Psychosocial Resilience Program for Mental Health Wellness

Overseen By Jason Jent, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Feeding tubes, Own meals

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve mental health and resilience in childcare centers by testing two different support programs. One group will receive the Jump Start Plus COVID Support, while the other will participate in the Healthy Caregivers-Healthy Children program, each lasting 24 months. Centers with more than 30 children aged 2 to 5, serving low-income families, and reflecting Miami-Dade County's ethnic diversity may be suitable candidates. Children in these centers should be aged 2-5 and enrolled in the center, but those with feeding tubes or bringing their own meals are not eligible. The goal is to determine which program better promotes psychosocial wellness in these settings. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance support programs for children and caregivers.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this program is safe for mental health wellness?

Research has shown that the Jump Start Plus COVID Support program helps people become more resilient and improve their mental health. Early results suggest that this program is safe for participants. It focuses on strategies like safety planning to boost mental well-being, which have shown promise in aiding recovery from difficult situations.

The study is in a "Not Applicable" phase, meaning it doesn't involve testing a new drug or medical device. Instead, it evaluates a mental health support program. As a result, there are no reports of serious side effects or risks like those found in drug trials.

In similar programs, participants generally handle the activities well. This suggests that people can safely participate in the Jump Start Plus COVID Support program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Psychosocial Resilience Program for Mental Health Wellness because it uniquely targets mental health by focusing on building resilience through psychosocial support. Unlike standard treatments that often revolve around medication or traditional therapy, this program emphasizes strengthening the mental well-being of both caregivers and children. The Jump Start Plus COVID Support component is designed to specifically address the ongoing stresses of the pandemic, offering tailored support that adapts to current challenges. This innovative approach aims to bolster mental health by fostering resilience, which could lead to more sustainable wellness outcomes.

What evidence suggests that this trial's programs could be effective for mental health wellness?

Research shows that the Jump Start Plus COVID Support (JS+CS) program, available to participants in this trial, helps build resilience in childcare settings. This online program aims to improve mental health by providing tips on managing behavior and ensuring safety. Studies have found that the program enhances protective factors in young children, helping them handle stress better. Based on a community model, it supports children's social and emotional growth, which is crucial during challenging times like the COVID-19 pandemic. This approach is expected to improve mental health for both children and caregivers. ^{1 3 6 7 8}

Who Is on the Research Team?

Ruby Natale, PhD, PsyD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child is between 2 and 5 years old.

Center: Serve low-income families

Center: Reflect the ethnic diversity of Miami-Dade County (60% Hispanic, 20% Non-Hispanic Black, 20% Non-Hispanic White)

Exclusion Criteria

Children that bring their own meals

Children with feeding tubes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the Jump Start Plus COVID Support intervention or the Healthy Caregivers-Healthy Children intervention

24 months

Follow-up

Participants are monitored for changes in psychosocial functioning and stress levels

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Caregivers-Healthy Children (HC2)
• Jump Start Plus COVID Support

Trial Overview 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.

How Is the Trial Designed?

Group I: Jump Start Plus COVID Support (JS+CS) Group Experimental Treatment 1 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 Group Active Control 1 Intervention

Participants in this group will receive the Healthy Caregivers-Healthy Children intervention for 24 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The systematic review identified only 11 study protocols focused on psychosocial interventions for children and their caregivers during the COVID-19 pandemic, highlighting a significant lack of research in this area.

Most interventions targeted parents and caregivers rather than children directly, indicating a need for more direct approaches to address anxiety, depression, and stress in children affected by the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Ameliorate the Psychosocial Effects of the COVID-19 Pandemic on Children-A Systematic Review. Boldt, K., Coenen, M., Movsisyan, A., et al.[2021]

The HUGS/Abrazos program effectively addressed the increased toxic stressors faced by pregnant women and families during the COVID-19 pandemic, providing essential support through patient navigation and behavioral health resources.

The program was widely adopted, with 392 families referred and a 79% follow-up rate, demonstrating its strong acceptance and potential for long-term impact on community health amidst ongoing challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation Evaluation of HUGS/Abrazos During the COVID-19 Pandemic: A Program to Foster Resiliency in Pregnancy and Early Childhood. Liu, M., Simione, M., Perkins, ME., et al.[2022]

The Summer Institute in Global Mental Health and Psychosocial Support provides essential training for professionals working with communities affected by severe adversities, focusing on enhancing social connectedness and resilience.

The program emphasizes the importance of supportive organizational contexts, understanding complex systems, and fostering healing, using a mix of teaching methods including interactive exercises and case studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Resilience in Families, Communities, and Organizations: A Training Program in Global Mental Health and Psychosocial Support. Saul, J., Simon, W.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05445518?term=AREA%5BBasicSearch%5D(jump)&rank=9

NCT05445518 | Jump Start Plus COVID-19 Support The Jump Start Plus COVID Support intervention is a resiliency program that provides behavior management and safety programs administered weekly via zoom.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9694403/

Designing a virtual mental health consultation program to ... This randomized controlled trial will study the role of a community-based, childcare center-support system in improving resilience and mitigating the long-term ...

3. mdpi.com mdpi.com/2227-9067/12/7/812

Strengthening Early Childhood Protective Factors Through ... Jump Start Plus COVID Support (JS+CS) [36] is an infant and early childhood mental health consultation (IECMHC) program that adapted the Georgetown Model of ...

4. preprints.org preprints.org/manuscript/202505.1072/v1

Strengthening Early Childhood Protective Factors Through ... Jump Start Plus COVID Support (JS+CS) [36] is an infant and early childhood mental health consultation (IECMHC) program that adapted the ...

5. researchgate.net researchgate.net/publication/365755198_Designing_a_virtual_mental_health_consultation_program_to_support_and_strengthen_childcare_centers_impacted_by_COVID-19_A_randomized_controlled_trial_protocol

Designing a virtual mental health consultation program to ... The Jump Start + COVID Support (JS + CS) model, is a community-based intervention that aims to support childcare centers in promoting young children's social- ...

6. withpower.com withpower.com/trial/phase-mental-health-wellness-1-7-2022-61736

Psychosocial Resilience Program for Mental Health Wellness Trial Overview The study is testing the Jump Start Plus COVID Support program designed to boost resilience and psychosocial functioning among young children ...

7. pandemicpact.org pandemicpact.org/grants/P23104

Jump Start+:COVID Support to improve resiliency and ... This is a Type 1 hybrid effectiveness-implementation trial studying the role of a community- based, childcare center-support system in improving resilience and ...

8. ctv.veeva.com ctv.veeva.com/study/jump-start-plus-covid-19-support

Jump Start Plus COVID-19 Support - ClinicalTrials.Veeva The purpose of the study is to further develop and examine the Jump Start Plus COVID Support (JS+CS) program, which encourages improved ...