5Minutes4Myself: A Wellness Program for Caregivers
Primary Purpose
Autism, Stress, Autism Spectrum Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing coaching and habit-building app
Sponsored by
About this trial
This is an interventional other trial for Autism focused on measuring Wellness, Caregivers, Lifestyle, Stressor
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Community Sites
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Convenience sample participants
Arm Description
In this feasibility study all participants will receive the intervention.
Outcomes
Primary Outcome Measures
SF-36 Questionnaire
Survey assessing mental and physical health
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.
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.
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.
Five facets of Mindfulness Questionnaire
Assess degree of mindfulness
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.
Participant Feedback
An important outcome measure will be direct participant feedback. Program feedback will be collected via focus group participation.
Secondary Outcome Measures
Full Information
NCT ID
NCT03771001
First Posted
November 30, 2018
Last Updated
June 13, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT03771001
Brief Title
5Minutes4Myself: A Wellness Program for Caregivers
Official Title
5Minutes4Myself: A Wellness Program for Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2015 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Stress, Autism Spectrum Disorder
Keywords
Wellness, Caregivers, Lifestyle, Stressor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Convenience sample participants
Arm Type
Other
Arm Description
In this feasibility study all participants will receive the intervention.
Intervention Type
Other
Intervention Name(s)
Motivational Interviewing coaching and habit-building app
Intervention Description
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
Primary Outcome Measure Information:
Title
SF-36 Questionnaire
Description
Survey assessing mental and physical health
Time Frame
Up to 6 months
Title
Perceived Stress Scale
Description
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.
Time Frame
Up to 6 months
Title
Ryff's Psychological Well-Being Scale
Description
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.
Time Frame
Up to 6 months
Title
Center for Epidemiological Depression Scale-Revised
Description
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.
Time Frame
Up to 6 months
Title
Five facets of Mindfulness Questionnaire
Description
Assess degree of mindfulness
Time Frame
Up to 6 months
Title
Modified System Usability Scale
Description
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.
Time Frame
Up to 6 months
Title
Participant Feedback
Description
An important outcome measure will be direct participant feedback. Program feedback will be collected via focus group participation.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Larson, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Sites
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
5Minutes4Myself: A Wellness Program for Caregivers
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