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Tracking Information | |||||
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First Received Date † | December 22, 2005 | ||||
Last Updated Date | September 15, 2008 | ||||
Start Date † | December 2004 | ||||
Current Primary Outcome Measures † |
Pain, mood, and stress self-rating scales [ Time Frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00269581 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Headstrong Intervention for Pediatric Headache | ||||
Official Title † | Headstrong Intervention for Recurrent Pediatric Headache | ||||
Brief Summary | Purpose of this study is to determine if a CD-ROM computer program (called "Headstrong") is effective in helping children cope with chronic headaches. |
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Detailed Description | Children, 7-12 years, with recurrent headaches are randomly assigned to an educational CD-ROM program or the Headstrong CD-ROM program. We anticipate that those assigned to the active (Headstrong) program group will have significantly greater reductions in headache frequency, duration, and severity and improvements in mood and quality of life. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Chronic Headaches | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 92 | ||||
Estimated Completion Date | November 2008 | ||||
Estimated Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion criteria:
Exclusion criteria:
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Gender | Both | ||||
Ages | 7 Years to 12 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00269581 | ||||
Responsible Party | Michael Rapoff, University of Kansas Medical Center | ||||
Secondary IDs †† | |||||
Study Sponsor † | University of Kansas | ||||
Collaborators †† | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
Investigators † |
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Information Provided By | University of Kansas | ||||
Verification Date | September 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |