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| Name | Class |
|---|---|
| Norlien Foundation | OTHER |
| Women and Children's Health Research Institute, Canada | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer-based PAF | Experimental | Standard medical care followed by computer-based personalized assessment feedback (PAF). |
|
| Computer-based sham | Sham Comparator | Standard medical care followed by a computer-based sham. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Retention Rates |
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Study Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Children's Hospital Emergency Department | Calgary | Alberta | Canada | |||
| Stollery Children's Hospital Emergency Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28801399 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medical Care Plus Computer-based PAF | Computer-based Personalized Assessment Feedback: This brief intervention targeted norm misperceptions, for example summarizing a youth's drinking in comparison to same average male or female in the general population. Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns. |
| FG001 | Medical Care Plus Computer-based Sham | Computer-based sham: Similar in format and duration as the Personalized Assessment Feedback but engaged youth in nutrition and exercise-related questions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Medical Care Followed by Computer-based PAF | Standard medical care followed by a brief intervention (computer-based personalized assessment feedback) that targeted norm misperceptions, for example summarizing a youth's drinking in comparison to same average male or female in the general population. Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 1 and 3 months post-intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Medical Care Followed by Computer-based PAF | Standard medical care followed by a brief intervention (computer-based personalized assessment feedback) that targeted norm misperceptions, for example summarizing a youth's drinking in comparison to same average male or female in the general population. Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda Newton | University of Alberta | 780-248-5581 | an6@ualberta.ca |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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|
| 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. |
|
| 1 and 3 months post-intervention |
| Knowledge of Treatment Allocation | 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). | 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. | 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? | 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? | 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? | 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. | 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. | 3-months post-intervention |
| Edmonton |
| Alberta |
| T6G 2C8 |
| Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| BG001 | Standard Medical Care Followed by Computer-based Sham | Standard medical care followed by a computer-based sham intervention. The sham was similar in format and duration as the Personalized Assessment Feedback but engaged youth in nutrition and exercise-related questions. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Met AUDIT-C cut-score of 3 for harmful and hazardous drinking | 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 are summed and range from 0 to 12 with higher scores reflecting more consumption. A cut-score of 3 is recommended for identifying youth with harmful and hazardous drinking. | Count of Participants | Participants |
|
| Report of using other substances prior to ED visit | Count of Participants | Participants |
|
| OG001 | Standard Medical Care Followed by Computer-based Sham | Standard medical care followed by a computer-based sham intervention. The sham was similar in format and duration as the Personalized Assessment Feedback but engaged youth in nutrition and exercise-related questions. |
|
|
| 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. | The recruitment rate was calculated as the number of enrolled participants (n=44) divided by the number of eligible participants (n=117). | Posted | Count of Participants | Participants | 18 months |
|
|
|
| Secondary | Retention Rates | We were interested in the overall study retention rates at 1- and 3-months post-intervention, and not retention rates per arm, as the purpose of calculating the rates was to assess the feasibility of a follow-up period in a definitive randomized controlled trial. | Posted | Count of Participants | Participants | 1 and 3 months post-intervention |
|
|
|
| Secondary | Knowledge of Treatment Allocation | Total number of participants analyzed was 44. Each allocation guess by staff/physicians/nurses was analyzed using the number of adolescents allocated to each arm: 18 to intervention; 26 to control. | Posted | Count of Participants | Participants | No | 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). | Posted | Count of Participants | Participants | 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. | Due to the large amount of missing data (at 1-month [52.3%] and 3-months [59.0%] post-intervention) we did not assess change in utilization from baseline to 1- and 3-months post-intervention (pre-specified secondary outcome) as the results would be prone to bias. | Posted | Count of Participants | Participants | 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? | Posted | Count of Participants | Participants | 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? | Posted | Count of Participants | Participants | 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? | Posted | Count of Participants | Participants | 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. | Due to the large amount of missing data (at 1-month [52.3%] and 3-months [59.0%] post-intervention) we did not assess change in utilization from baseline to 1- and 3-months post-intervention (pre-specified secondary outcome) as the results would be prone to bias. | Posted | Count of Participants | Participants | 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. | Due to the large amount of missing data (at 1-month [52.3%] and 3-months [59.0%] post-intervention) we did not assess change in utilization from baseline to 1- and 3-months post-intervention (pre-specified secondary outcome) as the results would be prone to bias. | Posted | Count of Participants | Participants | 3-months post-intervention |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Standard Medical Care Followed by Computer-based Sham | Standard medical care followed by a computer-based sham intervention. The sham was similar in format and duration as the Personalized Assessment Feedback but engaged youth in nutrition and exercise-related questions. | 0 | 26 | 0 | 26 | 0 | 26 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Guess: allocated to control |
|
| Guess: I do not know |
|
| Adolescent was allocated to control |
|
|
| Disagreed |
|
| Strongly disagreed |
|
| Unknown/No response |
|
| This computer program was easy to use |
|
| I was able to finish the computer program quickly |
|
| The program helped me think about what I do |
|
| The feedback the program gave me was believable |
|
| Never used |
|
| Missing |
|
| Psychiatrist/Psychologist/SW |
|
| Clinic |
|
| Crisis service |
|
| General physician (GP) |
|
| School-based service |
|
| Family/Friends |
|
| Hotline |
|
| Self-help |
|
| Internet |
|
| Neutral |
|
| Good idea |
|
| Definitely good idea |
|
| Missing response |
|
| Yes and delayed seeking services |
|
| Yes and stopped from seeking services |
|
| Missing |
|
| Feelings about what others would think |
|
| Lack of information that affected services sought |
|
| Concerns about time it takes to get help |
|
| Health services were not readily available |
|
| Didn't want to talk about sensitive problem |
|
| Problem with setting up appointments or contact |
|
| Problem with getting to where treatment available |
|
| Neutral |
|
| Can help |
|
| Definitely can help |
|
| Missing response |
|
| Never used |
|
| Missing |
|
| Psychiatrist/Psychologist/SW |
|
| Clinic |
|
| Crisis service |
|
| General physician (GP) |
|
| School-based service |
|
| Family/Friends |
|
| Hotline |
|
| Self-help |
|
| Internet |
|
| Never used |
|
| Missing |
|
| Psychiatrist/Psychologist/SW |
|
| Clinic |
|
| Crisis service |
|
| General physician (GP) |
|
| School-based service |
|
| Family/Friends |
|
| Hotline |
|
| Self-help |
|
| Internet |
|