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

270 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment FamilyChildCare app for stress and childhood development?

Research on similar mobile apps shows they can help parents by providing easy access to information and support, which can reduce stress and improve parenting skills. For example, apps like 'Home-but not Alone' and 'Thrive by Five' have been designed to improve parenting outcomes and child development by offering educational content and support. ^{1 2 3 4 5}

How is the FamilyChildCare app treatment different from other treatments for stress and childhood development?

The FamilyChildCare app is unique because it is a digital tool designed to support both parents and children by improving mental health and well-being through an accessible, online platform. Unlike traditional treatments, it offers a self-delivered, cost-effective approach that can be used universally, focusing on enhancing parenting skills and the parent-child relationship. ^{2 3 6 7 8}

What is the purpose of this trial?

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.

Research Team

Lucine Francis, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Designing an App for Parents and Caregivers to Promote Cognitive and Socioemotional Development and Well-being Among Children Aged 0 to 5 Years in Diverse Cultural Settings: Scientific Framework. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Effects of a Mobile-Based Intervention for Parents of Children With Crying, Sleeping, and Feeding Problems: Randomized Controlled Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of the 'Home-but not Alone' mobile health application educational programme on parental outcomes: a randomized controlled trial, study protocol. [2019]

4. Australia pubmed.ncbi.nlm.nih.gov

Using a mobile phone application in youth mental health - an evaluation study. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A randomized-controlled trial to examine the effectiveness of the 'Home-but not Alone' mobile-health application educational programme on parental outcomes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Universal Digital Programs for Promoting Mental and Relational Health for Parents of Young Children: A Systematic Review and Meta-Analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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