NCT06255093

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 13, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

August 9, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

February 5, 2024

Last Update Submit

August 7, 2024

Conditions

Keywords

AnxietyMental HealthPsychological WellnessRecreational ActivitiesCommunity programsSchool-aged YouthParks and RecreationAfterschool Activities

Outcome Measures

Primary Outcomes (8)

  • Proportion of participants referred to youth community-based programs with potential to promote mental health that are free/low-cost

    Up to 4 months

  • Number of youth community-based programs with potential to promote mental wellness offered that are free/low-cost (self-reported)

    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)

    Up to 4 months

  • Number of consented participants who complete self-screening assessment

    Baseline

  • Proportion of consented participants who complete self-screening assessment

    Baseline

  • Proportion of participants who visited the online resources page

    Up to 4 months

  • Change in anxiety symptoms, as measured by survey

    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

    KIDSCREEN #27- Health Screen QUestionnaire for Children and Young People ( Parent version)

    Baseline, up to 6 months

Other Outcomes (2)

  • Barriers to youth program enrollment and attendance, as measured by post-participation survey

    Up to 6 months

  • Participant Satisfaction, as measured by participant satisfaction survey

    Up to 6 months

Study Arms (2)

Pre-Surveys Only

OTHER

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

Pre-Surveys, Recreational Program Referral, Post Surveys

OTHER

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

Interventions

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.

Pre-Surveys, Recreational Program Referral, Post Surveys

Receive online wellness education and anxiety treatment options information

Pre-Surveys Only

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Self-reported primary residence within the pre-identified communities
  • Age 8-12 years at enrollment
  • Provision of signed and dated informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Miami-Dade County Parks and Recreation

Miami, Florida, 33128, United States

Location

Durham Parks and Recreation

Durham, North Carolina, 27701, United States

Location

Related Publications (14)

  • D'Agostino EM, Frazier SL, Hansen E, Patel HH, Ahmed Z, Okeke D, Nardi MI, Messiah SE. Two-Year Changes in Neighborhood Juvenile Arrests After Implementation of a Park-Based Afterschool Mental Health Promotion Program in Miami-Dade County, Florida, 2015-2017. Am J Public Health. 2019 Jun;109(S3):S214-S220. doi: 10.2105/AJPH.2019.305050.

    PMID: 31241997BACKGROUND
  • Frazier SL, Cappella E, Atkins MS. Linking mental health and after school systems for children in urban poverty: preventing problems, promoting possibilities. Adm Policy Ment Health. 2007 Jul;34(4):389-99. doi: 10.1007/s10488-007-0118-y. Epub 2007 Mar 6.

    PMID: 17340183BACKGROUND
  • Frazier SL, Dinizulu SM, Rusch D, Boustani MM, Mehta TG, Reitz K. Building Resilience After School for Early Adolescents in Urban Poverty: Open Trial of Leaders @ Play. Adm Policy Ment Health. 2015 Nov;42(6):723-36. doi: 10.1007/s10488-014-0608-7.

    PMID: 25425012BACKGROUND
  • Frazier SL, Mehta TG, Atkins MS, Hur K, Rusch D. Not just a walk in the park: efficacy to effectiveness for after school programs in communities of concentrated urban poverty. Adm Policy Ment Health. 2013 Sep;40(5):406-18. doi: 10.1007/s10488-012-0432-x.

    PMID: 22843303BACKGROUND
  • Frazier SL, Rusch D, Coxe S, Stout TJ, Helseth SA, Dirks MA, Bustamante EE, Atkins MS, Glisson C, Green PD, Bhaumik D, Bhaumik R. After-School Programs and Children's Mental Health: Organizational Social Context, Program Quality, and Children's Social Behavior. J Clin Child Adolesc Psychol. 2021 Mar-Apr;50(2):215-228. doi: 10.1080/15374416.2019.1683849. Epub 2020 Feb 14.

    PMID: 32058822BACKGROUND
  • Goodman AC, Ouellette RR, D'Agostino EM, Hansen E, Lee T, Frazier SL. Promoting healthy trajectories for urban middle school youth through county-funded, parks-based after-school programming. J Community Psychol. 2021 Sep;49(7):2795-2817. doi: 10.1002/jcop.22587. Epub 2021 Apr 29.

    PMID: 33914915BACKGROUND
  • Hedemann ER, Frazier SL. Leveraging After-School Programs to Minimize Risks for Internalizing Symptoms Among Urban Youth: Weaving Together Music Education and Social Development. Adm Policy Ment Health. 2017 Sep;44(5):756-770. doi: 10.1007/s10488-016-0758-x.

    PMID: 27544670BACKGROUND
  • Jennings V, Baptiste AK, Osborne Jelks N, Skeete R. Urban Green Space and the Pursuit of Health Equity in Parts of the United States. Int J Environ Res Public Health. 2017 Nov 22;14(11):1432. doi: 10.3390/ijerph14111432.

    PMID: 29165367BACKGROUND
  • Jones SE, Ethier KA, Hertz M, DeGue S, Le VD, Thornton J, Lim C, Dittus PJ, Geda S. Mental Health, Suicidality, and Connectedness Among High School Students During the COVID-19 Pandemic - Adolescent Behaviors and Experiences Survey, United States, January-June 2021. MMWR Suppl. 2022 Apr 1;71(3):16-21. doi: 10.15585/mmwr.su7103a3.

    PMID: 35358165BACKGROUND
  • McCormick R. Does Access to Green Space Impact the Mental Well-being of Children: A Systematic Review. J Pediatr Nurs. 2017 Nov-Dec;37:3-7. doi: 10.1016/j.pedn.2017.08.027. Epub 2017 Sep 4.

    PMID: 28882650BACKGROUND
  • Parenteau AM, Boyer CJ, Campos LJ, Carranza AF, Deer LK, Hartman DT, Bidwell JT, Hostinar CE. A review of mental health disparities during COVID-19: Evidence, mechanisms, and policy recommendations for promoting societal resilience. Dev Psychopathol. 2023 Oct;35(4):1821-1842. doi: 10.1017/S0954579422000499. Epub 2022 Sep 13.

    PMID: 36097815BACKGROUND
  • Racine N, McArthur BA, Cooke JE, Eirich R, Zhu J, Madigan S. Global Prevalence of Depressive and Anxiety Symptoms in Children and Adolescents During COVID-19: A Meta-analysis. JAMA Pediatr. 2021 Nov 1;175(11):1142-1150. doi: 10.1001/jamapediatrics.2021.2482.

    PMID: 34369987BACKGROUND
  • Saltzman LY, Lesen AE, Henry V, Hansel TC, Bordnick PS. COVID-19 Mental Health Disparities. Health Secur. 2021 Jun;19(S1):S5-S13. doi: 10.1089/hs.2021.0017. Epub 2021 May 19.

    PMID: 34014118BACKGROUND
  • Twohig-Bennett C, Jones A. The health benefits of the great outdoors: A systematic review and meta-analysis of greenspace exposure and health outcomes. Environ Res. 2018 Oct;166:628-637. doi: 10.1016/j.envres.2018.06.030. Epub 2018 Jul 5.

    PMID: 29982151BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehavior

Study Officials

  • Emily D'agostino, DPH

    Duke University

    PRINCIPAL INVESTIGATOR
  • Christoph Horniik, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be self-triaged to one of two study arms: (1) Pre-surveys only (did not meet referral criteria based on screening assessment) and receive online mental wellness education and anxiety treatment options information; (2) 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 12, 2024

Study Start

February 13, 2024

Primary Completion

July 12, 2024

Study Completion

August 30, 2024

Last Updated

August 9, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations