5Minutes4Myself: A Wellness Program for Caregivers

Autism Spectrum Disorder Clinical Trial

Official title:

5Minutes4Myself: A Wellness Program for Caregivers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03771001
• Other study ID #: 2015-1004
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2025

Study information

• Verified date: June 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

This study is designed to:

1. Conduct focus groups with caregivers of autistic children to understand specific stressors that they experience;

2. Gather baseline data including surveys of health and well-being;

3. 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;

4. Coach participants over the 4-6 months of their program; and

5. 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:

1. 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),

2. get introduced to the study procedures and research team (Principal Investigator, Researcher, and MI-trained Masters-level occupational therapy and counseling graduate students); and

3. 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:

1. Completion of Focus Group;

2. Re-administration of 'baseline' surveys (now considered 'post-intervention');

3. Assessing the usability of the app via the MSUS; and

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Primary caregivers for child with autism OR primary caregiver of grandchild

2. 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

3. Willingness to commit sufficient time to participate in the program

4. Desire to participate in a lifestyle/wellness program

Exclusion Criteria:

1. 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

2. Caregivers with significant mental illness (except for those diagnosed or treated for depression who will be included)

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Stress

Intervention

Other:
• Motivational Interviewing coaching and habit-building app
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

Locations

Country	Name	City	State
United States	Community Sites	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-36 Questionnaire	Survey assessing mental and physical health	Up to 6 months
Primary	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.	Up to 6 months
Primary	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.	Up to 6 months
Primary	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.	Up to 6 months
Primary	Five facets of Mindfulness Questionnaire	Assess degree of mindfulness	Up to 6 months
Primary	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.	Up to 6 months
Primary	Participant Feedback	An important outcome measure will be direct participant feedback. Program feedback will be collected via focus group participation.	Up to 6 months