Brief Alcohol E-Interventions Study
14 juin 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
352
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Michigan
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Detroit, Michigan, États-Unis, 48202
- Wayne State University
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Drinks Per Day
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Heavy Drinking Days Per Month
Délai: 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
|
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Report of Alcohol Related Consequences
Délai: 1 month and 3 months after baseline
|
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
Délai: 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.
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1 month and 3 months after baseline
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Emily Grekin, PhD, Wayne State University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
23 décembre 2016
Achèvement primaire (Réel)
25 septembre 2017
Achèvement de l'étude (Réel)
13 janvier 2018
Dates d'inscription aux études
Première soumission
31 octobre 2016
Première soumission répondant aux critères de contrôle qualité
31 octobre 2016
Première publication (Estimation)
2 novembre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 juin 2019
Dernière vérification
1 juin 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R21AA023660 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
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