Headstrong Intervention for Pediatric Headache - Full Text View

Sponsor:	University of Kansas
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Headstrong Intervention for Recurrent Pediatric Headache

Resource links provided by NLM:

MedlinePlus related topics: Headache

U.S. FDA Resources

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:	April 2011
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Educational CD-Rom	Other: Educational CD-rom Educational CD-Rom
Experimental: 2 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:	Michael Rapoff, University of Kansas Medical Center
ClinicalTrials.gov Identifier:	NCT00269581 History of Changes
Other Study ID Numbers:	9578, NS46641
Study First Received:	December 22, 2005
Last Updated:	April 22, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

migraine
tension headaches
chronic daily headaches

Additional relevant MeSH terms:

Headache
Headache Disorders
Pain
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012