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Mobile Coach for Parents of Children and Adolescents With Chronic Pain

Primary Purpose

Parents, Chronic Pain, Pediatric Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness for Resilience in Illness: Support for Parents
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parents

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Pediatric Pain and Palliative Care Program Research Offices

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile application

Arm Description

Psychosocial support for parents, including: brief audio mindfulness recordings, videos, and psychoeducational materials.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 21, 2017
Last Updated
April 11, 2018
Sponsor
University of California, Los Angeles
Collaborators
BodiMojo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03356275
Brief Title
Mobile Coach for Parents of Children and Adolescents With Chronic Pain
Official Title
Mobile Coach for Parents of Children and Adolescents With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
March 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
BodiMojo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parents, Chronic Pain, Pediatric Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile application
Arm Type
Experimental
Arm Description
Psychosocial support for parents, including: brief audio mindfulness recordings, videos, and psychoeducational materials.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness for Resilience in Illness: Support for Parents
Intervention Description
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 Outcome Measure Information:
Title
Ratio of the days during the 30-day intervention period during which participants use the app
Description
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.
Time Frame
At the conclusion of the final day of the intervention (Day 30)
Title
Acceptance
Description
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.
Time Frame
Within 7 days of competing the intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lonnie K Zeltzer, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Pediatric Pain and Palliative Care Program Research Offices
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Mobile Coach for Parents of Children and Adolescents With Chronic Pain

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