- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04803682
A Smoking Prevention Program (ASPIRE) and Mentoring for Preventing Smoking Among High School Youths
ASPIRE+ Mentoring Moon Shot Youth Lung Prevention
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Première phase 1
Contacts et emplacements
Lieux d'étude
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Texas
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Houston, Texas, États-Unis, 77030
- M D Anderson Cancer Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
Ancillary studies (pre and post questionnaire)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Required number of participants should be 40 mentors and 100 mentees
Délai: 3 years
|
At least 40 mentors and 100 mentees.
|
3 years
|
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Number of participants required to complete baseline and post-intervention assessments should be 35 mentors and 80 mentees
Délai: 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
Délai: 3 years
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At least 5 of 7 sessions of mentor/mentee interactions
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3 years
|
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Participants with the ability to provide the level of satisfaction with the program
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tobacco related knowledge among mentees
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Alexander V Prokhorov, M.D. Anderson Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2015-0258 (Autre identifiant: M D Anderson Cancer Center)
- NCI-2019-02481 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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