Jump Start Plus COVID-19 Support

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness 1
• Intervention / Treatment: Behavioral: Jump Start Plus COVID Support; Behavioral: Healthy Caregivers-Healthy Children (HC2)

• Study Type: Interventional
• Enrollment (Actual): 1505
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Center Inclusion Criteria:

1. Have greater than 30 children ages 2- to 5-years old
2. Serve low-income families
3. Reflect the ethnic diversity of Miami-Dade County (60%Hispanic, 20% Non-Hispanic Black, 20% Non-Hispanic White

Child Inclusion Criteria:

1. Child ages 2-5 years old
2. Child enrolled in a childcare center

Exclusion Criteria:

• Children with feeding tubes or those that bring their own meals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jump Start Plus COVID Support (JS+CS) Group; Participants in this group will receive the Jump Start Plus COVID Support intervention for 24 months.	Behavioral: Jump Start Plus COVID Support; The Jump Start Plus COVID Support intervention is a resiliency program that provides behavior management and safety programs administered weekly via zoom.
Active Comparator: Healthy Caregivers-Healthy Children (HC2) Control Group; Participants in this group will receive the Healthy Caregivers-Healthy Children intervention for 24 months.	Behavioral: Healthy Caregivers-Healthy Children (HC2); The HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	Baseline, Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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.	Baseline, up to 3 years

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Ruby Natale, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): May 19, 2026

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 20220115; R01HD105474 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No