Responding With Evidence and Access for Childhood Headaches

NARecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

August 22, 2023

Primary Completion Date

July 31, 2027

Study Completion Date

December 31, 2027

Conditions
HeadacheHeadache DisordersHeadache, MigraineMigraineMigraine DisordersMigraine With AuraMigraine Without AuraChronic Migraine
Interventions
BEHAVIORAL

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."

DRUG

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).

Trial Locations (14)

14226

RECRUITING

Dent Neurological Institute, Amherst

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

19810

RECRUITING

Nemours Children's Health System, Wilmington

25701

RECRUITING

Marshall Health, Huntington

30328

RECRUITING

Clinical Integrative Research Center of Atlanta, Inc, Atlanta

35233

RECRUITING

University of Alabama at Birmingham Children's of Alabama, Birmingham

38103

RECRUITING

University of Tennessee Health Science Center/ LeBonheur Children's Hospital, Memphis

40292

RECRUITING

University of Louisville Health/Norton, Louisville

43205

RECRUITING

Nationwide Childrens, Columbus

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

80045

RECRUITING

University of Colorado/Children's Hospital Colorado, Aurora

94115

RECRUITING

University of California San Francisco, San Francisco

85016-7710

RECRUITING

Phoenix Children's Hospital - Barrow Neurological Institute, Phoenix

70118-5720

RECRUITING

Louisiana State Univ/Children's Hospital of New Orleans, New Orleans

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

lead

Children's Hospital Medical Center, Cincinnati

OTHER