Mental Health Wellness 1NCT05445518
Jump Start Plus COVID-19 Support
A study testing Jump Start Plus COVID Support and Healthy Caregivers-Healthy Children (HC2) in people with Mental Health Wellness 1, run by University of Miami at 1 site in United States.
Trial summary
The purpose of the study is to further develop and examine the Jump Start Plus COVID Support (JS+CS) program, which encourages improved psychosocial functioning by promoting resiliency in childcare centers. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Jump Start Plus COVID Support and Healthy Caregivers-Healthy Children (HC2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,505 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 19 May 2026
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Children with feeding tubes or those that bring their own meals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Jump Start Plus: Coronavirus Disease (COVID-19) Support to Improve Resiliency and Mitigate Risks in Childcare Centers Serving Children From Low-income Ethnic Minority Backgrounds.
The purpose of the study is to further develop and examine the Jump Start Plus COVID Support (JS+CS) program, which encourages improved psychosocial functioning by promoting resiliency in childcare centers.
- Conditions
- Mental Health Wellness 1
- Being tested
- Jump Start Plus COVID Support, Healthy Caregivers-Healthy Children (HC2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jump Start Plus COVID SupportBehavioural
The Jump Start Plus COVID Support intervention is a resiliency program that provides behavior management and safety programs administered weekly via zoom.
Healthy Caregivers-Healthy Children (HC2)Behavioural
The HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom.
| Study group | Role | What they receive |
|---|---|---|
| Jump Start Plus COVID Support (JS+CS) Group | Experimental | Participants in this group will receive the Jump Start Plus COVID Support intervention for 24 months. Receives: Behavioral: Jump Start Plus COVID Support |
| Healthy Caregivers-Healthy Children (HC2) Control Group | Active comparator | Participants in this group will receive the Healthy Caregivers-Healthy Children intervention for 24 months. Receives: Behavioral: Healthy Caregivers-Healthy Children (HC2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Environment Rating Scale Scores
The Health Environment Rating Scale has a total score ranging from 0 to 70 with higher scores indicating healthier practices
Measured: Baseline, Up to 3 years
Change in Strengths and Difficulties Questionnaire Scores
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, Up to 3 years
Change in Devereux Early Childhood Assessments Scores
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 and a lower score on Initiative, Self-Control, Attachment indicated better protective factors.
Measured: Baseline, Up to 3 years
Secondary outcomes (5)
Change in Brief Resilient Coping Scale Scores
The Brief Resilient Coping Scale is a measure with a range of score from 4 to 20 with a higher score indicating better coping.
Measured: Baseline, Up to 3 years
Change in Childcare Worker Job Stress Index Scores
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, Up to 3 years
Change in Every Day Stressors Index Scores
The Every Day Stressors Index is a total score that ranges from 0 to 80 with higher scores indicating higher levels of stress.
Measured: Baseline, Up to 3 years
Change in Healthy Caregivers-Healthy Children Survey
Teacher and parents complete this survey on the number of reported nutrition and physical activity practices
Measured: Baseline, Up to 3 years
Change in Teacher Opinion 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, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Aug 2022
- Primary completion31 Oct 2025
- Study completion19 May 2026
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,505 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Ruby Natale, University of Miami
- Investigators
- Ruby Natale, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445518
- Sponsor's protocol ID
- 20220115
- Other IDs
- R01HD105474
- Status last verified
- May 2026
- First submitted
- 1 Jul 2022
- Last updated
- 22 May 2026
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jump Start Plus: Coronavirus Disease (COVID-19) Support to Improve Resiliency and Mitigate Risks in Childcare Centers Serving Children From Low-income Ethnic Minority Backgrounds.
- ClinicalTrials.gov ID
- NCT05445518
- Acronym / sponsor ID
- 20220115
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,505 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 6 Jul 2022 (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 the study is to further develop and examine the Jump Start Plus COVID Support (JS+CS) program, which encourages improved psychosocial functioning by promoting resiliency in childcare centers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jump Start Plus COVID Support (JS+CS) Group | Experimental | Behavioral: Jump Start Plus COVID SupportParticipants in this group will receive the Jump Start Plus COVID Support intervention for 24 months. |
| Healthy Caregivers-Healthy Children (HC2) Control Group | Active comparator | Behavioral: Healthy Caregivers-Healthy Children (HC2)Participants in this group will receive the Healthy Caregivers-Healthy Children intervention for 24 months. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Children with feeding tubes or those that bring their own meals.
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 Plus COVID SupportThe Jump Start Plus COVID Support intervention is a resiliency program that provides behavior management and safety programs administered weekly via zoom. | Behavioural | Jump Start Plus COVID Support (JS+CS) Group |
| Healthy Caregivers-Healthy Children (HC2)The HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom. | Behavioural | Healthy Caregivers-Healthy Children (HC2) Control Group |
Primary outcome
Change in Health Environment Rating Scale Scores
Time frame: Baseline, Up to 3 years
The Health Environment Rating Scale has a total score ranging from 0 to 70 with higher scores indicating healthier practices
Change in Strengths and Difficulties Questionnaire Scores
Time frame: Baseline, Up to 3 years
The Strengths and Difficulties Questionnaire is a total difficulties score that ranges from 0 to 40 with higher scores indicating less child behavior concerns.
Change in Devereux Early Childhood Assessments Scores
Time frame: Baseline, Up to 3 years
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 and a lower score on Initiative, Self-Control, Attachment indicated better protective factors.
5 secondary outcomes
Change in Brief Resilient Coping Scale Scores
Time frame: Baseline, Up to 3 years
Change in Childcare Worker Job Stress Index Scores
Time frame: Baseline, Up to 3 years
Change in Every Day Stressors Index Scores
Time frame: Baseline, Up to 3 years
Change in Healthy Caregivers-Healthy Children Survey
Time frame: Baseline, Up to 3 years
Change in Teacher Opinion Survey
Time frame: Baseline, up to 3 years
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 22 May 2026.
- 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 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 Plus COVID Support and Healthy Caregivers-Healthy Children (HC2) 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 22 May 2026. 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 Health Environment Rating Scale Scores (time frame: Baseline, Up to 3 years). The study lists 3 primary outcomes in all. 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 22 May 2026.