Actively Recruiting
Mind Body Balance for Pediatric Migraine
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-18
260
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Migraine headaches affect over 6 million children and adolescents in the United States, making it one of the most common childhood disorders. This trial is investigating a nurse-delivered mind and body intervention to help reduce headache days in youth ages 10 to 17 who experience migraines. The study uses a factorial design to evaluate different doses of three treatment components to find the best approach for reducing headache frequency. Participants receive one of several intervention combinations involving a mind and body skills introduction session lasting either 20 or 40 minutes, supported by daily home practice through either a migraine-specific interactive web portal or a handout, and some receive a follow-up phone call about four weeks after the session to encourage adherence. The study tests how varying the session length, home practice support, and phone call follow-up influences headache management. Throughout the study, participants will be assessed for changes in the number of headache days from baseline to eight weeks after randomization, as well as changes in headache-related disability using the PedMIDAS score. Nurses will monitor adherence and skill use, and participants will complete interviews and questionnaires in English. The trial aims to optimize this intervention package to improve accessibility and effectiveness for youth with migraine headaches.
CONDITIONS
Brief Title
Mind Body Balance for Pediatric Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of migraine with or without aura or chronic migraine meeting International Classification of Headache Disorders criteria
- Headache frequency between 4 and 28 days in 28 days based on diary
- PedMIDAS Disability Score greater than 4 and less than 140
- Use or stable dose of specified nutraceuticals or preventive migraine medications during the study
- English speaking and able to complete interviews and questionnaires in English
You will not qualify if you...
- Continuous migraine with unrelenting headache for 28 days
- Use of non-specific acute medication more than 3 times per week or migraine-specific acute medication more than 6 times per month
- PedMIDAS Disability Score greater than 140
- Pregnant youth or sexually active without medically accepted contraception
- Severe psychiatric disease, alcohol or drug dependence, developmental delays, or other conditions interfering with safe participation or adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks post randomization
Participants receive a mind and body skill introduction session lasting either 20 or 40 minutes. They will then engage in daily home practice using either a migraine-specific interactive web portal or a handout with explanations and a home practice plan. Approximately 4 weeks after the introductory session, some participants will receive a follow-up phone call lasting 5 to 10 minutes to promote adherence to home practice and answer questions.
1 introductory session visit and 1 follow-up phone call (for some participants)
Trial Site Locations
Total: 2 locations
1
University of Colorado/Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Active, Not Recruiting
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
L
LeighAnn Chamberlin, MEd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
8
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