- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04803682
A Smoking Prevention Program (ASPIRE) and Mentoring for Preventing Smoking Among High School Youths
ASPIRE+ Mentoring Moon Shot Youth Lung Prevention
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiesteder
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- M D Anderson Cancer Center
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Participate in ASPIRE and mentorship program
Andre navn:
Ancillary studies (pre and post questionnaire)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Required number of participants should be 40 mentors and 100 mentees
Tidsramme: 3 years
|
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
Tidsramme: 3 years
|
At least 80% completion rates.
|
3 years
|
|
All participants are required to attend at least 5 of 7 sessions of mentor to mentees interactions
Tidsramme: 3 years
|
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
Tidsramme: 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.
|
3 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Tobacco related knowledge among mentees
Tidsramme: 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
|
3 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Alexander V Prokhorov, M.D. Anderson Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2015-0258 (Annen identifikator: M D Anderson Cancer Center)
- NCI-2019-02481 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
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