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Headstrong Intervention for Pediatric Headache

NCT ID: NCT00269581

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Chronic Headaches

Keywords

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migraine tension headaches chronic daily headaches

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Educational CD-Rom

Group Type OTHER

Educational CD-rom

Intervention Type OTHER

Educational CD-Rom

2

Headstrong CD-rom

Group Type EXPERIMENTAL

Headstrong CD-rom

Intervention Type OTHER

Headstrong CD-rom

Interventions

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Educational CD-rom

Educational CD-Rom

Intervention Type OTHER

Headstrong CD-rom

Headstrong CD-rom

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Michael Rapoff, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Michael Rapoff, Ph.D.

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael Rapoff, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Children's Mercy Hospital Kansas City

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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9578

Identifier Type: -

Identifier Source: org_study_id

NS46641

Identifier Type: -

Identifier Source: secondary_id