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

1200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Healthy Caregivers-Healthy Children (HC2), Jump Start Plus COVID Support?

Research shows that supporting caregivers' mental health and providing resources can improve children's behavior and well-being, especially during stressful times like the COVID-19 pandemic. Programs that focus on building resilience in caregivers and children have been shown to help reduce anxiety and stress. ^{1 2 3 4 5}

Is the Psychosocial Resilience Program for Mental Health Wellness safe for humans?

The HUGS/Abrazos program, which is similar to the Psychosocial Resilience Program, was well adopted and considered appropriate and acceptable, with no safety concerns reported during its implementation for pregnant women and families with young children. ^{3 4 5 6 7}

How does the Psychosocial Resilience Program for Mental Health Wellness treatment differ from other treatments?

The Psychosocial Resilience Program for Mental Health Wellness, involving Healthy Caregivers-Healthy Children (HC2) and Jump Start Plus COVID Support, is unique because it focuses on building resilience in caregivers and children by addressing social needs and providing behavioral health support, particularly in the context of the COVID-19 pandemic. This treatment is distinct in its use of community health workers and a centralized resource system to streamline care and support families facing pandemic-related stress. ^{3 6 8 9 10}

What is the purpose of this trial?

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.

Research Team

Ruby Natale, PhD, PsyD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Caregivers' Experiences During the COVID-19 Pandemic and Their Children's Behavior. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Mental health trajectories of individuals and families following the COVID-19 pandemic: Study protocol of a longitudinal investigation and prevention program. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Interventions to Ameliorate the Psychosocial Effects of the COVID-19 Pandemic on Children-A Systematic Review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Designing a virtual mental health consultation program to support and strengthen childcare centers impacted by COVID-19: A randomized controlled trial protocol. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Fast and the Furious: The Rapid Implementation of Tele-mental Health Practices Within a Children's Advocacy Center. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Fostering Resilience in Pregnancy and Early Childhood During the COVID-19 Pandemic: The HUGS/Abrazos Program Design and Implementation. [2021]

7. Switzerland 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Child and Adolescent Psychosocial Support Programs Following Natural Disasters-a Scoping Review of Emerging Evidence. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Risk and resilience of well-being in caregivers of young children in response to the COVID-19 pandemic. [2021]