Alcohol ConsumptionNCT01146665
Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department
A study testing Computer-based PAF in people with Alcohol Consumption, run by University of Alberta at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Computer-based PAF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Alberta Children's Hospital Emergency Department
Calgary, Alberta
Stollery Children's Hospital Emergency Department
Edmonton, Alberta, T6G 2C8
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
About this study
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
- Being tested
- Computer-based PAF, Computer-based Sham
- Keywords
- alcohol consumption, personalized assessment feedback, youth, emergency department
- Medical subject headings
- Alcohol Drinking, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based PAFBehavioural
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 ShamBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Computer-based PAF | Experimental | Standard medical care followed by computer-based personalized assessment feedback (PAF). Receives: Behavioral: Computer-based PAF |
| Computer-based sham | Sham comparator | Standard medical care followed by a computer-based sham. Receives: Behavioral: Computer-based Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1 and 3 months post-intervention
Secondary outcomes (10)
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.
Measured: 18 months
Retention Rates
Measured: 1 and 3 months post-intervention
Knowledge of Treatment Allocation
Measured: post-intervention (day 1)
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).
Measured: youth: post-intervention (day 1)
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.
Measured: Baseline
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?
Measured: Baseline
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?
Measured: Baseline
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?
Measured: Baseline
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.
Measured: 1-month post-intervention
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.
Measured: 3-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Norlien Foundation, Women and Children's Health Research Institute, Canada
- Responsible party
- Principal investigator, Mandi Newton, University of Alberta
- Investigators
- Amanda Newton, PhD, Principal investigator, Faculty of Medicine and Dentistry, University of AlbertaKathryn Dong, MD, Principal investigator, Faculty of Medicine and Dentistry, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146665
- Sponsor's protocol ID
- Pro00011650
- Status last verified
- Oct 2018
- First submitted
- 15 Jun 2010
- Last updated
- 29 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28801399
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Computer-Based Intervention for Alcohol Misuse in the Emergency Department
- ClinicalTrials.gov ID
- NCT01146665
- Acronym / sponsor ID
- Pro00011650
- Conditions
- Alcohol Consumption
- Keywords
- alcohol consumption, personalized assessment feedback, youth, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Norlien Foundation, Women and Children's Health Research Institute, Canada
- Study start
- Jul 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Jun 2010 (estimated)
- Results
- Posted 10 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-based PAF | Experimental | Behavioral: Computer-based PAFStandard medical care followed by computer-based personalized assessment feedback (PAF). |
| Computer-based sham | Sham comparator | Behavioral: Computer-based ShamStandard medical care followed by a computer-based sham. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-based PAFThis 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. | Behavioural | Computer-based PAF |
| Computer-based ShamThis 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. | Behavioural | Computer-based sham |
Primary outcome
Change in Youth Alcohol Use
Time frame: baseline, 1 and 3 months post-intervention
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.
10 secondary outcomes
Recruitment Rate
Time frame: 18 months
Retention Rates
Time frame: 1 and 3 months post-intervention
Knowledge of Treatment Allocation
Time frame: post-intervention (day 1)
PAF Feasibility and Acceptability
Time frame: youth: post-intervention (day 1)
Change in Health Care System Utilization by Youth
Time frame: Baseline
Receptivity to Receiving Services: Seeking Help/Treatment
Time frame: Baseline
Perceived Barriers to Services
Time frame: Baseline
Receptivity to Services: Doctors/Counselors Can Help
Time frame: Baseline
Change in Health Care System Utilization by Youth
Time frame: 1-month post-intervention
Change in Health Care System Utilization by Youth
Time frame: 3-months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28801399Newton 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.
Related trials for Alcohol Consumption
RecruitingPhase 1
Nicotinic Receptor Genetic Variation and Alcohol Reward
Alcohol Drinking
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Not yet recruitingEarly Phase 1
Examining the Role of Sensitivity to Uncertain Threat and Alcohol Response in Risk for Alcohol Use Disorder Following Sexual Assault in College Women
Sexual Assault, Alcohol Intoxication
RecruitingObservational study
NIAAA Natural History Protocol
Alcohol Use Disorder
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Newton, PhD principal investigator
Faculty of Medicine and Dentistry, University of Alberta
Kathryn Dong, MD principal investigator
Faculty of Medicine and Dentistry, University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based PAF in people with Alcohol Consumption, run by University of Alberta at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Youth Alcohol Use (time frame: baseline, 1 and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01146665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.