Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department
Primary Purpose
Alcohol Consumption
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Computer-based PAF
Computer-based Sham
Sponsored by

About this trial
This is an interventional treatment trial for Alcohol Consumption focused on measuring alcohol consumption, personalized assessment feedback, youth, emergency department
Eligibility 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
Sites / Locations
- Alberta Children's Hospital Emergency Department
- Stollery Children's Hospital Emergency Department
- IWK Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Computer-based PAF
Computer-based sham
Arm Description
Standard medical care followed by computer-based personalized assessment feedback (PAF).
Standard medical care followed by a computer-based sham.
Outcomes
Primary Outcome Measures
Change in Youth Alcohol Use
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.
Secondary Outcome Measures
Recruitment Rate
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.
Retention Rates
Knowledge of Treatment Allocation
PAF Feasibility and Acceptability
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).
Change in Health Care System Utilization by Youth
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.
Receptivity to Receiving Services: Seeking Help/Treatment
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?
Perceived Barriers to Services
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?
Receptivity to Services: Doctors/Counselors Can Help
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?
Change in Health Care System Utilization by Youth
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.
Change in Health Care System Utilization by Youth
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.
Full Information
NCT ID
NCT01146665
First Posted
June 15, 2010
Last Updated
October 31, 2018
Sponsor
University of Alberta
Collaborators
Norlien Foundation, Women and Children's Health Research Institute, Canada
1. Study Identification
Unique Protocol Identification Number
NCT01146665
Brief Title
Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department
Official Title
Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
Norlien Foundation, Women and Children's Health Research Institute, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
Keywords
alcohol consumption, personalized assessment feedback, youth, emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computer-based PAF
Arm Type
Experimental
Arm Description
Standard medical care followed by computer-based personalized assessment feedback (PAF).
Arm Title
Computer-based sham
Arm Type
Sham Comparator
Arm Description
Standard medical care followed by a computer-based sham.
Intervention Type
Behavioral
Intervention Name(s)
Computer-based PAF
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computer-based Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Youth Alcohol Use
Description
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.
Time Frame
baseline, 1 and 3 months post-intervention
Secondary Outcome Measure Information:
Title
Recruitment Rate
Description
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.
Time Frame
18 months
Title
Retention Rates
Time Frame
1 and 3 months post-intervention
Title
Knowledge of Treatment Allocation
Time Frame
post-intervention (day 1)
Title
PAF Feasibility and Acceptability
Description
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).
Time Frame
youth: post-intervention (day 1)
Title
Change in Health Care System Utilization by Youth
Description
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.
Time Frame
Baseline
Title
Receptivity to Receiving Services: Seeking Help/Treatment
Description
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?
Time Frame
Baseline
Title
Perceived Barriers to Services
Description
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?
Time Frame
Baseline
Title
Receptivity to Services: Doctors/Counselors Can Help
Description
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?
Time Frame
Baseline
Title
Change in Health Care System Utilization by Youth
Description
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.
Time Frame
1-month post-intervention
Title
Change in Health Care System Utilization by Youth
Description
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.
Time Frame
3-months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Newton, PhD
Organizational Affiliation
Faculty of Medicine and Dentistry, University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathryn Dong, MD
Organizational Affiliation
Faculty of Medicine and Dentistry, University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital Emergency Department
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Stollery Children's Hospital Emergency Department
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28801399
Citation
Newton AS, Dow N, Dong K, Fitzpatrick E, Cameron Wild T, Johnson DW, Ali S, Colman I, Rosychuk RJ; Pediatric Emergency Research Canada. A randomised controlled pilot trial evaluating feasibility and acceptability of a computer-based tool to identify and reduce harmful and hazardous drinking among adolescents with alcohol-related presentations in Canadian pediatric emergency departments. BMJ Open. 2017 Aug 11;7(8):e015423. doi: 10.1136/bmjopen-2016-015423.
Results Reference
derived
Learn more about this trial
Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department
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