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Responding With Evidence and Access for Childhood Headaches

Primary Purpose

Headache, Headache Disorders, Headache, Migraine

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBT

Amitriptyline

About this trial

This is an interventional treatment trial for Headache focused on measuring headache, migraine, cognitive behavioral therapy, pediatrics, diaphragmatic breathing, progressive muscle relaxation, imagery, relaxation, biofeedback

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama at Birmingham Children's of Alabama
Phoenix Children's Hospital - Barrow Neurological Institute
University of California San Francisco
University of Colorado/Children's Hospital Colorado
Nemours Children's Health System
Clinical Integrative Research Center of Atlanta, Inc
University of Louisville Health/Norton
Louisiana State Univ/Children's Hospital of New Orleans
Dent Neurological Institute
Cincinnati Children's Hospital Medical CenterRecruiting
Nationwide Childrens
Children's Hospital of Philadelphia
University of Tennessee Health Science Center/ LeBonheur Children's Hospital
Marshall Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

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

CBT alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Change in absolute headache disability score on PedMIDAS

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.

Change in absolute headache days

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.

Full Information

NCT ID

NCT05889624

First Posted

May 10, 2023

Last Updated

August 30, 2023

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Patient-Centered Outcomes Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05889624

Brief Title

Responding With Evidence and Access for Childhood Headaches

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 22, 2023 (Actual)

Primary Completion Date

July 31, 2027 (Anticipated)

Study Completion Date

December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Masking Description

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.

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

CBT alone

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

CBT

Other Intervention Name(s)

Cognitive Behavioral Therapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Amitriptyline

Intervention Description

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 Information:

Title

Change in number of headache days

Description

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.

Time Frame

baseline to weeks 4-8 to weeks 20-24 (post treatment)

Title

Reduction to a PedMIDAS score of 20 or less

Description

Time Frame

baseline to weeks 20-24 (post treatment)

Secondary Outcome Measure Information:

Title

Change in absolute headache disability score on PedMIDAS

Description

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.

Time Frame

baseline to weeks 20-24 (post treatment)

Title

Change in absolute headache days

Description

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.

Time Frame

baseline to weeks 4-8 to weeks 20-24 (post treatment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

LeighAnn Chamberlin, MEd

Phone

513-636-9739

leighann.chamberlin@cchmc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Megan Pfeiffer

Phone

513-636-1846

megan.pfeiffer@cchmc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Powers, PhD

Organizational Affiliation

Cincinnati Childrens Medical Center, Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham Children's of Alabama

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaylnn Harris

Phone

205-638-6821

jalynnharris@uabmc.edu

First Name & Middle Initial & Last Name & Degree

Scott Turner, DNP

Facility Name

Phoenix Children's Hospital - Barrow Neurological Institute

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016-7710

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Reena Rastogi

rrastogi@phoenixchildrens.com

First Name & Middle Initial & Last Name & Degree

Reena Rastogi, Md

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amy Gelfand

gelfanda@neuropeds.ucsf.edu

First Name & Middle Initial & Last Name & Degree

Amy Gelfand, MD

Facility Name

University of Colorado/Children's Hospital Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lindsey Lang

Lindsey.Lang@childrenscolorado.org

First Name & Middle Initial & Last Name & Degree

Marcy Yonker, MD

Facility Name

Nemours Children's Health System

City

Wilmington

State/Province

Delaware

ZIP/Postal Code

19810

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Rayfield

Phone

302-651-6979

jessica.rayfield@nemours.com

First Name & Middle Initial & Last Name & Degree

Tara Pezzuto, DNP

Facility Name

Clinical Integrative Research Center of Atlanta, Inc

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jazmine Roman

Phone

678-528-0961

jroman@pandaneuro.com

First Name & Middle Initial & Last Name & Degree

Frank Berenson, MD

First Name & Middle Initial & Last Name & Degree

Chaouki Khoury, MD

Facility Name

University of Louisville Health/Norton

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40292

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lauren Evansczyk

lauren.evanczyk@nortonhealthcare.org

First Name & Middle Initial & Last Name & Degree

Elizabeth Doll, MD

Facility Name

Louisiana State Univ/Children's Hospital of New Orleans

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70118-5720

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathryn Peneguy

Kathryn.Peneguy@lcmchealth.org

First Name & Middle Initial & Last Name & Degree

Rashmi Rao, MD

Facility Name

Dent Neurological Institute

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rebecca Hogan

Phone

716-558-5670

rhogan@dentinstitute.com

First Name & Middle Initial & Last Name & Degree

Jennifer McVige, MD

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paula LaFollette

Phone

513-636-1840

reachstudy@cchmc.org

First Name & Middle Initial & Last Name & Degree

Joanne Kacperski, MD

Facility Name

Nationwide Childrens

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Colin Peachey

Colin.Peachey@nationwidechildrens.org

First Name & Middle Initial & Last Name & Degree

Ann Pakalnis, MD

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Blanca Marquez de Prado

Phone

267-602-9784

marquezdeb@chop.edu

First Name & Middle Initial & Last Name & Degree

Christina Szperka, MD

Facility Name

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

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38103

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ankita Gosh

aghosh9@uthsc.edu

First Name & Middle Initial & Last Name & Degree

Ankita Gosh, MD

Facility Name

Marshall Health

City

Huntington

State/Province

West Virginia

ZIP/Postal Code

25701

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hillary Salava

Phone

304-691-6859

riegel@marshall.edu

First Name & Middle Initial & Last Name & Degree

Ivan Lopez, MD

12. IPD Sharing Statement

Learn more about this trial

Responding With Evidence and Access for Childhood Headaches

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