Brief Alcohol E-Interventions Study
14 juni 2019 uppdaterad av: Emily Grekin, Wayne State University
Optimizing E-interventions for Alcohol Use: Do Common Factors Apply?
The project seeks to develop an effective computer-delivered brief intervention to reduce alcohol use using the Multiphase Optimization Strategy (MOST).
Sixteen different versions of the intervention will be tested with manipulation of common factors (empathy & positive regard), use of a voice, and use of an animated narrator.
Participants will include 352 undergraduate students randomly assigned to one intervention condition; follow-up assessments will take place at one and 3 months.
The main outcome will be means drink per day over the past 30 day.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The proposed project seeks to develop a maximally effective computer-delivered brief intervention (CDBI) for reducing heavy alcohol use.
To accomplish this, we will use the Multiphase Optimization Strategy (MOST), an efficient method for optimizing intervention content, beginning with factorial designs evaluating main and interaction effects of specific intervention components.
Our selection of components will be guided by: (a) Common Factors Theory, which highlights the tremendous contribution of non-specific factors, such as empathy and positive regard, to therapy outcomes, but which is of unknown relevance to CDBIs; and (b) Media Equation Theory, which suggests that people automatically respond to computers in social ways, particularly when those computers replicate human characteristics.
To accomplish these goals, we will examine outcomes of computer-delivered brief interventions in which common factors (empathy & positive regard), use of a voice, and use of an animated narrator are systematically manipulated using a factorial design.
We will also systematically manipulate the presence vs. absence of motivational content in order to examine possible interactions between common factors and specific motivational techniques.
Participants will be 352 undergraduates who are randomly assigned to 1 of 16 intervention conditions.
Mean drinks per day over the past 30 days will be measured at 1 and 3-month follow-ups.
Secondary analyses will also examine past month heavy drinking days, alcohol-related consequences, and intention to reduce alcohol use.
We hypothesize that there will be significant main effects for (1) the factor consistent with Common Factors Theory (empathy and positive regard), (2) the two factors consistent with Media Equation Theory (voice and narrator), and (3) the presence of motivational content.
We further hypothesize that mean drinks/day will be lower when (1) the common factors (empathy, positive regard) are combined with a voice and/or narrator or (2) motivational content is combined with common factors and/or a voice/narrator.
Studietyp
Interventionell
Inskrivning (Faktisk)
352
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Wayne State University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean Drinks Per Day
Tidsram: 1 month and 3 months after baseline
|
Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.
|
1 month and 3 months after baseline
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Heavy Drinking Days Per Month
Tidsram: 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
|
1 month and 3 months after baseline
|
|
Report of Alcohol Related Consequences
Tidsram: 1 month and 3 months after baseline
|
Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire
|
1 month and 3 months after baseline
|
|
Intention to Reduce Alcohol Use
Tidsram: 1 month and 3 months after baseline
|
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.
|
1 month and 3 months after baseline
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Emily Grekin, PhD, Wayne State University
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
23 december 2016
Primärt slutförande (Faktisk)
25 september 2017
Avslutad studie (Faktisk)
13 januari 2018
Studieregistreringsdatum
Först inskickad
31 oktober 2016
Först inskickad som uppfyllde QC-kriterierna
31 oktober 2016
Första postat (Uppskatta)
2 november 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 juni 2019
Senast verifierad
1 juni 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R21AA023660 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
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Kliniska prövningar på Brief Tablet-based Intervention to Address Heavy Alcohol Use
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