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临床试验/NCT03771001
NCT03771001终止不适用

5Minutes4Myself: A Wellness Program for Caregivers

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
1
主要终点
Five facets of Mindfulness Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

Convenience sample participants

Other

In this feasibility study all participants will receive the intervention.

干预措施: Motivational Interviewing coaching and habit-building app (Other)

结局指标

主要结局

Five facets of Mindfulness Questionnaire

时间窗: Up to 6 months

Assess degree of mindfulness

SF-36 Questionnaire

时间窗: Up to 6 months

Survey assessing mental and physical health

Perceived Stress Scale

时间窗: 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

时间窗: 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

时间窗: 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.

Modified System Usability Scale

时间窗: 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

时间窗: Up to 6 months

An important outcome measure will be direct participant feedback. Program feedback will be collected via focus group participation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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