Online intervention for managing migraines in adolescents
Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)
PHASE2 · Children's Hospital Medical Center, Cincinnati · NCT04567355
This study is testing an online program called Migraine Manager to see if it can help teenagers aged 11 to 17 with migraines have fewer headache days and improve their overall well-being.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 11 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT04567355 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of an online tailored intervention called Migraine Manager in improving headache outcomes for adolescents aged 11 to 17 who experience migraines. Participants will be randomly assigned to either the Migraine Manager intervention or an attention control group. The study will assess the primary outcome of headache days through online daily diaries before and after the intervention, with follow-up assessments at 3, 6, 9, and 12 months. Secondary outcomes will include health-related quality of life and migraine disability, focusing on adherence to healthy habits such as hydration, regular meals, exercise, and sleep.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11 to 17 with a confirmed diagnosis of migraine experiencing 8 or more headache days per month.
Not a fit: Patients with pervasive developmental disorders or serious mental illnesses may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the frequency of migraine attacks in adolescents and improve their overall quality of life.
How similar studies have performed: Other studies have shown promise in using online interventions for chronic conditions, suggesting potential success for this approach in managing migraines.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of migraine using current International Classification of Headache Disorders Criteria (ICHD-3) for migraine with or without aura * Frequency of 8 or more headaches per month * Access to the internet whether public (e.g., library) or private (e.g., home, personal) * English fluency for patient and caregiver Exclusion Criteria: * Patients with a diagnosis of pervasive developmental disorder as determined by medical chart review * Patients with a diagnosis of or serious mental illness (e.g., psychotic disorder) as determined by medical chart review
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Kevin Hommel, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Kevin Hommel, PhD
- Email: kevin.hommel@cchmc.org
- Phone: 513-803-0407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Migraine, Migraine Disorders