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Psychosocial Resilience Program for Mental Health Wellness

N/A
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to enhance the Jump Start Plus COVID Support program, which helps improve mental and social well-being in childcare centers by building resilience among children and staff.

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.
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.
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
Select...
My child is between 2 and 5 years old.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Devereux Early Childhood Assessments Scores
Change in Health Environment Rating Scale Scores
Change in Strengths and Difficulties Questionnaire Scores
Secondary study objectives
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for mental health wellness, such as those studied in the Jump Start Plus COVID Support program, focus on psychosocial support and resiliency promotion. These treatments work by enhancing coping strategies, reducing stress, and fostering a sense of community and support. Methods like cognitive-behavioral therapy (CBT), mindfulness practices, and social support networks alter negative thought patterns, promote relaxation and emotional regulation, and provide a supportive environment. This comprehensive approach is crucial for mental health wellness patients as it addresses both psychological and social factors, leading to improved mental health outcomes.
Interventions to identify and manage depression delivered by 'nontraditional' providers to community-dwelling older adults: A realist review.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,746,254 Total Patients Enrolled
1 Trials studying Mental Health Wellness
642 Patients Enrolled for Mental Health Wellness
University of MiamiLead Sponsor
955 Previous Clinical Trials
427,653 Total Patients Enrolled
Ruby NatalePrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
348 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: Jump Start Plus COVID Support (JS+CS) Group, Healthy Caregivers-Healthy Children (HC2) Control 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
~475 spots leftby Aug 2026