Responding With Evidence and Access for Childhood Headaches
Cognitive Behavioral Therapy Via Telehealth + Amitriptyline Compared to Cognitive Behavioral Therapy Via Telehealth: Pediatric Migraine Prevention (Responding With Evidence and Access for Childhood Headaches)
2 other identifiers
interventional
400
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedStudy Start
First participant enrolled
August 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 6, 2026
March 1, 2026
3.9 years
May 10, 2023
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in number of headache days
This outcome measures whether there is a 50% reduction in the number of headaches days based on a self reported daily headache diary, per 28-day period, between the two arms.
baseline to weeks 4-8 to weeks 20-24 (post treatment)
Reduction to a PedMIDAS score of 20 or less
The PedMIDAS scale which evaluates the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions are answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale is administered at baseline (covering the three months prior to enrollment) and at the endpoint visit (covering last three months of enrollment). This outcome measures whether there is a reduction in migraine related disability measured by the Pediatric Migraine Disability Scale (PedMIDAS) between the two arms. A reduction to a score of 20 or less, indicating mild impact of less is a meaningful outcome for patients and families and considered clinically significant.
baseline to weeks 20-24 (post treatment)
Secondary Outcomes (4)
Change in absolute reduction in severe headache days
baseline to weeks 20-24 (post treatment)
Change in absolute headache days
baseline to weeks 4-8 to weeks 20-24 (post treatment)
Change in absolute headache disability score on PedMIDAS
baseline to weeks 20-24 (post treatment)
Safety and tolerability of treatments (CBT and Amitriptyline)
randomization to weeks 20-24 (post treatment)
Other Outcomes (3)
Exploratory: Change in self-reported physical and psychosocial functioning (functional impact)
baseline to weeks 20-24 (post treatment)
Exploratory: Change in self-reported quality of life
baseline to weeks 20-24 (post treatment)
Exploratory: Impact of social determinants of health
baseline
Study Arms (2)
CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline)
EXPERIMENTALThis 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.
CBT alone
EXPERIMENTALThis 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
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of Alabama at Birmingham Children's of Alabama
Birmingham, Alabama, 35233, United States
Phoenix Children's Hospital - Barrow Neurological Institute
Phoenix, Arizona, 85016-7710, United States
University of California San Francisco
San Francisco, California, 94115, United States
University of Colorado/Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Nemours Children's Health System
Wilmington, Delaware, 19810, United States
Clinical Integrative Research Center of Atlanta, Inc
Atlanta, Georgia, 30328, United States
University of Louisville Health/Norton
Louisville, Kentucky, 40292, United States
Louisiana State Univ/Children's Hospital of New Orleans
New Orleans, Louisiana, 70118-5720, United States
Dent Neurological Institute
Amherst, New York, 14226, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Childrens
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Tennessee Health Science Center/ LeBonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Dell Children's Hospital-UT Health
Austin, Texas, 78712, United States
Marshall Health
Huntington, West Virginia, 25701, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Powers, PhD
Cincinnati Childrens Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Only the principal investigator will remain blinded to the randomization assignment. All other study staff including the project manager, assistant project manager, study statistician, site investigators and study staff, participants, and their parents will be aware of the treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2023
First Posted
June 5, 2023
Study Start
August 22, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 6, 2026
Record last verified: 2026-03