- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02983864
Group Alcohol Interventions for College Men
3. marts 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret 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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
93
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Brian T Wymbs, PhD, Ohio University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2017
Primær færdiggørelse (Faktiske)
1. november 2019
Studieafslutning (Faktiske)
1. november 2019
Datoer for studieregistrering
Først indsendt
1. december 2016
Først indsendt, der opfyldte QC-kriterier
2. december 2016
Først opslået (Skøn)
6. december 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16-F-33
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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