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Completed

NCT Number: NCT00269581

Headstrong Intervention for Pediatric Headache

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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Key information

Conditions

Chronic Headaches Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Tension-Type Headache

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational CD-rom

Other

Educational CD-Rom

Headstrong CD-rom

Other

Headstrong CD-rom

Primary outcomes

  1. Pain, mood, and stress self-rating scales

    Time frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Michael Rapoff, Ph.D.

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Headstrong Intervention for Recurrent Pediatric Headache

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Dec 23, 2005
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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