11.Secondary Outcome
Title IOWA Inattentive/Overactive Scale - Counselor
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard Behavior Therapy - week 1 5.36  (0.57)
Standard Behavior Therapy - week 2 5.57  (0.58)
Standard Behavior Therapy - week 3 6.15  (0.60)
Standard Behavior Therapy - week 4 5.78  (0.58)
Modified Behavior Therapy - week 1 5.51  (0.58)
Modified Behavior Therapy - week 2 5.59  (0.58)
Modified Behavior Therapy - week 3 5.95  (0.60)
Modified Behavior Therapy - week 4 6.14  (0.58)
12.Secondary Outcome
Title IOWA Inattentive/Overactive Scale - Parent
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard Behavior Therapy - week 1 6.71  (0.59)
Standard Behavior Therapy - week 2 7.11  (0.60)
Standard Behavior Therapy - week 3 6.88  (0.58)
Standard Behavior Therapy - week 4 6.10  (0.59)
Modified Behavior Therapy - week 1 6.15  (0.63)
Modified Behavior Therapy - week 2 6.38  (0.60)
Modified Behavior Therapy - week 3 6.12  (0.58)
Modified Behavior Therapy - week 4 6.09  (0.58)
13.Secondary Outcome
Title IOWA Oppositional-defiant Scale - Counselor
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard Behavior Therapy - week 1 4.55  (0.56)
Standard Behavior Therapy - week 2 4.99  (0.58)
Standard Behavior Therapy - week 3 4.47  (0.56)
Standard Behavior Therapy - week 4 4.85  (0.58)
Modified Behavior Therapy - week 1 4.20  (0.56)
Modified Behavior Therapy - week 2 5.01  (0.58)
Modified Behavior Therapy - week 3 4.94  (0.56)
Modified Behavior Therapy - week 4 5.38  (0.58)
14.Secondary Outcome
Title IOWA Oppositional-defiant Scale - Parent
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard Behavior Therapy - week 1 6.71  (0.70)
Standard Behavior Therapy - week 2 6.99  (0.56)
Standard Behavior Therapy - week 3 6.50  (0.63)
Standard Behavior Therapy - week 4 6.15  (0.63)
Modified Behavior Therapy - week 1 5.75  (0.75)
Modified Behavior Therapy - week 2 5.80  (0.57)
Modified Behavior Therapy - week 3 5.26  (0.65)
Modified Behavior Therapy - week 4 5.20  (0.62)
15.Secondary Outcome
Title WPRF Serious Conduct Problems Scale - Counselor
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard Behavior Therapy - week 1 1.71  (0.12)
Standard Behavior Therapy - week 2 1.81  (0.12)
Standard Behavior Therapy - week 3 1.69  (0.12)
Standard Behavior Therapy - week 4 1.70  (0.12)
Modified Behavior Therapy - week 1 1.66  (0.12)
Modified Behavior Therapy - week 2 1.83  (0.12)
Modified Behavior Therapy - week 3 1.88  (0.12)
Modified Behavior Therapy - week 4 1.91  (0.12)
16.Secondary Outcome
Title WPRF Serious Conduct Problems Scale - Parent
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard Behavior Therapy - week 1 2.47  (0.19)
Standard Behavior Therapy - week 2 2.48  (0.19)
Standard Behavior Therapy - week 3 2.22  (0.19)
Standard Behavior Therapy - week 4 1.96  (0.16)
Modified Behavior Therapy - week 1 2.05  (0.21)
Modified Behavior Therapy - week 2 1.94  (0.19)
Modified Behavior Therapy - week 3 2.03  (0.19)
Modified Behavior Therapy - week 4 2.00  (0.16)
17.Secondary Outcome
Title WPRF Rule Following Problems - Counselor
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard Behavior Therapy - week 1 2.07  (0.14)
Standard Behavior Therapy - week 2 2.18  (0.15)
Standard Behavior Therapy - week 3 2.17  (0.15)
Standard Behavior Therapy - week 4 2.19  (0.16)
Modified Behavior Therapy - week 1 2.10  (0.14)
Modified Behavior Therapy - week 2 2.17  (0.15)
Modified Behavior Therapy - week 3 2.26  (0.15)
Modified Behavior Therapy - week 4 2.30  (0.15)
18.Secondary Outcome
Title WPRF Rule Following Problems - Parent
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard Behavior Therapy - week 1 3.63  (0.25)
Standard Behavior Therapy - week 2 3.88  (0.26)
Standard Behavior Therapy - week 3 3.37  (0.25)
Standard Behavior Therapy - week 4 3.47  (0.24)
Modified Behavior Therapy - week 1 3.35  (0.26)
Modified Behavior Therapy - week 2 3.31  (0.26)
Modified Behavior Therapy - week 3 3.12  (0.26)
Modified Behavior Therapy - week 4 3.31  (0.24)
19.Secondary Outcome
Title WPRF Overall Problems - Counselor
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard Behavior Therapy - week 1 3.42  (0.18)
Standard Behavior Therapy - week 2 3.66  (0.19)
Standard Behavior Therapy - week 3 3.49  (0.19)
Standard Behavior Therapy - week 4 3.46  (0.18)
Modified Behavior Therapy - week 1 3.36  (0.18)
Modified Behavior Therapy - week 2 3.38  (0.19)
Modified Behavior Therapy - week 3 3.63  (0.19)
Modified Behavior Therapy - week 4 3.72  (0.18)
20.Secondary Outcome
Title WPRF Overall Problems - Parent
Hide Description 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.
Time Frame Weekly
Hide Outcome Measure Data
Hide Analysis Population Description
Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 45
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard Behavior Therapy - week 1 3.68  (0.27)
Standard Behavior Therapy - week 2 3.98  (0.26)
Standard Behavior Therapy - week 3 3.57  (0.24)
Standard Behavior Therapy - week 4 3.42  (0.25)
Modified Behavior Therapy - week 1 3.65  (0.29)
Modified Behavior Therapy - week 2 3.62  (0.26)
Modified Behavior Therapy - week 3 3.43  (0.25)
Modified Behavior Therapy - week 4 3.44  (0.25)
21.Secondary Outcome
Title How Much Did Your Child Benefit From Treatment?
Hide Description 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").
Time Frame End of each treatment, at weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard behavior therapy 2.31  (0.15)
Modified behavior therapy 2.45  (0.15)
22.Secondary Outcome
Title How Much Did You (the Parent) Benefit From Treatment?
Hide Description 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").
Time Frame End of each treatment, at weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard behavior therapy 2.36  (0.13)
Modified behavior therapy 2.40  (0.13)
23.Secondary Outcome
Title How Much Did Your Child Enjoy the Treatment?
Hide Description 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").
Time Frame End of each treatment, at weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard behavior therapy 1.89  (0.15)
Modified behavior therapy 2.12  (0.15)
24.Secondary Outcome
Title Would You Send Your Child to This Treatment Again?
Hide Description 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").
Time Frame End of each treatment, at weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard behavior therapy 3.83  (0.06)
Modified behavior therapy 3.83  (0.06)
25.Secondary Outcome
Title Recommend Treatment?
Hide Description 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").
Time Frame End of each treatment, at weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard behavior therapy 3.90  (0.04)
Modified behavior therapy 3.97  (0.04)
26.Secondary Outcome
Title Overall Satisfaction
Hide Description 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").
Time Frame End of each treatment, at weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard behavior therapy 3.75  (0.07)
Modified behavior therapy 3.83  (0.07)
27.Secondary Outcome
Title Overall Effectiveness
Hide Description 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").
Time Frame End of each treatment, at weeks 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
Overall Number of Participants Analyzed 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Standard behavior therapy 3.66  (0.10)
Modified behavior therapy 3.60  (0.10)
28.Secondary Outcome
Title Overall Treatment Recommendation - Counselor
Hide Description 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
Time Frame End of all treatment, at week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One excluded because only completed one block of treatment.
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
Responded equally to both treatments 34
Responded best to standard treatment 27
Responded best to modified treatment 23
Did not respond to either treatment 16
29.Secondary Outcome
Title Overall Treatment Recommendation - Parent
Hide Description 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
Time Frame End of all treatment, at week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One excluded because only completed one block of treatment.
Arm/Group Title Overall Sample
Hide Arm/Group Description:
Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons.
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
Responded best to standard treatment 41
Responded best to modified treatment 59
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and other (Not including Serious) Adverse Events were not collected / assessed.
 
Arm/Group Title Modified Behavior Treatment Then Standard Behavior Treatment Standard Behavior Treatment Then Modified Behavior Treatment
Hide Arm/Group Description Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
All-Cause Mortality
Modified Behavior Treatment Then Standard Behavior Treatment Standard Behavior Treatment Then Modified Behavior Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Modified Behavior Treatment Then Standard Behavior Treatment Standard Behavior Treatment Then Modified Behavior Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Modified Behavior Treatment Then Standard Behavior Treatment Standard Behavior Treatment Then Modified Behavior Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dan Waschbusch
Organization: Penn State Hershey Medical Center
Phone: 7175318514
EMail: dwaschbusch@hmc.psu.edu
Layout table for additonal information
Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT01362946    
Other Study ID Numbers: 1R34MH085796-01A2 ( U.S. NIH Grant/Contract )
1R34MH085796-01A2 ( U.S. NIH Grant/Contract )
First Submitted: January 7, 2011
First Posted: June 1, 2011
Results First Submitted: March 3, 2015
Results First Posted: January 15, 2016
Last Update Posted: January 15, 2016