An Intervention to Improve Adolescent Headache Self-management
- Conditions
- HeadachePain
- Interventions
- Behavioral: pain self management app on smartphone
- Registration Number
- NCT02475005
- Lead Sponsor
- Stephen F Butler, PhD
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mobile self management app on smartphone pain self management app on smartphone Mobile self management app on smartphone
- Primary Outcome Measures
Name Time Method Change in pain coping at 2 months, 3 months, and 6 months post-baseline 2 months, 3 months, 6 months Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998
Change in quality of life at 2 months, 3 months, and 6 months post-baseline 2 months, 3 months, 6 months Measured by PedMIDAS - Hershey et al., 2001
Change in headache intensity at 2 months, 3 months, and 6 months post-baseline 2 months, 3 months, 6 months "In the past 7 days, how would you rate your headache pain on average..." from 0-no pain to 10-worst possible pain
Change in headache frequency at 2 months, 3 months, and 6 months post-baseline 2 months, 3 months, 6 months 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?"
- Secondary Outcome Measures
Name Time Method Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline 2 months, 3 months, 6 months Measured by Pain Self-Efficacy Scale - Burch, Tsao, et al., 2006
Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline 2 months, 3 months, 6 months Ask caregivers: "How many full school days did your child miss in the past 30 days due to headaches?"
Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline 2 months, 3 months, 6 months Measured by parent report version of the PedsQL 4.0 (Varni et al., 1999)
Change in health care utilization at 2 months, 3 months, and 6 months post-baseline 2 months, 3 months, 6 months 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?
Trial Locations
- Locations (1)
Inflexxion
🇺🇸Newton, Massachusetts, United States