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Headstrong Intervention for Pediatric Headache

This study has been completed.
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Michael Rapoff, Ph.D., University of Kansas Medical Center Research Institute Identifier:
First received: December 22, 2005
Last updated: September 24, 2012
Last verified: September 2012
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Headstrong Intervention for Recurrent Pediatric Headache

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

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

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

Enrollment: 35
Study Start Date: August 2004
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Educational CD-Rom
Other: Educational CD-rom
Educational CD-Rom
Experimental: 2
Headstrong CD-rom
Other: Headstrong CD-rom
Headstrong CD-rom

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.

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
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Please refer to this study by its identifier: 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 Identifier: NCT00269581     History of Changes
Other Study ID Numbers: 9578
Study First Received: December 22, 2005
Last Updated: September 24, 2012

Keywords provided by University of Kansas Medical Center:
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 processed this record on May 22, 2017