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

NCT01146665 | Completed Results

• 1 other identifier: Pro00011650
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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.

Conditions

Alcohol Consumption

Keywords

alcohol consumption; personalized assessment feedback; youth; emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Recruitment Rate

  18 months

• Retention Rates

  1 and 3 months post-intervention

• Knowledge of Treatment Allocation

  post-intervention (day 1)

• PAF Feasibility and Acceptability

  youth: post-intervention (day 1)

• Change in Health Care System Utilization by Youth

  Baseline

Study Arms (2)

Computer-based PAF

EXPERIMENTAL

Standard medical care followed by computer-based personalized assessment feedback (PAF).

Behavioral: Computer-based PAF

Computer-based sham

SHAM COMPARATOR

Standard medical care followed by a computer-based sham.

Behavioral: Computer-based Sham

Interventions

Computer-based PAF BEHAVIORAL

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 PAF

Computer-based Sham BEHAVIORAL

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.

Computer-based sham

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Norlien Foundation: collaborator
• Women and Children's Health Research Institute, Canada: collaborator

Study Sites (3)

Alberta Children's Hospital Emergency Department

Calgary, Alberta, Canada

Location

Stollery Children's Hospital Emergency Department

Edmonton, Alberta, T6G 2C8, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 28801399 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Emergencies

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Amanda Newton
• Organization: University of Alberta

an6@ualberta.ca

780-248-5581

Study Officials

• Amanda Newton, PhD

  Faculty of Medicine and Dentistry, University of Alberta

  PRINCIPAL INVESTIGATOR

• Kathryn Dong, MD

  Faculty of Medicine and Dentistry, University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pediatrics

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 17, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 29, 2018
• Results First Posted: September 10, 2018

Record last verified: 2018-10

Locations

CA (3)