Clinical trial NCT04803682: A Smoking Prevention Program (ASPIRE) and Mentoring for Preventing Smoking Among High School Youths
Official title: ASPIRE+ Mentoring Moon Shot Youth Lung Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Subject
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-03-18
Enrollment: 94
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Required number of participants should be 40 mentors and 100 mentees
timeFrame: 3 years
measure: Number of participants required to complete baseline and post-intervention assessments should be 35 mentors and 80 mentees
timeFrame: 3 years
measure: All participants are required to attend at least 5 of 7 sessions of mentor to mentees interactions
timeFrame: 3 years
measure: Participants with the ability to provide the level of satisfaction with the program
timeFrame: 3 years
Secondary outcomes:
measure: Tobacco related knowledge among mentees
timeFrame: 3 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Alexander V Prokhorov
role: PRINCIPAL_INVESTIGATOR
References: