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

31. Oktober 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

44

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada
        • Alberta Children's Hospital Emergency Department
      • Edmonton, Alberta, Kanada, T6G 2C8
        • Stollery Children's Hospital Emergency Department
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3K 6R8
        • IWK Health Centre

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre bis 17 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Computer-based PAF
Standard medical care followed by computer-based personalized assessment feedback (PAF).
Verhalten: 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.
Schein-Komparator: Computer-based sham
Standard medical care followed by a computer-based sham.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Youth Alcohol Use
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Recruitment Rate
Zeitfenster: 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
Zeitfenster: 1 and 3 months post-intervention
1 and 3 months post-intervention
Knowledge of Treatment Allocation
Zeitfenster: post-intervention (day 1)
post-intervention (day 1)
PAF Feasibility and Acceptability
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Alberta

Mitarbeiter

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

Ermittler

  • Hauptermittler: Amanda Newton, PhD, Faculty of Medicine and Dentistry, University of Alberta
  • Hauptermittler: Kathryn Dong, MD, Faculty of Medicine and Dentistry, University of Alberta

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2010

Primärer Abschluss (Tatsächlich)

1. Januar 2013

Studienabschluss (Tatsächlich)

1. März 2013

Studienanmeldedaten

Zuerst eingereicht

15. Juni 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juni 2010

Zuerst gepostet (Schätzen)

17. Juni 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. November 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Oktober 2018

Zuletzt verifiziert

1. Oktober 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Pro00011650

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