Back to resultsHeadstrong Intervention for Pediatric Headache
Primary Purpose
Chronic Headaches
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Educational CD-rom
Headstrong CD-rom
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Headaches focused on measuring migraine, tension headaches, chronic daily headaches
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
- Children's Mercy Hospital Kansas City
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
1
2
Arm Description
Educational CD-Rom
Headstrong CD-rom
Outcomes
Primary Outcome Measures
Pain, mood, and stress self-rating scales
Secondary Outcome Measures
Quality of life
Headache-related disability
Full Information
NCT ID
NCT00269581
First Posted
December 22, 2005
Last Updated
September 24, 2012
Sponsor
Michael Rapoff, Ph.D.
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00269581
Brief Title
Headstrong Intervention for Pediatric Headache
Official Title
Headstrong Intervention for Recurrent Pediatric Headache
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Rapoff, Ph.D.
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Headaches
Keywords
migraine, tension headaches, chronic daily headaches
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Educational CD-Rom
Arm Title
2
Arm Type
Experimental
Arm Description
Headstrong CD-rom
Intervention Type
Other
Intervention Name(s)
Educational CD-rom
Intervention Description
Educational CD-Rom
Intervention Type
Other
Intervention Name(s)
Headstrong CD-rom
Intervention Description
Headstrong CD-rom
Primary Outcome Measure Information:
Title
Pain, mood, and stress self-rating scales
Time Frame
Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
Title
Headache-related disability
Time Frame
Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rapoff, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Children's Mercy Hospital Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Headstrong Intervention for Pediatric Headache
We'll reach out to this number within 24 hrs