An Intervention to Improve Adolescent Headache Self-management (TH)

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.

Study Overview

• Status: Completed
• Conditions: Pain; Headache
• Intervention / Treatment: Behavioral: pain self management app on smartphone

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.

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Newton, Massachusetts, United States, 02464
      • Inflexxion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

[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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile self management app on smartphone	Behavioral: pain self management app on smartphone
No Intervention: Treatment as usual; Treatment as usual (control group)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stephen F Butler, PhD

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2014
• Primary Completion (Actual): November 28, 2017
• Study Completion (Actual): November 28, 2017

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 17, 2015
• First Posted (Estimate): June 18, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: adolescent; headache; self management app
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: 2R44HD066920-03A1 (U.S. NIH Grant/Contract)