Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, … (NCT04453657) | Clinical Trial Compass
By InvitationNot Applicable
Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, Family Engagement, and School Readiness Amid COVID-19
United States270 participantsStarted 2021-02-04
Plain-language 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.
Who can participate
Age range
3 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Perceived Level of Stress as assessed by the Perceived Stress Scale
Timeframe: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
2
Change in Perceived Level of Informational Support as assessed by the PROMIS Informational Support Short Form
Timeframe: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
3
Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question
Timeframe: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
4
Change in Social, Emotional, and Behavior Functioning in Children as assessed by the Social Competence and Behavior Evaluation for Children
Timeframe: At pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart