- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04803682
A Smoking Prevention Program (ASPIRE) and Mentoring for Preventing Smoking Among High School Youths
ASPIRE+ Mentoring Moon Shot Youth Lung Prevention
연구 개요
상세 설명
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of training selected eleventh grade high school student volunteers to provide an intervention involving mentoring combined with social support activities.
II. To increase ninth grade high school student well-being, which would ultimately influence tobacco related knowledge and resistance skills regarding tobacco uptake among ninth grade high school program participants.
EXPLORATORY OBJECTIVES:
I. Mentor ability, confidence, and intention (ACI) to address tobacco use and dependence and providing anti-tobacco advice to mentees.
II. To determine the scores on mentoring competencies. III. To determine the influences of social support and self-esteem by mentors. IV. To determine the quality and satisfaction with the relationships among mentors and mentees.
V. To determine level of knowledge about nicotine and tobacco products among mentees.
VI. To determine susceptibility to tobacco use among non-smokers. VII. To determine progression through stages of change among smokers.
OUTLINE:
Participants complete online ASPIRE course over 3.5-4 hours.
HIGH SCHOOL MENTORS: Eleventh grade high school students receive mentor training over 4-5 hours on how to mentor ninth grade students.
ALL STUDENTS: Mentors and mentees are paired up so that eleventh grade high school students mentor the ninth grade high school students over 30 minutes for 7 sessions about the different types of tobacco products (such as cigarettes, cigars, hookah, and so on) and the dangers of these products.
연구 유형
등록 (실제)
단계
- 초기 1단계
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- M D Anderson Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Ages 13-18
- Enrolled in grades nine or eleven
- Speaks and understands English
- Parent or legally authorized guardian (LAR) provide written consent for study participation
- Student provides written assent for study participation
Exclusion Criteria
- Unable to speak and understand English
- Lives in the same household with another participant in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Prevention (ASPIRE, mentorship)
Participants complete online ASPIRE course over 3.5-4 hours. HIGH SCHOOL MENTORS: Eleventh grade high school students receive mentor training over 4-5 hours on how to mentor ninth grade students. ALL STUDENTS: Mentors and mentees are paired up so that eleventh grade high school students mentor the ninth grade high school students over 30 minutes for 7 sessions about the different types of tobacco products (such as cigarettes, cigars, hookah, and so on) and the dangers of these products. |
Participate in ASPIRE and mentorship program
다른 이름들:
Ancillary studies (pre and post questionnaire)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Required number of participants should be 40 mentors and 100 mentees
기간: 3 years
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At least 40 mentors and 100 mentees.
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3 years
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Number of participants required to complete baseline and post-intervention assessments should be 35 mentors and 80 mentees
기간: 3 years
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At least 80% completion rates.
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3 years
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All participants are required to attend at least 5 of 7 sessions of mentor to mentees interactions
기간: 3 years
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At least 5 of 7 sessions of mentor/mentee interactions
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3 years
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Participants with the ability to provide the level of satisfaction with the program
기간: 3 years
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Training program for mentors and overall program satisfaction.
Seventeen-item rating scale (1 = not skilled at all to 7 = extremely skilled) about facets of mentoring.
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3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Tobacco related knowledge among mentees
기간: 3 years
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Assessed by comparing pre and post intervention scores.
Three-item rating scale (0 = no ability/confidence/intention to 4 = high ability, confidence, and intention) Nineteen-item scale measuring quality of mentor to mentee relationship.
Four point Likert scale (1 = not true at all to 4 = very true) Twenty-five item scale.
Multiple choice questions to measure tobacco and nicotine product knowledge developed by ASPIRE study team
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3 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Alexander V Prokhorov, M.D. Anderson Cancer Center
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
- 2015-0258 (기타 식별자: M D Anderson Cancer Center)
- NCI-2019-02481 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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