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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
Inflexxion
Newton, Massachusetts, United States
Change in pain coping at 2 months, 3 months, and 6 months post-baseline
Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998
Time frame: 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
Time frame: 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?"
Time frame: 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
Time frame: 2 months, 3 months, 6 months
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
Time frame: 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?"
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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?
Time frame: 2 months, 3 months, 6 months