- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01146665
Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department
31 de octubre de 2018 actualizado por: Mandi Newton, University of Alberta
Alcohol misuse amongst youth is a significant clinical and public health problem.
The Emergency Department (ED) is an important setting for the treatment of alcohol-related problems as it is often the first point of contact between youth, their families, and the healthcare system.
This pilot study will assess the feasibility and acceptability of a computer-based intervention in the ED for youth with alcohol-related presentations.
The investigators research team will: (1) evaluate the methodological and operational processes involved in study recruitment and intervention implementation, (2) determine recruitment and retention rates, and (3) obtain preliminary data on the difference in alcohol consumption at different time points.
The clinical and health service implications of this research will be used to plan further investigations designed to improve the standard of ED care among youth aged 12 to 16 with alcohol-related presentations.
This research will also help optimize the planning and development of a full-scale randomized controlled clinical trial of a computer-based intervention designed to reduce higher-risk alcohol consumption and alcohol-related health and social problems in this target population.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
44
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Alberta
-
Calgary, Alberta, Canadá
- Alberta Children's Hospital Emergency Department
-
Edmonton, Alberta, Canadá, T6G 2C8
- Stollery Children's Hospital Emergency Department
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canadá, B3K 6R8
- IWK Health Centre
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años a 17 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Study Inclusion Criteria:
- Youth aged 12 to 17 years who present to the Emergency Department (ED) with an alcohol-related problem.
- Medically stable
Alcohol involvement will be determined by youth self-report of drinking alcohol prior to event necessitating a visit to the ED and/or a positive Blood Alcohol Content (BAC).
Study Exclusion Criteria:
- Youth who require hospital admission
- Youth whose ED presentation is linked to drugs aside from alcohol
- Youth who report other drug use within the last 24 hours prior to ED presentation
- Youth who do not speak or understand English
- Youth who are currently enrolled in a treatment program for alcohol use
- Youth who are accompanied by a non-guardianship adult but are not considered Mature Minors
- Youth who do not have the capacity to give informed consent as determined by their attending ED physician
- Youth do not have regular access to their own telephone
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Computer-based PAF
Standard medical care followed by computer-based personalized assessment feedback (PAF).
|
This intervention includes standard medical care followed by receipt of computer-based Personalized Assessment Feedback (PAF).
PAF is a type of brief intervention that targets norm misperceptions, for example summarizing a person's drinking in comparison to the average male or female in the general population.
Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns.
|
Comparador falso: Computer-based sham
Standard medical care followed by a computer-based sham.
|
This intervention includes standard medical care followed by receipt of a computer-based sham.
The sham is similar in format and duration as the computer-based Personalized Assessment Feedback but will engage youth in nutrition and exercise-related questions.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Youth Alcohol Use
Periodo de tiempo: baseline, 1 and 3 months post-intervention
|
AUDIT-C (Alcohol Use Disorders Identification Test Consumption subscale): 1 item regarding frequency of alcohol consumption, 1 item regarding the amount of alcohol consumption, and 1 item regarding the frequency of binge drinking.
Scores range from 0 to 12 with higher scores reflecting more consumption.
The change in alcohol use report below reflects the change in AUDIT-C scores with negative values indicating a reduction in score and positive values indicating an increase in score.
|
baseline, 1 and 3 months post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Recruitment Rate
Periodo de tiempo: 18 months
|
To be calculated following active recruitment (18 months from study start date of patient enrolment).
The recruitment rate relates to recruitment into the study, and not recruitment per arm as randomization and allocation occurred after enrolment.
|
18 months
|
Retention Rates
Periodo de tiempo: 1 and 3 months post-intervention
|
1 and 3 months post-intervention
|
|
Knowledge of Treatment Allocation
Periodo de tiempo: post-intervention (day 1)
|
post-intervention (day 1)
|
|
PAF Feasibility and Acceptability
Periodo de tiempo: youth: post-intervention (day 1)
|
The acceptability of the Personalized Assessment Feedback (PAF) intervention will be assessed by youth post-intervention (only youth allocated to the PAF intervention).
Measure assessed acceptability (satisfaction with the intervention, perceptions of the helpfulness, credibility of the personalized assessment feedback) and feasibility (time to completion, user friendliness).
|
youth: post-intervention (day 1)
|
Change in Health Care System Utilization by Youth
Periodo de tiempo: Baseline
|
The Child and Adolescent Services Assessment (CASA) is a self-report instrument designed to assess the use of community- and hospital-based health and social services.
We focused each question so that we collected service use for an alcohol use problem.
|
Baseline
|
Receptivity to Receiving Services: Seeking Help/Treatment
Periodo de tiempo: Baseline
|
As part of CASA measure (secondary outcome measure to measure health and social services utilization) adolescents were asked two additional questions on receptivity to receiving services.
The data below reflects the first question: On a scale of 1-5, where 1 is it's definitely a bad idea and 5 it's definitely a good idea, do you think that if someone you knew had an alcohol use problem they should get help or seek treatment?
|
Baseline
|
Perceived Barriers to Services
Periodo de tiempo: Baseline
|
As part of CASA measure (secondary outcome measure to measure health and social services utilization) adolescents answered 8 additional questions on perceived barriers to services: 1) Do you have any feelings such as dislike, distrust or fear about talking with doctors, counselors or other professionals?
2) Do you have any feelings about what other people would think if you sought help?
3) Do you find there is a lack of information that affected health services sought?
4) Do you have any concerns about the amount of time it takes to get help?
5) Were the health services you sought just not readily available?
6) Did you feel you just didn't want to talk to anyone about such a sensitive problem?
7) Was there a problem with registration, setting up appointments or contacting professionals?
8) Was there a problem getting to where treatment was available?
|
Baseline
|
Receptivity to Services: Doctors/Counselors Can Help
Periodo de tiempo: Baseline
|
As part of CASA measure (secondary outcome measure to measure health and social services utilization) adolescents were asked two additional questions on receptivity to receiving services.
The data below reflects the second question: On a scale of 1-5, where 1 is it's definitely cannot help and 5 it definitely can help, do you think that doctors or counselors can help with alcohol use problems in general?
|
Baseline
|
Change in Health Care System Utilization by Youth
Periodo de tiempo: 1-month post-intervention
|
The Child and Adolescent Services Assessment (CASA) is a self-report instrument designed to assess the use of community- and hospital-based health and social services.
We focused each question so that we collected service use for an alcohol use problem.
|
1-month post-intervention
|
Change in Health Care System Utilization by Youth
Periodo de tiempo: 3-months post-intervention
|
The Child and Adolescent Services Assessment (CASA) is a self-report instrument designed to assess the use of community- and hospital-based health and social services.
We focused each question so that we collected service use for an alcohol use problem.
|
3-months post-intervention
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Amanda Newton, PhD, Faculty of Medicine and Dentistry, University of Alberta
- Investigador principal: Kathryn Dong, MD, Faculty of Medicine and Dentistry, University of Alberta
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2010
Finalización primaria (Actual)
1 de enero de 2013
Finalización del estudio (Actual)
1 de marzo de 2013
Fechas de registro del estudio
Enviado por primera vez
15 de junio de 2010
Primero enviado que cumplió con los criterios de control de calidad
16 de junio de 2010
Publicado por primera vez (Estimar)
17 de junio de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de noviembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
31 de octubre de 2018
Última verificación
1 de octubre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00011650
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. .
Ensayos clínicos sobre Consumo de alcohol
-
Karolinska InstitutetTerminadoConsumo de alcohol | Dependencia al alcohol | Alcohol; Uso nocivo | Trastorno por consumo de alcohol | Abuso de alcoholSuecia
-
Charles Drew University of Medicine and ScienceRetiradoConsumo de alcohol | Trastorno por consumo de alcohol | Abuso de alcohol | Problema de alcohol
-
University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyTerminadoBebiendo alcohol | Consumo, AlcoholNueva Zelanda
-
HBSAReclutamientoConsumo excesivo de alcohol, consumo de alcohol por menores de edad, beber y conducir, daños relacionados con el alcoholEstados Unidos
-
Karolinska InstitutetRegion StockholmTerminadoDependencia al alcohol | Trastorno por consumo de alcohol | Abuso de alcohol | Uso nocivo de alcoholSuecia
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Activo, no reclutandoAlcohol; uso, problemaEstados Unidos
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)TerminadoAlcohol; uso, problemaEstados Unidos
-
University of Central FloridaInscripción por invitación
-
Boston Medical CenterBoston University; National Institute on Alcohol Abuse and Alcoholism (NIAAA)TerminadoDependencia al alcohol | Abuso de alcohol | Uso no saludable de alcohol | Cantidades peligrosas de consumo de alcohol | Uso peligroso de alcoholEstados Unidos
-
University of ThessalyEuropean Social FundTerminadoDependencia al alcohol | Trastorno por consumo de alcohol | Consumo excesivo de alcohol | Abuso de alcohol
Ensayos clínicos sobre Computer-based PAF
-
Notal Vision Ltd.TerminadoPoblación AMD: AMD intermedia o avanzada | Población DR: con o sin edema macular diabéticoIsrael
-
Mackay Medical CollegeTerminadoProblema de salud mentalTaiwán
-
University of Nevada, RenoTerminadoTrastorno sicologico | Funcionamiento InterpersonalEstados Unidos
-
Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
-
University Hospital, BordeauxTerminadoEnfermedad de ParkinsonFrancia
-
University College, LondonDesconocidoEstilo de vida sedentario | Apetito y Trastornos Generales de la NutriciónReino Unido
-
University of UtahReclutamiento
-
Universidade da MadeiraServiço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.Reclutamiento
-
University of UtahTerminadoHeridas y LesionesEstados Unidos
-
Universidad Francisco de VitoriaHospital Beata María AnaTerminado