- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01164306
The Impact of a Tobacco Control Intervention in African-American Families
The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at:
- preventing tobacco initiation in youth
- promoting anti-tobacco socialization in the home
- decreasing environmental tobacco smoke exposure in children
- promoting successful cessation in parent/guardian smokers.
Control arm participants receive general health education. This family-based approach is implemented with school systems as the primary point of entry.
Aperçu de l'étude
Statut
Description détaillée
All research participants (children and parents/guardians) will be recruited from 14 schools (7 control and 7 intervention; 7 urban and 7 rural) in a Southeastern U.S.
Self-report measures are at: baseline, end of year one, year 2, end of year two, and years three and four. Biological measures of salivary cotinine are at Baseline, end of treatment (year 2) and end of study (year 4).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Georgia
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Augusta, Georgia, États-Unis, 30912
- Georgia Health Sciences University
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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:
- child being of African-American ethnicity
- in a 4th grade classroom of randomized schools
- parent or guardian that 4th grade child resides with at least 50% of the time
- have access to a telephone or mobile phone
Exclusion Criteria:
- not being a child of African-American ethnicity
- not being a parent or guardian that an eligible child lives with at least 50% of the time
- not having access to a telephone or cell phone
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: LifeSkills training
|
LifeSkills Training (Botvin's) is an evidenced based substance abuse prevention program for elementary school students to learn skills to resist tobacco, alcohol, drug abuse, and violence. Parent LifeSkills will also be utilized. Parents are provided a parent manual and DVD to use at home with their child to reinforce what they are taught in school-based LifeSkills sessions.
Autres noms:
For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.
Autres noms:
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Comparateur actif: Healthy Lifestyle Behaviors
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The healthy lifestyle behavior choices curriculum augments the state health curriculum in the assigned study schools. Parents will also be given health related information by mail to parallel the information students receive in school health classes.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Primary prevention of tobacco use in youth
Délai: Baseline
|
Self-report and salivary cotinine is assessed to measure this outcome
|
Baseline
|
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Primary prevention of tobacco use in youth
Délai: Year 2
|
Self-report and salivary cotinine is assessed to measure this outcome.
|
Year 2
|
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Primary prevention of tobacco use in youth
Délai: Year 4
|
Self-report and salivary cotinine is assessed to measure this outcome.
|
Year 4
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Smoking cessation in parents/guardians
Délai: 3 months
|
3 months
|
|
Smoking cessation in parents/guardians
Délai: 6 months
|
6 months
|
|
Smoking cessation in parents/guardians
Délai: Year 1
|
Year 1
|
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Smoking cessation in parents/guardians
Délai: Year 2
|
Year 2
|
|
Smoking cessation in parents/guardians
Délai: Year 4
|
Year 4
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Martha S Tingen, PhD, Augusta University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01CA118066 (Subvention/contrat des NIH des États-Unis)
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