Migraine Manager (R01)

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.

Conditions

• Migraine
• Migraine Disorders

Interventions

BEHAVIORAL

Migraine 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati

  lead OTHER

Principal Investigators

• Kevin Hommel, PhD · Children's Hospital Medical Center, Cincinnati

• Scott Powers, PhD · Children's Hospital Medical Center, Cincinnati

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

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

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

• James Peugh, PhD · Children's Hospital Medical Center, Cincinnati

• Lee Ritterband, MD · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-10

Primary Completion

2026-05-31

Completion

2026-06-30

Countries

• United States

Study Locations