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Psychosocial Resilience Program for Mental Health Wellness

Led By Ruby Natale
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child: Child ages 2-5 years old
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 3 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will help to improve the psychosocial functioning of childcare centers by promoting resiliency in them.

Who is the study for?
This trial is for children aged 2-5 enrolled in childcare centers serving low-income families in Miami-Dade County, aiming to reflect its ethnic diversity (60% Hispanic, 20% Non-Hispanic Black, and 20% Non-Hispanic White). Centers must have more than 30 kids within this age range.Check my eligibility
What is being tested?
The study is testing the Jump Start Plus COVID Support program designed to boost resilience and psychosocial functioning among young children during the pandemic by providing support at their childcare centers.See study design
What are the potential side effects?
Since this intervention focuses on psychosocial support rather than medical treatment, traditional side effects are not expected. However, there may be varying responses to the program based on individual child experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My child is between 2 and 5 years old.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Devereux Early Childhood Assessments Scores
Change in Health Environment Rating Scale Scores
Change in Strengths and Difficulties Questionnaire Scores
Secondary outcome measures
Change in Brief Resilient Coping Scale Scores
Change in Childcare Worker Job Stress Index Scores
Change in Every Day Stressors Index Scores
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Jump Start Plus COVID Support (JS+CS) GroupExperimental Treatment1 Intervention
Participants in this group will receive the Jump Start Plus COVID Support intervention for 24 months.
Group II: Healthy Caregivers-Healthy Children (HC2) Control GroupActive Control1 Intervention
Participants in this group will receive the Healthy Caregivers-Healthy Children intervention for 24 months.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,944 Previous Clinical Trials
2,658,860 Total Patients Enrolled
1 Trials studying Mental Health Wellness
640 Patients Enrolled for Mental Health Wellness
University of MiamiLead Sponsor
893 Previous Clinical Trials
407,548 Total Patients Enrolled
Ruby NatalePrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
1,000 Total Patients Enrolled

Media Library

Healthy Caregivers-Healthy Children (HC2) Clinical Trial Eligibility Overview. Trial Name: NCT05445518 — N/A
Mental Health Wellness Research Study Groups: Healthy Caregivers-Healthy Children (HC2) Control Group, Jump Start Plus COVID Support (JS+CS) Group
Mental Health Wellness Clinical Trial 2023: Healthy Caregivers-Healthy Children (HC2) Highlights & Side Effects. Trial Name: NCT05445518 — N/A
Healthy Caregivers-Healthy Children (HC2) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05445518 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research project still recruiting participants?

"The data found on clinicaltrials.gov confirms that this medical experimentation is currently in the recruitment process, with its first listing being posted August 1st and most recent change occurring at the end of August 29th."

Answered by AI

How many participants are currently undergoing treatment in this clinical experiment?

"Affirmative, the records hosted on clinicaltrials.gov point to this trial's ongoing recruitment process which began on August 1st 2022 and was most recently renewed at the end of that same month. A total of 1200 people are desired for enrollment from one medical site."

Answered by AI

What is the fundamental purpose of this investigation?

"As the primary goal of this 3-year trial, researchers are to observe any changes in Health Environment Rating Scale Scores. Secondary objectives encompass a transformation in Brief Resilient Coping Scale Scores (4 to 20; higher scores imply better coping), Childcare Worker Job Stress Index Scores (22 to 110; greater scores suggest more stress) and Healthy Caregivers-Healthy Children Survey outcomes (parents & teachers report number of nutrition & physical activity behaviour)."

Answered by AI
~725 spots leftby Aug 2026