<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03771001</url>
  </required_header>
  <id_info>
    <org_study_id>2015-1004</org_study_id>
    <nct_id>NCT03771001</nct_id>
  </id_info>
  <brief_title>5Minutes4Myself: A Wellness Program for Caregivers</brief_title>
  <official_title>5Minutes4Myself: A Wellness Program for Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study refines a wellness program designed for caregivers of autistic children&#xD;
      called 5Minutes4Myself and further investigates its feasibility. Participants will attend a&#xD;
      workshop to consent, participate in focus groups on lifestyle issues, and complete a baseline&#xD;
      survey. Participants will have an individualized consultation with a coach to develop their&#xD;
      tailored wellness program and be introduced to an app that support habits to build wellness&#xD;
      activities into their daily life. The app provides the participant with their goal profile,&#xD;
      tailored reminders, weekly check-ins, and delivers a micro-mindfulness program. Coaches will&#xD;
      check-in monthly with participants and work together to modify their program as desired.&#xD;
      After 4-6 months, participants will gather for a closing workshop to discuss their lifestyle&#xD;
      and to evaluate the program. Pre-/post-surveys will examine health, well-being, stress,&#xD;
      depression, and mindfulness. The app usability will be assessed using the Modified Systems&#xD;
      Usability Scale (MSUS) as well as usage data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to:&#xD;
&#xD;
        1. Conduct focus groups with caregivers of autistic children to understand specific&#xD;
           stressors that they experience;&#xD;
&#xD;
        2. Gather baseline data including surveys of health and well-being;&#xD;
&#xD;
        3. Administer an individualized wellness program by using motivational interviews (MI) to&#xD;
           individually tailor the program for each participant, train participants to use an app&#xD;
           designed to support the adoption of lifestyle changes;&#xD;
&#xD;
        4. Coach participants over the 4-6 months of their program; and&#xD;
&#xD;
        5. Assess the usability of the app and the impact of the wellness program on caregiver's&#xD;
           health and well-being.&#xD;
&#xD;
      Participants will be invited to the University of Wisconsin-Madison campus or participate&#xD;
      online where they will:&#xD;
&#xD;
        1. complete baseline surveys of physical and mental health, mindfulness, stress, and&#xD;
           wellbeing (Center for Epidemiology Depression Scale -Revised; Five Facet Mindfulness&#xD;
           Questionnaire; Perceived Stress Scale; Psychological Well-being Scale; Rand Short&#xD;
           Form-36),&#xD;
&#xD;
        2. get introduced to the study procedures and research team (Principal Investigator,&#xD;
           Researcher, and MI-trained Masters-level occupational therapy and counseling graduate&#xD;
           students); and&#xD;
&#xD;
        3. participate in focus groups to introduce the 5Minutes4Myself program, offer data on&#xD;
           current lifestyles, and receive training on how to use the app&#xD;
&#xD;
      Participants will be assigned coaches. They will work together in an initial lifestyle&#xD;
      coaching session and continue meeting monthly for 4-6 months. To assess the fidelity of the&#xD;
      coaching sessions, motivation interviewing sessions (initial and monthly) will be audio-- or&#xD;
      video--taped to assess fidelity via the Motivational Interviewing Treatment Integrity tool&#xD;
      (MITI). Participants will be asked to complete an assessment of their satisfaction with the&#xD;
      coaching. Data will be archived for the ongoing project.&#xD;
&#xD;
      The coaches will use Motivational Interviewing strategies to identify barriers to&#xD;
      implementing the mindfulness program, foster commitment talk, and elicit the participant's&#xD;
      strategy for implementing the mindfulness program in their daily life. Participants may&#xD;
      request additional consultation through the weekly app goal check-in or via email.&#xD;
&#xD;
      The app will host all baseline surveys allowing them to be completed electronically. The&#xD;
      baseline surveys will be completed prior to the first coaching session. The app will also be&#xD;
      used as a &quot;habit builder&quot; providing personalized notifications as to when a goal activity&#xD;
      will be created, will have goal check ins for each goal, and will collect usage data for&#xD;
      audio mindfulness podcasts that are part of the program. Usage data will show how often and&#xD;
      for how long participants listened to a podcast during the intervention.&#xD;
&#xD;
      After completing the 4-6 month intervention, participants will return for another workshop&#xD;
      that will include:&#xD;
&#xD;
        1. Completion of Focus Group;&#xD;
&#xD;
        2. Re-administration of 'baseline' surveys (now considered 'post-intervention');&#xD;
&#xD;
        3. Assessing the usability of the app via the MSUS; and&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Feasibility study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SF-36 Questionnaire</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Survey assessing mental and physical health</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Stress Scale</measure>
    <time_frame>Up to 6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ryff's Psychological Well-Being Scale</measure>
    <time_frame>Up to 6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Center for Epidemiological Depression Scale-Revised</measure>
    <time_frame>Up to 6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Five facets of Mindfulness Questionnaire</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Assess degree of mindfulness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified System Usability Scale</measure>
    <time_frame>Up to 6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant Feedback</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>An important outcome measure will be direct participant feedback. Program feedback will be collected via focus group participation.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Autism</condition>
  <condition>Stress</condition>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Convenience sample participants</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this feasibility study all participants will receive the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Motivational Interviewing coaching and habit-building app</intervention_name>
    <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</description>
    <arm_group_label>Convenience sample participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Primary caregivers for child with autism OR primary caregiver of grandchild&#xD;
&#xD;
          2. Child cared for is between 8 - 21 for caregivers of children with autism and 5-21&#xD;
             years of age for grandchildren being parented by grandparents&#xD;
&#xD;
          3. Willingness to commit sufficient time to participate in the program&#xD;
&#xD;
          4. Desire to participate in a lifestyle/wellness program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Caregivers of children younger than 8 years of age or older than 21 years of age for&#xD;
             sample of parents of children with autism and Caregiver of child younger than 5 or&#xD;
             older than 21 for grandparents parenting grandchildren&#xD;
&#xD;
          2. Caregivers with significant mental illness (except for those diagnosed or treated for&#xD;
             depression who will be included)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Larson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Community Sites</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wellness</keyword>
  <keyword>Caregivers</keyword>
  <keyword>Lifestyle</keyword>
  <keyword>Stressor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03771001
org study id: 2015-1004
nct id: NCT03771001
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Feasibility study
primary purpose: Other
masking: None (Open Label)
measure: SF-36 Questionnaire
time frame: Up to 6 months
description: Survey assessing mental and physical health
measure: Perceived Stress Scale
time frame: Up to 6 months
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.
measure: Ryff's Psychological Well-Being Scale
time frame: Up to 6 months
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.
measure: Center for Epidemiological Depression Scale-Revised
time frame: Up to 6 months
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.
measure: Five facets of Mindfulness Questionnaire
time frame: Up to 6 months
description: Assess degree of mindfulness
measure: Modified System Usability Scale
time frame: Up to 6 months
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.
measure: Participant Feedback
time frame: Up to 6 months
description: An important outcome measure will be direct participant feedback. Program feedback will be collected via focus group participation.
arm group label: Convenience sample participants
arm group type: Other
description: In this feasibility study all participants will receive the intervention.
intervention type: Other
intervention name: Motivational Interviewing coaching and habit-building app
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
arm group label: Convenience sample participants
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elizabeth Larson, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No