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

250 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Jump Start on the Go (JS Go) for mental health wellness?

Research shows that mobile health apps and online treatments can effectively manage anxiety and depression symptoms, suggesting that similar digital interventions like JS Go might also be beneficial for mental health wellness. ^{1 2 3 4 5}

How is the treatment Jump Start on the Go (JS Go) different from other mental health treatments?

Jump Start on the Go (JS Go) is unique because it may incorporate digital health solutions and mobile tools, similar to other innovative mental health programs, to support mental wellness, making it more accessible and adaptable to individual needs compared to traditional in-person therapies. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to test the Jump Start on the Go (JS Go), an app-based program and see how helpful it is at improving resiliency and behavior support within childcare settings.

Research Team

Ruby Natale, PhD, PsyD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 '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]

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]

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]

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]

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]

References

1. Canada 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. [2022]

2. Canada 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. [2020]

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

Guided online treatment in routine mental health care: an observational study on uptake, drop-out and effects. [2022]

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

Longitudinal Urgent Care Psychiatry as a Unique Access Point for Underserved Patients. [2020]

5. Netherlands 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. [2022]

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

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

7. Canada 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. [2020]

8. Canada pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of a Codeveloped e-Mental Health Intervention for University Students: Protocol for a Randomized Controlled Trial. [2023]

9. United States 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. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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