Headstrong Intervention for Pediatric Headache

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Rapoff, Ph.D., University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00269581
First received: December 22, 2005
Last updated: September 24, 2012
Last verified: September 2012

December 22, 2005
September 24, 2012
August 2004
April 2010   (final data collection date for primary outcome measure)
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 ]
Pain, mood, and stress self-rating scales
Complete list of historical versions of study NCT00269581 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up ] [ Designated as safety issue: No ]
  • Headache-related disability [ Time Frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up ] [ Designated as safety issue: No ]
  • Quality of life
  • Headache-related disability
Not Provided
Not Provided
 
Headstrong Intervention for Pediatric Headache
Headstrong Intervention for Recurrent 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Headaches
  • Other: Educational CD-rom
    Educational CD-Rom
  • Other: Headstrong CD-rom
    Headstrong CD-rom
  • 1
    Educational CD-Rom
    Intervention: Other: Educational CD-rom
  • Experimental: 2
    Headstrong CD-rom
    Intervention: Other: Headstrong CD-rom
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
May 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
7 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00269581
9578, NS46641
Yes
Michael Rapoff, Ph.D., University of Kansas Medical Center Research Institute
Michael Rapoff, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Michael Rapoff, PhD University of Kansas
University of Kansas
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP