- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02188797
Substance Use and Sexual Risk Reduction Intervention for Homeless Youth
Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study addresses an important gap in prevention services for homeless youth by conducting a pilot test of an innovative 4-session integrated substance use and sexual risk reduction program for this population that is feasible to deliver in settings where these youth seek services. The study has 2 specific aims:
Aim 1: Investigate whether homeless youth who participate in the program show reductions in substance use and intentions, behavior and consequences, as well as sexual activity intentions and risk behavior, over a 3-month period compared to a usual care control sample of youth who do not receive the program.
Aim 2: Gain a better understanding of intervention effects by exploring whether improvements in self-efficacy, readiness to change, outcome expectancies, and exposure to peer substance use and offers serve as explanatory mechanisms for reductions in substance use- and sexual activity- related intentions and risk behaviors among youth who participate in the program.
The program will be evaluated using a form of group-randomized design, although with crossover of conditions and groups to avoid the problems of power reduction associated with conventional group randomization. The unit of analysis will be the individual, but individuals will be assigned to groups based on the agency where they are seeking services. Youth at two drop-in centers serving homeless youth will either be in the intervention condition or a "usual care" control condition. The field period will be divided into four phases. The two agencies will alternate across phases in serving as the "intervention site" or "control site," with each agency having a total of two intervention phases and two control phases.
Intervention Condition: This condition involves a four-session voluntary intervention that is delivered within a drop-in center setting and is based on the investigator's previous intervention work with adolescents and young adults. Each session lasts approximately 1 hour. The intervention focuses on both sexual risk behavior and substance use. Although some sessions focus more heavily on sexual risk and others on substance use, each session includes content that emphasizes the interrelated nature of these two risk behaviors. In all sessions, participants will receive a personalized feedback sheet that specifically addresses a topic being discussed during that particular session. An motivational interviewing approach will be used to present material during the group sessions.
"Usual Care" Condition: The "usual care" condition reflects the resources typically available in settings that serve homeless youth: an HIV informational brochure that discusses the connection between substance use and HIV risk, and a Community Resource Guide that lists free or low-cost substance use and HIV-related services.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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Hollywood, California, États-Unis
- My Friend's Place
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Venice Beach, California, États-Unis, 90291
- Safe Place for Youth
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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:
- between 18-24 years, receiving services at one of the participating drop-in centers, planning to be in the study area for the next month
Exclusion Criteria:
- obvious cognitive impairment observed during screening process; non-English speaking
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 |
---|---|
Expérimental: Group MI risk reduction program
Participants receive four 1-hour group motivational interviewing sessions focused on reducing substance use and sexual risk behavior.
They also receive an HIV information brochure and Community Resource Guide.
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Aucune intervention: Usual care control
Participant receive HIV information brochure and Community Resource Guide.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in substance use
Délai: baseline, 3 months
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past month quantity-frequency of alcohol and marijuana; past 3 months frequency of alcohol, binge drinking, marijuana, crack, cocaine, heroin, methamphetamine, ecstasy, hallucinogens, inhalants, prescription drug misuse
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baseline, 3 months
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Change in substance use intentions
Délai: baseline, 3 months
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Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs
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baseline, 3 months
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Change in negative consequences from drinking
Délai: baseline, 3 months
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baseline, 3 months
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Change in use of drinking protective strategies
Délai: baseline, 3 months
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baseline, 3 months
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Change in number of different sex partners
Délai: baseline, 3 months
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baseline, 3 months
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Change in condom use
Délai: baseline, 3 months
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baseline, 3 months
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Change in substance use before or during sex
Délai: baseline, 3 months
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baseline, 3 months
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Change in HIV knowledge
Délai: baseline, 3 months
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baseline, 3 months
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Change in sex-related protective strategies
Délai: baseline, 3 months
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baseline, 3 months
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Change in sexual intentions
Délai: baseline, 3 months
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Separate items for intentions for buying/getting condoms, carrying condoms, talking to partner about condoms, using condoms, using condoms when drinking or using drugs, getting tested
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baseline, 3 months
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Change in HIV testing
Délai: baseline, 3 months
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Self-report of being tested in lifetime, past 3 months
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baseline, 3 months
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Collaborateurs et enquêteurs
Parrainer
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
- R34DA034813 (Subvention/contrat des NIH des États-Unis)
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Essais cliniques sur Group MI risk reduction program
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Lady Davis InstituteComplétéSclérodermie systémiqueCanada