Jump Start Plus COVID Support for Mental Health Wellness 1

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FL
Mental Health Wellness 1
Jump Start Plus COVID Support - Behavioral
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Baseline, up to 3 years

Year 3
Change in Brief Resilient Coping Scale Scores
Change in Childcare Worker Job Stress Index Scores
Change in Devereux Early Childhood Assessments Scores
Change in Every Day Stressors Index Scores
Change in Health Environment Rating Scale Scores
Change in Healthy Caregivers-Healthy Children Survey
Change in Strengths and Difficulties Questionnaire Scores
Year 3
Change in Teacher Opinion Survey

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Healthy Caregivers-Healthy Children (HC2) Control Group
1 of 2
Jump Start Plus COVID Support (JS+CS) Group
1 of 2
Active Control
Experimental Treatment

1200 Total Participants · 2 Treatment Groups

Primary Treatment: Jump Start Plus COVID Support · No Placebo Group · N/A

Jump Start Plus COVID Support (JS+CS) Group
Behavioral
Experimental Group · 1 Intervention: Jump Start Plus COVID Support · Intervention Types: Behavioral
Healthy Caregivers-Healthy Children (HC2) Control Group
Behavioral
ActiveComparator Group · 1 Intervention: Healthy Caregivers-Healthy Children (HC2) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, up to 3 years
Closest Location: University of Miami · Miami, FL
Photo of University of Miami 1Photo of University of Miami 2Photo of University of Miami 3
1991First Recorded Clinical Trial
1 TrialsResearching Mental Health Wellness 1
620 CompletedClinical Trials

Who is running the clinical trial?

University of MiamiLead Sponsor
780 Previous Clinical Trials
380,562 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,785 Previous Clinical Trials
2,220,598 Total Patients Enrolled
Ruby NatalePrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
1,000 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have at least 30 children ages 2- to 5-years old.
You serve low-income families.
You are of Hispanic, Black, or White ethnicity.
You are a child who attends a childcare center.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.