- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02952872
Brief Alcohol E-Interventions Study
Optimizing E-interventions for Alcohol Use: Do Common Factors Apply?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Wayne State University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mean Drinks Per Day
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Heavy Drinking Days Per Month
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Emily Grekin, PhD, Wayne State University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R21AA023660 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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