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RECRUITING
NCT05889624
NA

Responding With Evidence and Access for Childhood Headaches

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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

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).

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