An interventional study of App-based Mindfulness Intervention in Stress and Anxiety, sponsored by MaineHealth. Suspended at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by MaineHealth · Not applicable, Interventional, and Treatment
The purpose of this clinical trial is to investigate the effectiveness of a mobile app-based mindfulness program in improving the mental well-being of caregivers with a child diagnosed with autism spectrum disorder (ASD) who live in rural areas of Maine. The primary question the investigators aim to answer is whether this mindfulness intervention can reduce stress and anxiety in these rural caregivers of children with ASD. Participants in the trial will engage in a 30-day mindfulness program that they can complete over a maximum of 60 days. During this time, they will practice short daily mindfulness lessons and respond to a set of brief questions regarding their anxiety levels. Ultimately, the investigators want to assess whether this intervention helps these caregivers feel less stressed and anxious.
Caregivers of children with autism spectrum disorder (ASD) often experience heightened stress, anxiety, and social isolation, leading to a reduced quality of life when compared to the general population and caregivers of children with other chronic health conditions. Rural caregivers of children with ASD face additional challenges due to limited access to diagnostic and treatment services, which result in delayed ASD diagnoses and increased emergency department utilization. These families are at an elevated risk of adverse outcomes linked to both the challenges of rural living and the responsibilities of caring for a child with ASD. Therefore, it is imperative to identify scalable and accessible mental health resources that effectively alleviate the stress and anxiety experienced by these caregivers living in remote regions.
This study aims to bridge the research gap by offering an innovative mobile-app based mindfulness-training program designed to reduce stress and anxiety. In this interventional pilot study, participants in the trial will engage in a 30-day mindfulness program that they can complete over a maximum of 60 days. During this time, they will practice short daily mindfulness lessons and respond to a set of brief questions regarding their anxiety levels. The study will also collect data at baseline, midpoint, endpoint, and 1-year follow-up to assess adherence, satisfaction, and changes in stress and anxiety over time. Stakeholder involvement has been essential in shaping the study design, ensuring its relevance, and developing pathways for future studies.
The study targets rural caregivers of children with ASD living in Maine, aiming to include a total of 40 caregivers (20 cohabitating romantic couples). By integrating both parents into the intervention framework, this study seeks to harness their unique insights, enhance intervention participation, and provide a more comprehensive approach to addressing the complex mental health challenges in this population. This holistic approach, integrating the experiences and perspectives of both parents, strives to improve caregivers' well-being while also enhancing the care they provide for their children.
Exclusion Criteria:
All study participants will receive the app-based mindfulness intervention.
Behavioral: App-based Mindfulness Intervention
Participants in the trial will engage in a 30-day app-based mindfulness program called Unwinding Anxiety that they can complete over a maximum of 60 days. During this time, they will practice short daily mindfulness lessons and respond to a set of brief questions regarding their anxiety levels. Ultimately, we want to assess whether this intervention helps these caregivers feel less stressed and anxious.
stress
Parental Stress Scale (PSS). The PSS will be used to assess levels of stress experienced by caregivers with a child with autism as well as both positive and negative aspects of parenting. The PSS is a self-reported 18-item, 5-point Likert scale with responses ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The total possible score ranges from 18 to 90, after summing all items; with higher scores reflecting higher caregiver stress.
Time frame: admission, daily from study admission up to 60-days, completion of mindfulness training (anytime between days 30-60, this will vary by participant), 1-year follow-up
anxiety
Generalized Anxiety Disorder-7 Scale (GAD-7). The GAD-7 is a self-reported measure that consists of seven items measuring worry and anxiety. Each item is scored on a four-point Likert scale with responses ranging from 0 ("not at all") to 3 ("extremely"). The total possible scores range from 0 to 21, after summing all items; with higher scores reflecting greater anxiety severity.
Time frame: admission, daily from study admission up to 60-days, completion of mindfulness training (anytime between days 30-60, this will vary by participant), 1-year follow-up
intervention adherence
Adherence to the Unwinding Anxiety intervention will be measured by calculating the proportion of mindfulness training completed out of the 30 possible modules.
Time frame: daily from study admission up to 60-days
intervention satisfaction
Abbreviated Acceptability Rating Profile (AARP). The AARP will be used to assess satisfaction of the Unwinding Anxiety mobile application intervention. The AARP is a self-reported 8-item, 6-point Likert scale with responses ranging from 1("strongly agree") to 6 ("strongly agree"). The total possible scores range from 8 to 48, after summing all items; with higher scores reflecting higher intervention satisfaction.
Time frame: study midpoint (anytime between days 15-30, this will vary by participant) and completion of mindfulness training (anytime between days 30-60, this will vary by participant)
Plan to share: Yes — Our Individual Participant Data (IPD) sharing plan promotes responsible data sharing, prioritizing participant privacy and consent. It covers de-identified demographic, behavioral, and daily experience data from a 60-day mindfulness study. Data access requires formal agreements with qualified researchers, ensuring privacy and responsible usage. Collaboration and scientific contribution are encouraged, with data security measures including encryption and REDCap usage. The plan adheres to high ethical and privacy standards, striking a balance between research advancement and participant protection. It underscores our commitment to ethical data handling, fostering scientific progress while respecting participant privacy.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is suspended, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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