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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

StatusSuspended
PhaseNot applicable
Started2021-02-04
View on ClinicalTrials.gov ↗

Amendment history

2026-09-22
critical
Trial status changed: Enrolling by Invitation → Suspended
Recruitment suspended: Continuing to pursue additional funding to continue with the study
Final enrollment: 35 participants (planned 270)
Primary completion pushed: 2026-09 → 2026-12
Completion pushed: 2026-09 → 2026-12
2025-09-30
minor
Study Status v14
Primary completion date2025-09→2026-09
Completion date2025-09→2026-09
2024-09-13
minor
Study Status v13
Primary completion date2024-09→2025-09
2023-09-07
minor
Study Status v12
Primary completion date2023-09→2024-09
Completion date2024-09→2025-09
2022-09-29
minor
Study Status v11
Primary completion date2022-09→2023-09
Completion date2023-09→2024-09
Show 10 earlier versions
2022-08-26
minor
Study Status v10
Completion date2022-09→2023-09
2021-09-02
minor
Study Status v9
Primary completion date2021-09→2022-09
Completion date2021-09→2022-09
2021-02-05
minor
Study Status v8
Start dateestimated 2021-02→confirmed 2021-02-04
2021-01-19
minor
Study Status v7
Start date2021-01→2021-02
2020-12-16
minor
Study Status v6
Start date2020-12→2021-01
2020-11-02
minor
Study Status v5
Start date2020-10→2020-12
2020-10-14
notable
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Enrolling by Invitation
Study sites0→1
2020-09-17
minor
Study Status v3
Start date2020-09→2020-10
2020-08-19
minor
Study Status v2
Primary completion date2021-07→2021-09
Completion date2021-07→2021-09
Start date2020-07→2020-09
2020-07-07
minor
Study Identification, Study Status, Study Design v1
Enrollment target30→270
Study title-30 characters
[...] romote Health, Family Engagement, and School Readiness Amid Coronavirus Disease of 2019 (COVID-19)
2020-06-30
minor
Original filing
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.
Trial Details
NCT Number NCT04453657
Lead Sponsor Johns Hopkins University
Conditions Stress, Psychological, Child Behavior, Social Competence
Enrollment 35 participants
Start Date 2021-02-04
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-21