Tele-Wellness App for Stress and Childhood Development

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Not enrolled, Not in Baltimore, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tele-wellness app, FamilyChildCare (provisional name), designed to support stress management and child development for Family Child Care Home (FCCH) providers in Baltimore City. The app provides self-care tips and parenting support to caregivers and parents, along with engaging learning materials for children in areas like literacy and nutrition. It is ideal for licensed FCCH providers offering services during COVID-19 and parents of young children aged 3–6 who use these services. Participants need a smartphone, tablet, or computer to access the app and resources. As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative tools that could enhance child care and stress management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this tele-wellness app is safe for children and caregivers?

Research has shown that the FamilyChildCare app assists family child care providers and parents. It supports self-care and parenting while offering additional resources for children. The app includes engaging learning activities for children, focusing on early reading, math, social-emotional skills, and nutrition.

Although specific safety data for the app is unavailable, the trial phase is labeled "Not Applicable." This designation typically indicates that the study focuses on evaluating the app's effectiveness rather than identifying safety issues, as in drug trials.

Generally, digital wellness apps are considered low-risk because they provide educational content and support rather than medication or physical treatments. Participants should feel comfortable using the app, as it is unlikely to cause any health problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FamilyChildCare app because it offers a new way to support stress management and childhood development through a digital platform. Unlike traditional therapy sessions or in-person interventions, this app provides an interactive digital toolkit that families can access anytime and anywhere over a 15-week period. This flexibility allows for consistent engagement and the ability to tailor the experience to individual needs, potentially making it more effective and accessible than current options like face-to-face counseling or group workshops. The app's focus on both stress and developmental support in one integrated platform also sets it apart from existing treatments that typically address these issues separately.

What evidence suggests that the FamilyChildCare app is effective for stress and childhood development?

Research suggests that the FamilyChildCare app, used by participants in this trial, might help reduce stress and improve parenting skills. Studies have shown that similar online programs can boost parents' confidence in their parenting. One study found that online tools can lower caregiver stress and improve children's behavior. The app also includes fun learning activities for kids, which might aid early reading and math skills. Although specific data on this app is limited, these findings indicate potential benefits for both parents and children. ^{6 7 8 9 10}

Who Is on the Research Team?

Lucine Francis, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

All participants must have access to a smartphone, tablet, or computer.

I am a parent or guardian of a young child using services from a study-enrolled Family Child Care provider.

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.

Exclusion Criteria

FCCH providers who do not have at least 1 parent consenting to participate in the study.

I am a parent of a young child (3-6 years old) and have not used licensed family child care for essential personnel programs.

FCCH providers not operating in Baltimore City

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

App Tailoring

Tailoring the existing app, Escribo Play, to include self-care and parenting/parent engagement support for Family Child Care Home Providers and parents.

Not specified

Engagement

Participants engage with the digital toolkit for 15 weeks, including access to gamified learning materials and tele-wellness support.

15 weeks

Continuous engagement with the app

Follow-up

Participants complete post-surveys to assess changes in stress, informational support, and social-emotional functioning.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FamilyChildCare (provisional name of app)

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

A mobile phone self-monitoring tool for mental health was used by 47 adolescents over 2-4 weeks, showing high engagement with 91% of entries completed in the first week.

Paediatricians found the tool beneficial, with 92% of them reporting it helped them understand their patients better, and 88% of participants felt the data accurately reflected their experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a mobile phone application in youth mental health - an evaluation study. Reid, SC., Kauer, SD., Khor, AS., et al.[2019]

The psychoeducational app significantly reduced parenting stress among users, with a reported decrease in stress levels compared to a waitlist control group, indicating its potential effectiveness in supporting parents of children with crying, sleeping, and feeding issues.

Parents using the app also gained more knowledge about their children's symptoms, suggesting that the app not only helps reduce stress but also educates parents, which could lead to better management of their children's issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Mobile-Based Intervention for Parents of Children With Crying, Sleeping, and Feeding Problems: Randomized Controlled Trial. Augustin, M., Licata-Dandel, M., Breeman, LD., et al.[2023]

The mobile application 'Ebe Evimde (My Home Midwife)' significantly improved self-efficacy levels in mothers during the postpartum period, as evidenced by a notable difference between pretest and posttest scores in the intervention group of 60 mothers.

The application also effectively reduced postpartum anxiety levels, showing a strong negative relationship between pretest and posttest anxiety scores in the intervention group, while no significant changes were observed in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the Ebe Evimde application on the self-efficacy and anxiety levels of mothers: Randomized controlled trial. Bozkurt, MA., Cesur, B.[2023]

Young people generally engage well with mobile-based mental health apps, showing some positive effects on emotional self-awareness, although many outcomes were not statistically significant.

Despite the potential of these apps to improve access to mental health services and support self-help, the current literature is limited, highlighting the need for more research to validate their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of mobile apps and technologies in child and adolescent mental health: a systematic review. Punukollu, M., Marques, M.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0885200624001364

Family Check-Up Online effects on parenting and ... The current study demonstrates the effectiveness of the FCU-O intervention for improving parent-reported parenting skills, parenting self-efficacy, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9887516/

Evaluating the Effectiveness of the Supportive Parenting ... The SPA intervention consisted of a mobile app–based psychoeducation and peer support program to support parents from pregnancy to 6 months post partum.

3. researchgate.net researchgate.net/publication/384296004_Family_Check-Up_Online_Effects_of_a_Virtual_Randomized_Trial_on_Parent_Stress_Parenting_and_Child_Outcomes_in_Early_Adolescence

Effects of a Virtual Randomized Trial on Parent Stress ... Outcomes included caregiver reports of perceived stress and parenting, and youth conduct problems and depressive symptoms. Using a multilevel ...

4. mdpi.com mdpi.com/2227-9067/12/6/800

Efficacy, Feasibility, and Utility of a Mental Health ... This study evaluated the efficacy, feasibility, and utility of Jump Start on the Go (JS Go), a bilingual, AI-enabled mobile application.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10193093/

Parenting app to support socio-emotional and cognitive ... The iterative codesign process informed the development of a culturally relevant app for parents and caregivers of children in the early years.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0190740924002706

Family child care educators' experiences and decision ... This study focused on the experiences of family child care educators, how they made decisions about operating during the first year of the COVID-19 pandemic.

7. publications.aap.org publications.aap.org/pediatrics/article/148/2/e2021052582/179805/Preventing-Childhood-Toxic-Stress-Partnering-With

Preventing Childhood Toxic Stress: Partnering With ... This revised policy statement on childhood toxic stress acknowledges a spectrum of potential adversities and reaffirms the benefits of an ecobiodevelopmental ...

8. nwcommons.nwciowa.edu nwcommons.nwciowa.edu/cgi/viewcontent.cgi?article=1472&context=education_masters

Implementing Changes in Family Childcare Programs to ... A decrease in negative behavior and an increase in positive behavior were revealed in this research study. Keywords: early childhood education, family childcare ...

9. erikson.edu erikson.edu/wp-content/uploads/2019/01/FCC-Network-Landscape_Technical-Report_Erikson-Institute_Jan2019.pdf

Mapping The Family Child Care Network Landscape: ... State licensing or certification systems are intended to protect the health and safety of children through requirements for providers such as: 1) the number of ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4307839/

Unstable and Multiple Child Care Arrangements and ... Growing evidence suggests that child care instability is associated with child behavior problems, but existing studies confound different types of instability.