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Completed

NCT Number: NCT02475005

An Intervention to Improve Adolescent Headache Self-management

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.

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Key information

Conditions

Pain Headache Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inflexxion

Newton, Massachusetts, 02464, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

[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

Treatment and study plan

pain self management app on smartphone

Behavioral

Primary outcomes

  1. Change in pain coping at 2 months, 3 months, and 6 months post-baseline

    Time frame: 2 months, 3 months, 6 months

    Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998

  2. Change in headache intensity at 2 months, 3 months, and 6 months post-baseline

    Time frame: 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

  3. Change in headache frequency at 2 months, 3 months, and 6 months post-baseline

    Time frame: 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?"

  4. Change in quality of life at 2 months, 3 months, and 6 months post-baseline

    Time frame: 2 months, 3 months, 6 months

    Measured by PedMIDAS - Hershey et al., 2001

Secondary outcomes

  1. Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline

    Time frame: 2 months, 3 months, 6 months

    Measured by Pain Self-Efficacy Scale - Burch, Tsao, et al., 2006

  2. Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline

    Time frame: 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?"

  3. Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline

    Time frame: 2 months, 3 months, 6 months

    Measured by parent report version of the PedsQL 4.0 (Varni et al., 1999)

  4. Change in health care utilization at 2 months, 3 months, and 6 months post-baseline

    Time frame: 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?

Sponsors and collaborators

Lead sponsor

Stephen F Butler, PhD

Industry

Registry information

Acronym: TH

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 18, 2015
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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