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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT04803682
Collaborator
National Cancer Institute (NCI) (NIH)
94
Enrollment
1
Location
1
Arm
62.2
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Preventive Intervention
  • Behavioral: Questionnaire Administration
 Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

  1. To evaluate the feasibility of training selected eleventh grade high school student volunteers to provide an intervention involving mentoring combined with social support activities.

  2. 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:

  1. Mentor ability, confidence, and intention (ACI) to address tobacco use and dependence and providing anti-tobacco advice to mentees.

  2. 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.

  3. To determine level of knowledge about nicotine and tobacco products among mentees.

  4. 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 Design

Study Type:
Interventional
Actual Enrollment :
94 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
ASPIRE+ Mentoring Moon Shot Youth Lung Prevention
Actual Study Start Date :
Jan 8, 2016
Actual Primary Completion Date :
Mar 16, 2021
Actual Study Completion Date :
Mar 16, 2021

Arms and Interventions

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:
  • PREVENTATIVE
  • Prevention
  • Prevention Measures
  • prophylaxis
  • PRYLX

    • Behavioral: Questionnaire Administration
    Ancillary studies (pre and post questionnaire)

    Outcome Measures

    Primary Outcome Measures

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

    1. Tobacco related knowledge among mentees [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Alexander V Prokhorov, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04803682
    Other Study ID Numbers:
    • 2015-0258
    • NCI-2019-02481
    • 2015-0258
    First Posted:
    Mar 18, 2021
    Last Update Posted:
    Mar 18, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 18, 2021