Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05925868 |
| Other study ID # |
186-SB22-056 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2023 |
| Est. completion date |
November 23, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Boise State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The number of children with special health care needs (CSHCN) in the US is nearly 20% of
children representing approximately 14.6 million children nationally. A subgroup of CSHCN are
children who have the most intensive healthcare needs known as children with a medical
complexity (CMC). Parents of CMC experience many challenges. In addition to typical caregiver
tasks, parents of a CMC may experience added stress and are more likely to experience higher
rates of anxiety, depression, and post-traumatic stress disorder than parents of healthy
children. This project aims to explore the acceptability and feasibility of a mindfulness
mobile application for parents of a CMC as well as determine the effectiveness of mindfulness
application use on stress, depression, and family management in parents of a CMC. Forty-five
participants will be recruited and given access to a mindfulness application and instructed
to use it at least 4 days a week for at least 10 minutes. Parents will fill out
questionnaires on app usage, as well as stress, depression, and family management. This work
will be accomplished through a pilot single arm approach.
Description:
Significance The prevalence of pediatric chronic conditions is increasing rapidly. Medical
advances in the last half-century created a dramatic change in the prevalence of
childhood-onset diseases leading to a growing number of CSHCN, increasing >400% since the
1960s.The estimated prevalence of CMC ranges from 1% to 5% or approximately 680,000 children
depending on the definition. The majority of parents function as unlicensed caregivers in
managing life-sustaining technologies and administering medications and caring for their CMC
as well as their other well children in the household. Parents of CMC experience worse mental
and physical health outcomes compared to parents of healthy children. They face many
challenges such as difficulty accessing medical and nonmedical services and financial
problems related to costs associated with the child's care. It is well documented that these
parents experience high levels of stress and depression. 60% of parents of a child with
chronic illness experience depression compared to 10% in mothers of healthy newborns. Parents
of CMC are at higher risk for experiencing suboptimal mental health outcomes over time. In
addition to poor psychological outcomes, parent caregivers also experience worse physical
health such as low back pain due to lifting, migraine headaches, chronic fatigue, sleep
deprivation, and stomach/intestinal ulcers. Although not specifically studied in parents of
CMC, a recent systematic review found that the effects of stress included poor general
physical health, increased pain and disability, lower quality of life, and higher risk of
all-cause mortality.
While psychological interventions have been shown to improve parent distress, parenting
behaviors, and family conflict in parents of a CSHCN, less is known about parents of a CMC.
These parents often have significant and diverse needs and benefit from specific, targeted
interventions. Previously tested interventions include: parenting programs, targeted parent
behavior change such as cognitive behavioral therapy, peer support, psychological
interventions, resourcefulness training. Other studies indicate that improving psychological
outcomes of caregivers affects emergency room visits and hospitalizations. Parents of CMC
often lack the resources to obtain assistance. This will be one of the first studies to
examine a simple, cost-effective intervention that parents can access from their home. Future
studies aimed at understanding the physical and psychological effects and benefits of a
mindfulness app are important for this vulnerable population.
Innovation The research is novel in its approach of examining the feasibility and
acceptability of a mindfulness app in parent caregivers of this vulnerable population of CMC
for a period of 28 days. Mindfulness meditation delivered in a traditional format (i.e., 8
weekly in-person 60-90 minute sessions) has become a popular practice to improve mental
health with several researchers reporting a decrease in depressive symptoms, stress, and
anxiety in parents of a child with chronic illness. Despite these benefits, traditional
mindfulness programs can be difficult to access because they are time and cost-intensive.
Mobile applications (apps) for smartphones present an opportunity to overcome barriers
associated with typical mindfulness meditation programs. There are several popular
mindfulness apps available. One of the most widely used apps, Headspace®, offers hundreds of
hours of instructor-guided meditation exercises. Mindfulness app use has benefited users in
as little as 10 days but is often studied for 28 days. Although there is significant research
demonstrating the effectiveness of mindfulness programs delivered through a mobile app in
other populations, to the investigator's knowledge, there is no research examining the use
and efficacy in parents of CMC.
Approach Research Design. The proposed study is a single arm pilot study to explore the
feasibility, acceptability and efficacy of the intervention and to identify intervention and
protocol challenges prior to development of a RCT.
Inclusion/Exclusion criteria. Inclusion criteria are parents: 1. 18 years or older of a child
with medical complexity, 2. with daily access to a mobile device (i.e. smartphone or tablet),
3. score > 4 on Perceived Stress Scale-4 (PSS-4), and 4. able to read English (the
mindfulness app is only available in English). Exclusion criteria: a current mindfulness
practice (i. e., practice ≥15 min per day of meditation or yoga within the past 6 months).
Recruitment. Forty-five participants will be recruited from a local non-profit organization
and local community hospital's pediatric specialty outpatient clinic. The non profit supports
approximately 115 families and the pediatric clinics oversee the care of approximately 4,000
CMC throughout the state of Idaho. An informational flyer will be distributed to families in
the pediatric specialty clinic patient waiting areas. The flyer will have a link and QR code
to the enrollment forms including a questionnaire to screen for eligibility and a copy of the
consent form with the study procedures. The two sites will provide an opportunity for
increased recruitment and sample diversity. For this pilot study, 45 participants will allow
for potential attrition and a sufficient number to meet the pilot study aims and provide an
effect size for a power analysis in larger studies. The investigators believe that the study
team can successfully manage 45 participants with initial contact, weekly and end-of-study
follow-up.
Consent. Participants will email the consent forms to the PI after reading the study
procedures.
Intervention. Once the consent form is returned, the PI will assign a number to the
participant. This spreadsheet will have their name, email address, and cellphone number. It
will be stored electronically and separate from the consent forms in a secure, password
protected. The PI will send the participants an electronic link to fill out the baseline
study questionnaires. Upon completion, the research assistant will send the participants a
code and directions to download the mindfulness app, Headspace®. Headspace was selected
because it had the highest average rating (4.0 out of 5) in a review of 23 mindfulness apps.
A confirmatory text message will be sent to participants reminding them which program to
start and to use the app at minimum 4 days per week for at least 10 minutes for four weeks.
Participants will be asked to work through the Basic course 1, 2, and 3 consisting of 10
sessions ranging from 4 minutes to 11 minutes, each. The basic course provides the
fundamentals of meditation and mindfulness. In the Basics 2 course, participants start to
deepen their practice, and in the Basic 3 course, they will apply mindfulness to everyday
life. If participants complete the Basic courses, they will be asked to continue using the
app, but can choose optional classes from the Headspace library. The undergraduate research
assistant will send weekly text message reminders to encourage participant app use.
Data collection. Each week, the undergraduate research assistant will send out the
appropriate questionnaires to participants. All data will be collected using Qualtrics via an
email link. Participants will be able to complete the surveys at a time that is convenient
and a location that is comfortable for them. Participants will receive a $75 Amazon gift card
for completing the baseline and the Week 4 questionnaires. Instruments. For Aim 1,
participants will complete a brief weekly engagement and enjoyment questionnaire by providing
the total number of Headspace app minutes and programs used. At the end of the 4 week
intervention, parents will complete a questionnaire on feasibility and acceptability. For Aim
2, participants will complete stress, depression, and family management surveys at baseline
and at the end of the 4 week intervention (approximately 25 minutes to complete all
instruments at baseline and week 4). In addition, participants will complete brief, weekly
stress and engagement/enjoyment instruments that should take less than 5 minutes to finish
(Table 1). The following questionnaires will be used:
Demographics. Participants will complete a demographic questionnaire to examine parent
demographics (i.e., age, gender, income, education, occupation) and child clinical variables
(i.e., age, number of providers seen, diagnosis, time since diagnosis).
Stress. The Pediatric Inventory for Parents (PIP) is a 42-item self-report tool that was
developed to measure parenting stress related to caring for a child with a chronic illness.
Depression. The Patient Health Questionnaire (PHQ-9) is a 9-item self report tool that was
developed to measure the severity of depression. For each question, participants rate their
level of feeling on a scale of 0 - 3 (0 = not at all; 3 = nearly every day).
Family Management. The Family Management Measurement (FaMM) is a 45-item questionnaire used
to measure how parents manage the care of their child with a chronic illness.
Weekly Stress Questionnaire. The Perceived Stress Scale (PSS-10), a 10-item questionnaire
used to assess stress, has been used in a variety of populations. The total scale scores
range from 0 to 40; higher scores indicate more perceived stress.
Usage and Enjoyment Questionnaire. This is based on a previous questionnaire and consists of
closed-ended questions such as, how many minutes they used the app, what programs they used,
and to what extent the activities were enjoyable or difficult to complete.
Feasibility and Acceptability Questionnaire. This is based on a previous questionnaire. It
consists of closed-ended and open-ended questions that ask parents to rate the app, whether
they would recommend it, and asks about their experience using the app and whether they
intend to continue its use.
Data management and analysis. The surveys will be administered online via Qualtrics.
Confidentiality will be maintained by storing all data on a password protected server
maintained by Boise State University. Only study personnel will have access to the data. The
investigators will address analysis of Aim 1 with descriptive statistics from the Feasibility
and Acceptability and the Usage and Enjoyment questionnaires. Investigators will employ
content analysis of responses to the open-ended questions from the Feasibility and
Acceptability questionnaire to develop themes. For analysis of Aim 2, descriptive statistics
will be used to describe parent stress, depression and family management. To address the
hypotheses in Aim 2, the investigators will use repeated measures ANOVA in a mixed model
framework to identify changes in stress, depression, and family management indices,
controlling for weekly usage minutes. Additional covariates of weekly stress, app enjoyment,
and baseline demographics may also be examined as covariates in this model. The need for
propensity score weighting will be evaluated. The assessment of study dropouts, and the
extent to which these participants may bias the overall statistical findings, will be
conducted at the outset of the data analysis. In addition to ensuring model validity, these
analyses will help identify barriers for this population in using the app or participating in
mindfulness-based stress reduction in general.
