Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT06255093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
You & Me Healthy: Youth Empowered Self-Care Substudy (YES)
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
You & Me Healthy: Youth Empowered Self-Care Substudy (YES)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YES
Brief Summary:
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
Community-based programs can include:
* Afterschool programs
* Local parks and recreation activities
* Youth social programming
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: