What side effects are associated with this type of intervention?

Psychosocial support and resiliency promotion treatments, such as cognitive-behavioral therapy (CBT) and counseling, are generally safe but can have side effects. These may include emotional discomfort during sessions, temporary increases in anxiety or distress, and fatigue from the mental effort involved in therapy. The effectiveness of these interventions can vary based on individual differences, such as baseline mental health status and personal motivation.

What prior FDA approvals exist?

FDA-approved treatments for mental health wellness include medications such as SSRIs (e.g., fluoxetine, sertraline) and SNRIs (e.g., venlafaxine, duloxetine), which are used to treat depression and anxiety disorders. Non-pharmacological interventions like Cognitive Behavioral Therapy (CBT) and other psychotherapies are also widely recognized for their effectiveness in enhancing psychosocial functioning and resilience, similar to the goals of the Jump Start Plus COVID Support program.

What other types of research exist?

Promising alternatives to Jump Start Plus COVID Support for mental health wellness in 2024 include: 1) Online mental health promotion programs with student co-design and integration into mandatory activities, 2) Mindfulness interventions combined with other smoking cessation treatments, 3) Comprehensive behavioral therapy with frequent and extended counseling sessions, and 4) Supportive therapy emphasizing positive encouragement, education, and emotional support.

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Psychosocial Resilience Program for Mental Health Wellness

N/A

Recruiting

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

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

Select...

My child is between 2 and 5 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to 3 years

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

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.

0 / 1Eligibility criteria met

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.

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