- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05889624
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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Migraine is the second most disabling disease in the world. Research has primarily focused on treating migraine in adults; however, approximately 10% of children and adolescents have migraine, suggesting that up to 7 million youth are impacted in the United States alone. Given that the majority of youth have migraine symptoms that persist into adulthood, there is a critical need to identify and improve access to the most effective preventive migraine treatments for this population as a means of reducing the long-term healthcare burden and functional impairment of this illness.
This comparative effectiveness study will test CBT while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) to CBT alone.
Participants will be involved in the study for approximately 28 weeks, with the first 4 weeks being a baseline period and the next 8 weeks involving six telehealth CBT sessions for both study groups (CBT while taking a clinically-prescribed pill-based prevention therapy [amitriptyline] compared to CBT alone), and dose titration of clinically-prescribed medication (amitriptyline) for the CBT + clinically-prescribed, pill-based prevention therapy (amitriptyline) group. During the remaining 16 weeks the participants will maintain the dose of medication (in the CBT + clinically-prescribed, pill-based prevention therapy (amitriptyline) group) and attend "booster" CBT sessions held three times over 4 months.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: LeighAnn Chamberlin, MEd
- Phone Number: 513-636-9739
- Email: leighann.chamberlin@cchmc.org
Study Contact Backup
- Name: Megan Pfeiffer
- Phone Number: 513-636-1846
- Email: megan.pfeiffer@cchmc.org
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- Recruiting
- University of Alabama at Birmingham Children's of Alabama
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Contact:
- Jaylnn Harris
- Phone Number: 205-638-6821
- Email: jalynnharris@uabmc.edu
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Principal Investigator:
- Scott Turner, DNP
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Arizona
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Phoenix, Arizona, United States, 85016-7710
- Recruiting
- Phoenix Children's Hospital - Barrow Neurological Institute
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Principal Investigator:
- Reena Rastogi, Md
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Contact:
- Ying He
- Email: jhe@phoenixchildrens.com
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California
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San Francisco, California, United States, 94115
- Not yet recruiting
- University of California San Francisco
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Contact:
- Kaiulani Williams
- Email: Kaiulani.Williams@ucsf.edu
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Principal Investigator:
- Hannah Shapiro, MD
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Colorado
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Aurora, Colorado, United States, 80045
- Not yet recruiting
- University of Colorado/Children's Hospital Colorado
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Principal Investigator:
- Marcy Yonker, MD
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Contact:
- Cameron Bendalin
- Email: cameron.bendalin@childrenscolorado.org
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Delaware
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Wilmington, Delaware, United States, 19810
- Recruiting
- Nemours Children's Health System
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Contact:
- Jessica Rayfield
- Phone Number: 302-651-6979
- Email: jessica.rayfield@nemours.com
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Principal Investigator:
- Tara Pezzuto, DNP
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Georgia
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Atlanta, Georgia, United States, 30328
- Not yet recruiting
- Clinical Integrative Research Center of Atlanta, Inc
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Contact:
- Jazmine Roman
- Phone Number: 678-528-0961
- Email: jroman@pandaneuro.com
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Principal Investigator:
- Frank Berenson, MD
-
Principal Investigator:
- Chaouki Khoury, MD
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Kentucky
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Louisville, Kentucky, United States, 40292
- Not yet recruiting
- University of Louisville Health/Norton
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Contact:
- Lauren Evansczyk
- Email: lauren.evanczyk@nortonhealthcare.org
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Principal Investigator:
- Elizabeth Doll, MD
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Louisiana
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New Orleans, Louisiana, United States, 70118-5720
- Recruiting
- Louisiana State Univ/Children's Hospital of New Orleans
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Contact:
- Kathryn Peneguy
- Email: Kathryn.Peneguy@lcmchealth.org
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Principal Investigator:
- Rashmi Rao, MD
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New York
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Amherst, New York, United States, 14226
- Recruiting
- Dent Neurological Institute
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Contact:
- Rebecca Hogan
- Phone Number: 716-558-5670
- Email: rhogan@dentinstitute.com
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Principal Investigator:
- Jennifer McVige, MD
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Ohio
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Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital Medical Center
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Contact:
- Paula LaFollette
- Phone Number: 513-636-1840
- Email: reachstudy@cchmc.org
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Principal Investigator:
- Joanne Kacperski, MD
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Columbus, Ohio, United States, 43205
- Recruiting
- Nationwide Childrens
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Contact:
- Colin Peachey
- Email: Colin.Peachey@nationwidechildrens.org
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Principal Investigator:
- Ann Pakalnis, MD
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia
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Contact:
- Blanca Marquez de Prado
- Phone Number: 267-602-9784
- Email: marquezdeb@chop.edu
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Principal Investigator:
- Christina Szperka, MD
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Tennessee
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Memphis, Tennessee, United States, 38103
- Recruiting
- University of Tennessee Health Science Center/ LeBonheur Children's Hospital
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Principal Investigator:
- Ankita Gosh, MD
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Contact:
- Kara Lessel
- Email: Kara.Lessel@mlh.org
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West Virginia
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Huntington, West Virginia, United States, 25701
- Recruiting
- Marshall Health
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Contact:
- Hillary Salava
- Phone Number: 304-691-6859
- Email: riegel@marshall.edu
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Principal Investigator:
- Ivan Lopez, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
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).
|
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of headache days
Time Frame: baseline to weeks 4-8 to weeks 20-24 (post treatment)
|
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
Time Frame: baseline to weeks 20-24 (post treatment)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in absolute headache disability score on PedMIDAS
Time Frame: baseline to weeks 20-24 (post treatment)
|
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 post treatment visit (covering last three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this study. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. |
baseline to weeks 20-24 (post treatment)
|
Change in absolute headache days
Time Frame: baseline to weeks 4-8 to weeks 20-24 (post treatment)
|
This outcome measures whether there is an absolute 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)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Scott Powers, PhD, Cincinnati Childrens Medical Center, Cincinnati
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Migraine Disorders
- Headache
- Headache Disorders
- Migraine without Aura
- Migraine with Aura
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Adrenergic Uptake Inhibitors
- Amitriptyline
Other Study ID Numbers
- REACH Study (Allergan, Inc.)
- MP-2021C3-24936 (Other Grant/Funding Number: PCORI)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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