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

NCT ID: NCT01146665

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Computer-based PAF

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

Group Type: EXPERIMENTAL

Computer-based PAF

Intervention Type: 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 sham

Standard medical care followed by a computer-based sham.

Group Type: SHAM_COMPARATOR

Computer-based Sham

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norlien Foundation

OTHER

Sponsor Role: collaborator

Women and Children's Health Research Institute, Canada

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Mandi Newton

Assistant Professor, Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amanda Newton, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine and Dentistry, University of Alberta

Kathryn Dong, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine and Dentistry, University of Alberta

Locations

Alberta Children's Hospital Emergency Department

Calgary, Alberta, Canada

Stollery Children's Hospital Emergency Department

Edmonton, Alberta, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28801399 (View on PubMed)

Other Identifiers

Pro00011650

Identifier Type: -

Identifier Source: org_study_id