- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03120767
Wellness Initiative at New York University (WIN)
연구 개요
상세 설명
WIN has been designed to enhance student wellness and personal success during college and after graduation from New York University. The program is grounded in the current understanding of adolescent and young adult development, neuroscience, and positive psychology and aims to increase resilience within students by building knowledge and skills in key areas proven to enhance wellness, including communication, executive functioning, social support, cognitive behavioral techniques, stress management, emotion regulation, and sense of purpose. WIN will achieve these aims by teaching this knowledge and skills to students in a class ("Risk and Resilience") and via participation in various activities within a residential Living and Learning Community. Students will not only receive training and support in establishing healthy exercise, nutrition, and sleep habits, students will also be taught core components of cognitive-behavior therapy, mindfulness, and organizational skills training.
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.
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years old
- a student at NYU (Ascertained by their nyu.edu email address)
- residing in Founder's Hall (corroborated by NYU Housing)
Exclusion Criteria:
- Provided the potential participant has met the above inclusion criteria, there are no exclusion criteria.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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)
|
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.
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.
|
|
활성 비교기: 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
|
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.
|
|
간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Perceived Stress Scale
기간: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
measures subjective experience of stress
|
Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Center for Epidemiologic Studies Depression Scale
기간: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months))
|
Measures clinically significant depressive symptomatology
|
Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months))
|
|
Beck Anxiety Inventory
기간: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
Measures clinically significant anxious symptomatology
|
Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
|
Dysfunctional Attitudes Scale
기간: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
Measures to what extent respondents hold attitudes or beliefs that hinder performance
|
Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
|
American College Health Association-National College Health Assessment II
기간: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
a national college survey that asks about a variety of college student behaviors, such as risk-taking behaviors, alcohol consumption, nutrition, etc.
|
Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
|
Brief Cope
기간: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
measures methods by which respondents cope with stressors in their lives
|
Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
|
Interpersonal Communication Skills Inventory
기간: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
measures interpersonal components of effective communication: an adequate self-concept; the ability to be a good listener; the skills of expressing one's thoughts and ideas clearly; being able to cope with emotions; and the willingness of disclose oneself to others
|
Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
|
Cognitive-Behavioral Therapy Skills Questionnaire
기간: Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
measures use of Cognitive-Behavioral Therapy techniques: behavioral activation and cognitive restructuring
|
Change from Baseline to Immediate Post 5 months later; Change from Immediate Post to Follow-Ups (Follow-Ups begin 4 months after Post and continue annually for up to the next 36 months)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jess Shatkin, MD, MPH, New York University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 16-02124
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
건강증진에 대한 임상 시험
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH) 그리고 다른 협력자들완전한
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University of Dublin, Trinity College알려지지 않은Brain Health 은퇴 엘리트 선수
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Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH) 그리고 다른 협력자들아직 모집하지 않음
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University아직 모집하지 않음Focus Health 임산부
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University College London HospitalsUniversity College, London완전한
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Gümüşhane UniversıtyKaradeniz Technical University완전한Kelkit District State Hospital Home Health Unit에 등록 | 가정 간호 환자칠면조
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The Mediterranean Institute for the Advance of...Carlos III Health Institute; European Regional Development Fund; Andalusian Regional Ministry... 그리고 다른 협력자들아직 모집하지 않음
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Hopital MontfortChildren's Hospital of Eastern Ontario Research Institute모병열 스트레스 장애 | 1차 의료 | 환경 노출 | 위험 감소 행동 | 공중 위생 | 열 노출 | 기후 변화 | 예방 건강 서비스(PREV HEALTH SERV) | 건강한 과목캐나다
Risk and Resilience에 대한 임상 시험
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Tan Tock Seng HospitalMarquette University; Lee Kong Chian School of Medicine, Nanyang Technological University아직 모집하지 않음
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Université Catholique de LouvainKU Leuven; Epsylon, ASBL아직 모집하지 않음
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Vanderbilt University Medical Center모집하지 않고 적극적으로
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University of South CarolinaWayne State University; Henan University완전한
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Johns Hopkins UniversityHealth Resources and Services Administration (HRSA)완전한
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University Hospitals Cleveland Medical CenterSomaLogic, Inc.완전한
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University of OregonSpecial X Inc.완전한부모-자녀 관계 | 육아 | 아동 행동 | 발달 장애 | 개발 지연 | 발달 장애, 아동미국
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University Hospitals Cleveland Medical Center알려지지 않은