CARE Program + Valera App Interventions for Parenting Challenges During Coronavirus

(CARE Trial)

Recruiting at 2 trial locations

Overseen By Maria Pondikos, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Serious psychiatric, Substance use, Neurocognitive, others

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

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help parents and caregivers in the Bronx manage stress and support their children during the COVID-19 pandemic. It tests different programs and tools, including the CARE Program (Connecting and Reflecting Experience) and the Valera app, to determine which reduces stress and improves family well-being. The trial includes several groups, such as parents of children receiving mental health or autoimmune disorder treatment and healthcare workers. Primary caregivers facing moderate stress who are patients or workers at Montefiore Medical Center may be a good fit. As an unphased trial, this study offers participants the chance to contribute to innovative solutions for stress management and family support.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the CARE Program, a group activity for parents, helps build strong connections with their children. Studies indicate that most participants find this program easy to engage in. Participants have reported improved family relationships and communication, with no major negative effects.

The Valera Health App offers online mental health services, including therapy and medication management. Feedback from users and professionals suggests that the app is safe and user-friendly. It includes additional safety features and integrates smoothly into users' daily routines without adding stress.

Although the CARE Program and Valera Health App are not typical medical treatments, evidence suggests they are safe and easy to use. No reports of serious negative effects make them promising options for managing stress and improving family dynamics during challenging times. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARE Program combined with the Valera App because it offers a unique approach to addressing parenting challenges during the pandemic. Unlike traditional parental education programs, this method integrates digital health technology, providing on-demand support through the Valera App. This app, especially with care manager functionality, allows for personalized guidance and real-time feedback, which is not typically available with standard educational resources. This combination of personalized digital support and structured parental guidance aims to enhance the effectiveness of interventions for parents navigating mental health and autoimmune challenges in their children, potentially leading to more dynamic and responsive solutions.

What evidence suggests that this trial's treatments could be effective for parenting challenges during the coronavirus pandemic?

Research has shown that the CARE Program, one of the interventions in this trial, helps reduce child abuse by supporting parents. Evidence suggests that programs like CARE can help parents manage stress and improve family relationships, especially during challenging times like the COVID-19 pandemic. The Valera Health App, another intervention in this trial, is a digital tool that simplifies access to mental health resources and support. Studies on similar apps have demonstrated improvements in parenting skills and stress reduction. Participants in this trial may receive the CARE Program alone, the Valera Health App alone, or a combination of both. Using the CARE Program alongside the Valera Health App might offer additional benefits by providing both emotional support and practical tools for parents. This approach aims to help caregivers manage stress and enhance their family’s well-being during difficult times. ^{2 4 5 6 7}

Who Is on the Research Team?

Jonathan Alpert, MD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

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

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

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CARE Program
• CARE Program and Valera Application
• CARE Program and Valera Application with care manager functionality
• Parental Education
• Parental Education and Valera Application
• Valera Application
• Valera Application with care manager functionality

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.

How Is the Trial Designed?

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+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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 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 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 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 '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]

Citations

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eConnect: implementation and preliminary evaluation of a ... Here we report on pre- and post-treatment changes of parent, youth, and family functioning, which we discuss in relation to previously published ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8444790/

Parenting During COVID‐19: A Study of Parents' Experiences ... This study describes parenting experiences at the beginning of the COVID‐19 pandemic and examines differences across parent gender and family income level.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0190740923005170

A qualitative study with care-experienced young people ... The study findings offer insight into how interventions and services may be developed and optimised moving forward to ensure that they are meeting the needs of ...

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Parenting Interventions During the COVID-19 Pandemic Evidence shows that parenting interventions are an effective method of reducing caregiver-perpetrated child maltreatment. The recent COVID-19 pandemic has ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32072881/

The Connecting and Reflecting Experience (CARE) This paper describes the implementation of a mentalizing-focused group parenting intervention. The Connecting and Reflecting Experience (CARE) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9490759/

Pilot Study of a Telehealth Group Parenting Intervention The Connecting and Reflecting Experience (CARE) program is a group parenting intervention designed to support secure parent-child attachment relationships ...

7. cebc4cw.org cebc4cw.org/program/connect-an-attachment-based-program-for-parents-and-caregivers/detailed

CEBC » Connect An Attachment Based Program ... Connect is a 10-session program for caregivers of preteens/teens with behavioral issues, aiming to improve parental reflective function and sensitivity.