AutismNCT03771001
5Minutes4Myself: A Wellness Program for Caregivers
A study testing Motivational Interviewing coaching and habit-building app in people with Autism and Stress, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This research study refines a wellness program designed for caregivers of autistic children called 5Minutes4Myself and further investigates its feasibility. Participants will attend a workshop to consent, participate in focus groups on lifestyle issues, and complete a baseline survey. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autism, Stress, Autism Spectrum Disorder
- What is being tested?
- Motivational Interviewing coaching and habit-building app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 30 May 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Primary caregivers for child with autism OR primary caregiver of grandchild
- Child cared for is between 8 - 21 for caregivers of children with autism and 5-21 years of age for grandchildren being parented by grandparents
- Willingness to commit sufficient time to participate in the program
- Desire to participate in a lifestyle/wellness program
Who cannot join
- Caregivers of children younger than 8 years of age or older than 21 years of age for sample of parents of children with autism and Caregiver of child younger than 5 or older than 21 for grandparents parenting grandchildren
- Caregivers with significant mental illness (except for those diagnosed or treated for depression who will be included)
Trial locations and contacts
1 site in 1 country.
About this study
This research study refines a wellness program designed for caregivers of autistic children called 5Minutes4Myself and further investigates its feasibility. Participants will attend a workshop to consent, participate in focus groups on lifestyle issues, and complete a baseline survey. Participants will have an individualized consultation with a coach to develop their tailored wellness program and be introduced to an app that support habits to build wellness activities into their daily life. The app provides the participant with their goal profile, tailored reminders, weekly check-ins, and delivers a micro-mindfulness program. Coaches will check-in monthly with participants and work together to modify their program as desired. After 4-6 months, participants will gather for a closing workshop to discuss their lifestyle and to evaluate the program. Pre-/post-surveys will examine health, well-being, stress, depression, and mindfulness. The app usability will be assessed using the Modified Systems Usability Scale (MSUS) as well as usage data.
Read the detailed description
This study is designed to:
- Conduct focus groups with caregivers of autistic children to understand specific stressors that they experience;
- Gather baseline data including surveys of health and well-being;
- Administer an individualized wellness program by using motivational interviews (MI) to individually tailor the program for each participant, train participants to use an app designed to support the adoption of lifestyle changes;
- Coach participants over the 4-6 months of their program; and
- Assess the usability of the app and the impact of the wellness program on caregiver's health and well-being.
Participants will be invited to the University of Wisconsin-Madison campus or participate online where they will:
- complete baseline surveys of physical and mental health, mindfulness, stress, and wellbeing (Center for Epidemiology Depression Scale -Revised; Five Facet Mindfulness Questionnaire; Perceived Stress Scale; Psychological Well-being Scale; Rand Short Form-36),
- get introduced to the study procedures and research team (Principal Investigator, Researcher, and MI-trained Masters-level occupational therapy and counseling graduate students); and
- participate in focus groups to introduce the 5Minutes4Myself program, offer data on current lifestyles, and receive training on how to use the app
Participants will be assigned coaches. They will work together in an initial lifestyle coaching session and continue meeting monthly for 4-6 months. To assess the fidelity of the coaching sessions, motivation interviewing sessions (initial and monthly) will be audio-- or video--taped to assess fidelity via the Motivational Interviewing Treatment Integrity tool (MITI). Participants will be asked to complete an assessment of their satisfaction with the coaching. Data will be archived for the ongoing project.
The coaches will use Motivational Interviewing strategies to identify barriers to implementing the mindfulness program, foster commitment talk, and elicit the participant's strategy for implementing the mindfulness program in their daily life. Participants may request additional consultation through the weekly app goal check-in or via email.
The app will host all baseline surveys allowing them to be completed electronically. The baseline surveys will be completed prior to the first coaching session. The app will also be used as a "habit builder" providing personalized notifications as to when a goal activity will be created, will have goal check ins for each goal, and will collect usage data for audio mindfulness podcasts that are part of the program. Usage data will show how often and for how long participants listened to a podcast during the intervention.
After completing the 4-6 month intervention, participants will return for another workshop that will include:
- Completion of Focus Group;
- Re-administration of 'baseline' surveys (now considered 'post-intervention');
- Assessing the usability of the app via the MSUS; and
- Conditions
- Autism, Stress, Autism Spectrum Disorder
- Being tested
- Motivational Interviewing coaching and habit-building app
- Keywords
- Wellness, Caregivers, Lifestyle, Stressor
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing coaching and habit-building appOther
Coaches will use a manualized motivational interviewing approach and participants' wellness promoting changes will be supported via a habit building app that also delivers a micro-mindfulness program
| Study group | Role | What they receive |
|---|---|---|
| Convenience sample participants | Other | In this feasibility study all participants will receive the intervention. Receives: Other: Motivational Interviewing coaching and habit-building app |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 Questionnaire
Survey assessing mental and physical health
Measured: Up to 6 months
Perceived Stress Scale
The Perceived Stress Scale is a measure of the degree to which the participant perceives their life as stressful. A series of 10 questions are asked to which the participant answers either: 0 = Never; 1 = Almost Never; 2 = Sometimes; 3 = Fairly Often; 4 = Very Often. The scoring for positively worded questions is calculated by reversing the response (0=4, 1=3, 2=2, 3=1, 4=0). Higher total scores indicate more perceived stress.
Measured: Up to 6 months
Ryff's Psychological Well-Being Scale
Ryff's Psychological Well-Being is a self-reported scale to assess well-being. Participants respond to various statements about autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance and indicate how true each statement is of them on a 6-point Likert scale. Higher scores are representative of greater sense of well-being.
Measured: Up to 6 months
Center for Epidemiological Depression Scale-Revised
The Center for Epidemiological Depression Scale (Revised; CESD-R) is a self-reported assessment where the participant answers 20 questions about how they have felt or behaved over the past 1-2 weeks. It is scored: 0 = Not at All or less than 1 day; 1 = 1-2 days; 2 = 3-4 days; 3 = 5-7 days; 4 = nearly every 5 for 2 weeks. Higher scores indicate greater depressive state.
Measured: Up to 6 months
Five facets of Mindfulness Questionnaire
Assess degree of mindfulness
Measured: Up to 6 months
Modified System Usability Scale
The Modified System Usability Scale is a 10 item questionnaire where the participants have 5 responses ranging from Strongly Agree to Strongly Disagree. The responses are assigned values such that the total score ranges from 1-100 with higher scores indicating increased usability.
Measured: Up to 6 months
Participant Feedback
An important outcome measure will be direct participant feedback. Program feedback will be collected via focus group participation.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study startNov 2015
- Primary completion30 May 2025
- Study completion30 May 2025
Why it stopped: lack of funding to rebuild the app
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Larson, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771001
- Sponsor's protocol ID
- 2015-1004
- Status last verified
- Oct 2025
- First submitted
- 30 Nov 2018
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larson E, Mattie RL, Riffkin SA. Assessment of Acceptability, Usage, and Impact on Caregivers of Children With Autism's Stress and Mindfulness: Multiple-Method Feasibility Study of the 5Minutes4Myself App's Mindfulness Module. JMIR Hum Factors. 2024 Oct 31;11:e54171. doi: 10.2196/54171.
PubMed 39480802
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5Minutes4Myself: A Wellness Program for Caregivers
- ClinicalTrials.gov ID
- NCT03771001
- Acronym / sponsor ID
- 2015-1004
- Conditions
- Autism, Stress, Autism Spectrum Disorder
- Keywords
- Wellness, Caregivers, Lifestyle, Stressor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding to rebuild the app
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 10 Dec 2018 (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.
This research study refines a wellness program designed for caregivers of autistic children called 5Minutes4Myself and further investigates its feasibility. Participants will attend a workshop to consent, participate in focus groups on lifestyle issues, and complete a baseline survey. Participants will have an individualized consultation with a coach to develop their tailored wellness program and be introduced to an app that support habits to build wellness activities into their daily life. The app provides the participant with their goal profile, tailored reminders, weekly check-ins, and delivers a micro-mindfulness program. Coaches will check-in monthly with participants and work together to modify their program as desired. After 4-6 months, participants will gather for a closing workshop to discuss their lifestyle and to evaluate the program. Pre-/post-surveys will examine health, well-being, stress, depression, and mindfulness. The app usability will be assessed using the Modified Systems Usability Scale (MSUS) as well as usage data.
Detailed description
This study is designed to:
- Conduct focus groups with caregivers of autistic children to understand specific stressors that they experience;
- Gather baseline data including surveys of health and well-being;
- Administer an individualized wellness program by using motivational interviews (MI) to individually tailor the program for each participant, train participants to use an app designed to support the adoption of lifestyle changes;
- Coach participants over the 4-6 months of their program; and
- Assess the usability of the app and the impact of the wellness program on caregiver's health and well-being.
Participants will be invited to the University of Wisconsin-Madison campus or participate online where they will:
- complete baseline surveys of physical and mental health, mindfulness, stress, and wellbeing (Center for Epidemiology Depression Scale -Revised; Five Facet Mindfulness Questionnaire; Perceived Stress Scale; Psychological Well-being Scale; Rand Short Form-36),
- get introduced to the study procedures and research team (Principal Investigator, Researcher, and MI-trained Masters-level occupational therapy and counseling graduate students); and
- participate in focus groups to introduce the 5Minutes4Myself program, offer data on current lifestyles, and receive training on how to use the app
Participants will be assigned coaches. They will work together in an initial lifestyle coaching session and continue meeting monthly for 4-6 months. To assess the fidelity of the coaching sessions, motivation interviewing sessions (initial and monthly) will be audio-- or video--taped to assess fidelity via the Motivational Interviewing Treatment Integrity tool (MITI). Participants will be asked to complete an assessment of their satisfaction with the coaching. Data will be archived for the ongoing project.
The coaches will use Motivational Interviewing strategies to identify barriers to implementing the mindfulness program, foster commitment talk, and elicit the participant's strategy for implementing the mindfulness program in their daily life. Participants may request additional consultation through the weekly app goal check-in or via email.
The app will host all baseline surveys allowing them to be completed electronically. The baseline surveys will be completed prior to the first coaching session. The app will also be used as a "habit builder" providing personalized notifications as to when a goal activity will be created, will have goal check ins for each goal, and will collect usage data for audio mindfulness podcasts that are part of the program. Usage data will show how often and for how long participants listened to a podcast during the intervention.
After completing the 4-6 month intervention, participants will return for another workshop that will include:
- Completion of Focus Group;
- Re-administration of 'baseline' surveys (now considered 'post-intervention');
- Assessing the usability of the app via the MSUS; and
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Convenience sample participants | Other | Other: Motivational Interviewing coaching and habit-building appIn this feasibility study all participants will receive the intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Primary caregivers for child with autism OR primary caregiver of grandchild
- Child cared for is between 8 - 21 for caregivers of children with autism and 5-21 years of age for grandchildren being parented by grandparents
- Willingness to commit sufficient time to participate in the program
- Desire to participate in a lifestyle/wellness program
Key exclusion criteria (2 listed)
- Caregivers of children younger than 8 years of age or older than 21 years of age for sample of parents of children with autism and Caregiver of child younger than 5 or older than 21 for grandparents parenting grandchildren
- Caregivers with significant mental illness (except for those diagnosed or treated for depression who will be included)
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 |
|---|---|---|
| Motivational Interviewing coaching and habit-building appCoaches will use a manualized motivational interviewing approach and participants' wellness promoting changes will be supported via a habit building app that also delivers a micro-mindfulness program | Other | Convenience sample participants |
Primary outcome
SF-36 Questionnaire
Time frame: Up to 6 months
Survey assessing mental and physical health
Perceived Stress Scale
Time frame: Up to 6 months
The Perceived Stress Scale is a measure of the degree to which the participant perceives their life as stressful. A series of 10 questions are asked to which the participant answers either: 0 = Never; 1 = Almost Never; 2 = Sometimes; 3 = Fairly Often; 4 = Very Often. The scoring for positively worded questions is calculated by reversing the response (0=4, 1=3, 2=2, 3=1, 4=0). Higher total scores indicate more perceived stress.
Ryff's Psychological Well-Being Scale
Time frame: Up to 6 months
Ryff's Psychological Well-Being is a self-reported scale to assess well-being. Participants respond to various statements about autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance and indicate how true each statement is of them on a 6-point Likert scale. Higher scores are representative of greater sense of well-being.
Center for Epidemiological Depression Scale-Revised
Time frame: Up to 6 months
The Center for Epidemiological Depression Scale (Revised; CESD-R) is a self-reported assessment where the participant answers 20 questions about how they have felt or behaved over the past 1-2 weeks. It is scored: 0 = Not at All or less than 1 day; 1 = 1-2 days; 2 = 3-4 days; 3 = 5-7 days; 4 = nearly every 5 for 2 weeks. Higher scores indicate greater depressive state.
Five facets of Mindfulness Questionnaire
Time frame: Up to 6 months
Assess degree of mindfulness
Modified System Usability Scale
Time frame: Up to 6 months
The Modified System Usability Scale is a 10 item questionnaire where the participants have 5 responses ranging from Strongly Agree to Strongly Disagree. The responses are assigned values such that the total score ranges from 1-100 with higher scores indicating increased usability.
Participant Feedback
Time frame: Up to 6 months
An important outcome measure will be direct participant feedback. Program feedback will be collected via focus group participation.
Results and safety
The study was stopped early (reason given: lack of funding to rebuild the app). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Derived from this study: PubMed 39480802Larson E, Mattie RL, Riffkin SA. Assessment of Acceptability, Usage, and Impact on Caregivers of Children With Autism's Stress and Mindfulness: Multiple-Method Feasibility Study of the 5Minutes4Myself App's Mindfulness Module. JMIR Hum Factors. 2024 Oct 31;11:e54171. doi: 10.2196/54171.
- Individual participant dataSharing planned: No
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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.
Elizabeth Larson, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing coaching and habit-building app in people with Autism and Stress, run by University of Wisconsin, Madison 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 27 Oct 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?
The study was stopped early (reason given: lack of funding to rebuild the app). 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?
SF-36 Questionnaire (time frame: Up to 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03771001, which also lists 1 linked publication.
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 27 Oct 2025.