Headstrong Intervention for Pediatric Headache

This study is ongoing, but not recruiting participants.

First Received: December 22, 2005 Last Updated: September 15, 2008 History of Changes

Sponsors and Collaborators:	University of Kansas National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00269581

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 III

MedlinePlus related topics: Headache

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Headstrong Intervention for Recurrent Pediatric Headache

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 ]

Estimated Enrollment:	92
Study Start Date:	December 2004
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Educational CD-Rom	Other: Educational CD-rom Educational CD-Rom
2: Experimental 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

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

University of Kansas

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:

Michael Rapoff, PhD

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center ( Michael Rapoff )
Study ID Numbers:	NS46641
Study First Received:	December 22, 2005
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00269581 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

migraine
tension headaches
chronic daily headaches

Study placed in the following topic categories:

Signs and Symptoms
Migraine Disorders
Tension-Type Headache
Headache
Central Nervous System Diseases

Neurologic Manifestations
Pain
Brain Diseases
Recurrence
Headache Disorders

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Headache
Central Nervous System Diseases

Neurologic Manifestations
Pain
Brain Diseases
Headache Disorders

ClinicalTrials.gov processed this record on May 06, 2009