Mind Body Balance for Pediatric Migraine
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Migraine
- Headache
- Headache Disorders
- Headache, Migraine
- Migraine
- Migraine Disorders
- Migraine With Aura
- Migraine Without Aura
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Only than study staff whose role requires unblinding (project manager and the nurse or interventionist providing the treatment) will be made aware of each participant's study assignment by the statistician. Other study personnel (including assessors of key variables) will remain blinded to treatment assignment.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 10 years and 17 years
- Gender
- Both males and females
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 bo...
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.
Tracking Information
- NCT #
- NCT04715685
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Principal Investigator: Scott Powers, PhD Children's Hospital Medical Center, Cincinnati
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