<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/NCT04453657</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00250864</org_study_id>
    <nct_id>NCT04453657</nct_id>
  </id_info>
  <brief_title>Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, Family Engagement, and School Readiness Amid COVID-19</brief_title>
  <official_title>Adapting and Delivering a Tele-Wellness Supported Digital Toolkit to Baltimore City's Approved Family Child Care Home Providers Caring for Children of Essential Workers: Promoting Health, Early Literacy, and Quality Parent Engagement Amid COVID-19: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</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>
      The investigators aim to deliver a tele-wellness supported app to Baltimore City's Family&#xD;
      Child Care Home (FCCH) providers who are caring for children of Essential Personnel. Once a&#xD;
      pre-survey is conducted, login information will be assigned to 30 Family Child Care Home&#xD;
      providers and parents the FCCH serve. Providers and Parents will receive self-care and&#xD;
      parenting/parent engagement support through the app and through a tele-wellness service, Ask&#xD;
      a Nurse, provided by community health nurses at the Johns Hopkins School of Nursing. Children&#xD;
      will have access to gamified learning materials in early literacy, math, social-emotional&#xD;
      learning, and nutrition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will adapt and deliver a tele-wellness supported digital toolkit via an app&#xD;
      for Baltimore City's Family Child Care Home (FCCH) providers and the families the FCCH serve.&#xD;
      Through this digital toolkit, the investigators aim to provide related self-care support,&#xD;
      parent/parent engagement support for both Family Child Care Home providers and parents, and&#xD;
      provide access to early literacy, math, social-emotional learning, and nutrition games for&#xD;
      children (3-6 years old). Additionally, Family Child Care Home providers and parents will&#xD;
      have access to a hotline and email to the Ask a Nurse program-a tele-wellness program run by&#xD;
      community registered nurses at Johns Hopkins School of Nursing. Through Ask a Nurse,&#xD;
      providers and parents will be able to receive wellness counseling from licensed registered&#xD;
      nurses and care coordination to address specific social needs. The tele-wellness service is&#xD;
      NOT intended to directly address health issues, diagnose, or prescribe. In summary, Family&#xD;
      Child Care Home providers will have access to self-care and parent engagement resources and&#xD;
      parents will have access to self-care and parenting resources in addition to the games for&#xD;
      the child(ren).&#xD;
&#xD;
      The first phase of this study is to tailor an existing app, Escribo Play that already has&#xD;
      gamified early literacy and math tools, and expand its scope by including self-care and&#xD;
      parenting/parent engagement support for Family Child Care Home Providers and the parents the&#xD;
      FCCH serve. Additionally, the investigators are creating gamified social-emotional learning&#xD;
      and nutrition games for the children.&#xD;
&#xD;
      The second phase is a pre-post test where the investigator will recruit FCCH providers&#xD;
      enrolled in the Essential Personnel Child Care or School-Aged program and the parents the&#xD;
      FCCH serve to fill out health surveys before and 15 weeks post engagement with the app.&#xD;
&#xD;
      The investigators hypothesize that engagement with the digital toolkit will improve provider&#xD;
      and parental perceived level of stress, informational support, access to learning games, as&#xD;
      well as social, emotional, and behavioral functioning in children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 4, 2021</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2024</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Perceived Level of Stress as assessed by the Perceived Stress Scale</measure>
    <time_frame>At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart</time_frame>
    <description>Family Child Care Home Providers &amp; Parents: Perceived Stress Scale (PSS)-10 is a 10-item tool widely used to measure the degree to which circumstances in one's life are deemed as stressful in the general population. The PSS was designed for use in community samples with at least a junior high school education. The items are easy to understand, and the response alternatives are simple to grasp. Six items of the PSS-10 are negatively phrased (item 1, 2, 3, 6, 9, 10; negative perception subscale, while the remaining four (item 4, 5, 7 and 8; positive perception subscale) are positively phrased items and require reverse coding. Total PSS-10 score will be calculated by summing scores. A total score ranges 0-40 where a higher score indicates higher perceived stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Perceived Level of Informational Support as assessed by the PROMIS Informational Support Short Form</measure>
    <time_frame>At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart</time_frame>
    <description>Family Child Care Home Providers &amp; Parents: Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support Short Form 8a assesses the perceived availability of helpful information or advice. It is an 8-item tool and each item has 5 response options ranging in values from one to five-1=Never 2=Rarely 3=Sometimes 4=Usually 5=Always with a range of 8-40. Total raw scores, sum of values to responses, will be calculated. A Score conversion table found in the Appendix of the tool will be used to translate the total raw score or pro-rated score into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question</measure>
    <time_frame>At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart</time_frame>
    <description>Family Child Care Home providers will be asked in the pre/post-surveys whether they are aware of the existence of the Maryland Early Childhood Family Engagement Framework and Toolkit- a 91-page document developed by the Maryland State Department of Education to guide child care providers in best practices for family engagement. Family Child Care Home providers will respond either&#xD;
i. Yes, I am aware of it but have not read it ii. Yes, I am aware of it and have read the report iii. No, I am not aware of it</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Social, Emotional, and Behavior Functioning in Children as assessed by the Social Competence and Behavior Evaluation for Children</measure>
    <time_frame>At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart</time_frame>
    <description>The social, emotional, and behavioral functioning in children will be assessed by parents responding to items on the Social Competence and Behavior Evaluation for Children: The Short Form (SCBE)-30. It is a 30 item tool with a 6 point response option- Never (1), Sometimes (2 or 3), Often (4 or 5), or Always (6). The SCBE-30 has three subscales (10 items each): Anger-Aggression (cronbach's α = 0.93 in the current sample), Anxiety-Withdrawal (cronbach's α = 0.87), and Social Competence (cronbach's α = 0.89). The SCBE-30 was developed for children from ages three to six and has been shown to have high interrater and test-retest reliability and internal consistency. Sums of each subscale will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of the Parent-Child Care Relationship as assessed by the Supportive Parent-Caregiver Relationship Subscale</measure>
    <time_frame>At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart</time_frame>
    <description>Family Child Care Home Provider and Parents: The Supportive Parent-Caregiver Relationship Sub-scale from Scales Measuring Aspects of Child-Care Quality Supportive Parent-Caregiver Relationship assess the perceived quality of the Parent-Child Care Relationship. The provider report contains 6 items with a 5 point response scale-1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Always. The scale will be adapted to ask about the general relationship to all parents, not any specific parent. The parent report contains 6 items with a 5 point response scale-1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Always. The mean score &amp; alpha will be reported. Reported Mean=26.9, SD=3.4, Alpha=.84)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Stress, Psychological</condition>
  <condition>Child Behavior</condition>
  <condition>Social Competence</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There is only one arm in this study. All recruited and consented participants will fill out a pre-survey, engage with the digital toolkit for 15 weeks, then fill out a post-survey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FamilyChildCare (provisional name of app)</intervention_name>
    <description>Parents will provide their child(ren) access to a smartphone, tablet, or computer for approximately 30 minutes, three times per week for 15 weeks with a total dosage of instruction of about 22.5 hours. Parents and providers will receive self-care, parenting, and parent engagement tips and resources through push notifications twice a day. Additionally, daily reminders will be sent to parents through push notification to give their child(ren) access to the learning games. After 15 weeks of app engagement, the providers and parents will be contacted by the PI to notify them of the 15 week time mark and provide the information for post-surveys via Qualtrics.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Licensed Family Child Care Home Providers operating in Baltimore City who are approved&#xD;
             or was once approved to remain open during COVID-19 through the Essential Personnel&#xD;
             Child Care or School-Aged Program.&#xD;
&#xD;
          -  Parents or legal adult guardians of young children (3-6 years old) who have utilized&#xD;
             or continue to utilize the services of Family Child Care Home providers enrolled in&#xD;
             the study.&#xD;
&#xD;
          -  All participants must have access to a smartphone, tablet, or computer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Licensed Family Child Care Home Providers not enrolled or was never enrolled in the&#xD;
             Essential Personnel Child Care or School-Aged Program&#xD;
&#xD;
          -  Parents of young children (3-6 years old) who have not utilized the services of&#xD;
             Licensed Family Child Care Home Providers in the Essential Personnel Child Care or&#xD;
             School-Aged Program&#xD;
&#xD;
          -  FCCH providers not operating in Baltimore City&#xD;
&#xD;
          -  FCCH providers who do not have at least 1 parent consenting to participate in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lucine Francis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins School of Nursing</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Family Child Care Home Providers</keyword>
  <keyword>Parents</keyword>
  <keyword>Young Children</keyword>
  <keyword>Multi-component Self-Care</keyword>
  <keyword>Tele-Wellness Service</keyword>
  <keyword>Child care provider stress</keyword>
  <keyword>Child care provider informational support</keyword>
  <keyword>Behavior and Social functioning in Children</keyword>
  <keyword>Educational learning games</keyword>
  <keyword>Parent Engagement</keyword>
  <keyword>Early Learning Intervention</keyword>
  <keyword>Parenting</keyword>
  <keyword>Social emotional learning games</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</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/NCT04453657
org study id: IRB00250864
nct id: NCT04453657
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aim to deliver a tele-wellness supported app to Baltimore City's Family
      Child Care Home (FCCH) providers who are caring for children of Essential Personnel. Once a
      pre-survey is conducted, login information will be assigned to 30 Family Child Care Home
      providers and parents the FCCH serve. Providers and Parents will receive self-care and
      parenting/parent engagement support through the app and through a tele-wellness service, Ask
      a Nurse, provided by community health nurses at the Johns Hopkins School of Nursing. Children
      will have access to gamified learning materials in early literacy, math, social-emotional
      learning, and nutrition.
The investigators will adapt and deliver a tele-wellness supported digital toolkit via an app
      for Baltimore City's Family Child Care Home (FCCH) providers and the families the FCCH serve.
      Through this digital toolkit, the investigators aim to provide related self-care support,
      parent/parent engagement support for both Family Child Care Home providers and parents, and
      provide access to early literacy, math, social-emotional learning, and nutrition games for
      children (3-6 years old). Additionally, Family Child Care Home providers and parents will
      have access to a hotline and email to the Ask a Nurse program-a tele-wellness program run by
      community registered nurses at Johns Hopkins School of Nursing. Through Ask a Nurse,
      providers and parents will be able to receive wellness counseling from licensed registered
      nurses and care coordination to address specific social needs. The tele-wellness service is
      NOT intended to directly address health issues, diagnose, or prescribe. In summary, Family
      Child Care Home providers will have access to self-care and parent engagement resources and
      parents will have access to self-care and parenting resources in addition to the games for
      the child(ren).

      The first phase of this study is to tailor an existing app, Escribo Play that already has
      gamified early literacy and math tools, and expand its scope by including self-care and
      parenting/parent engagement support for Family Child Care Home Providers and the parents the
      FCCH serve. Additionally, the investigators are creating gamified social-emotional learning
      and nutrition games for the children.

      The second phase is a pre-post test where the investigator will recruit FCCH providers
      enrolled in the Essential Personnel Child Care or School-Aged program and the parents the
      FCCH serve to fill out health surveys before and 15 weeks post engagement with the app.

      The investigators hypothesize that engagement with the digital toolkit will improve provider
      and parental perceived level of stress, informational support, access to learning games, as
      well as social, emotional, and behavioral functioning in children.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Perceived Level of Stress as assessed by the Perceived Stress Scale
time frame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
description: Family Child Care Home Providers & Parents: Perceived Stress Scale (PSS)-10 is a 10-item tool widely used to measure the degree to which circumstances in one's life are deemed as stressful in the general population. The PSS was designed for use in community samples with at least a junior high school education. The items are easy to understand, and the response alternatives are simple to grasp. Six items of the PSS-10 are negatively phrased (item 1, 2, 3, 6, 9, 10; negative perception subscale, while the remaining four (item 4, 5, 7 and 8; positive perception subscale) are positively phrased items and require reverse coding. Total PSS-10 score will be calculated by summing scores. A total score ranges 0-40 where a higher score indicates higher perceived stress.
measure: Change in Perceived Level of Informational Support as assessed by the PROMIS Informational Support Short Form
time frame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
description: Family Child Care Home Providers & Parents: Patient-Reported Outcomes Measurement Information System (PROMIS) Informational Support Short Form 8a assesses the perceived availability of helpful information or advice. It is an 8-item tool and each item has 5 response options ranging in values from one to five-1=Never 2=Rarely 3=Sometimes 4=Usually 5=Always with a range of 8-40. Total raw scores, sum of values to responses, will be calculated. A Score conversion table found in the Appendix of the tool will be used to translate the total raw score or pro-rated score into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
measure: Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question
time frame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
description: Family Child Care Home providers will be asked in the pre/post-surveys whether they are aware of the existence of the Maryland Early Childhood Family Engagement Framework and Toolkit- a 91-page document developed by the Maryland State Department of Education to guide child care providers in best practices for family engagement. Family Child Care Home providers will respond either
i. Yes, I am aware of it but have not read it ii. Yes, I am aware of it and have read the report iii. No, I am not aware of it
measure: Change in Social, Emotional, and Behavior Functioning in Children as assessed by the Social Competence and Behavior Evaluation for Children
time frame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
description: The social, emotional, and behavioral functioning in children will be assessed by parents responding to items on the Social Competence and Behavior Evaluation for Children: The Short Form (SCBE)-30. It is a 30 item tool with a 6 point response option- Never (1), Sometimes (2 or 3), Often (4 or 5), or Always (6). The SCBE-30 has three subscales (10 items each): Anger-Aggression (cronbach's α = 0.93 in the current sample), Anxiety-Withdrawal (cronbach's α = 0.87), and Social Competence (cronbach's α = 0.89). The SCBE-30 was developed for children from ages three to six and has been shown to have high interrater and test-retest reliability and internal consistency. Sums of each subscale will be calculated.
measure: Change in Quality of the Parent-Child Care Relationship as assessed by the Supportive Parent-Caregiver Relationship Subscale
time frame: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
description: Family Child Care Home Provider and Parents: The Supportive Parent-Caregiver Relationship Sub-scale from Scales Measuring Aspects of Child-Care Quality Supportive Parent-Caregiver Relationship assess the perceived quality of the Parent-Child Care Relationship. The provider report contains 6 items with a 5 point response scale-1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Always. The scale will be adapted to ask about the general relationship to all parents, not any specific parent. The parent report contains 6 items with a 5 point response scale-1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Always. The mean score & alpha will be reported. Reported Mean=26.9, SD=3.4, Alpha=.84)
arm group label: Intervention
arm group type: Experimental
description: There is only one arm in this study. All recruited and consented participants will fill out a pre-survey, engage with the digital toolkit for 15 weeks, then fill out a post-survey.
intervention type: Device
intervention name: FamilyChildCare (provisional name of app)
description: Parents will provide their child(ren) access to a smartphone, tablet, or computer for approximately 30 minutes, three times per week for 15 weeks with a total dosage of instruction of about 22.5 hours. Parents and providers will receive self-care, parenting, and parent engagement tips and resources through push notifications twice a day. Additionally, daily reminders will be sent to parents through push notification to give their child(ren) access to the learning games. After 15 weeks of app engagement, the providers and parents will be contacted by the PI to notify them of the 15 week time mark and provide the information for post-surveys via Qualtrics.
arm group label: Intervention
criteria: 
gender: All
minimum age: 3 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lucine Francis, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress, Psychological
sharing ipd: No