Migraine Manager (R01)

Description

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.

Conditions

Migraine, Migraine Disorders

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Study Overview

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Study Details

Study overview

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.

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

Migraine Manager (R01)

Condition
Migraine
Intervention / Treatment

-

Contacts and Locations

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

11 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Medical Center, Cincinnati,

Kevin Hommel, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Scott Powers, PhD, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati

Andrew Hershey, MD, PhD, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati

Susan LeCates, MSN, FNP, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati

Marielle Kabbouche-Samaha, MD, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati

James Peugh, PhD, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati

Lee Ritterband, MD, STUDY_CHAIR, University of Virginia

Study Record Dates

2025-05-31