A Smoking Prevention Program (ASPIRE) and Mentoring for Preventing Smoking Among High School Youths

NCT ID: NCT04803682

Last Updated: 2021-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-08

Study Completion Date

2021-03-16

Brief Summary

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This early phase I trial studies how well A Smoking Prevention Interactive Experience (ASPIRE) program and mentorship works in preventing smoking in high school students. ASPIRE is an online-based, youth-centered tobacco prevention and cessation program. The goal of this research study is to learn if training eleventh grade high school students to be tobacco-free role models and mentors for ninth grade high school students is possible and will positively influence the younger peers.

Detailed Description

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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.

Conditions

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Healthy Subject

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Preventive Intervention

Intervention Type BEHAVIORAL

Participate in ASPIRE and mentorship program

Questionnaire Administration

Intervention Type BEHAVIORAL

Ancillary studies (pre and post questionnaire)

Interventions

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Preventive Intervention

Participate in ASPIRE and mentorship program

Intervention Type BEHAVIORAL

Questionnaire Administration

Ancillary studies (pre and post questionnaire)

Intervention Type BEHAVIORAL

Other Intervention Names

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PREVENTATIVE Prevention Prevention Measures prophylaxis PRYLX

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander V Prokhorov

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2019-02481

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-0258

Identifier Type: OTHER

Identifier Source: secondary_id

2015-0258

Identifier Type: -

Identifier Source: org_study_id

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