ParentsNCT03356275
Mobile Coach for Parents of Children and Adolescents With Chronic Pain
A study testing Mindfulness for Resilience in Illness: Support for Parents in people with Parents and Chronic Pain, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parents, Chronic Pain, Pediatric Disorder
- What is being tested?
- Mindfulness for Resilience in Illness: Support for Parents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2017to 13 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to provide consent
- Inability to speak and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Pediatric Pain and Palliative Care Program Research Offices
Los Angeles, California, 90095
About this study
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
- Being tested
- Mindfulness for Resilience in Illness: Support for Parents
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness for Resilience in Illness: Support for ParentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile application | Experimental | Psychosocial support for parents, including: brief audio mindfulness recordings, videos, and psychoeducational materials. Receives: Behavioral: Mindfulness for Resilience in Illness: Support for Parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 7 days of competing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start18 Dec 2017
- Primary completion13 Mar 2018
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- BodiMojo, Inc.
- Responsible party
- Principal investigator, Lonnie Zeltzer, University of California, Los Angeles
- Investigators
- Lonnie K Zeltzer, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356275
- Sponsor's protocol ID
- R43HD090774
- Status last verified
- Apr 2018
- First submitted
- 21 Nov 2017
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Coach for Parents of Children and Adolescents With Chronic Pain
- ClinicalTrials.gov ID
- NCT03356275
- Acronym / sponsor ID
- R43HD090774
- Conditions
- Parents, Chronic Pain, Pediatric Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- BodiMojo, Inc.
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile application | Experimental | Behavioral: Mindfulness for Resilience in Illness: Support for ParentsPsychosocial support for parents, including: brief audio mindfulness recordings, videos, and psychoeducational materials. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to provide consent
- Inability to speak and understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness for Resilience in Illness: Support for ParentsMobile 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. | Behavioural | Mobile application |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lonnie K Zeltzer, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness for Resilience in Illness: Support for Parents in people with Parents and Chronic Pain, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.