Headstrong Intervention for Pediatric Headache

Chronic Headaches Clinical Trial

Official title:

Headstrong Intervention for Recurrent Pediatric Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269581
• Other study ID #: 9578
• Secondary ID: NS46641
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: September 24, 2012
• Start date: August 2004
• Est. completion date: May 2010

Study information

• Verified date: September 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Headaches
• Headache

Intervention

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

Locations

Country	Name	City	State
United States	Children's Mercy Hospital Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Michael Rapoff, Ph.D.	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain, mood, and stress self-rating scales		Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up	No
Secondary	Quality of life		Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up	No
Secondary	Headache-related disability		Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up	No