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Substance Use and Sexual Risk Reduction Intervention for Homeless Youth

15. april 2016 oppdatert av: RAND

Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless

The goal of this study is to evaluate a group-based motivational interviewing (MI)-delivered risk reduction program for homeless young adults. It is hypothesized that youth who participate in the program will show greater reductions in substance use 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 participate in the program.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • California
      • Hollywood, California, Forente stater
        • My Friend's Place
      • Venice Beach, California, Forente stater, 90291
        • Safe Place for Youth

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 24 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Ingen inngripen: Usual care control
Participant receive HIV information brochure and Community Resource Guide.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in substance use
Tidsramme: baseline, 3 months
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
baseline, 3 months
Change in substance use intentions
Tidsramme: baseline, 3 months
Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs
baseline, 3 months
Change in negative consequences from drinking
Tidsramme: baseline, 3 months
baseline, 3 months
Change in use of drinking protective strategies
Tidsramme: baseline, 3 months
baseline, 3 months
Change in number of different sex partners
Tidsramme: baseline, 3 months
baseline, 3 months
Change in condom use
Tidsramme: baseline, 3 months
baseline, 3 months
Change in substance use before or during sex
Tidsramme: baseline, 3 months
baseline, 3 months
Change in HIV knowledge
Tidsramme: baseline, 3 months
baseline, 3 months
Change in sex-related protective strategies
Tidsramme: baseline, 3 months
baseline, 3 months
Change in sexual intentions
Tidsramme: baseline, 3 months
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
baseline, 3 months
Change in HIV testing
Tidsramme: baseline, 3 months
Self-report of being tested in lifetime, past 3 months
baseline, 3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2014

Primær fullføring (Faktiske)

1. august 2015

Studiet fullført (Faktiske)

1. august 2015

Datoer for studieregistrering

Først innsendt

10. juli 2014

Først innsendt som oppfylte QC-kriteriene

10. juli 2014

Først lagt ut (Anslag)

14. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

19. april 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. april 2016

Sist bekreftet

1. april 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • R34DA034813 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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