Mobile Coach for Parents of Children and Adolescents With Chronic Pain

• ClinicalTrials.gov Identifier: NCT03356275
• Recruitment Status: Completed
• First Posted: November 29, 2017
• Last Update Posted: April 12, 2018
• Sponsor: University of California, Los Angeles
• Collaborator: BodiMojo, Inc.
• Information provided by (Responsible Party): Lonnie Zeltzer, University of California, Los Angeles

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.

Condition or disease	Intervention/treatment	Phase
Parents; Chronic Pain; Pediatric Disorder	Behavioral: Mindfulness for Resilience in Illness: Support for Parents	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Mobile Coach for Parents of Children and Adolescents With Chronic Pain
• Actual Study Start Date: December 18, 2017
• Actual Primary Completion Date: March 13, 2018
• Actual Study Completion Date: March 13, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mobile application; Psychosocial support for parents, including: brief audio mindfulness recordings, videos, and psychoeducational materials.	Behavioral: Mindfulness for Resilience in Illness: Support for Parents; 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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

UCLA Pediatric Pain and Palliative Care Program Research Offices

Los Angeles, California, United States, 90095

Sponsors and Collaborators

University of California, Los Angeles

BodiMojo, Inc.

Investigators

• Principal Investigator: Lonnie K Zeltzer, MD; University of California, Los Angeles

More Information

• Responsible Party: Lonnie Zeltzer, Distinguished Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03356275
• Other Study ID Numbers: R43HD090774 ( U.S. NIH Grant/Contract )
• First Posted: November 29, 2017
• Last Update Posted: April 12, 2018
• Last Verified: April 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations