- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02983864
Group Alcohol Interventions for College Men
3. mars 2020 oppdatert av: Ohio University
Examining an Integrated Bystander and Alcohol Program for Sexual Assault Perpetration: A Preliminary Randomized Controlled Trial
The objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault intervention.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Although research suggests that sexual assault interventions based on Bystander and Social Norms theory help to reduce sexual assault among college men, these programs do not completely eliminate sexual assault and their effects tend to fade over time.
Unfortunately, there is minimal research on whether (1) decreasing alcohol use concurrently decreases sexual assault perpetration among college men and (2) whether alcohol interventions can be incorporated into existing sexual assault programs for college men (i.e., Bystander/Social Norms programs).
Therefore, the objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault intervention.
Specifically, the alcohol only intervention will consist of the Brief Alcohol Screening and Intervention for College Students (BASICS), an empirically-supported intervention for college student drinking.
The integrated alcohol and sexual assault intervention, which we have termed Ohio University's Combined Alcohol and Normative Intervention program (OU CAN), will be modeled after BASICS and empirically-supported Bystander and Social Norms interventions for sexual assault.
The current study will recruit 100 college men who are sanctioned by their university to receive an alcohol intervention for violating a campus alcohol policy: by definition an indicated and at-risk population for sexual assault perpetration.
Men will be followed for 6 months to determine the effects of the intervention on sexual assault perpetration and other primary outcomes (e.g., bystander behavior).
Studietype
Intervensjonell
Registrering (Faktiske)
93
Fase
- Ikke aktuelt
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 og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Must be 18 or older; must be an Ohio University student; must be male; must be sanctioned to receive an alcohol intervention by Ohio University
Exclusion Criteria:
- Under the age of 18
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Alcohol and Relaxation
This arm will receive a brief (2-hour) alcohol intervention based on motivational interviewing termed BASICS and a brief (1.5 hour) relaxation intervention
|
A one session intervention focused on reducing drinking with motivational interviewing
A one session intervention focused on increasing relaxation skills
|
|
Aktiv komparator: Alcohol and Relationships
This arm will receive a brief (4-hour), two session, integrated alcohol and relationship intervention based on motivational interviewing designed to increase healthy alcohol use and sexual behavior.
The interventions are based on an integrated BASICS and integrated Bystander protocols
|
A one session intervention focused on reducing drinking and sexual behavior while drinking
A one session intervention focused on reducing sexual assault with a focus on the role of alcohol
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sexual Experiences Survey
Tidsramme: 6 months post-intervention
|
A self-report measure that examines potential sexual assault behaviors
|
6 months post-intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Bystander Behavior Scale
Tidsramme: 6 months post-intervention
|
A self-report measure that examines opportunities and engagement in prosocial bystander behavior.
|
6 months post-intervention
|
|
Illinois Rape Myth Acceptance Scale
Tidsramme: 6 months post-intervention
|
A self-report measure that examines rape supportive beliefs
|
6 months post-intervention
|
|
Sexual Social Norms Inventory
Tidsramme: 6 months post-intervention
|
A self-report measure that examines sexual normative beliefs
|
6 months post-intervention
|
|
Alcohol use Disorders Identification Test
Tidsramme: 6 months post-intervention
|
A self-report measure that examines alcohol use
|
6 months post-intervention
|
|
Comprehensive Effects of Alcohol
Tidsramme: 6 months post-intervention
|
A self-report measure that examines expectancies of alcohol use
|
6 months post-intervention
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Brian T Wymbs, PhD, Ohio University
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 2017
Primær fullføring (Faktiske)
1. november 2019
Studiet fullført (Faktiske)
1. november 2019
Datoer for studieregistrering
Først innsendt
1. desember 2016
Først innsendt som oppfylte QC-kriteriene
2. desember 2016
Først lagt ut (Anslag)
6. desember 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. mars 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 16-F-33
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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. .