Mental Health Wellness 1NCT06374550
Jump Start on the Go: Improving Resiliency and the Social-Emotional Development of At-Risk Preschool Children
A study testing Jump Start on the Go and Jump Start Plus Coronavirus Support in people with Mental Health Wellness 1, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Jump Start on the Go and Jump Start Plus Coronavirus Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1. any participants who do not speak English or Spanish or Creole.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Jump Start on the Go: Improving Resiliency and the Social-Emotional Development of At-Risk Preschool Children in Childcare Centers Using a Mobile Application
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.
- Conditions
- Mental Health Wellness 1
- Being tested
- Jump Start on the Go, Jump Start Plus Coronavirus Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jump Start on the GoBehavioural
Centers will receive the Jump Start On The Go mental health program via a mobile app. This will entail receiving 12-24 mental health consultation sessions in which a licensed mental health consultant will use a mobile app that will provide directors and teachers with access to information such as videos, infographics, and an Artificial Intelligence Chatbot on how to work with children with challenging behaviors. Participants will receive the intervention once per week for up to 1 hour.
Jump Start Plus Coronavirus SupportBehavioural
The Jump Start Plus Coronavirus Support intervention is a resiliency program that provides behavior management and safety programs administered weekly via zoom.
| Study group | Role | What they receive |
|---|---|---|
| Jump Start on the Go Group | Experimental | Participants will be in this group for a total of up to 12 months. These participants will receive the intervention via a mobile app. Receives: Behavioral: Jump Start on the Go |
| Jump Start plus Coronavirus Support Group | Active comparator | Participants will be in this group for a total of up to 12 months. Receives: Behavioral: Jump Start Plus Coronavirus Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in classroom practices as measured by Health Environment Rating Scale
The Health Environment Rating Scale is a measure with a range of score from 0 to 70 with higher score indicating better classroom practices.
Measured: Baseline, 2 months after baseline, and up to 1 year
Secondary outcomes (7)
Change in child behaviors as measured by Devereux Early Childhood Assessments (DECA)
The Devereux Early Childhood Assessments is a measure with a range of score from 0 to 100 with higher score on Behavior Concerns indicating more problem behaviors.
Measured: Baseline, 2 months after baseline, and up to 1 year
Change in child behaviors as measured by Strengths and Difficulties Questionnaire (SDQ)
The Strengths and Difficulties Questionnaire is a total difficulties score that ranges from 0 to 40 with higher scores indicating less child behavior concerns.
Measured: Baseline and up to 1 year
Change in resiliency as measured by Brief Resiliency Coping Scale
The Brief Resiliency Coping Scale is a total score that ranges from 4 to 20 with higher scores indicating higher levels of coping
Measured: Baseline and up to 1 year
Change in stress as measured by Childcare Worker Job Stress Index
The Childcare Worker Job Stress Index is a total score that ranges from 22 to 110 with higher scores indicating higher levels of stress
Measured: Baseline and up to 1 year
Change in stress as measured by Everyday Stressors Index
The Everyday Stressors Index is a total score that ranges from 0 to 80 with higher scores indicating higher levels of stress.
Measured: Baseline and up to 1 year
Change in satisfaction as measured by Teacher Opinion and Satisfaction survey
The Teacher Opinion survey is a measure with a range of score from 12 to 44 with higher score indicating better self-efficacy as it relates to teaching practices.
Measured: Baseline and up to 1 year
Mobile Application satisfaction as measured by the Mobile Application Rating Scale
The Mobile Application Rating Scale is a measure with a range of scores from 29-145 with higher score indicating better engagement, functionality, aesthetics, and information quality, as well as application subjective quality.
Measured: 2 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start10 Sep 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruby Natale, University of Miami
- Investigators
- Ruby Natale, PhD, PsyD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374550
- Sponsor's protocol ID
- 20231026
- Status last verified
- Aug 2025
- First submitted
- 15 Apr 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jump Start on the Go: Improving Resiliency and the Social-Emotional Development of At-Risk Preschool Children in Childcare Centers Using a Mobile Application
- ClinicalTrials.gov ID
- NCT06374550
- Acronym / sponsor ID
- 20231026
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jump Start on the Go Group | Experimental | Behavioral: Jump Start on the GoParticipants will be in this group for a total of up to 12 months. These participants will receive the intervention via a mobile app. |
| Jump Start plus Coronavirus Support Group | Active comparator | Behavioral: Jump Start Plus Coronavirus SupportParticipants will be in this group for a total of up to 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1. any participants who do not speak English or Spanish or Creole.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jump Start on the GoCenters will receive the Jump Start On The Go mental health program via a mobile app. This will entail receiving 12-24 mental health consultation sessions in which a licensed mental health consultant will use a mobile app that will provide directors and teachers with access to information such as videos, infographics, and an Artificial Intelligence Chatbot on how to work with children with challenging behaviors. Participants will receive the intervention once per week for up to 1 hour. | Behavioural | Jump Start on the Go Group |
| Jump Start Plus Coronavirus SupportThe Jump Start Plus Coronavirus Support intervention is a resiliency program that provides behavior management and safety programs administered weekly via zoom. | Behavioural | Jump Start plus Coronavirus Support Group |
Primary outcome
Change in classroom practices as measured by Health Environment Rating Scale
Time frame: Baseline, 2 months after baseline, and up to 1 year
The Health Environment Rating Scale is a measure with a range of score from 0 to 70 with higher score indicating better classroom practices.
7 secondary outcomes
Change in child behaviors as measured by Devereux Early Childhood Assessments (DECA)
Time frame: Baseline, 2 months after baseline, and up to 1 year
Change in child behaviors as measured by Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline and up to 1 year
Change in resiliency as measured by Brief Resiliency Coping Scale
Time frame: Baseline and up to 1 year
Change in stress as measured by Childcare Worker Job Stress Index
Time frame: Baseline and up to 1 year
Change in stress as measured by Everyday Stressors Index
Time frame: Baseline and up to 1 year
Change in satisfaction as measured by Teacher Opinion and Satisfaction survey
Time frame: Baseline and up to 1 year
Mobile Application satisfaction as measured by the Mobile Application Rating Scale
Time frame: 2 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruby Natale, PhD, PsyD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jump Start on the Go and Jump Start Plus Coronavirus Support in people with Mental Health Wellness 1, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in classroom practices as measured by Health Environment Rating Scale (time frame: Baseline, 2 months after baseline, and up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.