You & Me Healthy: Youth Empowered Self-Care Substudy (YES) (YES)

August 7, 2024 updated by: Duke University

You & Me Healthy: Youth Empowered Self-Care, or YES, is a study that aims to link 150 youth ages 8-12 and families to free or low-cost community-based programs, resources, and clinical care options that promote mental wellness and help reduce anxiety.

Community-based programs can include:

  • Afterschool programs
  • Local parks and recreation activities
  • Youth social programming

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The You & Me Healthy; Youth Empowered Self-care study seeks to evaluate a direct-to-participant mental health intervention for youth living in underserved communities, comprising online self-screening tools, educational materials and online linkage to treatment options, and referral to free or low-cost accessible out-of-school community-based resources. Participants will self-'triage' online to access education, community resources, and clinical care options when necessary. This work will provide access and explore mechanisms for addressing wellness and anxiety needs among youth drawing from self-reported and web interaction data over a 4-month period. The central hypothesis is that the researchers will demonstrate the value of a direct-to-participant, community asset based mental health promotion program in response to COVID-19 impacts. In addition, the team aims to specifically identify approaches to enable access to community-based anxiety and mental wellness resources in underserved populations.

Out-of-school youth programs play an important role in supporting students' mental health, yet program participation has dwindled since the COVID-19 pandemic. These programs provide students with psychosocial, developmental, and health and wellness benefits. Specifically, structured youth programs can engage students in recreation, provide academic enrichment, access to green spaces, as well as opportunities for promoting social interaction and connectedness with peers, adaptive functioning, mentorship, as well as resilience, mental health, and well-being. Out-of-school youth programs are particularly critical for students who live in under resourced communities with high transportation vulnerability and limited access to community-based recreation, although unmet demand for programs is highest in underserved areas. Nationally, 9 out of 10 parents agree that out-of-school youth programs are important to their community, and 80% of North Carolina parents indicate that these programs give them peace of mind and help them to keep their jobs. Out-of-school youth programs also have been proposed as an ideal setting for supporting children's health and wellness. Put simply, out-of-school youth programs provide students with safe and supportive settings for recreation, mentorship, learning, and structure that are particularly essential for underserved communities. However, the COVID-19 pandemic has created hardships for youth to attend out-of-school programs nationwide. Prior to the COVID-19 pandemic, over 10 million youth participated in out-of-school programs nationally, although more than 80% of programs reported difficulties providing ongoing services during the COVID-19 pandemic due to poor enrollment. The gap in psychosocial support typically provided through out-of-school youth programs has likely exacerbated mental health needs during the pandemic, particularly for underserved students, and further overburdening the health care system.

The research team is working together with two large community organizations as partners for this study (Durham Parks and Recreation Department and Miami-Dade County Parks and Recreation Department), who will coordinate directly with 150 youth and families (75 participants per site) to link youth to community-based youth programs that have potential to support youth mental health needs. All eligible and consented participants will complete basic data collection including demographics, mental health symptom questions, additional barriers to program enrollment and attendance, and satisfaction survey questions using REDCap. Participants will also receive online resource linkage to mental wellness education and anxiety treatment locations as applicable.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33128
        • Miami-Dade County Parks and Recreation
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Durham Parks and Recreation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:

    1. Self-reported primary residence within the pre-identified communities
    2. Age 8-12 years at enrollment
    3. Provision of signed and dated informed consent form

Exclusion Criteria:

  • There are no exclusion criteria for this study if all above inclusion criteria are met.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pre-Surveys Only
Pre-surveys only (did not meet referral criteria based on screening assessment) and receive online wellness education and anxiety treatment options information
Behavioral: Pre-surveys only
Receive online wellness education and anxiety treatment options information
Other: Pre-Surveys, Recreational Program Referral, Post Surveys
Pre-surveys, meet referral criteria, referred to a program, post-surveys. Post-surveys will occur at the end of the out-of-school program, or 4 months after joining the program (whichever comes first).
Behavioral: Community-based recreation program referral
Provide referral to local Parks and Recreation for programs of interest and participation. Participants will have the option to join a program (up to 4months) and have access to additional resources via study webpage to identify support services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants referred to youth community-based programs with potential to promote mental health that are free/low-cost
Time Frame: Up to 4 months
Up to 4 months
Number of youth community-based programs with potential to promote mental wellness offered that are free/low-cost (self-reported)
Time Frame: Up to 4 months
Up to 4 months
Number of youth enrollees to community-based programs with potential to promote mental wellness that are free/low-cost (self-reported)
Time Frame: Up to 4 months
Up to 4 months
Number of consented participants who complete self-screening assessment
Time Frame: Baseline
Baseline
Proportion of consented participants who complete self-screening assessment
Time Frame: Baseline
Baseline
Proportion of participants who visited the online resources page
Time Frame: Up to 4 months
Up to 4 months
Change in anxiety symptoms, as measured by survey
Time Frame: Baseline, up to 6 months
Scale: Screen for Child Anxiety Related Emotional Disorders (SCARED) Survey- Parent Version
Baseline, up to 6 months
Change in mental wellness needs, as measured by survey
Time Frame: Baseline, up to 6 months
KIDSCREEN #27- Health Screen QUestionnaire for Children and Young People ( Parent version)
Baseline, up to 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Barriers to youth program enrollment and attendance, as measured by post-participation survey
Time Frame: Up to 6 months
Up to 6 months
Participant Satisfaction, as measured by participant satisfaction survey
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Miami-Dade County Parks and Recreation
Durham Parks and Recreation (Durham, NC)

Investigators

  • Principal Investigator: Emily D'agostino, DPH, Duke University
  • Principal Investigator: Christoph Horniik, MD, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2024

Primary Completion (Actual)

July 12, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRO00114773

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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