NCT06169501

Mindfulness Intervention for Caregivers of Autism in Rural Environments

Assessing a Mobile App-based Mindfulness Training to Improve Mental Health of Caregivers of Children With Autism Spectrum Disorder in Rural Areas

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: MaineHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Stress
• Anxiety

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-15
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2023-12-13
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States