NCT00269581

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

5.7 years

First QC Date

December 22, 2005

Last Update Submit

September 24, 2012

Conditions

Chronic Headaches

Keywords

migrainetension headacheschronic daily headaches

Outcome Measures

Primary Outcomes (1)

  • Pain, mood, and stress self-rating scales

    Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up

Secondary Outcomes (2)

  • Quality of life

    Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up

  • Headache-related disability

    Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up

Study Arms (2)

1

OTHER

Educational CD-Rom

Other: Educational CD-rom

2

EXPERIMENTAL

Headstrong CD-rom

Other: Headstrong CD-rom

Interventions

Educational CD-romOTHER

Educational CD-Rom

1
Headstrong CD-romOTHER

Headstrong CD-rom

2

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Children's Mercy Hospital Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Headache DisordersMigraine DisordersTension-Type Headache

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, Primary

Study Officials

  • Michael Rapoff, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 23, 2005

Study Start

August 1, 2004

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

US(2)