Chronic HeadachesPhase 3NCT00269581
Headstrong Intervention for Pediatric Headache
A Phase 3 study testing Educational CD-rom and Headstrong CD-rom in people with Chronic Headaches, run by Michael Rapoff, Ph.D. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Chronic Headaches
- What is being tested?
- Educational CD-rom and Headstrong CD-rom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to May 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
Children's Mercy Hospital Kansas City
Kansas City, Missouri, 64108
About this study
Official title: Headstrong Intervention for Recurrent Pediatric Headache
Purpose of this study is to determine if a CD-ROM computer program (called "Headstrong") is effective in helping children cope with chronic headaches.
Read the 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.
- Conditions
- Chronic Headaches
- Being tested
- Educational CD-rom, Headstrong CD-rom
- Keywords
- migraine, tension headaches, chronic daily headaches
- Medical subject headings
- Headache Disorders, Migraine Disorders, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational CD-romOther
Educational CD-Rom
Headstrong CD-romOther
Headstrong CD-rom
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Educational CD-Rom Receives: Other: Educational CD-rom |
| 2 | Experimental | Headstrong CD-rom Receives: Other: Headstrong CD-rom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, mood, and stress self-rating scales
Measured: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
Secondary outcomes (2)
Quality of life
Measured: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
Headache-related disability
Measured: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startAug 2004
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HeadachesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Rapoff, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Michael Rapoff, Ph.D., University of Kansas Medical Center
- Investigators
- Michael Rapoff, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269581
- Sponsor's protocol ID
- 9578
- Other IDs
- NS46641
- Status last verified
- Sep 2012
- First submitted
- 22 Dec 2005
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Headstrong Intervention for Recurrent Pediatric Headache
- ClinicalTrials.gov ID
- NCT00269581
- Acronym / sponsor ID
- 9578
- Conditions
- Chronic Headaches
- Keywords
- migraine, tension headaches, chronic daily headaches
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Michael Rapoff, Ph.D.University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Aug 2004
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 23 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Educational CD-romEducational CD-Rom |
| 2 | Experimental | Other: Headstrong CD-romHeadstrong CD-rom |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational CD-romEducational CD-Rom | Other | 1 |
| Headstrong CD-romHeadstrong CD-rom | Other | 2 |
Primary outcome
Pain, mood, and stress self-rating scales
Time frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Rapoff, PhD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Educational CD-rom and Headstrong CD-rom in people with Chronic Headaches, run by Michael Rapoff, Ph.D. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, mood, and stress self-rating scales (time frame: Baseline, Immediate Post-Treatment and 3, 6 and 12 Month Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.