Mobile Coach for Parents of Children and Adolescents With Chronic Pain

Chronic Pain Clinical Trial

Official title:

Mobile Coach for Parents of Children and Adolescents With Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356275
• Other study ID #: R43HD090774
• Status: Completed
• Phase: N/A
• First received: November 21, 2017
• Last updated: April 11, 2018
• Start date: December 18, 2017
• Est. completion date: March 13, 2018

Study information

• Verified date: April 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Parents
• Pediatric Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Pediatric Pain and Palliative Care Program Research Offices	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	BodiMojo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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