Mind Body Balance for Pediatric Migraine

Last updated: November 25, 2025
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting

Phase

N/A

Condition

Headaches

Migraine (Pediatric)

Chronic Pain

Treatment

home practice e-health

home practice handout

phone call

Clinical Study ID

NCT04715685
MOST Study
U01AT010132
  • Ages 10-17
  • All Genders

Study Summary

This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day reduction.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

  • PedMIDAS: PedMIDAS Disability Score > 4, indicating at least mild disruption indaily activities and < 140, indicating extreme disability that may require morecomprehensive, multi-component therapy

  • Use of one or more of the following prescribed nutraceuticals and/or preventiveanti-migraine medications at the time or randomization or be on a stable dose of oneor 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 inEnglish

Exclusion

Exclusion Criteria:

  • 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, suchas triptans, more than 6 times per month (to prevent medication overuse headache)

  • PedMIDAS Disability Score > 140, indicating extreme disability that may require morecomprehensive, multi-component therapy

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

  • Present severe psychiatric disease, alcohol or drug dependence, or documenteddevelopmental delays or impairments (e.g., autism, cerebral palsy, or mentalretardation) or other circumstances, that, in the opinion of the investigator, wouldinterfere with adherence to study requirements or safe participation in the study

Study Design

Total Participants: 260
Treatment Group(s): 5
Primary Treatment: home practice e-health
Phase:
Study Start date:
March 09, 2021
Estimated Completion Date:
May 31, 2026

Study Description

In the United States, over 6 million children and adolescents suffer from migraine headaches and it is 1 of the 5 most prevalent childhood disorders. Mind and body approaches can significantly help these youth, but getting access to this type of treatment is a challenge for families. Our mind and body study will test a mind and body intervention package delivered by health care professionals (i.e., nurses) introducing coping skills to youth ages 10 to 17 that have migraine.

Using a factorial design and the multiphase optimization strategy "MOST", in this study we are able to evaluate different doses of 3 treatment components (1. Duration of mind and body skill introduction session; 2. Home practice support intensity; and 3. Adherence prompt phone call) in one project. A screening experiment will be conducted to determine the dose of each treatment component for future evaluation of the optimized intervention package in a pragmatic or SMART trial.

Connect with a study center

  • University of Colorado/Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado/Children's Hospital Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Active - Recruiting

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