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

31. oktober 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

44

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 17 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Computer-based PAF
Standard medical care followed by computer-based personalized assessment feedback (PAF).
Atferdsmessig: 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.
Sham-komparator: Computer-based sham
Standard medical care followed by a computer-based sham.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Youth Alcohol Use
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
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.
18 months
Retention Rates
Tidsramme: 1 and 3 months post-intervention
1 and 3 months post-intervention
Knowledge of Treatment Allocation
Tidsramme: post-intervention (day 1)
post-intervention (day 1)
PAF Feasibility and Acceptability
Tidsramme: 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
Tidsramme: 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
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?
Baseline
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?
Baseline
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?
Baseline
Change in Health Care System Utilization by Youth
Tidsramme: 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
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Alberta

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2010

Primær fullføring (Faktiske)

1. januar 2013

Studiet fullført (Faktiske)

1. mars 2013

Datoer for studieregistrering

Først innsendt

15. juni 2010

Først innsendt som oppfylte QC-kriteriene

16. juni 2010

Først lagt ut (Anslag)

17. juni 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. november 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. oktober 2018

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pro00011650

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