RecruitingPhase 2NCT04567355

Migraine Manager (R01)

Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

160 participants

Start Date

Jun 10, 2021

Study Type

INTERVENTIONAL

Conditions

Migraine Migraine Disorders

Summary

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.

Eligibility

Min Age: 11 YearsMax Age: 17 Years

Inclusion Criteria4

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 Criteria2

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

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Interventions

BEHAVIORALMigraine Manager

Answers provided during the online assessment will result in certain intervention recommendations. Once assessments are completed, a treatment plan will be automatically generated for patient and parent guidance.