Headstrong Intervention for Pediatric Headache - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 22, 2005

Last Updated Date

September 15, 2008

Start Date ^†

December 2004

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00269581 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Quality of life
Headache-related disability

Descriptive Information

Brief Title ^†

Headstrong Intervention for Pediatric Headache

Official Title ^†

Headstrong Intervention for Recurrent Pediatric Headache

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Chronic Headaches

Intervention ^†

Other: Educational CD-rom
Other: Headstrong CD-rom

Study Arms / Comparison Groups

Other: Educational CD-Rom
Experimental: Headstrong CD-rom

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

November 2008

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

7 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00269581

Responsible Party

Michael Rapoff, University of Kansas Medical Center

Secondary IDs ^††

Study Sponsor ^†

University of Kansas

Collaborators ^††

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^†

Principal Investigator:

Michael Rapoff, PhD

University of Kansas

Information Provided By

University of Kansas

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.