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Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, Family Engagement, and School Readiness Amid COVID-19

Primary Purpose

Stress, Psychological, Child Behavior, Social Competence

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FamilyChildCare (provisional name of app)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress, Psychological focused on measuring Family Child Care Home Providers, Parents, Young Children, Multi-component Self-Care, Tele-Wellness Service, Child care provider stress, Child care provider informational support, Behavior and Social functioning in Children, Educational learning games, Parent Engagement, Early Learning Intervention, Parenting, Social emotional learning games

Eligibility Criteria

3 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Licensed Family Child Care Home Providers operating in Baltimore City who are approved or was once approved to remain open during COVID-19 through the Essential Personnel Child Care or School-Aged Program.
  • Parents or legal adult guardians of young children (3-6 years old) who have utilized or continue to utilize the services of Family Child Care Home providers enrolled in the study.
  • All participants must have access to a smartphone, tablet, or computer.

Exclusion Criteria:

  • Licensed Family Child Care Home Providers not enrolled or was never enrolled in the Essential Personnel Child Care or School-Aged Program
  • Parents of young children (3-6 years old) who have not utilized the services of Licensed Family Child Care Home Providers in the Essential Personnel Child Care or School-Aged Program
  • FCCH providers not operating in Baltimore City
  • FCCH providers who do not have at least 1 parent consenting to participate in the study.

Sites / Locations

  • Johns Hopkins School of Nursing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm 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.

Outcomes

Primary Outcome Measures

Change in Perceived Level of Stress as assessed by the Perceived Stress Scale
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.
Change in Perceived Level of Informational Support as assessed by the PROMIS Informational Support Short Form
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.
Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question
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
Change in Social, Emotional, and Behavior Functioning in Children as assessed by the Social Competence and Behavior Evaluation for Children
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.

Secondary Outcome Measures

Change in Quality of the Parent-Child Care Relationship as assessed by the Supportive Parent-Caregiver Relationship Subscale
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)

Full Information

First Posted
June 26, 2020
Last Updated
September 7, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04453657
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Child Behavior, Social Competence
Keywords
Family Child Care Home Providers, Parents, Young Children, Multi-component Self-Care, Tele-Wellness Service, Child care provider stress, Child care provider informational support, Behavior and Social functioning in Children, Educational learning games, Parent Engagement, Early Learning Intervention, Parenting, Social emotional learning games

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm 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(s)
FamilyChildCare (provisional name of app)
Intervention 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.
Primary Outcome Measure Information:
Title
Change in Perceived Level of Stress as assessed by the Perceived Stress Scale
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.
Time Frame
At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Title
Change in Perceived Level of Informational Support as assessed by the PROMIS Informational Support Short Form
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.
Time Frame
At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Title
Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question
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
Time Frame
At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Title
Change in Social, Emotional, and Behavior Functioning in Children as assessed by the Social Competence and Behavior Evaluation for Children
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.
Time Frame
At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Secondary Outcome Measure Information:
Title
Change in Quality of the Parent-Child Care Relationship as assessed by the Supportive Parent-Caregiver Relationship Subscale
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)
Time Frame
At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Licensed Family Child Care Home Providers operating in Baltimore City who are approved or was once approved to remain open during COVID-19 through the Essential Personnel Child Care or School-Aged Program. Parents or legal adult guardians of young children (3-6 years old) who have utilized or continue to utilize the services of Family Child Care Home providers enrolled in the study. All participants must have access to a smartphone, tablet, or computer. Exclusion Criteria: Licensed Family Child Care Home Providers not enrolled or was never enrolled in the Essential Personnel Child Care or School-Aged Program Parents of young children (3-6 years old) who have not utilized the services of Licensed Family Child Care Home Providers in the Essential Personnel Child Care or School-Aged Program FCCH providers not operating in Baltimore City FCCH providers who do not have at least 1 parent consenting to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucine Francis, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Nursing
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, Family Engagement, and School Readiness Amid COVID-19

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