ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder

This study is currently recruiting participants.
Study NCT00381407.   Last updated on September 29, 2008.   Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Organizational Skills Training for Children With Attention Deficit Hyperactivity Disorder
Official Title  Organizational Skills Treatment for ADHD Children
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.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary Outcome Measure  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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Homework Problems Checklist [ Time Frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year ] [ Designated as safety issue: No ]
Family Environment Scale [ Time Frame: Measured immediatly post-treatment, Month 1 post-treatment, and Months 1 and 4 into the following school year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Condition  Attention Deficit Disorder With Hyperactivity
Intervention  Behavioral: Organizational Skills Training
Behavioral: Contingency management (CM)
MEDLINE PMIDs
Links Click here for the NYU Child Study Center website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  180
Start Date  September 2006
Completion Date April 2011
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
Gender Both
Ages 8 Years to 11 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Robyn Stotter, BA     212-263-2734     robyn.stotter@med.nyu.edu    
Contact: Elizabeth Steinberg, BA     212-263-2738     elizabeth.steinberg@med.nyu.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00381407
Organization ID R01 MH74013
Secondary IDs †† DDTR B2-NDH
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Howard B. Abikoff, PhD     New York University Child Study Center    
Principal Investigator:     Karen Wells, PhD     Duke University    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date September 2008
First Received Date  September 25, 2006
Last Updated Date September 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers