Actively Recruiting
Responding With Evidence and Access for Childhood Headaches
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-06
400
Participants Needed
15
Research Sites
227 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Responding With Evidence and Access for Childhood Headaches
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of migraine with or without aura or continuous headache including migranous episodes based on International Classification of Headache Disorders criteria
- Experience 4 or more headache days in a 28-day prospective diary before randomization
- Eligible for clinical prescription of amitriptyline as preventive migraine treatment as determined by site principal investigator or medical staff
- Able to complete study visits and questionnaires in English
You will not qualify if you...
- Currently receiving amitriptyline and/or CBT specific to headache care
- Using prescribed preventive antimigraine medication within a period less than 5 half-lives before baseline phase
- Currently treated with onabotulinumtoxinA (Botox) or CGRP-based monoclonal antibodies for migraine prevention
- Youth who are pregnant
- Current or ongoing suicidal thoughts, suicide attempt within past 6 months, history of bipolar disorder, prolonged QT, significant constipation, or gastroparesis
- Any other condition that would interfere with study participation or medical care as judged by site investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
University of Alabama at Birmingham Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Children's Hospital - Barrow Neurological Institute
Phoenix, Arizona, United States, 85016-7710
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
4
University of Colorado/Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Nemours Children's Health System
Wilmington, Delaware, United States, 19810
Actively Recruiting
6
Clinical Integrative Research Center of Atlanta, Inc
Atlanta, Georgia, United States, 30328
Actively Recruiting
7
University of Louisville Health/Norton
Louisville, Kentucky, United States, 40292
Actively Recruiting
8
Louisiana State Univ/Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118-5720
Actively Recruiting
9
Dent Neurological Institute
Amherst, New York, United States, 14226
Actively Recruiting
10
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
11
Nationwide Childrens
Columbus, Ohio, United States, 43205
Actively Recruiting
12
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
University of Tennessee Health Science Center/ LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Actively Recruiting
14
Dell Children's Hospital-UT Health
Austin, Texas, United States, 78712
Actively Recruiting
15
Marshall Health
Huntington, West Virginia, United States, 25701
Actively Recruiting
Research Team
L
LeighAnn Chamberlin, MEd
CONTACT
M
Megan Pfeiffer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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