Mind Body Balance for Pediatric Migraine

This study is testing different ways to teach mind and body skills to young people (ages 10-17) who experience migraine headaches. It's looking at how different session lengths (20 or 40 minutes), types of home practice (online program or app handout), and a follow-up phone call affect headache days. The goal is to find the best combination of these approaches to help reduce how often migraines occur. You might be able to join if you are 10-17 years old, have a diagnosis of migraine, and experience headaches at least 4 days a month but no more than 28 days a month. Success in this study will be measured by a change in the number of headache days you experience over 8 weeks. The current status of this study is unclear.

Study design: This is an interventional study with a planned enrollment of 260 participants. It uses a factorial design to compare different combinations of behavioral interventions.
What's involved: Participants will attend a 20 or 40-minute session to learn mind and body skills. They will also engage in home practice using either an online program or apps, and may receive a 5-10 minute phone call about 4 weeks after their session.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome, change in headache days, is measured from baseline to 8 weeks post-randomization.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Mind Body Balance for Pediatric Migraine

Recruiting

NAAges 10–17InterventionalTreatment

Children's Hospital Medical Center, Cincinnati

~260 participants

Updated 2026-06-16 on ClinicalTrials.gov

What's tested:40 minute session20 minute sessionhome practice e-healthhome practice handoutphone call

At a glance

Recruiting sites

1 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in number of headache days

Measured over baseline to post treatment (8 weeks post randomization)

Conditions

Headache

Headache Disorders

Headache, Migraine

Migraine

Migraine Disorders

Migraine With Aura

Migraine Without Aura

Chronic Migraine

Where it's being run

2 sites across 2 states

Colorado1

Ohio1

Study leadership

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

Who to contact

LeighAnn Chamberlin, MEd

[email protected]

513-636-9739

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders(ICHD) criteria

Frequency: Headache frequency based upon prospective headache diary of 28 days must be ≥ 4 and ≤ 28.

PedMIDAS: PedMIDAS Disability Score \> 4, indicating at least mild disruption in daily activities and \< 140, indicating extreme disability that may require more comprehensive, multi-component therapy

Use of one or more of the following prescribed nutraceuticals and/or preventive anti-migraine medications at the time or randomization or be on a stable dose of one or more of the following throughout the 12 weeks of the study \[Vitamin B2 (Riboflavin), Co-Q 10 (Coenzyme Q10), Magnesium (Mg), Vitamin D2 or D3 (Erocalciferol/Cholecalciferol), Depakote (Divalproate), Inderal (Propanerol), Elavil ((Amitripyline), Topamax (Topiramate), Periactin (Cyproheptadine)\]

Language: English speaking, able to complete interviews and questionnaires in English

Exclusion

Continuous migraine defined as unrelenting headache for a 28 day period

Must agree not to take non-specific acute medication, such as NSAIDS (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications, such as triptans, more than 6 times per month (to prevent medication overuse headache)

PedMIDAS Disability Score \> 140, indicating extreme disability that may require more comprehensive, multi-component therapy

Youth who are pregnant, or those who are sexually active and not using a medically accepted form of contraception (barrier or hormonal methods)

Present severe psychiatric disease, alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) or other circumstances, that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study

What this trial measures

Change in number of headache daysbaseline to post treatment (8 weeks post randomization)
This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between the treatment groups over time. This will be assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days before the endpoint visit.

Trialytics