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

ASPIRE+ Mentoring Moon Shot Youth Lung Prevention

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Behavioral: Preventive Intervention; Behavioral: Questionnaire Administration

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Preventive Intervention; Participate in ASPIRE and mentorship program; Other Names: Prevention; PREVENTATIVE; Prevention Measures; prophylaxis; PRYLX; Behavioral: Questionnaire Administration; Ancillary studies (pre and post questionnaire)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Required number of participants should be 40 mentors and 100 mentees	At least 40 mentors and 100 mentees.	3 years
Number of participants required to complete baseline and post-intervention assessments should be 35 mentors and 80 mentees	At least 80% completion rates.	3 years
All participants are required to attend at least 5 of 7 sessions of mentor to mentees interactions	At least 5 of 7 sessions of mentor/mentee interactions	3 years
Participants with the ability to provide the level of satisfaction with the program	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco related knowledge among mentees	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	3 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Alexander V Prokhorov, M.D. Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2016
• Primary Completion (Actual): March 16, 2021
• Study Completion (Actual): March 16, 2021

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2015-0258 (Other Identifier: M D Anderson Cancer Center); NCI-2019-02481 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No