Recruiting

Observational StudyResponding With Evidence and Access for Childhood Headaches

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05889624

Conditions

Headache

Headache Disorders

Headache, Migraine

Migraine

Migraine Disorders

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

CBT

Amitriptyline

Study Details

Brief 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.

Conditions

Headache

Headache Disorders

Headache, Migraine

Migraine

Migraine Disorders

Study ID

NCT05889624

Start date

Aug 22, 2023

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline)

This intervention consists of Cognitive Behavioral (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements. This arm will also take a daily oral dose of Amitriptyline, which will be clinically prescribed and managed by the patient's headache provider.

experimental: CBT alone

This intervention arm consists of 6 Cognitive Behavioral Therapy (CBT), a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation, activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements.

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).

Primary outcome measure

Change in number of headache days [ Time Frame: baseline to weeks 4-8 to weeks 20-24 (post treatment) ]
Reduction to a PedMIDAS score of 20 or less [ Time Frame: baseline to weeks 20-24 (post treatment) ]

Central Contacts and Locations

Central contacts

LeighAnn Chamberlin, MEd

513-636-9739 leighann.chamberlin@cchmc.org

Megan Pfeiffer

513-636-1846 megan.pfeiffer@cchmc.org

Locations

University of Alabama at Birmingham Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Julio Sebastian Domingo

205-638-6821 jsebastiandomingo@uabmc.edu

Principal Investigator:

Scott Turner, DNP

Phoenix Children's Hospital - Barrow Neurological Institute

Recruiting

Phoenix, Arizona, United States, 85016-7710

Contacts

Nigel Negm

nnegm@phoenixchildrens.com

Principal Investigator:

Reena Rastogi, Md

University of California San Francisco

Recruiting

San Francisco, California, United States, 94115

Contacts

Rahel Abraham

Rahel.Abraham@ucsf.edu

Principal Investigator:

Hannah Shapiro, MD

University of Colorado/Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Andrew Levine

andrew.levine@childrenscolorado.org

Principal Investigator:

Marcy Yonker, MD

Nemours Children's Health System

Recruiting

Wilmington, Delaware, United States, 19810

Contacts

Jessica Rayfield

302-651-6979 jessica.rayfield@nemours.com

Principal Investigator:

Judy Adelizzi-Delany, DNP

Clinical Integrative Research Center of Atlanta, Inc

Recruiting

Atlanta, Georgia, United States, 30328

Contacts

Jazmine Roman

678-528-0961 jroman@pandaneuro.com

Principal Investigator:

Frank Berenson, MD

Norton Children's Neuroscience Institute/ UofL School of Medicine

Recruiting

Louisville, Kentucky, United States, 40292

Contacts

Lauren Evanczyk

lauren.evanczyk@nortonhealthcare.org

Principal Investigator:

Elizabeth Doll, MD

Louisiana State Univ/Children's Hospital of New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118-5720

Contacts

Kathryn Peneguy

Kathryn.Peneguy@lcmchealth.org

Principal Investigator:

Rashmi Rao, MD

Dent Neurological Institute

Recruiting

Amherst, New York, United States, 14226

Contacts

Andrea Bryan

716-250-2017 abryan@dentinstitute.com

Principal Investigator:

Jennifer McVige, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Paula LaFollette

513-636-1840 reachstudy@cchmc.org

Principal Investigator:

Joanne Kacperski, MD

Nationwide Childrens

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Alyssa Deeter

Alyssa.Deeter@nationwidechildrens.org

Principal Investigator:

Ann Pakalnis, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Blanca Marquez de Prado

267-602-9784 marquezdeb@chop.edu

Principal Investigator:

Christina Szperka, MD

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

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Talia Hill

talia.hill@lebonheur.org

Principal Investigator:

Ankita Gosh, MD

Dell Children's Hospital-UT Health

Recruiting

Austin, Texas, United States, 78712

Contacts

Valerie Cuellar

512-324-0000 valerie.cuellar@utexas.edu

Principal Investigator:

Sara Pavitt, MD

Marshall Health

Recruiting

Huntington, West Virginia, United States, 25701

Contacts

Hillary Salava

304-691-6859 riegel@marshall.edu

Principal Investigator:

Ivan Lopez, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

headache
migraine
cognitive behavioral therapy
pediatrics
diaphragmatic breathing
progressive muscle relaxation
imagery
relaxation
biofeedback

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.