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Responding With Evidence and Access for Childhood Headaches
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.
Official title: Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)
Key Details
Gender
All
Age Range
10 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2023-08-22
Completion Date
2027-12-31
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
CBT
During an 8-week active treatment, participants will receive 6 telehealth CBT sessions, followed by a maintenance phase (16 weeks) when participants will receive 3 "booster" CBT sessions. The sessions will be conducted by teletherapists from the Clinical Coordinating Center at Cincinnati Children's using a standardized treatment manual. A parent/legal guardian will be included in 2 sessions teaching ways to be active coaches, encouraging use of effective coping skills and refraining from reinforcement of maladaptive coping. Each session will be about 45 minutes.
Amitriptyline
During an 8-week active treatment, participants will begin taking a daily pill (amitriptyline) prescribed and managed clinically by the site headache provider. Amitriptyline will be taken once a day before bedtime. The weight based dosage will gradually be increased based on tolerability and a standardized titration protocol during the 8 week active treatment. The participant will remain on a maximum tolerated dose for the final 16 weeks (maintenance).
Locations (15)
University of Alabama at Birmingham Children's of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital - Barrow Neurological Institute
Phoenix, Arizona, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado/Children's Hospital Colorado
Aurora, Colorado, United States
Nemours Children's Health System
Wilmington, Delaware, United States
Clinical Integrative Research Center of Atlanta, Inc
Atlanta, Georgia, United States
University of Louisville Health/Norton
Louisville, Kentucky, United States
Louisiana State Univ/Children's Hospital of New Orleans
New Orleans, Louisiana, United States
Dent Neurological Institute
Amherst, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Childrens
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Tennessee Health Science Center/ LeBonheur Children's Hospital
Memphis, Tennessee, United States
Dell Children's Hospital-UT Health
Austin, Texas, United States
Marshall Health
Huntington, West Virginia, United States