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Completed

NCT Number: NCT03356275

Mobile Coach for Parents of Children and Adolescents With Chronic Pain

Chronic pain is estimated to affect 20% to 35% of children and adolescents around the world, and is associated with increased risk of anxiety and depression among children and adolescents, as well as coping challenges, anxiety, depression, and anger in their parents. For parents, learning to manage stress is critical, as parents play a significant role in a child's experience of pain. Parental behaviors such as over-involvement, solicitousness and rejection are associated with decreased functioning, including higher school absenteeism in children and teens. A number of interventions demonstrate that teaching skills to parents can have a direct and positive impact on the health of children and adolescents with chronic pain. The investigators propose to create and test the BodiMojo Parent Buddy which will provide parents with real-time, tailored and adaptive coping and stress management support and will provide a curriculum of skills for responding to a child in pain in order to promote child functioning.

Thirty parents of children ages 8-18 who have been diagnosed with a non-cancer chronic pain condition will participate in this user-testing study. Parents will complete a brief set of questionnaires before and after the intervention, and will be instructed to open and use the app each day for 30 days. Participants will complete audio mindfulness exercises, watch brief video clips, and read psychoeducational information about pain, coping, and communication skills. Post-intervention questionnaires will also include an acceptance test to assess participants' opinions about the helpfulness and usability of the app. Parent participation is expected to take around 3.5 hours total over the 30 day study period.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Pediatric Pain and Palliative Care Program Research Offices

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Parents who self-report parenting a child or adolescent ages 8-18 with non-cancer chronic pain.
  • Daily use of a smartphone (iOS, Android, or Windows) or tablet.
  • Ability to speak and understand English.

Exclusion criteria

  • Inability to provide consent
  • Inability to speak and understand English

Treatment and study plan

Mindfulness for Resilience in Illness: Support for Parents

Behavioral

Mobile application focusing on emotional coping skills for parents of children and adolescents with chronic pain. Components of the module include: library of mindfulness meditations/relaxations; peer support videos; and psychoeducational information related to pain, stress, and mindfulness.

Primary outcomes

  1. Ratio of the days during the 30-day intervention period during which participants use the app

    Time frame: At the conclusion of the final day of the intervention (Day 30)

    Determined by how often participants engaged and used certain features. To be considered feasible, participants must have opened the app on at least half of the days.

  2. Acceptance

    Time frame: Within 7 days of competing the intervention

    Determined by participants' responses to acceptance test questions in the following domains: (1) how much the participant liked the various app features; (2) how much participants liked the video and supplementary content; and (3) helpfulness of various app features. Responses will be given on a one to seven-point-scale ranging "terrible" to "excellent." The intervention will be deemed acceptable if at least 80% of participants rate each question an average of at least "5" ("good") on the 7-point scale.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • BodiMojo, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2017
Registry last updated
Apr 12, 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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