Headstrong Intervention for Pediatric Headache

This study has been completed.

Sponsor:

Collaborator:

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by (Responsible Party):

Michael Rapoff, Ph.D., University of Kansas Medical Center Research Institute

ClinicalTrials.gov Identifier:

NCT00269581

First received: December 22, 2005

Last updated: September 24, 2012

Last verified: September 2012

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized 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 Michael Rapoff, Ph.D., University of Kansas Medical Center Research Institute:

Primary Outcome Measures:

Pain, mood, and stress self-rating scales [ Time Frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up ]

Secondary Outcome Measures:

Quality of life [ Time Frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up ]
Headache-related disability [ Time Frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up ]


Enrollment:	35
Study Start Date:	August 2004
Study Completion Date:	May 2010
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 (Child)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Michael Rapoff, Ph.D.

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators


Principal Investigator:	Michael Rapoff, PhD	University of Kansas Medical Center

More Information


Responsible Party:	Michael Rapoff, Ph.D., Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:	NCT00269581 History of Changes
Other Study ID Numbers:	9578 NS46641
Study First Received:	December 22, 2005
Last Updated:	September 24, 2012

Keywords provided by Michael Rapoff, Ph.D., University of Kansas Medical Center Research Institute:


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 July 18, 2017

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