Migraine Manager (R01) (NCT04567355)
Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)
🩺 Plain-English Summary (8th-Grade Level)
The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to an attention control intervention in adolescents with migraines. We will conduct a randomized clinical trial to compare a sample of 80 youth (ages 11 to 17) with migraine receiving the online tailored adherence intervention to 80 youth in an attention control group. We will test whether adherence to healthy habit (hydration, regular meals, exercise, sleep) recommendations serves as a mechanism for improved headache outcomes. Clinically meaningful outcomes will be assessed by reliable, valid, and sensitive measures. The primary outcome (i.e., number of headache days) will be assessed via online daily diary pre- and post-intervention, with additional follow-up at 3, 6, 9, and 12 months. Secondary outcomes include health-related quality of life and migraine disability.
Who can join: Review the eligibility criteria below.
Location: Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
Age range: 11 Years to 17 Years
🧪 Interventions in This Study
- Migraine Manager (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Migraine
- A Study of Wearable Devices to Predict Migraines — Rochester, Minnesota
- Treatment for Migraine and Mood — The Bronx, New York
- Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine — Birmingham, Alabama
- A Study to Evaluate White Matter Hyperintensities in Migraine — Phoenix, Arizona
- Nerivio Efficacy Under High-Frequency Use — Bridgewater, New Jersey
Explore by condition: All Migraine clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.