AnxietyYESNCT06255093
You & Me Healthy: Youth Empowered Self-Care Substudy (YES)
A study testing Community-based recreation program referral and Pre-surveys only in people with Anxiety and Wellness, Psychological, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Wellness, Psychological
- What is being tested?
- Community-based recreation program referral and Pre-surveys only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Feb 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria for this study if all above inclusion criteria are met.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Durham Parks and Recreation
Durham, North Carolina, 27701
Miami-Dade County Parks and Recreation
Miami, Florida, 33128
About this study
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
Read the 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.
- Conditions
- Anxiety, Wellness, Psychological
- Being tested
- Community-based recreation program referral, Pre-surveys only
- Keywords
- Anxiety, Mental Health, Psychological Wellness, Recreational Activities, Community programs, School-aged Youth, Parks and Recreation, Afterschool Activities
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based recreation program referralBehavioural
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 onlyBehavioural
Receive online wellness education and anxiety treatment options information
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Behavioral: Community-based recreation program referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants referred to youth community-based programs with potential to promote mental health that are free/low-cost
Measured: Up to 4 months
Number of youth community-based programs with potential to promote mental wellness offered that are free/low-cost (self-reported)
Measured: 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)
Measured: Up to 4 months
Number of consented participants who complete self-screening assessment
Measured: Baseline
Proportion of consented participants who complete self-screening assessment
Measured: Baseline
Proportion of participants who visited the online resources page
Measured: Up to 4 months
Change in anxiety symptoms, as measured by survey
Scale: Screen for Child Anxiety Related Emotional Disorders (SCARED) Survey- Parent Version
Measured: 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)
Measured: Baseline, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start13 Feb 2024
- Primary completion12 Jul 2024
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Miami-Dade County Parks and Recreation, Durham Parks and Recreation (Durham, NC)
- Responsible party
- Sponsor
- Investigators
- Emily D'agostino, DPH, Principal investigator, Duke UniversityChristoph Horniik, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255093
- Sponsor's protocol ID
- PRO00114773
- Acronym
- YES
- Status last verified
- Jun 2024
- First submitted
- 5 Feb 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31241997Frazier 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.
PubMed 17340183Frazier 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.
PubMed 25425012Frazier 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.
PubMed 22843303Frazier 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.
PubMed 32058822Goodman 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.
PubMed 33914915Hedemann 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.
PubMed 27544670Jennings 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.
PubMed 29165367Jones 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.
PubMed 35358165McCormick 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.
PubMed 28882650Parenteau 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.
PubMed 36097815Racine 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.
PubMed 34369987Saltzman 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.
PubMed 34014118Twohig-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.
PubMed 29982151D'Agostino EM, Pulgaron ER, Neshteruk C, Brown-Lowery C, Abbot-Grimes P, Fadika T, Ward M, Sato J, Cooper M, Hansen E, Enwright E, Nardi MI, Forde J, Hicks A, Li T, Hornik CP. Youth Empowered Self-Care: a direct-to-participant intervention to promote mental well-being. BMC Public Health. 2026 Jun 29;26(1):2403. doi: 10.1186/s12889-026-28143-0.
PubMed 42374306
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- You & Me Healthy: Youth Empowered Self-Care Substudy (YES)
- ClinicalTrials.gov ID
- NCT06255093
- Acronym / sponsor ID
- YES / PRO00114773
- Conditions
- Anxiety, Wellness, Psychological
- Keywords
- Anxiety, Mental Health, Psychological Wellness, Recreational Activities, Community programs, School-aged Youth, Parks and Recreation, Afterschool Activities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Miami-Dade County Parks and Recreation, Durham Parks and Recreation (Durham, NC)
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Pre-Surveys Only | Other | Behavioral: Pre-surveys onlyPre-surveys only (did not meet referral criteria based on screening assessment) and receive online wellness education and anxiety treatment options information |
| Pre-Surveys, Recreational Program Referral, Post Surveys | Other | Behavioral: Community-based recreation program referralPre-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). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study if all above inclusion criteria are met.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based recreation program referralProvide 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. | Behavioural | Pre-Surveys, Recreational Program Referral, Post Surveys |
| Pre-surveys onlyReceive online wellness education and anxiety treatment options information | Behavioural | Pre-Surveys Only |
Primary outcome
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
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
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
Number of consented participants who complete self-screening assessment
Time frame: Baseline
Proportion of consented participants who complete self-screening assessment
Time frame: Baseline
Proportion of participants who visited the online resources page
Time frame: 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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 31241997D'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.
- Background: PubMed 17340183Frazier 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.
- Background: PubMed 25425012Frazier 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.
- Background: PubMed 22843303Frazier 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.
- Background: PubMed 32058822Frazier 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.
- Background: PubMed 33914915Goodman 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.
- Background: PubMed 27544670Hedemann 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.
- Background: PubMed 29165367Jennings 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.
- Background: PubMed 35358165Jones 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.
- Background: PubMed 28882650McCormick 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.
- Background: PubMed 36097815Parenteau 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.
- Background: PubMed 34369987Racine 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.
- About COVID-19Link provided by the sponsor.
- Afterschool in the time of COVID-19.Link provided by the sponsor.
- Inspiring Learning. Safe and Supportive. Lifeline for Working Families. This is Afterschool in North CarolinaLink provided by the sponsor.
- New Household Survey: North Carolina Is a 'Top 10 State for Afterschool, ' Even as Unmet Demand for Programs IncreasesLink provided by the sponsor.
- United States of America: Who coronavirus disease (covid-19) dashboard with vaccination data.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily D'agostino, DPH principal investigator
Duke University
Christoph Horniik, MD, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based recreation program referral and Pre-surveys only in people with Anxiety and Wellness, Psychological, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06255093, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.