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

NCT04803682 | Completed Early Phase 1

• 2 other identifiers: 2015-0258NCI-2019-02481
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Tobacco related knowledge among mentees

  3 years

Study Arms (1)

Prevention (ASPIRE, mentorship)

EXPERIMENTAL

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; Behavioral: Questionnaire Administration

Interventions

Preventive Intervention BEHAVIORAL

Participate in ASPIRE and mentorship program

Also known as: PREVENTATIVE, Prevention, Prevention Measures, prophylaxis, PRYLX

Prevention (ASPIRE, mentorship)

Questionnaire Administration BEHAVIORAL

Ancillary studies (pre and post questionnaire)

Prevention (ASPIRE, mentorship)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unable to speak and understand English
• Lives in the same household with another participant in the study

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Study Officials

• Alexander V Prokhorov

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: March 18, 2021
• Study Start: January 8, 2016
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

US (1)