Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06169501
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-11-13
Brief Title:
Mindfulness Intervention for Caregivers of Autism in Rural Environments
Sponsor:
MaineHealth
Organization:
MaineHealth
Study Overview
Official Title:
Assessing a Mobile App-based Mindfulness Training to Improve Mental Health of Caregivers of Children With Autism Spectrum Disorder in Rural Areas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIND-CARE
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None