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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA021904-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this study is to assess the psychometric properties of a brief screening questionnaire for alcohol problems among 9- to 18-year-old patients in pediatricians' offices, and to pilot test a personalized, computer-facilitated brief intervention delivered on a tablet computer and by the provider based on screening results.
The primary goal of this project is to develop a computerized screening program for primary care offices that is based on the NIAAA's new Alcohol Screening Guide for Children and Adolescents and assess its psychometric properties among nine- to 18-yr-old primary care patients. There is substantial evidence supporting the effectiveness of screening and brief intervention among adult primary care patients, primarily in the reduction of harmful drinking. However, there have been few studies of alcohol screening and brief intervention conducted among adolescents seen in busy primary care settings. This project will develop and validate a new computerized Alcohol Screening for Children and Adolescents (cASCA) program which incorporates the age-specific screening questions of the NIAAA Guide and includes the CRAFFT and AUDIT as secondary risk/problem assessments. We will add tobacco screening because tobacco use is the leading cause of cancer-related mortality in the US as well as screening for marijuana and other drug use so as to create a comprehensive screening instrument that includes all major substances that adolescents use.
Additionally, the NIAAA guide recommends that providers deliver a brief intervention in response to the screening results. Therefore, a secondary aim of this project will be to pilot-test a computer-facilitated Brief Intervention component using a randomized design comparing three groups: 1) screening with treatment as usual [cASCA/TAU]; 2) screening with the computer-facilitated brief intervention [cASCA/BI]. The BI component consists of patients viewing on the computer, immediately after the screening, their score and level of risk for a substance use problem, as well as several interactive pages of science and true-life stories about the health risks of substance use. Clinicians are then given the screen results and suggested talking points for a few minutes of brief counseling during the visit.
Hypothesis: Among 9- to 18-year-old primary care patients, those receiving cASCA/BI will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, at 3, 6, 9 and 12-months follow-up than those receiving treatment as usual.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| screening w/ computer brief intervention | Experimental | screening with computer-facilitated brief intervention |
|
| Screening with Treatment as Usual | No Intervention | Screening with Treatment as Usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computer-facilitated brief intervention | Behavioral | Immediate feedback to patient of screening results and risk for substance use problem, followed by 11 pages of science and true-life stories about health risks of adolescent substance use. Screening results then go to provider who reviews them with patient and gives brief counseling, and refers to an online motivational enhancement therapy intervention for patients at moderate/high risk for substance use problems. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Post-visit Drinking Day | Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups | 12-months follow-up |
| Time to First Post-visit Heavy Episodic Drinking Day | The number of days post-visit to first reported heavy episodic drinking day | 12-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Post-visit Cannabis Use Day | The number of days post-visit to first reported cannabis use day. | 12-months follow-up |
| Past-3-month Riding Risk | Self-reported riding in the past 3 months with a driver who had been drinking or using other drugs, stratified by reported riding risk in the past 3 months at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John R Knight, MD | Boston Children's Hospital | Principal Investigator |
| Sion K Harris, PhD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States | ||
| Boston Childrens Primary Care Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22566420 | Background | Harris SK, Csemy L, Sherritt L, Starostova O, Van Hook S, Johnson J, Boulter S, Brooks T, Carey P, Kossack R, Kulig JW, Van Vranken N, Knight JR. Computer-facilitated substance use screening and brief advice for teens in primary care: an international trial. Pediatrics. 2012 Jun;129(6):1072-82. doi: 10.1542/peds.2011-1624. Epub 2012 May 7. |
| Label | URL |
|---|---|
| Center for Adolescent Substance Abuse Research | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Computerized Screening w/ Provider Brief Intervention (cSBI) | cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit. |
| FG001 | Computerized Screening With Treatment as Usual (TAU) | The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Immediate Post-visit Questionnaire |
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| 3-months Follow-up |
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| 6-months Follow-up |
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| 9-month Follow-up |
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| 12-month Follow-up |
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12- to 18-year-olds arriving for their annual well-visit at participating pediatric practices
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| ID | Title | Description |
|---|---|---|
| BG000 | Computerized Screening w/ Provider Brief Intervention (cSBI) | cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline |
| 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 | Time to First Post-visit Drinking Day | Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups | Stratified: Participants who reported past-12-month use of alcohol or other drugs at baseline vs. Participants who reported no past-12-month use of alcohol or other drugs at baseline | Posted | Median | Inter-Quartile Range | days | 12-months follow-up |
|
1 year
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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 | Computerized Screening w/ Provider Brief Intervention (cSBI) | cSBI consists of adolescents self-administering on a tablet computer a screening questionnaire prior to seeing their provider. The computer program then immediately provides adolescents with personalized feedback, followed by brief psychoeducation illustrating the health-related risks of substance use. Providers then login to the tablet computer to access a Clinician Report Form which presents the patient's screening results, as well as discussion prompts to guide a few minutes of Motivational Interviewing-based brief counseling during the visit. |
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Same practitioners delivering both the CSBI and UC may have contaminated UC arm; only group difference we could assure was the CRAFFT screen. Relied on patients' reporting of intervention; did not obtain independent observations of practitioner behaviors. Relied on self-report. Unable to examine effects on use of certain drugs (low prevalence). Did not collect parents' views of CSBI system.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sion Kim Harris | Boston Children's Hospital | 8572184304 | sion.harris@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2018 | Feb 18, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| 12 months follow-up |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Longwood Pediatrics | Boston | Massachusetts | 02115 | United States |
| East Boston Neighborhood Health Center | East Boston | Massachusetts | 02128 | United States |
| Lexington Pediatrics | Lexington | Massachusetts | 02421 | United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 | Computerized Screening With Treatment as Usual (TAU) | The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| In grades 9-12 | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline | Count of Participants | Participants |
|
| Lives with two parents in home | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline | Count of Participants | Participants |
|
| Parent highest education level is college graduate or higher | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline | Count of Participants | Participants |
|
| Saw a pediatrician at visit | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline | Count of Participants | Participants |
|
| Saw a female practitioner | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline | Count of Participants | Participants |
|
| Had 6 or more prior visits with practitioner | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline | Count of Participants | Participants |
|
| Had CRAFFT score of 2 or greater | Score of >=2 suggests a serious problem and warrants clinical attention. C-Have you ever ridden in a CAR driven by someone (including yourself) who was "high" or had been using alcohol or drugs? R-Do you ever use alcohol or drugs to RELAX, feel better about yourself, or fit in? A-Do you ever use alcohol or drugs while you are by yourself, or ALONE? F-Do you ever FORGET things you did while using alcohol or drugs? F-Do your family or FRIENDS ever tell you that you should cut down on your drinking or drug use? T-Have you ever gotten into TROUBLE while you were using alcohol or drugs? | Participants who reported past-12-month use of alcohol or other drugs at baseline | Count of Participants | Participants |
|
| Hung out with friends who use alcohol/drugs | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline | Count of Participants | Participants |
|
| Has substance-involved siblings | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline | Count of Participants | Participants |
|
| Has substance-involved parents/guardians | We conducted analyses stratified by past-12-month use of any alcohol or other drugs reported at baseline | Count of Participants | Participants |
|
| OG001 | Computerized Screening With Treatment as Usual (TAU) | The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual. |
|
|
|
| Primary | Time to First Post-visit Heavy Episodic Drinking Day | The number of days post-visit to first reported heavy episodic drinking day | Participants who reported past-12-month use of alcohol or other drugs at baseline | Posted | Median | Inter-Quartile Range | days | 12-months follow-up |
|
|
|
|
| Secondary | Time to First Post-visit Cannabis Use Day | The number of days post-visit to first reported cannabis use day. | Stratified: Participants who reported past-12-month use of alcohol or other drugs at baseline vs. Participants who reported no past-12-month use of alcohol or other drugs at baseline | Posted | Median | Inter-Quartile Range | Days | 12-months follow-up |
|
|
|
|
| Secondary | Past-3-month Riding Risk | Self-reported riding in the past 3 months with a driver who had been drinking or using other drugs, stratified by reported riding risk in the past 3 months at baseline | Participants with riding risk at baseline vs. those with no riding risk at baseline. (Differences in number of participants analyzed at each follow-up time point is due to number of survey respondents at that time point. For example, in the cSBI group at baseline, 64 participants reported having riding risk. At 3 months follow-up, 44 of those completed a survey, and 20 of those 44 reported having riding risk at the 3-months follow-up.) | Posted | Number | participants | 12 months follow-up |
|
|
|
|
| 0 |
| 626 |
| 0 |
| 626 |
| 0 |
| 626 |
| EG001 | Computerized Screening With Treatment as Usual (TAU) | The comparison group also completed the computerized screening tool. However, this group did not receive any feedback or psychoeducation, and their providers did not receive the screening results. During the visit, adolescents in this group received treatment as usual. | 0 | 243 | 0 | 243 | 0 | 243 |
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| Male |
|
| Other or multirace |
|
| Hispanic |
|
| Other or multirace |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| Participants who reported no past-12-month use of alcohol or other drugs at baseline |
|
|
| Cox Proportional Hazard |
| 0.76 |
| 2-Sided |
| 95 |
| 0.44 |
| 1.32 |
| Superiority |
| Riding risk at baseline : 6 months |
|
|
| Riding risk at baseline : 9 months |
|
|
| Riding risk at baseline : 12 months |
|
|
| No riding risk at baseline : Baseline, No. |
|
|
| No riding risk at baseline : 6 months |
|
|
| No riding risk at baseline : 9 months |
|
|
| No riding risk at baseline : 12 months |
|
|
| Risk Ratio (RR) |
| 0.73 |
| 2-Sided |
| 95 |
| 0.44 |
| 1.19 |
| Superiority |
| Participants with riding risk at baseline: Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU. | Risk Ratio (RR) | 0.58 | 2-Sided | 95 | 0.37 | 0.91 | Superiority |
| Participants with no riding risk at baseline: Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU. | Risk Ratio (RR) | 0.72 | 2-Sided | 95 | 0.43 | 1.23 | Superiority |
| Participants with no riding risk at baseline: Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU. | Risk Ratio (RR) | 1.33 | 2-Sided | 95 | 0.67 | 2.66 | Superiority |
| Participants with no riding risk at baseline: Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU. | Risk Ratio (RR) | 0.99 | 2-Sided | 95 | 0.50 | 1.99 | Superiority |