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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04715685
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact LeighAnn Chamberlin, MEd
Phone 513-636-9739
Email leighann.chamberlin@cchmc.org
Status Recruiting
Phase N/A
Start date March 9, 2021
Completion date May 31, 2025

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