Jump Start on the Go for Mental Health Wellness

Overseen By Ruby Natale, PhD, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Non-English, Non-Spanish, Non-Creole

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

Compensation: Varies

Number of Visits: 2

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app-based program called Jump Start on the Go, designed to improve resiliency and behavior support for young children in childcare settings. The study will evaluate the app's effectiveness in supporting children's mental health and behavior. Participants will join one of two groups: one using the Jump Start app and another receiving additional coronavirus support. The trial seeks parents with children aged 2 to 5 enrolled in a participating childcare center, particularly those serving low-income families and reflecting Miami Dade County's ethnic diversity.

As an unphased study, this trial offers parents a unique chance to contribute to innovative solutions that could enhance their children's mental health and behavior support.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Jump Start on the Go app is safe?

Research shows that the Jump Start on the Go (JS Go) program is designed to support mental health and wellness. Although specific studies on the app's safety are lacking, programs like JS Go typically use non-invasive methods, making them less likely to cause physical harm compared to treatments involving medication or medical procedures.

The trial phase is marked as "Not Applicable," indicating that JS Go is likely in the early stages of testing for this purpose, often resulting in limited direct safety data. However, app-based mental wellness programs generally aim to improve mental health through guidance, education, and support, which are usually well-tolerated.

If the app were unsafe, it typically wouldn't reach this stage of testing. Participants should feel reassured by this general information, but staying informed and discussing any concerns with the research team is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about "Jump Start on the Go" because it offers a unique approach to mental health wellness through a mobile app. Unlike traditional methods that often require in-person therapy sessions or medication, this app-based intervention provides flexible and accessible support for users on the go. This digital delivery method could make mental health care more convenient and personalized, potentially reaching individuals who might not have easy access to traditional resources. Additionally, the integration with coronavirus support suggests a tailored response to the unique stressors associated with the pandemic, making it highly relevant for today's challenges.

What evidence suggests that the Jump Start on the Go app is effective for improving resiliency and behavior support in childcare settings?

Research shows that Jump Start on the Go (JS Go), an app-based program, improves resilience and behavior in childcare settings. In this trial, participants will join one of two groups: the "Jump Start on the Go Group," receiving the intervention via a mobile app, or the "Jump Start plus Coronavirus Support Group," which includes additional support. Studies have found that JS Go performs as well as the traditional Jump Start program. The app, available in two languages, uses artificial intelligence to engage users easily. Early findings suggest it effectively supports mental health by aiding social and emotional development. Although more data is needed to confirm these results fully, initial outcomes are promising for boosting resilience in children. ^{6 7 8 9 10}

Who Is on the Research Team?

Ruby Natale, PhD, PsyD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for at-risk preschool children who could benefit from improved resiliency and social-emotional development. Specific eligibility criteria are not provided, but typically participants would be selected based on certain risk factors or needs in these areas.

Inclusion Criteria

Parents must have a child enrolled in the childcare center that is participating in the study

Center must serve low income families

My center cares for over 30 children aged 2 to 5.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Jump Start on the Go intervention via a mobile app

12 months

Baseline, 2 months after baseline, and up to 1 year

Follow-up

Participants are monitored for changes in classroom practices, child behaviors, resiliency, and stress levels

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Jump Start on the Go

Trial Overview

The study is testing 'Jump Start on the Go', an app-based program designed to enhance resiliency and provide behavior support in childcare settings. It will evaluate how effective this digital intervention is compared to other methods or no intervention.

How Is the Trial Designed?

Group I: Jump Start on the Go Group Experimental Treatment 1 Intervention

Participants will be in this group for a total of up to 12 months. These participants will receive the intervention via a mobile app.

Group II: Jump Start plus Coronavirus Support Group Active Control 1 Intervention

Participants will be in this group for a total of up to 12 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

BeWell@Digital is a project focused on enhancing the mental health of youth in the Western Balkans through digital health solutions and peer support services.

The project aims to raise awareness and provide sustainable support for mental health issues, particularly addressing challenges that arose during the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BeWell@Digital - Supporting Young People's Mental Health in Western Balkans with E-solutions. Čič, K., Tošić, B.[2022]

The 'ACTivate your wellbeing' program was successfully adapted for young people aged 16 to 24 through a participatory co-design approach, which involved feedback and collaboration to create new content and features.

The formative evaluation showed that participants who engaged with the updated website for a shorter duration (3 weeks) had a higher completion rate (68%) and improved well-being scores, indicating that shorter, focused interventions may be more effective for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of ACTivate Your Wellbeing, a Digital Health and Well-being Program for Young Persons: Co-design Approach. Brown, M., Lord, E., John, A.[2023]

In a study of 104 patients seeking mental health care, 53% opted for a five-week guided online treatment, which significantly improved symptoms of depression and anxiety after five weeks, with effect sizes of 0.94 and 1.07, respectively.

The findings suggest that online problem-solving treatment can effectively reduce waiting times for mental health care and enhance recovery speed, making it a valuable first step before traditional face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided online treatment in routine mental health care: an observational study on uptake, drop-out and effects. Kenter, R., Warmerdam, L., Brouwer-Dudokdewit, C., et al.[2022]

The study will evaluate the effectiveness and cost of Thought Spot, a web- and mobile-based tool designed to improve mental health help-seeking among postsecondary students, through a randomized controlled trial involving students from three institutions in Ontario, Canada.

The primary outcome will be the change in help-seeking intentions, and the economic evaluation will assess the cost-effectiveness of Thought Spot compared to usual care, with results expected to inform resource allocation for mental health initiatives in educational settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web- and Mobile-Based Map of Mental Health Resources for Postsecondary Students (Thought Spot): Protocol for an Economic Evaluation. Kaur, A., Isaranuwatchai, W., Jaffer, A., et al.[2020]

A systematic review of 15 studies with 2627 participants found that app-based mHealth interventions significantly reduced anxiety symptoms, particularly when the interventions lasted at least 7 weeks, but showed no significant effect on depression symptoms.

Despite some positive effects on anxiety, the overall evidence for the clinical use of these mHealth interventions is inconclusive due to small effect sizes and concerns about study quality, indicating a need for further research on optimal treatment duration and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Minimum Effective Dose of App-Based Mobile Health Interventions for Anxiety and Depression Symptom Reduction: Systematic Review and Meta-Analysis. Lu, SC., Xu, M., Wang, M., et al.[2022]

In a study involving 126 women with bulimia nervosa, implementing regular telephone prompts significantly improved adherence to an Internet-based aftercare program compared to a group that did not receive prompts.

Although most women in the telephone prompt group were only reached once or twice, the overall adherence rate was notably higher, indicating that even minimal contact can enhance participation in self-directed mental health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of telephone prompts on the adherence to an Internet-based aftercare program for women with bulimia nervosa: A secondary analysis of data from a randomized controlled trial. Beintner, I., Jacobi, C.[2022]

The beta test of the Mind Guide mobile health app, involving 16 post-9/11 veterans with PTSD and alcohol use disorder, showed significant reductions in PTSD symptoms and alcohol-related issues, indicating its potential efficacy as an intervention.

The app demonstrated promising effects on related factors such as craving, perceived stress, and emotion regulation, suggesting that mindfulness-based techniques may help veterans manage their conditions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a mobile mindfulness smartphone app for post-traumatic stress disorder and alcohol use problems for veterans: Beta test results and study protocol for a pilot randomized controlled trial. Davis, JP., Pedersen, ER., Borsari, B., et al.[2023]

A study involving 24 community members with lived experience of depression and anxiety identified key factors that influence engagement with self-guided e-mental health programs, emphasizing the need for personalized feedback and information about program effectiveness.

The development of an engagement-facilitation intervention (EFI) could significantly improve community uptake of these programs by addressing personal barriers and normalizing their use, highlighting the importance of involving individuals with lived experience in the design process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer-Guided Development of an Engagement-Facilitation Intervention for Increasing Uptake and Adherence for Self-Guided Web-Based Mental Health Programs: Focus Groups and Online Evaluation Survey. Gulliver, A., Calear, AL., Sunderland, M., et al.[2020]

A walk-in psychiatry model was implemented in an urgent care clinic, allowing 23% of patients (80 out of 355) to access initial psychiatric evaluations without prior appointments, improving access for those who typically miss scheduled visits.

Patients with Medicaid and those without a college degree were significantly more likely to use the walk-in service, indicating that this model may effectively reach historically underserved populations in need of mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Urgent Care Psychiatry as a Unique Access Point for Underserved Patients. Kroll, DS., Wrenn, K., Grimaldi, JA., et al.[2020]

The Minder app, designed specifically for university students, is being tested in a randomized controlled trial with 1496 participants to evaluate its effectiveness in improving mental health and reducing substance use over a 30-day period.

Primary outcomes include changes in anxiety, depression, and alcohol consumption, with assessments occurring at baseline, 2 weeks, and 30 days, aiming to provide scalable mental health support for students during a critical life transition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of a Codeveloped e-Mental Health Intervention for University Students: Protocol for a Randomized Controlled Trial. Wang, AY., Vereschagin, M., Richardson, CG., et al.[2023]

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