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Brief Alcohol E-Interventions Study

perjantai 14. kesäkuuta 2019 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

352

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

    • Michigan
      • Detroit, Michigan, Yhdysvallat, 48202
        • Wayne State University

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Tehtävätehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.
Kokeellinen: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Mean Drinks Per Day
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Heavy Drinking Days Per Month
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Tutkijat

  • Päätutkija: Emily Grekin, PhD, Wayne State University

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 23. joulukuuta 2016

Ensisijainen valmistuminen (Todellinen)

Maanantai 25. syyskuuta 2017

Opintojen valmistuminen (Todellinen)

Lauantai 13. tammikuuta 2018

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 31. lokakuuta 2016

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 31. lokakuuta 2016

Ensimmäinen Lähetetty (Arvio)

Keskiviikko 2. marraskuuta 2016

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 17. kesäkuuta 2019

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 14. kesäkuuta 2019

Viimeksi vahvistettu

Lauantai 1. kesäkuuta 2019

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muut tutkimustunnusnumerot

  • R21AA023660 (Yhdysvaltain NIH-apuraha/sopimus)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

PÄÄTTÄMÄTÖN

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