- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00381407
Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder
Organizational Skills Treatment for ADHD Children
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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North Carolina
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Durham, North Carolina, United States, 27708
- Duke University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Participants will receive organizational skills training program
|
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.
|
|
Experimental: 2
Participants will receive contingency management program
|
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.
|
|
No Intervention: 3
Participants will receive wait list condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
|
|
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
|
Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Homework Problems Checklist
Time Frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
|
Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
|
|
Family Environment Scale
Time Frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
|
Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
|
|
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
|
Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Howard B. Abikoff, PhD, New York University Child Study Center
- Principal Investigator: Karen Wells, PhD, Duke University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH074013 (U.S. NIH Grant/Contract)
- DDTR B2-NDH
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