Clinical trial NCT03771001: 5Minutes4Myself: A Wellness Program for Caregivers
Official title: 5Minutes4Myself: A Wellness Program for Caregivers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism
Stress
Autism Spectrum Disorder
Keywords: Wellness
Caregivers
Lifestyle
Stressor
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: OTHER

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:

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

Eligibility criteria: 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)

Primary outcomes:
measure: SF-36 Questionnaire
timeFrame: Up to 6 months
measure: Perceived Stress Scale
timeFrame: Up to 6 months
measure: Ryff's Psychological Well-Being Scale
timeFrame: Up to 6 months
measure: Center for Epidemiological Depression Scale-Revised
timeFrame: Up to 6 months
measure: Five facets of Mindfulness Questionnaire
timeFrame: Up to 6 months
measure: Modified System Usability Scale
timeFrame: Up to 6 months
measure: Participant Feedback
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Community Sites
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Elizabeth Larson, PhD
role: PRINCIPAL_INVESTIGATOR
References: