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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04771195
Other study ID # 24593
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 30, 2021
Est. completion date May 2024

Study information

Verified date May 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The central goal of this project is to produce a novel, precise, and comprehensive account of social factors in young adult mental health - using a novel combination of network nominations, ecological momentary assessment, and neuroimaging methods. To that end, the investigators will collect data from two successive classes of college undergraduates (i.e., classes of 2023 and 2024) over the course of their collegiate tenure.


Description:

The proposed work will consist of four key components. The investigators will collect data from the class of 2023 in each of their remaining years at college, producing (i) longitudinal data that will allow them to probe the long-term mental health effects of connections made during the transition to college, as well as mental health issues and resilience in the wake of the COVID-19 pandemic as a function of social connectedness. The investigators will leverage this rich dataset to build (ii) prospective quantitative models to predict mental health outcomes later in college based on a range of social factors measured early in college. They will further collect (iii) a longitudinal replication cohort, the class of 2024, allowing to establish the robustness of their initial findings across samples. Finally, the investigators will add (iv) a neuroimaging component to this dataset in a subset of the class of 2024. This will allow them to examine brain "markers" of connectedness, and add them to a prospective model, providing a novel integration across brain, behavior, and community levels of analysis, and a synthetic assessment of social factors in long-term mental health.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 2000
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Stanford undergraduate students in the classes of 2023 and 2024, as well as all students who reside in their dorms. - Exclusion Criteria: People under the age of 18 -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Score on self-reported depression measure: Center for Epidemiological Studies Scale - 10 item version. Range = 0 to 30. Higher scores indicate more depressive symptoms September 2021 - May 2024
Primary Anxiety Score on self-reported anxiety measure: State-Trait Anxiety Inventory - 20 item version. Range = 20 to 80. Higher scores indicate more symptoms of anxiety. September 2021 - May 2024
Secondary Loneliness Score on self-reported loneliness measure: University of California Loneliness Scale - 8 item version. Range = 1 to 5. Higher score indicate greater feeling of loneliness. September 2021 - May 2024
Secondary Stress Score on self-reported stress measure: Perceived Stress Scale. Range = 1 to 3. Higher scores indicate greater feeling of stress. September 2021 - May 2024
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