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Responding With Evidence and Access for Childhood Headaches

Sponsor: Children's Hospital Medical Center, Cincinnati • ClinicalTrials.gov ID: NCT05889624

Registry updated: 2026-09-21

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Description

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.

Interventions

CBT (Behavioral)
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 (Drug)
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).

Eligibility criteria

Inclusion Criteria: * Diagnosis: Migraine with or without aura that meets the International Classification of Headache Disorders (ICHD) criteria 5 or presentation of continuous headache that includes migranous episodes based upon headache history obtained by site PI or designee. (includes presentation with or without medication overuse headache as well) * Headache Frequency: 4 or more headache days based upon prospective headache diary of 28 days prior to randomization * Amitriptyline Eligible: Site PI or medical staff determined participant to be eligible for clinical prescription of amitriptyline as a preventive treatment for migraine * English fluency: Able to complete the study visits and questionnaires in English Exclusion Criteria: * Current treatment includes amitriptyline and/or CBT specific to headache care * Current prescribed preventive antimigraine medication within a period equivalent to \< 5 half-lives of that medication before entering the baseline phase * Current treatment with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibody medications for migraine prevention * Youth who are pregnant * Report of current or ongoing suicidal thoughts. Suicide attempt within the past six months. History of bipolar disorder, prolonged QT, or pre-existing significant constipation or gastroparesis * Any and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the participant

Conditions

Headache Headache Disorders Headache, Migraine Migraine Migraine Disorders Migraine With Aura Migraine Without Aura Chronic Migraine

Locations

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
Norton Children's Neuroscience Institute/ UofL School of Medicine — 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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