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Tele-Wellness App for Stress and Childhood Development

N/A
Waitlist Available
Led By Lucine Francis, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
Awards & highlights
No Placebo-Only Group

Summary

This trial will provide FCCH providers and parents with a tele-wellness supported app that will offer self-care and parenting/parent engagement support, as well as gamified learning materials for children in early literacy, math, social-emotional learning, and nutrition.

Who is the study for?
This trial is for licensed Family Child Care Home providers in Baltimore City caring for children of essential personnel, and parents or guardians of young children (3-6 years old) using these services. Participants must have access to a smartphone, tablet, or computer.
What is being tested?
The study tests a tele-wellness supported app called FamilyChildCare that offers self-care and parenting support through an 'Ask a Nurse' service and provides children with gamified learning materials covering literacy, math, social skills, and nutrition.
What are the potential side effects?
Since this intervention involves the use of an educational app rather than medication or medical procedures, traditional side effects are not applicable. However, there may be indirect effects on stress levels or behavior changes due to the information provided.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart
This trial's timeline: 3 weeks for screening, Varies for treatment, and at pre and post surveys lasting 30-45 minutes each, up to 15 weeks apart for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question
Change in Perceived Level of Informational Support as assessed by the PROMIS Informational Support Short Form
Change in Perceived Level of Stress as assessed by the Perceived Stress Scale
+1 more
Secondary study objectives
Change in Quality of the Parent-Child Care Relationship as assessed by the Supportive Parent-Caregiver Relationship Subscale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,321 Previous Clinical Trials
14,873,671 Total Patients Enrolled
Lucine Francis, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

FamilyChildCare (provisional name of app) Clinical Trial Eligibility Overview. Trial Name: NCT04453657 — N/A
Stress Research Study Groups: Intervention
Stress Clinical Trial 2023: FamilyChildCare (provisional name of app) Highlights & Side Effects. Trial Name: NCT04453657 — N/A
FamilyChildCare (provisional name of app) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04453657 — N/A
~45 spots leftby Sep 2025