Healthy SubjectEarly Phase 1NCT04803682
A Smoking Prevention Program (ASPIRE) and Mentoring for Preventing Smoking Among High School Youths
A Early Phase 1 study testing Preventive Intervention and Questionnaire Administration in people with Healthy Subject, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- Preventive Intervention and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2016to 16 Mar 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Unable to speak and understand English
- Lives in the same household with another participant in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Healthy Subject
- Being tested
- Preventive Intervention, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive InterventionBehavioural
Also called PREVENTATIVE, Prevention, Prevention Measures, prophylaxis
Participate in ASPIRE and mentorship program
Questionnaire AdministrationBehavioural
Ancillary studies (pre and post questionnaire)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Preventive Intervention; Behavioral: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Required number of participants should be 40 mentors and 100 mentees
At least 40 mentors and 100 mentees.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 3 years
Secondary outcomes (1)
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start8 Jan 2016
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alexander V Prokhorov, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803682
- Sponsor's protocol ID
- 2015-0258
- Other IDs
- NCI-2019-02481, 2015-0258
- Status last verified
- Mar 2021
- First submitted
- 9 May 2019
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASPIRE+ Mentoring Moon Shot Youth Lung Prevention
- ClinicalTrials.gov ID
- NCT04803682
- Acronym / sponsor ID
- 2015-0258
- Conditions
- Healthy Subject
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jan 2016 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (ASPIRE, mentorship) | Experimental | Behavioral: Preventive Intervention, Behavioral: Questionnaire AdministrationParticipants 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 may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to speak and understand English
- Lives in the same household with another participant in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive InterventionAlso: PREVENTATIVE, Prevention, Prevention Measures, prophylaxisParticipate in ASPIRE and mentorship program | Behavioural | Prevention (ASPIRE, mentorship) |
| Questionnaire AdministrationAncillary studies (pre and post questionnaire) | Behavioural | Prevention (ASPIRE, mentorship) |
Primary outcome
Required number of participants should be 40 mentors and 100 mentees
Time frame: 3 years
At least 40 mentors and 100 mentees.
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.
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
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.
1 secondary outcome
Tobacco related knowledge among mentees
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander V Prokhorov principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Preventive Intervention and Questionnaire Administration in people with Healthy Subject, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Required number of participants should be 40 mentors and 100 mentees (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.