Mindfulness Intervention for Caregivers of Autism in Rural Environments

NCT06169501 | Suspended DMC

• 1 other identifier: 2085966
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Anxiety

Keywords

caregivers; autism; anxiety; stress; mindfulness; intervention; mobile app-based

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 (2)

• intervention adherence

  daily from study admission up to 60-days

• intervention satisfaction

  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)

Study Arms (1)

Intervention

EXPERIMENTAL

All study participants will receive the app-based mindfulness intervention.

Behavioral: App-based Mindfulness Intervention

Interventions

App-based Mindfulness Intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

Glickman Lauder Center of Excellence

Portland, Maine, 04102, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Autistic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Kahsi A Pedersen, PhD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: December 13, 2023
• Study Start: June 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication. End date 3-5 years.
• Access Criteria: Access and Qualifications: Access to de-identified data will be granted exclusively to qualified researchers who enter into formal data sharing agreements. This approach serves to safeguard participant privacy and consent, limiting access to trusted individuals dedicated to responsible data utilization.

Locations

US (1)