5Minutes4Myself Wellness Program for Caregiver Stress

Overseen By Elizabeth Larson, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Significant mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to refine and test a wellness program designed to help caregivers of autistic children manage stress. Participants will work with coaches and use an app to build healthy habits through personalized wellness plans, mindfulness activities, and regular check-ins. The goal is to assess how well this program integrates into daily life and to measure changes in stress and well-being. The trial suits primary caregivers of autistic children or grandparents caring for grandchildren who seek to improve their lifestyle and stress management. As an unphased trial, this study offers caregivers a unique opportunity to enhance their well-being through innovative wellness strategies.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the 5Minutes4Myself wellness program is safe for caregivers?

Research shows that the 5Minutes4Myself program helps caregivers of autistic children manage stress through wellness activities. Specific safety information for this program is not available. The study primarily assesses the program's practicality for participants, rather than testing safety as in drug trials.

The program includes activities like mindfulness exercises, which are generally safe and have been used in other wellness programs without major issues. Most people handle these activities well. If there are any concerns, consulting a healthcare provider before joining may be helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The 5Minutes4Myself Wellness Program for caregivers is unique because it focuses on providing a convenient and practical approach to reduce stress in caregivers. Unlike traditional therapies that might require lengthy sessions or professional guidance, this program is designed to be easily integrated into daily life, allowing caregivers to dedicate just a few minutes each day to self-care. Researchers are excited about this program because it empowers caregivers with simple, effective strategies to manage stress, potentially improving their well-being without the need for complex or time-consuming interventions.

What evidence suggests that the 5Minutes4Myself wellness program is effective for caregiver stress?

Research has shown that the 5Minutes4Myself wellness program helps caregivers of autistic children reduce stress and improve well-being. Studies have found that the program's mindfulness section boosts caregivers' mindfulness and sense of well-being. Caregivers reported that the program positively impacted their lives by providing practical tools for daily challenges. The app and coaching were easy to use and offered much-needed support. Early results suggest that daily use of the app can significantly lower stress levels and enhance overall health. ^{1 2 4 6 7}

Who Is on the Research Team?

Elizabeth Larson, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for primary caregivers of autistic children aged 8-21, or grandparents parenting grandchildren aged 5-21. Participants should have a desire to engage in a wellness program and be able to commit time to it. Those caring for children outside these age ranges or with significant mental illness (except treated depression) cannot join.

Inclusion Criteria

I care for a child with autism aged 8-21 or am a grandparent caring for a grandchild aged 5-21.

Primary caregivers for child with autism OR primary caregiver of grandchild

I am willing to dedicate the necessary time for this program.

Exclusion Criteria

I am a caregiver without major mental illness, except for treated depression.

I am a caregiver for a child with autism who is either under 8 or over 21, or I am a grandparent caring for a grandchild who is under 5 or over 21.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Baseline Assessment and Program Introduction

Participants complete baseline surveys, participate in focus groups, and receive training on the wellness program and app usage

1-2 weeks

1 workshop (in-person or virtual)

Individualized Wellness Program

Participants engage in a tailored wellness program with monthly coaching sessions and app-based activities

4-6 months

Monthly coaching sessions (in-person or virtual), weekly app check-ins

Follow-up and Program Evaluation

Participants complete post-intervention surveys and participate in a closing workshop to evaluate the program

1-2 weeks

1 workshop (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• 5Minutes4Myself: A Wellness Program for Caregivers

Trial Overview

The study tests the '5Minutes4Myself' wellness program, which includes motivational coaching and an app that helps build healthy habits. Caregivers will attend workshops, receive tailored programs, use the app for reminders and mindfulness exercises, and have monthly coach check-ins.

How Is the Trial Designed?

Group I: Convenience sample participants Experimental Treatment 1 Intervention

In this feasibility study all participants will receive the intervention.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

This pilot study successfully recruited family caregivers of dementia patients for a randomized controlled trial of mindfulness-based stress reduction, exceeding recruitment goals and achieving a high retention rate of 92% at 2 months and 90% at 6 months.

The study highlights that innovative recruitment strategies, such as outreach to health plan members and press coverage, can effectively address challenges in engaging caregivers, despite barriers like cultural perceptions and time commitments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruiting and retaining family caregivers to a randomized controlled trial on mindfulness-based stress reduction. Whitebird, RR., Kreitzer, MJ., Lewis, BA., et al.[2021]

Written emotional disclosure showed a significant short-term reduction in caregiver burden, as measured by the Zarit Caregiver Burden Index, with a decline of -4.21 points at week 4 compared to control, although this effect diminished by week 8.

While overall distress and quality of life worsened for all groups, the written emotional disclosure group experienced the least worsening, suggesting it may be a beneficial strategy for managing caregiver distress in the context of advanced liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. Tapper, EB., Saleh, ZM., Lizza, S., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11542669/

Multiple-Method Feasibility Study of the 5Minutes4Myself ...

We aimed to assess the feasibility of 5Minutes4Myself app's mindfulness module (usability, usage, and impact on caregivers' levels of mindfulness and perceived ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03771001

5Minutes4Myself: A Wellness Program for Caregivers

This research study refines a wellness program designed for caregivers of autistic children called 5Minutes4Myself and further investigates its feasibility.

3.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/00084174231172036

5Minutes4Myself: Development of a Wellness Program for ...

Background. Many caregivers of autistic children experience increased stress, and diminished health often due to the caregiving demands.

4.

research.aota.org

research.aota.org/ajot/article/73/4_Supplement_1/7311520408p1/9230/A-Wellness-Tool-for-Caregivers-of-Children-With

A Wellness Tool for Caregivers of Children With Autism ...

The 5Minutes4Myself program introduces a quick and user-friendly way for caregivers of children with ASD, who are known to experience lower levels of wellbeing ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37106578/

Development of a Wellness Program for Caregivers ...

Caregivers viewed resulting 5Minutes4Myself program as filling a significant service gap; its hybrid design used in-person coaching and a habit- ...

6.

withpower.com

withpower.com/trial/phase-autism-spectrum-disorder-10-2015-9e224

5Minutes4Myself Wellness Program for Caregiver Stress

Is the 5Minutes4Myself Wellness Program for Caregiver Stress safe for humans? The research articles do not provide specific safety data for the 5Minutes4Myself ...

7.

research.aota.org

research.aota.org/ajot/article/71/4_Supplement_1/7111515254p1/7175/5Minutes4Myself-Developing-a-Feasible-Tailored

5Minutes4Myself: Developing a Feasible, Tailored Wellness ...

PURPOSE: Decades of research have outlined the negative impacts of caregiving, especially for parents of children with autism, including ...