Clinical trial NCT03356275: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parents
Chronic Pain
Pediatric Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: BodiMojo, Inc.
First posted: 2017-11-29
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Ratio of the days during the 30-day intervention period during which participants use the app
timeFrame: At the conclusion of the final day of the intervention (Day 30)
measure: Acceptance
timeFrame: Within 7 days of competing the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Pediatric Pain and Palliative Care Program Research Offices
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Lonnie K Zeltzer, MD
role: PRINCIPAL_INVESTIGATOR
References: