Mobile Coach for Parents of Children and Adolescents With Chronic Pain

NCT03356275 | Completed

• 1 other identifier: R43HD090774
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Parents; Chronic Pain; Pediatric Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  At the conclusion of the final day of the intervention (Day 30)

• 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.

  Within 7 days of competing the intervention

Study Arms (1)

Mobile application

EXPERIMENTAL

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

Behavioral: Mindfulness for Resilience in Illness: Support for Parents

Interventions

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.

Mobile application

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• BodiMojo, Inc.: collaborator

Study Sites (1)

UCLA Pediatric Pain and Palliative Care Program Research Offices

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lonnie K Zeltzer, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 29, 2017
• Study Start: December 18, 2017
• Primary Completion: March 13, 2018
• Study Completion: March 13, 2018
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

US (1)