- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03125291
Optimizing a Drug Abuse Prevention Program for Dissemination (Bridges)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The goals of the RCT are to: 1) examine the effects of the BSP vs. a control group on targeted family and youth competencies at post-test, multiple systems of youth self-regulation at 6-month follow-up, and multiple youth outcomes at 1-year follow-up; 2) examine whether effects are mediated by program-induced improvements on targeted parent and youth competencies and by changes on multiple indicators of youth self-regulation; 3) examine program language (English vs. Spanish), baseline youth risk (including biological risk), and baseline family risk as moderators of BSP effects on youth outcomes and mediators; 4) examine whether variability in implementation accounts for variability in mediators and outcomes; and 5) conduct a cost analysis of the BSP vs. the original Bridges program, as well as estimate the cost-effectiveness of the BSP vs. the control group on delayed SU initiation and quantity and frequency of SU at 1-year follow-up.
Following pretest interviews, 7th grade students and their parents will be randomized to receive the BSP 4 -week program or the control group within each school. Those parents and adolescents assigned to the BSP will attend separate 1.25-hour groups simultaneously and then meet together for 45 minutes. Group meetings will be conducted at the school once per week for four weeks. Each week will cover a different topic. The parent program will focus on positive parenting and goal setting, parent-adolescent relationship strengthening, behavior management, and monitoring. The adolescent program will focus on personal goals and motivation, emotion regulation, cognitive control, and adaptive coping. Free dinner and childcare will be provided during group meetings.
The trial will include 3 additional assessment points beyond pretest: immediate posttest in 7th grade (W2), 6-month (W3) and one-year follow-up in 8th grade (W4). Assessment of multiple dimensions of self-regulation will address innovative questions for prevention. Teachers are asked to complete questionnaires; archival school data are also collected. The resulting intervention package and findings from the randomized trial will lay the foundation for dissemination of the BSP.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Arizona
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Tempe, Arizona, États-Unis, 85287-1106
- Arizona State 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:
- Adolescent enrolled in seventh grade in a participating school and their caregivers.
Exclusion Criteria:
- 7th grade students with developmental delays and severe disruptive behavior disorder
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Bridges Workshop
Participants will receive a one-time, 90-minute workshop.
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Expérimental: Bridges 4-week Program
Parents and adolescents will attend separate 1.25-hour groups simultaneously and then meet together for 45 minutes.
Group meetings will be conducted at the school once per week for four weeks.
Each week will cover a different topic.
The parent program will focus on positive parenting and goal setting, parent-adolescent relationship strengthening, behavior management, and monitoring.
The adolescent program will focus on personal goals and motivation, emotion regulation, cognitive control, and adaptive coping.
|
Participants receive 4, 2-hour sessions over a 6-week period.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Substance Use Problems and Risky Behaviors
Délai: 1 year.
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Self reported drug and alcohol initiation and/or use (Monitoring the Future), sexual initiation and risky sexual behavior (adapted from the national 2001 Youth Risk Behavior Survey).
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1 year.
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Mental Health
Délai: 1 Year
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Internalizing and externalizing symptoms(Child Behavior Checklist-parent report, Youth Self-report, and the Brief Problem Monitor- teacher form.
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1 Year
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Academic Outcomes
Délai: 1 Year
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School archival data (Grades, Disciplinary actions, and Absences)
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1 Year
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Nancy A Gonzales, PhD, Foundation Professor of Psychology and Associate Dean of Faculty
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 5R01DA035855-03 (Subvention/contrat des NIH des États-Unis)
- R01DA035855 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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