Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department
31. oktober 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
44
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alberta
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Calgary, Alberta, Canada
- Alberta Children's Hospital Emergency Department
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Edmonton, Alberta, Canada, T6G 2C8
- Stollery Children's Hospital Emergency Department
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 17 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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Sham-komparator: Computer-based sham
Standard medical care followed by a computer-based sham.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Youth Alcohol Use
Tidsramme: baseline, 1 and 3 months post-intervention
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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.
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baseline, 1 and 3 months post-intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment Rate
Tidsramme: 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.
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18 months
|
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Retention Rates
Tidsramme: 1 and 3 months post-intervention
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1 and 3 months post-intervention
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Knowledge of Treatment Allocation
Tidsramme: post-intervention (day 1)
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post-intervention (day 1)
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PAF Feasibility and Acceptability
Tidsramme: youth: post-intervention (day 1)
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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).
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youth: post-intervention (day 1)
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Change in Health Care System Utilization by Youth
Tidsramme: Baseline
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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.
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Baseline
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Receptivity to Receiving Services: Seeking Help/Treatment
Tidsramme: 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?
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Baseline
|
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Perceived Barriers to Services
Tidsramme: 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?
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Baseline
|
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Receptivity to Services: Doctors/Counselors Can Help
Tidsramme: 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?
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Baseline
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Change in Health Care System Utilization by Youth
Tidsramme: 1-month post-intervention
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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
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Change in Health Care System Utilization by Youth
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Amanda Newton, PhD, Faculty of Medicine and Dentistry, University of Alberta
- Ledende efterforsker: Kathryn Dong, MD, Faculty of Medicine and Dentistry, University of Alberta
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2010
Primær færdiggørelse (Faktiske)
1. januar 2013
Studieafslutning (Faktiske)
1. marts 2013
Datoer for studieregistrering
Først indsendt
15. juni 2010
Først indsendt, der opfyldte QC-kriterier
16. juni 2010
Først opslået (Skøn)
17. juni 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. oktober 2018
Sidst verificeret
1. oktober 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00011650
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .