Skip to main content
OpenTrials
Completed

NCT Number: NCT04803682

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subject

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preventive intervention

Behavioral

Participate in ASPIRE and mentorship program

Other names: PREVENTATIVE, Prevention, Prevention Measures, prophylaxis, PRYLX

Questionnaire Administration

Behavioral

Ancillary studies (pre and post questionnaire)

Primary outcomes

  1. Required number of participants should be 40 mentors and 100 mentees

    Time frame: 3 years

    At least 40 mentors and 100 mentees.

  2. Number of participants required to complete baseline and post-intervention assessments should be 35 mentors and 80 mentees

    Time frame: 3 years

    At least 80% completion rates.

  3. All participants are required to attend at least 5 of 7 sessions of mentor to mentees interactions

    Time frame: 3 years

    At least 5 of 7 sessions of mentor/mentee interactions

  4. Participants with the ability to provide the level of satisfaction with the program

    Time frame: 3 years

    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.

Secondary outcomes

  1. Tobacco related knowledge among mentees

    Time frame: 3 years

    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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

ASPIRE+ Mentoring Moon Shot Youth Lung Prevention

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2021
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.