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

This study has been completed.
Sponsor:
Collaborators:
Norlien Foundation
Women and Children's Health Research Institute, Canada
Information provided by (Responsible Party):
Mandi Newton, University of Alberta
ClinicalTrials.gov Identifier:
NCT01146665
First received: June 15, 2010
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Alcohol Consumption
Behavioral: Computer-based Personalized Assessment Feedback
Behavioral: Computer-based sham

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • change in youth alcohol use [ Time Frame: baseline, 1 and 3 months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in health care system utilization by youth [ Time Frame: baseline, 1 and 3 months post-intervention ] [ Designated as safety issue: No ]
  • recruitment rates [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To be calculated following active recruitment (18 months from study start date of patient enrolment).

  • retention rates [ Time Frame: 1 and 3 months post-intervention ] [ Designated as safety issue: No ]
  • knowledge of treatment allocation [ Time Frame: post-intervention (day 1) ] [ Designated as safety issue: No ]
  • PAF feasibility and acceptability [ Time Frame: youth: post-intervention (day 1); physicians and research staff: post-trial (18 months) ] [ Designated as safety issue: No ]
    The acceptability of the Personalized Assessment Feedback (PAF) intervention will be assessed by youth post-intervention and ED physicians and research staff post-trial using a study developed, 4-item questionnaire focusing on satisfaction with design and length of PAF, perceptions of helpfulness, credibility of the feedback provided by the PAF and user friendliness. PAF feasibility will be discussed by the team by examining the other secondary outcomes.


Enrollment: 44
Study Start Date: July 2010
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: medical care plus computer-based PAF Behavioral: Computer-based Personalized Assessment Feedback
This type of brief intervention 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 Comparator: medical care plus computer-based sham Behavioral: Computer-based sham
Similar in format and duration as the Personalized Assessment Feedback but will engage youth in nutrition and exercise-related questions.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146665

Locations
Canada, Alberta
Alberta Children's Hospital Emergency Department
Calgary, Alberta, Canada
Stollery Children's Hospital Emergency Department
Edmonton, Alberta, Canada, T6G 2C8
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
University of Alberta
Norlien Foundation
Women and Children's Health Research Institute, Canada
Investigators
Principal Investigator: Amanda Newton, PhD Faculty of Medicine and Dentistry, University of Alberta
Principal Investigator: Kathryn Dong, MD Faculty of Medicine and Dentistry, University of Alberta
  More Information

No publications provided

Responsible Party: Mandi Newton, Assistant Professor, Department of Pediatrics, University of Alberta
ClinicalTrials.gov Identifier: NCT01146665     History of Changes
Other Study ID Numbers: Pro00011650
Study First Received: June 15, 2010
Last Updated: May 9, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
alcohol consumption
personalized assessment feedback
youth
emergency department

Additional relevant MeSH terms:
Alcohol Drinking
Emergencies
Disease Attributes
Drinking Behavior
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014