Jump Start Plus COVID-19 Support

Mental Health Wellness 1 Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05445518
• Other study ID #: 20220115
• Secondary ID: R01HD105474
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 2026

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

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.
• Healthy Caregivers-Healthy Children (HC2)
The HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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