Headstrong Intervention for Pediatric Headache

Phase 3

Completed

• Conditions: Chronic Headaches
• Interventions: Other: Educational CD-rom; Other: Headstrong CD-rom

• Registration Number: NCT00269581
• Lead Sponsor: Michael Rapoff, Ph.D.

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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-12-22
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-23
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-24
• Last Update Posted: 2012-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Educational CD-rom	Educational CD-Rom
2	Headstrong CD-rom	Headstrong CD-rom

Primary Outcome Measures

Name	Time	Method
Pain, mood, and stress self-rating scales	Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up

Secondary Outcome Measures

Name	Time	Method
Headache-related disability	Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
Quality of life	Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up

Trial Locations

Locations (2)

Children's Mercy Hospital Kansas City; 🇺🇸 Kansas City, Missouri, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States