CARE Program + Valera App Interventions for Parenting Challenges During Coronavirus

(CARE Trial)

Overseen by Vilma Gabbay, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Serious psychiatric, Substance use, Neurocognitive, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests the CARE program and Valera Health app to help stressed caregivers in the Bronx. The CARE program offers group sessions for emotional support, while the Valera Health app provides digital mental health resources. These interventions aim to reduce stress and improve mental health among caregivers.

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 CARE Program + Valera App Interventions for Parenting Challenges During Coronavirus?

While there is no direct evidence for the CARE Program + Valera App specifically, research shows that mobile health apps can improve self-management and care coordination in various health conditions, suggesting potential benefits for parenting challenges as well. ^{1 2 3 4 5}

How is the CARE Program + Valera App treatment unique for parenting challenges during coronavirus?

The CARE Program + Valera App treatment is unique because it combines a structured parenting program with a mobile application, offering both educational content and support through technology. This approach provides parents with convenient access to resources and potentially enhances their ability to manage stress and improve their parenting skills during the pandemic. ^{6 7 8 9 10}

Research Team

Vilma Gabbay, MD

Principal Investigator

Albert Einstein College of Medicine

Eligibility Criteria

This trial is for primary caregivers in the Bronx experiencing high stress, especially those working on-site at Montefiore Medical Center or patients in psychiatric and rheumatology clinics there. It includes grandmothers and aunts but excludes those with neurocognitive issues, serious psychiatric/substance use problems, active child abuse cases, non-Spanish/English speakers, or prior similar app users.

Inclusion Criteria

Frontline health care providers must be required to work on site at Montefiore Medical Center (MMC)

You are the main caregiver and have a high perceived stress score on the Perceived Stress Scale.

You must be currently receiving care at the psychiatric and rheumatology clinics in Montefiore Medical Center (MMC).

Exclusion Criteria

My primary language is not English or Spanish.

You have a serious mental health or substance use problem that would make it difficult for you to fully take part in the study.

I do not have any mental conditions that would stop me from using online health services.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants partake in 12 one-hour group sessions once per week, using either the CARE program, Valera Health app, or both.

12 weeks

12 visits (in-person or virtual)

Follow-up

Participants are monitored for psychological and health outcomes, with surveys conducted at 6, 12, and 24 weeks.

24 weeks

3 visits (virtual)

Long-term Follow-up

Participants return for 6-month follow-ups to assess long-term outcomes.

6 months

Treatment Details

Interventions

• CARE Program (Behavioural Intervention)
• CARE Program and Valera Application (Behavioural Intervention)
• CARE Program and Valera Application with care manager functionality (Behavioural Intervention)
• Parental Education (Behavioural Intervention)
• Parental Education and Valera Application (Behavioural Intervention)
• Valera Application (Behavioural Intervention)
• Valera Application with care manager functionality (Behavioural Intervention)

Trial Overview The study tests various combinations of the CARE Program and Valera Application to alleviate parental stress due to COVID-19. Some will use both tools with added care manager support; others will try each tool separately or combined without extra support.

Participant Groups

Group I: Parents of children receiving mental health treatment at Montefiore Experimental Treatment 3 Interventions

Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app .

Group II: Parents of children being treated for autoimmune disorders at Montefiore Experimental Treatment 3 Interventions

Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.

Group III: Healthcare workers at Montefiore Experimental Treatment 3 Interventions

Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Dr. Philip Ozuah

Albert Einstein College of Medicine

Chief Medical Officer since 2019

MD from University of Ibadan, Nigeria

Dr. Yaron Tomer

Albert Einstein College of Medicine

Chief Executive Officer since 2021

MD from Sackler School of Medicine, Tel Aviv University

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

The Care4myHeart app was developed through a collaborative design process involving 18 stakeholders, including patients, family caregivers, and clinicians, ensuring that it meets the real needs of users for heart failure self-management.

The app features essential components for managing heart failure, such as health management tools, appointment scheduling, and personalized self-management plans, demonstrating the importance of stakeholder involvement in creating effective health technology solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a Consumer Mobile Health App for Heart Failure: Findings From the Nurse-Led Co-Design of Care4myHeart. Woods, L., Duff, J., Roehrer, E., et al.[2022]

The Engaging Parents in Education for Discharge (ePED) iPad application significantly improved the quality of discharge teaching as reported by parents, with higher scores on the Quality of Discharge Teaching Scale compared to traditional methods (p = .002).

While ePED enhanced discharge teaching quality, it did not show a significant difference in care coordination compared to usual discharge methods, and its association with 30-day readmissions was weak, indicating that while ePED is beneficial for teaching, further improvements in care coordination may be needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Engaging Parents in Education for Discharge (ePED) iPad Application to Improve Parent Discharge Experience. Lerret, SM., Johnson, NL., Polfuss, M., et al.[2023]

The Care4myHeart app, designed for self-management of heart failure, received an overall quality score of 3.53 out of 5, indicating it is considered 'acceptable' by users, particularly excelling in aesthetics and information delivery.

While the app showed potential for improving self-management through features like weight tracking and data visualization, its impact on health behavior change was perceived as low, highlighting a barrier to adoption due to the need for integration into existing routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Experiences of Using a Consumer mHealth App for Self-Management of Heart Failure: Mixed-Methods Study. Woods, LS., Duff, J., Roehrer, E., et al.[2020]

The study outlines a systematic protocol for evaluating health apps, including a PRISMA flow diagram to shortlist apps based on criteria like language, update frequency, and core functionality, ensuring a focused selection for clinical assessment.

An App Chronic Disease Checklist was developed to quantitatively assess the quality and reliability of health apps, with a proposed minimum score of 80% by consensus among raters to identify apps suitable for clinical trials, specifically targeting self-monitoring of asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App Chronic Disease Checklist: Protocol to Evaluate Mobile Apps for Chronic Disease Self-Management. Anderson, K., Burford, O., Emmerton, L.[2020]

A mobile application designed for developmental support care of premature infants was developed and evaluated, receiving high satisfaction scores from both experts (3.73/4) and users (3.43/4).

The app includes features like a diary, customized information, developmental play, and community support, and is expected to effectively aid in the development of children born prematurely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a mobile application focusing on developmental support care for Korean infants born prematurely: a methodological study. Park, JH., Cho, H.[2022]

Parents and caregivers of children with heart diseases face significant emotional and social challenges, including lack of support and financial difficulties, which hinder their ability to cope with caregiving demands.

A home-based health care program has been developed to empower these caregivers through multi-component interventions, aiming to improve their coping strategies and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowerment of the rural parents/caregivers of children with heart diseases in Namibia to facilitate coping with the demands of caring at home. Amakali, K., Small, LF.[2021]

The mobile application 'Descomplicando a Amamentação' received an outstanding Global Agreement Index of 0.99 for semantics and appearance, indicating that users found it highly understandable and visually appealing.

In terms of usability, the app scored an impressive average of 93 on the System Usability Scale, suggesting it is very easy to use and provides a satisfying experience for family members of newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the mobile application "Descomplicando a Amamentação" by family members of newborns. Lucchese, I., Góes, FGB., Souza, AN., 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]

Mobile application-based interventions have been found to be feasible and promising in improving parental well-being during the perinatal period, particularly in enhancing parenting self-efficacy, anxiety, and depression, based on a review of 12 studies involving various intervention types.

The review suggests that incorporating educational resources, psychotherapy, and peer support into these mobile interventions can further benefit parents, although more research is needed to assess the long-term effects and to include a more diverse participant population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile application-based perinatal interventions in improving parenting outcomes: A systematic review. Chua, JYX., Shorey, S.[2022]

The 'Bear Essentials' computerized parent training program significantly improved parents' knowledge about how to help reduce their preschoolers' immunization distress, particularly regarding reassurance and distraction techniques.

While the program changed parent and child behaviors positively, it did not lead to a significant reduction in child distress or pain during immunization, indicating that further modifications are needed for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated parent-training for preschooler immunization pain relief: a randomized controlled trial. Cohen, LL., Rodrigues, NP., Lim, CS., et al.[2018]

References

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

Design of a Consumer Mobile Health App for Heart Failure: Findings From the Nurse-Led Co-Design of Care4myHeart. [2022]

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

Using the Engaging Parents in Education for Discharge (ePED) iPad Application to Improve Parent Discharge Experience. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Patients' Experiences of Using a Consumer mHealth App for Self-Management of Heart Failure: Mixed-Methods Study. [2020]

4. Canada pubmed.ncbi.nlm.nih.gov

App Chronic Disease Checklist: Protocol to Evaluate Mobile Apps for Chronic Disease Self-Management. [2020]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Development of a mobile application focusing on developmental support care for Korean infants born prematurely: a methodological study. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Empowerment of the rural parents/caregivers of children with heart diseases in Namibia to facilitate coping with the demands of caring at home. [2021]

7. Brazil pubmed.ncbi.nlm.nih.gov

Evaluation of the mobile application "Descomplicando a Amamentação" by family members of newborns. [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]

9. Scotland pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile application-based perinatal interventions in improving parenting outcomes: A systematic review. [2022]

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

Automated parent-training for preschooler immunization pain relief: a randomized controlled trial. [2018]