Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02233946
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 871
• Locations: 5
• Arms: 2
• Duration (Months): 40.9
• Patients Per Site: 174.2
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prevention Harmful Effects	Behavioral: computer-facilitated brief intervention	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 871 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Computerized Alcohol Screening for Children and Adolescents (cASCA) in Primary Care
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: May 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: screening w/ computer brief intervention screening with computer-facilitated brief intervention	Behavioral: computer-facilitated brief intervention; 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.
No Intervention: Screening with Treatment as Usual Screening with Treatment as Usual

Outcome Measures

Primary Outcome Measures

1. Time to First Post-visit Drinking Day [12-months follow-up]

   Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups

2. Time to First Post-visit Heavy Episodic Drinking Day [12-months follow-up]

   The number of days post-visit to first reported heavy episodic drinking day

Secondary Outcome Measures

1. Time to First Post-visit Cannabis Use Day [12-months follow-up]

   The number of days post-visit to first reported cannabis use day.

2. Past-3-month Riding Risk [12 months follow-up]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• access to computer and email address

• available and willing to complete all follow ups by email or phone

• medically and emotionally stable

• can read and understand English

Exclusion Criteria:

• Patient has already participated in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111
2	Boston Childrens Primary Care Center	Boston	Massachusetts	United States	02115
3	Longwood Pediatrics	Boston	Massachusetts	United States	02115
4	East Boston Neighborhood Health Center	East Boston	Massachusetts	United States	02128
5	Lexington Pediatrics	Lexington	Massachusetts	United States	02421

Sponsors and Collaborators

• Boston Children's Hospital
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: John R Knight, MD, Boston Children's Hospital
• Principal Investigator: Sion K Harris, PhD, Boston Children's Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 13, 2018

More Information

Additional Information:

• Center for Adolescent Substance Abuse Research

Publications

• Harris SK, Csémy 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.

• Responsible Party: Sion Kim Harris, Co-Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT02233946
• Other Study ID Numbers: P00004862; 1R01AA021904-01
• First Posted: Sep 9, 2014
• Last Update Posted: Mar 11, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Sion Kim Harris, Co-Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital: Substance Abuse; Prevention; Youth; Alcohol; Drugs

Study Results

Participant Flow

Arm/Group Title	Computerized Screening w/ Provider Brief Intervention (cSBI)	Computerized Screening With Treatment as Usual (TAU)
Arm/Group Description	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.	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.
Period Title: Baseline
STARTED	628	243
COMPLETED	626	243
NOT COMPLETED	2	0
Period Title: Baseline
STARTED	626	243
COMPLETED	624	243
NOT COMPLETED	2	0
Period Title: Baseline
STARTED	624	243
COMPLETED	571	214
NOT COMPLETED	53	29
Period Title: Baseline
STARTED	571	214
COMPLETED	550	212
NOT COMPLETED	21	2
Period Title: Baseline
STARTED	550	212
COMPLETED	530	201
NOT COMPLETED	20	11
Period Title: Baseline
STARTED	530	201
COMPLETED	502	190
NOT COMPLETED	28	11

Baseline Characteristics

Arm/Group Title	Computerized Screening w/ Provider Brief Intervention (cSBI)	Computerized Screening With Treatment as Usual (TAU)	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	626	243	869
Age (years) [Mean (Standard Deviation) ]
Participants who reported past-12-month use of alcohol or other drugs at baseline	16.3 (1.3)	16.5 (1.3)	16.4 (1.3)
Participants who reported no past-12-month use of alcohol or other drugs at baseline	14.1 (1.8)	14.5 (1.7)	14.3 (1.8)
Sex: Female, Male (Count of Participants)
Female	80 12.8%	34 14%	114 13.1%
Male	68 10.9%	29 11.9%	97 11.2%
Female	236 37.7%	91 37.4%	327 37.6%
Male	242 38.7%	89 36.6%	331 38.1%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic White	69 11%	36 14.8%	105 12.1%
Hispanic	40 6.4%	15 6.2%	55 6.3%
Other or multirace	39 6.2%	12 4.9%	51 5.9%
Non-Hispanic White	203 32.4%	79 32.5%	282 32.5%
Hispanic	143 22.8%	58 23.9%	201 23.1%
Other or multirace	132 21.1%	43 17.7%	175 20.1%
Region of Enrollment (Count of Participants)
United States	626 100%	243 100%	869 100%
In grades 9-12 (Count of Participants)
Yes	141 22.5%	60 24.7%	201 23.1%
No	7 1.1%	3 1.2%	10 1.2%
Yes	197 31.5%	100 41.2%	297 34.2%
No	281 44.9%	80 32.9%	361 41.5%
Lives with two parents in home (Count of Participants)
Yes	103 16.5%	41 16.9%	144 16.6%
No	45 7.2%	22 9.1%	67 7.7%
Yes	380 60.7%	143 58.8%	523 60.2%
No	98 15.7%	37 15.2%	135 15.5%
Parent highest education level is college graduate or higher (Count of Participants)
Yes	100 16%	44 18.1%	144 16.6%
No	48 7.7%	19 7.8%	67 7.7%
Yes	306 48.9%	108 44.4%	414 47.6%
No	172 27.5%	72 29.6%	244 28.1%
Saw a pediatrician at visit (Count of Participants)
Yes	128 20.4%	50 20.6%	178 20.5%
No	20 3.2%	13 5.3%	33 3.8%
Yes	412 65.8%	152 62.6%	564 64.9%
No	66 10.5%	28 11.5%	94 10.8%
Saw a female practitioner (Count of Participants)
Yes	99 15.8%	50 20.6%	149 17.1%
No	49 7.8%	13 5.3%	62 7.1%
Yes	321 51.3%	117 48.1%	438 50.4%
No	157 25.1%	63 25.9%	220 25.3%
Had 6 or more prior visits with practitioner (Count of Participants)
Yes	90 14.4%	33 13.6%	123 14.2%
No	58 9.3%	30 12.3%	88 10.1%
Yes	284 45.4%	106 43.6%	390 44.9%
No	194 31%	74 30.5%	268 30.8%
Had CRAFFT score of 2 or greater (Count of Participants)
Yes	41 6.5%	18 7.4%	59 6.8%
No	107 17.1%	45 18.5%	152 17.5%
Hung out with friends who use alcohol/drugs (Count of Participants)
Yes	131 20.9%	57 23.5%	188 21.6%
No	17 2.7%	6 2.5%	23 2.6%
Yes	169 27%	82 33.7%	251 28.9%
No	309 49.4%	98 40.3%	407 46.8%
Has substance-involved siblings (Count of Participants)
Yes	59 9.4%	23 9.5%	82 9.4%
No	89 14.2%	40 16.5%	129 14.8%
Yes	40 6.4%	10 4.1%	50 5.8%
No	438 70%	170 70%	608 70%
Has substance-involved parents/guardians (Count of Participants)
Yes	25 4%	10 4.1%	35 4%
No	123 19.6%	53 21.8%	176 20.3%
Yes	27 4.3%	8 3.3%	35 4%
No	451 72%	172 70.8%	623 71.7%

Outcome Measures

1. Primary Outcome

Title	Time to First Post-visit Drinking Day
Description	Median (and interquartile range) for times to first use for the cSBI and Treatment As Usual (TAU) groups
Time Frame	12-months follow-up

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Computerized Screening w/ Provider Brief Intervention (cSBI)	Computerized Screening With Treatment as Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	570	212
Participants who reported past-12-month use of alcohol or other drugs at baseline	97	44
Participants who reported no past-12-month use of alcohol or other drugs at baseline	366	366

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Computerized Screening w/ Provider Brief Intervention (cSBI), Computerized Screening With Treatment as Usual (TAU)
	Comments	Participants who reported past-12-month use of alcohol or other drugs at baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 95%; 0.47 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Computerized Screening w/ Provider Brief Intervention (cSBI), Computerized Screening With Treatment as Usual (TAU)
	Comments	Participants who reported no past-12-month use of alcohol or other drugs at baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.57 to 1.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Time to First Post-visit Heavy Episodic Drinking Day
Description	The number of days post-visit to first reported heavy episodic drinking day
Time Frame	12-months follow-up

Outcome Measure Data

Analysis Population Description

Participants who reported past-12-month use of alcohol or other drugs at baseline

Arm/Group Title	Computerized Screening w/ Provider Brief Intervention (cSBI)	Computerized Screening With Treatment as Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	114	46
Median (Inter-Quartile Range) [days]	366	213

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Computerized Screening w/ Provider Brief Intervention (cSBI), Computerized Screening With Treatment as Usual (TAU)
	Comments	Participants who reported past-12-month use of alcohol or other drugs at baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95%; 0.40 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Time to First Post-visit Cannabis Use Day
Description	The number of days post-visit to first reported cannabis use day.
Time Frame	12-months follow-up

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Computerized Screening w/ Provider Brief Intervention (cSBI)	Computerized Screening With Treatment as Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	516	191
Participants who reported past-12-month use of alcohol or other drugs at baseline	101	83
Participants who reported no past-12-month use of alcohol or other drugs at baseline	366	366

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Computerized Screening w/ Provider Brief Intervention (cSBI), Computerized Screening With Treatment as Usual (TAU)
	Comments
	Type of Statistical Test	Superiority
	Comments	Participants who reported past-12-month use of alcohol or other drugs at baseline
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95%; 0.41 to 0.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Computerized Screening w/ Provider Brief Intervention (cSBI), Computerized Screening With Treatment as Usual (TAU)
	Comments	Participants who reported no past-12-month use of alcohol or other drugs at baseline
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.44 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Past-3-month Riding Risk
Description	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
Time Frame	12 months follow-up

Outcome Measure Data

Analysis Population Description

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.)

Arm/Group Title	Computerized Screening w/ Provider Brief Intervention (cSBI)	Computerized Screening With Treatment as Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	625	243
Riding risk at baseline : Baseline, No.	64 10.2%	35 14.4%
Riding risk at baseline : 6 months	20 3.2%	12 4.9%
Riding risk at baseline : 9 months	16 2.6%	13 5.3%
Riding risk at baseline : 12 months	18 2.9%	13 5.3%
No riding risk at baseline : Baseline, No.	561 89.6%	208 85.6%
No riding risk at baseline : 6 months	35 5.6%	19 7.8%
No riding risk at baseline : 9 months	33 5.3%	10 4.1%
No riding risk at baseline : 12 months	28 4.5%	11 4.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Computerized Screening w/ Provider Brief Intervention (cSBI), Computerized Screening With Treatment as Usual (TAU)
	Comments	Participants with riding risk at baseline: Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.50 to 1.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Computerized Screening w/ Provider Brief Intervention (cSBI), Computerized Screening With Treatment as Usual (TAU)
	Comments	Participants with riding risk at baseline: Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.44 to 1.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Computerized Screening w/ Provider Brief Intervention (cSBI), Computerized Screening With Treatment as Usual (TAU)
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 95%; 0.37 to 0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Computerized Screening w/ Provider Brief Intervention (cSBI), Computerized Screening With Treatment as Usual (TAU)
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.43 to 1.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Computerized Screening w/ Provider Brief Intervention (cSBI), Computerized Screening With Treatment as Usual (TAU)
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.33
	Confidence Interval	(2-Sided) 95%; 0.67 to 2.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Computerized Screening w/ Provider Brief Intervention (cSBI), Computerized Screening With Treatment as Usual (TAU)
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.50 to 1.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	1 year
Arm/Group Title	Computerized Screening w/ Provider Brief Intervention (cSBI)		Computerized Screening With Treatment as Usual (TAU)
Arm/Group Description	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.		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.
All Cause Mortality
	Computerized Screening w/ Provider Brief Intervention (cSBI)		Computerized Screening With Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/626 (0%)		0/243 (0%)
Serious Adverse Events
	Computerized Screening w/ Provider Brief Intervention (cSBI)		Computerized Screening With Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/626 (0%)		0/243 (0%)
Other (Not Including Serious) Adverse Events
	Computerized Screening w/ Provider Brief Intervention (cSBI)		Computerized Screening With Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/626 (0%)		0/243 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.