400
Participants
Start Date
August 22, 2023
Primary Completion Date
July 31, 2027
Study Completion Date
December 31, 2027
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).
RECRUITING
Dent Neurological Institute, Amherst
RECRUITING
Children's Hospital of Philadelphia, Philadelphia
RECRUITING
Nemours Children's Health System, Wilmington
RECRUITING
Marshall Health, Huntington
RECRUITING
Clinical Integrative Research Center of Atlanta, Inc, Atlanta
RECRUITING
University of Alabama at Birmingham Children's of Alabama, Birmingham
RECRUITING
University of Tennessee Health Science Center/ LeBonheur Children's Hospital, Memphis
RECRUITING
University of Louisville Health/Norton, Louisville
RECRUITING
Nationwide Childrens, Columbus
RECRUITING
Cincinnati Children's Hospital Medical Center, Cincinnati
RECRUITING
University of Colorado/Children's Hospital Colorado, Aurora
RECRUITING
University of California San Francisco, San Francisco
RECRUITING
Phoenix Children's Hospital - Barrow Neurological Institute, Phoenix
RECRUITING
Louisiana State Univ/Children's Hospital of New Orleans, New Orleans
Patient-Centered Outcomes Research Institute
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER