NCT06374550

Brief Summary

The purpose of this study is to test the Jump Start on the Go (JS Go), an app-based program and see how helpful it is at improving resiliency and behavior support within childcare settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

9 months

First QC Date

April 15, 2024

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in classroom practices as measured by Health Environment Rating Scale

    The Health Environment Rating Scale is a measure with a range of score from 0 to 70 with higher score indicating better classroom practices.

    Baseline, 2 months after baseline, and up to 1 year

Secondary Outcomes (7)

  • Change in child behaviors as measured by Devereux Early Childhood Assessments (DECA)

    Baseline, 2 months after baseline, and up to 1 year

  • Change in child behaviors as measured by Strengths and Difficulties Questionnaire (SDQ)

    Baseline and up to 1 year

  • Change in resiliency as measured by Brief Resiliency Coping Scale

    Baseline and up to 1 year

  • Change in stress as measured by Childcare Worker Job Stress Index

    Baseline and up to 1 year

  • Change in stress as measured by Everyday Stressors Index

    Baseline and up to 1 year

  • +2 more secondary outcomes

Study Arms (2)

Jump Start on the Go Group

EXPERIMENTAL

Participants will be in this group for a total of up to 12 months. These participants will receive the intervention via a mobile app.

Behavioral: Jump Start on the Go

Jump Start plus Coronavirus Support Group

ACTIVE COMPARATOR

Participants will be in this group for a total of up to 12 months.

Behavioral: Jump Start Plus Coronavirus Support

Interventions

Centers will receive the Jump Start On The Go mental health program via a mobile app. This will entail receiving 12-24 mental health consultation sessions in which a licensed mental health consultant will use a mobile app that will provide directors and teachers with access to information such as videos, infographics, and an Artificial Intelligence Chatbot on how to work with children with challenging behaviors. Participants will receive the intervention once per week for up to 1 hour.

Jump Start on the Go Group

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

Jump Start plus Coronavirus Support Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Centers must have \>30 children ages 2-to-5
  • Center must serve low income families
  • Centers must reflect the ethnic diversity of the Miami Dade County Public School System (60% Hispanic, 20% Non-Hispanic Black, 20% Non-Hispanic White).
  • Participants must speak English or Spanish or Creole
  • Parents must have a child enrolled in the childcare center that is participating in the study.
  • Children ages 2-5: Parent reported data (name, Date of Birth, behaviors)

You may not qualify if:

  • \. any participants who do not speak English or Spanish or Creole.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

  • Ruby Natale, PhD, PsyD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Pediatrics

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 18, 2024

Study Start

September 10, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations