StressMIND-CARENCT06169501
Mindfulness Intervention for Caregivers of Autism in Rural Environments
A study testing App-based Mindfulness Intervention in people with Stress and Anxiety, run by MaineHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- App-based Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glickman Lauder Center of Excellence
Portland, Maine, 04102
About this study
Official title: Assessing a Mobile App-based Mindfulness Training to Improve Mental Health of Caregivers of Children With Autism Spectrum Disorder in Rural Areas
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.
Read the 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.
- Being tested
- App-based Mindfulness Intervention
- Keywords
- caregivers, autism, anxiety, stress, mindfulness, intervention, mobile app-based
- Medical subject headings
- Anxiety Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based Mindfulness InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All study participants will receive the app-based mindfulness intervention. Receives: Behavioral: App-based Mindfulness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Adherence to the Unwinding Anxiety intervention will be measured by calculating the proportion of mindfulness training completed out of the 30 possible modules.
Measured: daily from study admission up to 60-days
intervention satisfaction
Abbreviated Acceptability Rating Profile (AARP). The AARP will be used to assess satisfaction of the Unwinding Anxiety mobile application intervention. The AARP is a self-reported 8-item, 6-point Likert scale with responses ranging from 1("strongly agree") to 6 ("strongly agree"). The total possible scores range from 8 to 48, after summing all items; with higher scores reflecting higher intervention satisfaction.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start15 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: Funding was terminated, seeing new funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kahsi A. Pedersen, MaineHealth
- Investigators
- Kahsi A Pedersen, PhD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169501
- Sponsor's protocol ID
- 2085966
- Acronym
- MIND-CARE
- Status last verified
- May 2025
- First submitted
- 13 Nov 2023
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our Individual Participant Data (IPD) sharing plan promotes responsible data sharing, prioritizing participant privacy and consent. It covers de-identified demographic, behavioral, and daily experience data from a 60-day mindfulness study. Data access requires formal agreements with qualified researchers, ensuring privacy and responsible usage. Collaboration and scientific contribution are encouraged, with data security measures including encryption and REDCap usage. The plan adheres to high ethical and privacy standards, striking a balance between research advancement and participant protection. It underscores our commitment to ethical data handling, fostering scientific progress while respecting participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a Mobile App-based Mindfulness Training to Improve Mental Health of Caregivers of Children With Autism Spectrum Disorder in Rural Areas
- ClinicalTrials.gov ID
- NCT06169501
- Acronym / sponsor ID
- MIND-CARE / 2085966
- Keywords
- caregivers, autism, anxiety, stress, mindfulness, intervention, mobile app-based
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding was terminated, seeing new funding.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: App-based Mindfulness InterventionAll study participants will receive the app-based mindfulness intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based Mindfulness InterventionParticipants 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. | Behavioural | Intervention |
Primary outcome
stress
Time frame: 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
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.
anxiety
Time frame: 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
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.
2 secondary outcomes
intervention adherence
Time frame: daily from study admission up to 60-days
intervention satisfaction
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Yes. Our Individual Participant Data (IPD) sharing plan promotes responsible data sharing, prioritizing participant privacy and consent. It covers de-identified demographic, behavioral, and daily experience data from a 60-day mindfulness study. Data access requires formal agreements with qualified researchers, ensuring privacy and responsible usage. Collaboration and scientific contribution are encouraged, with data security measures including encryption and REDCap usage. The plan adheres to high ethical and privacy standards, striking a balance between research advancement and participant protection. It underscores our commitment to ethical data handling, fostering scientific progress while respecting participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kahsi A Pedersen, PhD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based Mindfulness Intervention in people with Stress and Anxiety, run by MaineHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.