Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Organizational Skills Training
Contingency management (CM)
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Organizational Skills, Contingency Management
Eligibility Criteria
Inclusion Criteria:
- Between grades 3 and 5 in school
- Meets criteria for ADHD, any subtype (a formal diagnosis prior to study entry is not necessary)
- Meets minimum score requirements on either Conners Parent or Conners Teacher Rating Scales
- Meets minimum criteria for organizational, time management, and planning deficits, as reported by parent or teacher
- Estimated IQ is greater than 85, as determined by the Wechsler Abbreviated Scale of Intelligence
- Has a teacher that is willing to participate
- Parents' schedule will allow attendance at study visits
Exclusion Criteria:
- Attends an all-day special education classroom or works with a para-professional in school
- Diagnosis of pervasive developmental disorder (PDD), psychosis, bipolar disorder, or post-traumatic stress disorder (PTSD)
- Current history of significant suicidality or sexual or physical abuse
- Any other comorbid psychiatric diagnosis or medical condition with significant symptoms that may interfere with study participation (e.g., severe depression, obsessive-compulsive disorder [OCD], or cystic fibrosis)
- Child's teacher has previously participated in this study
Sites / Locations
- New York University School of Medicine
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
1
2
3
Arm Description
Participants will receive organizational skills training program
Participants will receive contingency management program
Participants will receive wait list condition
Outcomes
Primary Outcome Measures
Children's Organizational Skills Scale (COSS)
Academic Performance Rating Scale (APRS)
Secondary Outcome Measures
Homework Problems Checklist
Family Environment Scale
Behavior Assessment System for Children
Full Information
NCT ID
NCT00381407
First Posted
September 25, 2006
Last Updated
April 17, 2013
Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00381407
Brief Title
Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder
Official Title
Organizational Skills Treatment for ADHD Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effectiveness of organizational skills training in improving organizational, time management, and planning difficulties in children with attention deficit hyperactivity disorder.
Detailed Description
Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders among children. Children with ADHD frequently lack organizational, time management, and planning skills. These deficits can cause impaired functioning in multiple settings, including home, school, and peer relationships. Advancements in treatment options for these deficits, however, have been minimal. Previous research has indicated that organizational skills training (OST) is an effective intervention for improving organizational skills in children with ADHD. Its effectiveness relative to other available treatments is unknown. This study will compare the effectiveness of OST with that of contingency management (CM) and a waitlist condition in improving organizational, time management, and planning skills deficits in children with ADHD.
Participants in this study are randomly assigned to OST, CM, or Wait-List (WL). Participants in the OST and CM groups attend 20 1-hour sessions over 10 weeks. OST trains children to use a variety of techniques for improving their organizational skills. Both children and their parents attend every OST session. CM does not involve skills training. Rather, CM trains parents and teachers to identify desired "end" behaviors and to increase the frequency of these behaviors through the use of a structured reward system. Both children and their parents attend every CM session, but the children's participation will be minimal. Participants assigned to the waitlist condition will have the opportunity to receive their choice of either OST or CM once they have completed the study. All participants attend follow-up visits 1 month post-treatment. Participants assigned to OST and CM attend follow-up visits after 1 and 4 months into their next school grade. School performance, feelings about school, ADHD symptoms, organizational skills, family environment, medication or services received, and use of treatment strategies will be assessed at each follow-up visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, Organizational Skills, Contingency Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive organizational skills training program
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive contingency management program
Arm Title
3
Arm Type
No Intervention
Arm Description
Participants will receive wait list condition
Intervention Type
Behavioral
Intervention Name(s)
Organizational Skills Training
Intervention Description
Participants in the OST group attend twenty 1-hour sessions over 10 weeks. OST trains children to use a variety of techniques for improving their organizational skills. Both children and their parents attend every OST session.
Intervention Type
Behavioral
Intervention Name(s)
Contingency management (CM)
Intervention Description
Participants in the CM group will attend twenty 1-hour sessions over 10 weeks. CM trains parents and teachers to identify desired "end" behaviors and to increase the frequency of these behaviors through the use of a structured reward system. Both children and their parents attend every CM session, but the children's participation will be minimal.
Primary Outcome Measure Information:
Title
Children's Organizational Skills Scale (COSS)
Time Frame
Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
Title
Academic Performance Rating Scale (APRS)
Time Frame
Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
Secondary Outcome Measure Information:
Title
Homework Problems Checklist
Time Frame
Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
Title
Family Environment Scale
Time Frame
Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
Title
Behavior Assessment System for Children
Time Frame
Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between grades 3 and 5 in school
Meets criteria for ADHD, any subtype (a formal diagnosis prior to study entry is not necessary)
Meets minimum score requirements on either Conners Parent or Conners Teacher Rating Scales
Meets minimum criteria for organizational, time management, and planning deficits, as reported by parent or teacher
Estimated IQ is greater than 85, as determined by the Wechsler Abbreviated Scale of Intelligence
Has a teacher that is willing to participate
Parents' schedule will allow attendance at study visits
Exclusion Criteria:
Attends an all-day special education classroom or works with a para-professional in school
Diagnosis of pervasive developmental disorder (PDD), psychosis, bipolar disorder, or post-traumatic stress disorder (PTSD)
Current history of significant suicidality or sexual or physical abuse
Any other comorbid psychiatric diagnosis or medical condition with significant symptoms that may interfere with study participation (e.g., severe depression, obsessive-compulsive disorder [OCD], or cystic fibrosis)
Child's teacher has previously participated in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard B. Abikoff, PhD
Organizational Affiliation
New York University Child Study Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Wells, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.aboutourkids.org
Description
Click here for the NYU Child Study Center website
Learn more about this trial
Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder
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