Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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
Endpoint Classification: Efficacy Study
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:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
1
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.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269581

Locations
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.
Investigators
Principal Investigator: Michael Rapoff, PhD University of Kansas
  More Information

No publications provided

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, NS46641
Study First Received: December 22, 2005
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
migraine
tension headaches
chronic daily headaches

Additional relevant MeSH terms:
Headache
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014