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

Alcohol Consumption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146665
• Other study ID #: Pro00011650
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: March 2013

Study information

• Verified date: October 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Emergencies

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital Emergency Department	Calgary	Alberta
Canada	Stollery Children's Hospital Emergency Department	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Norlien Foundation, Women and Children's Health Research Institute, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 1 and 3 months post-intervention
Secondary	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.	18 months
Secondary	Retention Rates		1 and 3 months post-intervention
Secondary	Knowledge of Treatment Allocation		post-intervention (day 1)
Secondary	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).	youth: post-intervention (day 1)
Secondary	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.	Baseline
Secondary	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?	Baseline
Secondary	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?	Baseline
Secondary	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?	Baseline
Secondary	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.	1-month post-intervention
Secondary	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.	3-months post-intervention