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Sponsors and Collaborators: |
University of Kansas National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT00269581 |
Purpose of this study is to determine if a CD-ROM computer program (called "Headstrong") is effective in helping children cope with chronic headaches.
Condition | Intervention | Phase |
---|---|---|
Chronic Headaches |
Other: Educational CD-rom Other: Headstrong CD-rom |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Headstrong Intervention for Recurrent Pediatric Headache |
Estimated Enrollment: | 92 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Educational CD-Rom
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Other: Educational CD-rom
Educational CD-Rom
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2: Experimental
Headstrong CD-rom
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Other: Headstrong CD-rom
Headstrong CD-rom
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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.
Ages Eligible for Study: | 7 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, Missouri | |
Children's Mercy Hospital Kansas City | |
Kansas City, Missouri, United States, 64108 |
Principal Investigator: | Michael Rapoff, PhD | University of Kansas |
Responsible Party: | University of Kansas Medical Center ( Michael Rapoff ) |
Study ID Numbers: | NS46641 |
Study First Received: | December 22, 2005 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00269581 History of Changes |
Health Authority: | United States: Institutional Review Board |
migraine tension headaches chronic daily headaches |
Signs and Symptoms Migraine Disorders Tension-Type Headache Headache Central Nervous System Diseases |
Neurologic Manifestations Pain Brain Diseases Recurrence Headache Disorders |
Signs and Symptoms Nervous System Diseases Headache Central Nervous System Diseases |
Neurologic Manifestations Pain Brain Diseases Headache Disorders |