- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02188797
Substance Use and Sexual Risk Reduction Intervention for Homeless Youth
Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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California
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Hollywood, California, Stati Uniti
- My Friend's Place
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Venice Beach, California, Stati Uniti, 90291
- Safe Place for Youth
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: Usual care control
Participant receive HIV information brochure and Community Resource Guide.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in substance use
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: baseline, 3 months
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baseline, 3 months
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Change in use of drinking protective strategies
Lasso di tempo: baseline, 3 months
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baseline, 3 months
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Change in number of different sex partners
Lasso di tempo: baseline, 3 months
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baseline, 3 months
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Change in condom use
Lasso di tempo: baseline, 3 months
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baseline, 3 months
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Change in substance use before or during sex
Lasso di tempo: baseline, 3 months
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baseline, 3 months
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Change in HIV knowledge
Lasso di tempo: baseline, 3 months
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baseline, 3 months
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Change in sex-related protective strategies
Lasso di tempo: baseline, 3 months
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baseline, 3 months
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Change in sexual intentions
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R34DA034813 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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