Mindfulness Intervention for Caregivers of Autism in Rural Environments

Paused · Not applicable

Conditions studied: Stress, Anxiety

In brief

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.

Key facts

Study ID

NCT06169501

Run by

MaineHealth

People needed

40

Starts

2024-06-15

Expected to finish

2025-06-30

Last updated by the study team

2025-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The caregiver must be 18 years of age or older.
• The caregiver must have a zip code classified as rural according to the Rural-Urban Commuting Area codes (RUCA) in the state of Maine.
• The caregiver is currently living with a romantic partner (caregiver 2) who is also willing to participate in the study.
• The caregiver's romantic partner (caregiver 2) must be 18 years of age or older.
• 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).
• The caregiver must be able to speak and read English, regardless of whether English is their first language.
• The caregiver must have the capacity to comprehend and sign an informed consent form.
• 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).
• The caregiver must affirm that their child has received a clinical diagnosis of ASD.
• 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).
• The caregiver must possess a smartphone and have access to the internet.
• The caregiver must agree to participate in online assessments, as well as the 30-day mindfulness intervention using the Unwinding Anxiety (UA) mobile app.

You may not qualify if…

• 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.

Where it is running

• Glickman Lauder Center of Excellence — Portland, Maine, United States

Full record on ClinicalTrials.gov

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