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Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder

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: NCT00381407
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : April 19, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Howard Abikoff, NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Behavioral: Organizational Skills Training Behavioral: Contingency management (CM) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Organizational Skills Treatment for ADHD Children
Study Start Date : September 2006
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Participants will receive organizational skills training program
 Behavioral: Organizational Skills Training
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
 Behavioral: Contingency management (CM)
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Homework Problems Checklist [ Time Frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year ]
  2. Family Environment Scale [ Time Frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381407


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
NYU Langone Health
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Howard B. Abikoff, PhD New York University Child Study Center
Principal Investigator: Karen Wells, PhD Duke University
More Information
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Additional Information:

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Responsible Party: Howard Abikoff, Director, Institute for Attention Deficit Hyperactivity and Behavior Disorders, NYU Langone Health
ClinicalTrials.gov Identifier: NCT00381407    
Other Study ID Numbers: R01MH074013 ( U.S. NIH Grant/Contract )
R01MH074013 ( U.S. NIH Grant/Contract )
DDTR B2-NDH
First Posted: September 27, 2006    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013
Keywords provided by Howard Abikoff, NYU Langone Health:
ADHD
Organizational Skills
Contingency Management
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
 Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases