Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2017-09-01
2019-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preventing Health Damaging Behaviors in Male and Female Army Recruits
NCT01234103
Hospital Outcomes: Intervention in Moderately III Patients
NCT00256659
Implementing an Intervention to Foster Resident and Family Engagement in Care Planning
NCT04026698
5Minutes4Myself: A Wellness Program for Caregivers
NCT03771001
Caregiver-Child Interaction and Health Behaviors
NCT03162822
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In tandem with the implementation of WIN,the effectiveness of the program will be evaluated. A research study will offer benefits: first, it will provide the college with data for future estimations of student interest to assist in further expanding the scope of wellness; and second, it will provide the Child Study Center at NYU with the opportunity to explore the impact of teaching resilience skills to first-year college students and to modify, if appropriate course content to improve effectiveness.
A longitudinal study at NYU beginning in Fall of 2017 of 175 first-year students, who are randomly assigned to one of three conditions after consenting to participate in the research.
200 participants will be recruited during Spring and Summer of 2017 from the incoming first-year students who will begin classes in Fall 2017. It is anticipated that of the 200 enrolled via electronic assent prior to the beginning of the fall 2017 semester, some may not attend NYU and some may rethink the decision to participate and then not follow up with providing informed consent. As such, there will be over-enrolling via preliminary electronic assent so that the following enrollment can be achieved:
175 students will be assigned randomly into one of three conditions:
* 50 students to Condition 1 (enrolled in the Risk and Resilience course during Fall 2017 and directly encouraged to participate in the Founders Living and Learning Community wellness activities for the Fall of 2017)
* 75 students to Condition 2 (waitlisted to be enrolled in the Rick and Resilience course until Spring 2018, and not directly encouraged to participate in the WIN Living and Learning Community wellness activities)
* 50 students to Condition 3 (a control group that receives none of the interventions during the first year). This group will instead receive an online pamphlet that contains a number of wellness tips and advice for first-year students. Participants have access to the WIN Living and Learning Community wellness activities in Fall of 2017 and Spring of 2018, but are not directly encouraged to participate.
The progress of these 175 students will be measured at frequent intervals throughout the first and subsequent years at college, beginning with a baseline assessment battery once participants provide written informed consent in Fall of 2017, followed by a second survey in Winter 2018, another survey at the end of the academic year (May 2018), and then annually thereafter. In addition to collecting demographic factors (age, gender, race, ethnicity, and relationship status), the study will utilize empirically-based measures that will be self-reported by the students, using an online survey tool. These measures will capture a series of attributes that have been demonstrated as being important factors in psychological well-being, including:
* Perceived stress
* Depressive symptoms
* Anxiety symptoms
* Dysfunctional attitudes
* Risk behaviors (smoking, sexual activity, alcohol and drug usage, etc.)
* Coping skills
* Interpersonal communication
* Use of Cognitive-Behavioral Therapy techniques
* Health behaviors (exercise, nutrition, sleep, etc.)
Additional data will be collected to measure academic achievement, such as grade-point average and persistence in college.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Condition 1
enrolled in the Risk and Resilience course during Fall 2017 and directly encouraged to participate in the Founders Living and Learning Community wellness activities for the Fall of 2017 (Coordinated Wellness Programming)
Risk and Resilience
The "Risk and Resilience" course is a 14-week undergraduate seminar that is grounded in the current understanding of adolescent and young adult development, neuroscience, and positive psychology. Students will learn about key areas proven to enhance wellness, including communication, executive functioning, social support, self-efficacy, emotion regulation, and sense of purpose. Students will learn about healthy exercise, nutrition, and sleep habits, and develop skills in core components of cognitive-behavior therapy, mindfulness, and organizational skills.
Coordinated Wellness Programming
During the Fall of 2017, wellness activities will be provided within Founders Hall that support the theories and skills being taught in the "Risk and Resilience" course occurring in the same semester.
Condition 2
enrolled in the Risk and Resilience course in Spring 2018, and not directly encouraged to participate in the WIN Living and Learning Community wellness activities
Risk and Resilience
The "Risk and Resilience" course is a 14-week undergraduate seminar that is grounded in the current understanding of adolescent and young adult development, neuroscience, and positive psychology. Students will learn about key areas proven to enhance wellness, including communication, executive functioning, social support, self-efficacy, emotion regulation, and sense of purpose. Students will learn about healthy exercise, nutrition, and sleep habits, and develop skills in core components of cognitive-behavior therapy, mindfulness, and organizational skills.
Condition 3
a control group that receives none of the interventions during the first year. This group will instead receive an online pamphlet that contains a number of wellness tips and advice for first-year students. Condition 3 participants have access to the WIN Living and Learning Community wellness activities in Fall of 2017 and Spring of 2018, but are not directly encouraged to participate.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Risk and Resilience
The "Risk and Resilience" course is a 14-week undergraduate seminar that is grounded in the current understanding of adolescent and young adult development, neuroscience, and positive psychology. Students will learn about key areas proven to enhance wellness, including communication, executive functioning, social support, self-efficacy, emotion regulation, and sense of purpose. Students will learn about healthy exercise, nutrition, and sleep habits, and develop skills in core components of cognitive-behavior therapy, mindfulness, and organizational skills.
Coordinated Wellness Programming
During the Fall of 2017, wellness activities will be provided within Founders Hall that support the theories and skills being taught in the "Risk and Resilience" course occurring in the same semester.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* a student at NYU (Ascertained by their nyu.edu email address)
* residing in Founder's Hall (corroborated by NYU Housing)
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NYU Langone Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jess Shatkin, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
New York University
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16-02124
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.