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

Healthy Subject Clinical Trial

Official title:

ASPIRE+ Mentoring Moon Shot Youth Lung Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04803682
• Other study ID #: 2015-0258
• Secondary ID: NCI-2019-0248120
• Status: Completed
• Phase: Early Phase 1
• Start date: January 8, 2016
• Est. completion date: March 16, 2021

Study information

• Verified date: March 2021
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Behavioral:
• Preventive Intervention
Participate in ASPIRE and mentorship program
• Questionnaire Administration
Ancillary studies (pre and post questionnaire)

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Required number of participants should be 40 mentors and 100 mentees	At least 40 mentors and 100 mentees.	3 years
Primary	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
Primary	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
Primary	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	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