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Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department

31 de outubro de 2018 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

44

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Canadá
    • 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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos a 17 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Computer-based PAF
Standard medical care followed by computer-based personalized assessment feedback (PAF).
Comportamental: Computer-based 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Youth Alcohol Use
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Recruitment Rate
Prazo: 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
Prazo: 1 and 3 months post-intervention
1 and 3 months post-intervention
Knowledge of Treatment Allocation
Prazo: post-intervention (day 1)
post-intervention (day 1)
PAF Feasibility and Acceptability
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Alberta

Colaboradores

Women and Children's Health Research Institute, Canada
Norlien Foundation

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2010

Conclusão Primária (Real)

1 de janeiro de 2013

Conclusão do estudo (Real)

1 de março de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

15 de junho de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2010

Primeira postagem (Estimativa)

17 de junho de 2010

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de novembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de outubro de 2018

Última verificação

1 de outubro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Pro00011650

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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