Clinical trial NCT01146665: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Keywords: alcohol consumption
personalized assessment feedback
youth
emergency department
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Norlien Foundation
name: Women and Children's Health Research Institute, Canada
First posted: 2010-06-17
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Youth Alcohol Use
timeFrame: baseline, 1 and 3 months post-intervention
Secondary outcomes:
measure: Recruitment Rate
timeFrame: 18 months
measure: Retention Rates
timeFrame: 1 and 3 months post-intervention
measure: Knowledge of Treatment Allocation
timeFrame: post-intervention (day 1)
measure: PAF Feasibility and Acceptability
timeFrame: youth: post-intervention (day 1)
measure: Change in Health Care System Utilization by Youth
timeFrame: Baseline
measure: Receptivity to Receiving Services: Seeking Help/Treatment
timeFrame: Baseline
measure: Perceived Barriers to Services
timeFrame: Baseline
measure: Receptivity to Services: Doctors/Counselors Can Help
timeFrame: Baseline
measure: Change in Health Care System Utilization by Youth
timeFrame: 1-month post-intervention
measure: Change in Health Care System Utilization by Youth
timeFrame: 3-months post-intervention
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital Emergency Department
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital Emergency Department
state: Alberta
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: Faculty of Medicine and Dentistry, University of Alberta
name: Amanda Newton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine and Dentistry, University of Alberta
name: Kathryn Dong, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.