An Intervention to Improve Adolescent Headache Self-management

Study Overview
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Brief Summary
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The purpose of this study is to test the efficacy of a new app to help adolescents with chronic or reoccurring headaches self manage pain.

Detailed Description
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Headaches dramatically affect adolescents' overall functioning and quality of life. We have developed a highly engaging mobile-based program that will help adolescents to make connections between behaviors and symptoms, and to ultimately improve functioning and quality of life. The mobile-based program will provide a state of the art pain tracker, a variety of coping strategies, and information about self-management of symptoms. This app will offer a maximally engaging way to help adolescents track their pain, make connections between lifestyle and pain, and learn key self-management skills. The study involves the participant being randomized into either the experimental group, where he/she will be using this mobile application to track their headache symptoms, or the control group, where he/she will receive headache treatment as usual; the control group will not be using an app for this study. The intervention will last for two months. Participants will be assessed at baseline, at 2-months post baseline, at 3-months post baseline, and at 6-months post baseline. All participants will be asked to complete online questionnaires about their headaches. We plan to enroll 144 adolescent participants with headaches, as well as one caregiver (meaning a parent/guardian) for each adolescent.

Official Title
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An Intervention to Improve Adolescent Headache Self-management

Conditions
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Pain, Headache

Intervention / Treatment
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* Behavioral: pain self management app on smartphone


Participation Criteria
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Eligibility Criteria
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[The above age limits are specific to adolescent participants.] Inclusion Criteria - Adolescents Between ages 13 and 17 (inclusive) Able to read and speak English Has recurring headaches that are not related to another medical condition iPhone user with access to an iPhone [4/4S or later] for use during the intervention period Exclusion Criteria - Adolescents Secondary headache or seizure disorder. Examples include: increased intracranial pressure, hydrocephalus, traumatic brain injury, benign or cancerous brain Cognitive impairment or psychiatric condition that would interfere with ability to use the mobile application or complete the assessments Inclusion Criteria - Caregivers Parent or guardian of an adolescent who meets the above eligibility criteria for adolescent participants

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile self management app on smartphone<br>Mobile self management app on smartphone | Behavioral: pain self management app on smartphone<br> <br> |
| No Intervention: Treatment as usual<br>Treatment as usual (control group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain coping at 2 months, 3 months, and 6 months post-baseline | Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998 | 2 months, 3 months, 6 months | 
| Change in headache intensity at 2 months, 3 months, and 6 months post-baseline | In the past 7 days, how would you rate your headache pain on average... from 0-no pain to 10-worst possible pain | 2 months, 3 months, 6 months | 
| Change in headache frequency at 2 months, 3 months, and 6 months post-baseline | On how many days during the past 30 days have you had a headache? How many days in the past 30 were you completely headache free? | 2 months, 3 months, 6 months | 
| Change in quality of life at 2 months, 3 months, and 6 months post-baseline | Measured by PedMIDAS - Hershey et al., 2001 | 2 months, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline | Measured by Pain Self-Efficacy Scale - Burch, Tsao, et al., 2006 | 2 months, 3 months, 6 months | 
| Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline | Ask caregivers: How many full school days did your child miss in the past 30 days due to headaches? | 2 months, 3 months, 6 months | 
| Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline | Measured by parent report version of the PedsQL 4.0 (Varni et al., 1999) | 2 months, 3 months, 6 months | 
| Change in health care utilization at 2 months, 3 months, and 6 months post-baseline | Measured by asking caregiver to report information such as the following: How many days in the past 30 days did his/her child see a healthcare provider for his/her headaches? What types of treatment (including medications) has his/her child received for headaches in the past 30 days? | 2 months, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self management app, headache, adolescent