Jump Start Plus COVID-19 Support

NCT05445518 | Completed

• 2 other identifiers: 20220115R01HD105474
• Study Type: interventional
• Target: 1,505
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health Wellness 1

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in Brief Resilient Coping Scale Scores

  Baseline, Up to 3 years

• Change in Childcare Worker Job Stress Index Scores

  Baseline, Up to 3 years

• Change in Every Day Stressors Index Scores

  Baseline, Up to 3 years

• Change in Healthy Caregivers-Healthy Children Survey

  Baseline, Up to 3 years

• Change in Teacher Opinion Survey

  Baseline, up to 3 years

Study Arms (2)

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.

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.

Behavioral: Healthy Caregivers-Healthy Children (HC2)

Interventions

Jump Start Plus COVID Support BEHAVIORAL

The Jump Start Plus COVID Support intervention is a resiliency program that provides behavior management and safety programs administered weekly via zoom.

Jump Start Plus COVID Support (JS+CS) Group

Healthy Caregivers-Healthy Children (HC2) BEHAVIORAL

The HC2 intervention is an obesity prevention program that provides nutrition and healthy activities programs administered weekly via Zoom.

Healthy Caregivers-Healthy Children (HC2) Control Group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have greater than 30 children ages 2- to 5-years old
• Serve low-income families
• Reflect the ethnic diversity of Miami-Dade County (60%Hispanic, 20% Non-Hispanic Black, 20% Non-Hispanic White
• Child ages 2-5 years old
• Child enrolled in a childcare center

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

Study Officials

• Ruby Natale

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 6, 2022
• Study Start: August 1, 2022
• Primary Completion: October 31, 2025
• Study Completion: May 19, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)