- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02952872
Brief Alcohol E-Interventions Study
Optimizing E-interventions for Alcohol Use: Do Common Factors Apply?
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Wayne State University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Participants must be students at Wayne State University, aged 18 or older. Additionally, participants must report either (1) consuming 3 (women)/4 (men) drinks per day or 7 (women)/14 (men) drinks per week, (2) getting drunk at least once per week over the past 6 months or (3) binge drinking at least once per week over the past 6 months (i.e. more than 4 (women)/5 (men) drinks in a 2 hr. period).
Exclusion Criteria:
Individuals who are under the age of 18, or who do not meet the study's drinking criteria
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm 1
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and no motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 2
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 3
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and no motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 4
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 5
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and no motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 6
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and the presence of motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 7
7. Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, an animated narrator guiding the intervention, and no motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 8
Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 9
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and no motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 10
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and the presence of motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 11
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and no motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 12
Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and the presence of motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 13
13. Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and no motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 14
Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and the presence of motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 15
Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and no motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Eksperimentell: Arm 16
Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.
|
The intervention will be be tablet-based and take approximately 20 minutes to complete.
Content will focus on heavy alcohol use.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean Drinks Per Day
Tidsramme: 1 month and 3 months after baseline
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Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.
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1 month and 3 months after baseline
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Heavy Drinking Days Per Month
Tidsramme: 1 month and 3 months after baseline
|
Number of days participant reports drinking 4/5 (male/female) alcoholic drinks in a 2-hour period during the past 30 days
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1 month and 3 months after baseline
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Report of Alcohol Related Consequences
Tidsramme: 1 month and 3 months after baseline
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Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire
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1 month and 3 months after baseline
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Intention to Reduce Alcohol Use
Tidsramme: 1 month and 3 months after baseline
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Participants self-report intentions to reduce drinking on the Drinking Intentions Questionnaire.
On this questionnaire, participants rate how likely they are to reduce their drinking over the next week, month, and year on a scale ranging from '0 = Not at all likely' to '5 = Extremely likely.'
Higher scores mean greater intentions to reduce drinking.
In order to obtain more stable estimates and reduce type I error, responses to the week, month and year questions were summed to create a total drinking intentions score which could range from 0 to 15.
More specifically, scores on each individual scale item (i.e.
intentions to reduce drinking over the week, month and year) could range from 0 to 5. When summed together, these items created the total score (reported here) which could range from 0 to 15.
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1 month and 3 months after baseline
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Emily Grekin, PhD, Wayne State University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R21AA023660 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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