Clinical trial NCT06169501: Mindfulness Intervention for Caregivers of Autism in Rural Environments
Official title: Assessing a Mobile App-based Mindfulness Training to Improve Mental Health of Caregivers of Children With Autism Spectrum Disorder in Rural Areas
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stress
Anxiety
Keywords: caregivers
autism
anxiety
stress
mindfulness
intervention
mobile app-based
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional Study Model: This study employs a single-group assignment where participants are exposed to a mindfulness intervention for caregivers of children with autism spectrum disorders living in rural areas of Maine. The primary aim is to assess the intervention's impact on reducing caregiver stress and anxiety levels. Participants complete daily mindfulness lessons and report anxiety for up to 60 days.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. The caregiver must be 18 years of age or older.
2. The caregiver must have a zip code classified as rural according to the Rural-Urban Commuting Area codes (RUCA) in the state of Maine.
3. The caregiver is currently living with a romantic partner (caregiver 2) who is also willing to participate in the study.
4. The caregiver's romantic partner (caregiver 2) must be 18 years of age or older.
5. The caregiver is defined as an adult, whether biological or non-biological parent/guardian, who currently resides with and provides care for a child with Autism Spectrum Disorder (ASD).
6. The caregiver must be able to speak and read English, regardless of whether English is their first language.
7. The caregiver must have the capacity to comprehend and sign an informed consent form.
8. The caregiver must be a legally authorized representative and cannot be a guardian or foster parent under the Department of Health and Human Services (DHHS).
9. The caregiver must affirm that their child has received a clinical diagnosis of ASD.
10. Both the caregiver and the child must reside at an address classified as rural according to the Rural-Urban Commuting Area codes (RUCA) in the state of Maine (identified by zip code).
11. The caregiver must possess a smartphone and have access to the internet.
12. The caregiver must agree to participate in online assessments, as well as the 30-day mindfulness intervention using the Unwinding Anxiety (UA) mobile app.

Exclusion Criteria:

1. Any medical condition or impairment that would hinder the participant's ability to engage in a study that involves daily visual and auditory tasks, as well as comprehension and adherence to the study protocol. Examples of such impairments include deafness, blindness, impaired decision making capacity and impaired intellectual functioning.

Primary outcomes:
measure: stress
timeFrame: 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
measure: anxiety
timeFrame: 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
Secondary outcomes:
measure: intervention adherence
timeFrame: daily from study admission up to 60-days
measure: intervention satisfaction
timeFrame: 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)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Glickman Lauder Center of Excellence
state: Maine
Study officials:
affiliation: MaineHealth
name: Kahsi A Pedersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: