The Mental Health Effects of a Mindfulness App in Parents of a Child With Medical Complexity

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).