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Headstrong Intervention for Pediatric Headache

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ClinicalTrials.gov Identifier: NCT00269581
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : September 25, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Chronic Headaches Other: Educational CD-rom Other: Headstrong CD-rom Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Headstrong Intervention for Recurrent Pediatric Headache
Study Start Date : August 2004
Primary Completion Date : April 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Educational CD-Rom
Other: Educational CD-rom
Educational CD-Rom
Experimental: 2
Headstrong CD-rom
Other: Headstrong CD-rom
Headstrong CD-rom

Outcome Measures

Primary Outcome Measures :
  1. Pain, mood, and stress self-rating scales [ Time Frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up ]
  2. Headache-related disability [ Time Frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • 7-12 years of age
  • having recurrent, intermittent, nonmalignant headaches occurring on an average of at least once per week by parental or child report and separated by symptom-free periods
  • having a diagnosis by a nurse practitioner, pediatrician, or pediatric neurologist of migraine, muscle-contraction, or chronic daily headaches

Exclusion criteria:

  • their medical history and/or neurological exam suggests that headaches are secondary to another physical or developmental condition
  • their parents report they have been diagnosed with a mental health condition or they are receiving concurrent psychotherapy
  • their baseline headache diaries indicate an average headache frequency of less than one per week
Contacts and Locations

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): NCT00269581

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
Sponsors and Collaborators
Michael Rapoff, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Michael Rapoff, PhD University of Kansas Medical Center
More Information

Responsible Party: Michael Rapoff, Ph.D., Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00269581     History of Changes
Other Study ID Numbers: 9578
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012

Keywords provided by Michael Rapoff, Ph.D., University of Kansas Medical Center Research Institute:
tension headaches
chronic daily headaches

Additional relevant MeSH terms:
Headache Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases