Prevention Harmful Effects
Conditions
Keywords
Substance Abuse, Prevention, Youth, Alcohol, Drugs
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.
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.
Interventions
BEHAVIORALcomputer-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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to First Post-visit Cannabis Use Day | 12-months follow-up | The number of days post-visit to first reported cannabis use day. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 626 |
| 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. | 243 |
| Total | 869 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month Follow-up | Lost to Follow-up | 28 | 11 |
| 3-months Follow-up | Lost to Follow-up | 53 | 29 |
| 6-months Follow-up | Lost to Follow-up | 21 | 2 |
| 9-month Follow-up | Lost to Follow-up | 20 | 11 |
| Baseline | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Computerized Screening w/ Provider Brief Intervention (cSBI) | Computerized Screening With Treatment as Usual (TAU) | Total |
|---|---|---|---|
| Age, Continuous Participants who reported no past-12-month use of alcohol or other drugs at baseline | 14.1 years STANDARD_DEVIATION 1.8 | 14.5 years STANDARD_DEVIATION 1.7 | 14.3 years STANDARD_DEVIATION 1.8 |
| Age, Continuous Participants who reported past-12-month use of alcohol or other drugs at baseline | 16.3 years STANDARD_DEVIATION 1.3 | 16.5 years STANDARD_DEVIATION 1.3 | 16.4 years STANDARD_DEVIATION 1.3 |
| Had 6 or more prior visits with practitioner Participants who reported no past-12-month use of alcohol or other drugs at baseline No | 194 Participants | 74 Participants | 268 Participants |
| Had 6 or more prior visits with practitioner Participants who reported no past-12-month use of alcohol or other drugs at baseline Yes | 284 Participants | 106 Participants | 390 Participants |
| Had 6 or more prior visits with practitioner Participants who reported past-12-month use of alcohol or other drugs at baseline No | 58 Participants | 30 Participants | 88 Participants |
| Had 6 or more prior visits with practitioner Participants who reported past-12-month use of alcohol or other drugs at baseline Yes | 90 Participants | 33 Participants | 123 Participants |
| Had CRAFFT score of 2 or greater No | 107 Participants | 45 Participants | 152 Participants |
| Had CRAFFT score of 2 or greater Yes | 41 Participants | 18 Participants | 59 Participants |
| Has substance-involved parents/guardians Participants who reported no past-12-month use of alcohol or other drugs at baseline No | 451 Participants | 172 Participants | 623 Participants |
| Has substance-involved parents/guardians Participants who reported no past-12-month use of alcohol or other drugs at baseline Yes | 27 Participants | 8 Participants | 35 Participants |
| Has substance-involved parents/guardians Participants who reported past-12-month use of alcohol or other drugs at baseline No | 123 Participants | 53 Participants | 176 Participants |
| Has substance-involved parents/guardians Participants who reported past-12-month use of alcohol or other drugs at baseline Yes | 25 Participants | 10 Participants | 35 Participants |
| Has substance-involved siblings Participants who reported no past-12-month use of alcohol or other drugs at baseline No | 438 Participants | 170 Participants | 608 Participants |
| Has substance-involved siblings Participants who reported no past-12-month use of alcohol or other drugs at baseline Yes | 40 Participants | 10 Participants | 50 Participants |
| Has substance-involved siblings Participants who reported past-12-month use of alcohol or other drugs at baseline No | 89 Participants | 40 Participants | 129 Participants |
| Has substance-involved siblings Participants who reported past-12-month use of alcohol or other drugs at baseline Yes | 59 Participants | 23 Participants | 82 Participants |
| Hung out with friends who use alcohol/drugs Participants who reported no past-12-month use of alcohol or other drugs at baseline No | 309 Participants | 98 Participants | 407 Participants |
| Hung out with friends who use alcohol/drugs Participants who reported no past-12-month use of alcohol or other drugs at baseline Yes | 169 Participants | 82 Participants | 251 Participants |
| Hung out with friends who use alcohol/drugs Participants who reported past-12-month use of alcohol or other drugs at baseline No | 17 Participants | 6 Participants | 23 Participants |
| Hung out with friends who use alcohol/drugs Participants who reported past-12-month use of alcohol or other drugs at baseline Yes | 131 Participants | 57 Participants | 188 Participants |
| In grades 9-12 Participants who reported no past-12-month use of alcohol or other drugs at baseline No | 281 Participants | 80 Participants | 361 Participants |
| In grades 9-12 Participants who reported no past-12-month use of alcohol or other drugs at baseline Yes | 197 Participants | 100 Participants | 297 Participants |
| In grades 9-12 Participants who reported past-12-month use of alcohol or other drugs at baseline No | 7 Participants | 3 Participants | 10 Participants |
| In grades 9-12 Participants who reported past-12-month use of alcohol or other drugs at baseline Yes | 141 Participants | 60 Participants | 201 Participants |
| Lives with two parents in home Participants who reported no past-12-month use of alcohol or other drugs at baseline No | 98 Participants | 37 Participants | 135 Participants |
| Lives with two parents in home Participants who reported no past-12-month use of alcohol or other drugs at baseline Yes | 380 Participants | 143 Participants | 523 Participants |
| Lives with two parents in home Participants who reported past-12-month use of alcohol or other drugs at baseline No | 45 Participants | 22 Participants | 67 Participants |
| Lives with two parents in home Participants who reported past-12-month use of alcohol or other drugs at baseline Yes | 103 Participants | 41 Participants | 144 Participants |
| Parent highest education level is college graduate or higher Participants who reported no past-12-month use of alcohol or other drugs at baseline No | 172 Participants | 72 Participants | 244 Participants |
| Parent highest education level is college graduate or higher Participants who reported no past-12-month use of alcohol or other drugs at baseline Yes | 306 Participants | 108 Participants | 414 Participants |
| Parent highest education level is college graduate or higher Participants who reported past-12-month use of alcohol or other drugs at baseline No | 48 Participants | 19 Participants | 67 Participants |
| Parent highest education level is college graduate or higher Participants who reported past-12-month use of alcohol or other drugs at baseline Yes | 100 Participants | 44 Participants | 144 Participants |
| Race/Ethnicity, Customized Participants who reported no past-12-month use of alcohol or other drugs at baseline Hispanic | 143 Participants | 58 Participants | 201 Participants |
| Race/Ethnicity, Customized Participants who reported no past-12-month use of alcohol or other drugs at baseline Non-Hispanic White | 203 Participants | 79 Participants | 282 Participants |
| Race/Ethnicity, Customized Participants who reported no past-12-month use of alcohol or other drugs at baseline Other or multirace | 132 Participants | 43 Participants | 175 Participants |
| Race/Ethnicity, Customized Participants who reported past-12-month use of alcohol or other drugs at baseline Hispanic | 40 Participants | 15 Participants | 55 Participants |
| Race/Ethnicity, Customized Participants who reported past-12-month use of alcohol or other drugs at baseline Non-Hispanic White | 69 Participants | 36 Participants | 105 Participants |
| Race/Ethnicity, Customized Participants who reported past-12-month use of alcohol or other drugs at baseline Other or multirace | 39 Participants | 12 Participants | 51 Participants |
| Region of Enrollment United States | 626 Participants | 243 Participants | 869 Participants |
| Saw a female practitioner Participants who reported no past-12-month use of alcohol or other drugs at baseline No | 157 Participants | 63 Participants | 220 Participants |
| Saw a female practitioner Participants who reported no past-12-month use of alcohol or other drugs at baseline Yes | 321 Participants | 117 Participants | 438 Participants |
| Saw a female practitioner Participants who reported past-12-month use of alcohol or other drugs at baseline No | 49 Participants | 13 Participants | 62 Participants |
| Saw a female practitioner Participants who reported past-12-month use of alcohol or other drugs at baseline Yes | 99 Participants | 50 Participants | 149 Participants |
| Saw a pediatrician at visit Participants who reported no past-12-month use of alcohol or other drugs at baseline No | 66 Participants | 28 Participants | 94 Participants |
| Saw a pediatrician at visit Participants who reported no past-12-month use of alcohol or other drugs at baseline Yes | 412 Participants | 152 Participants | 564 Participants |
| Saw a pediatrician at visit Participants who reported past-12-month use of alcohol or other drugs at baseline No | 20 Participants | 13 Participants | 33 Participants |
| Saw a pediatrician at visit Participants who reported past-12-month use of alcohol or other drugs at baseline Yes | 128 Participants | 50 Participants | 178 Participants |
| Sex: Female, Male Participants who reported no past-12-month use of alcohol or other drugs at baseline Female | 236 Participants | 91 Participants | 327 Participants |
| Sex: Female, Male Participants who reported no past-12-month use of alcohol or other drugs at baseline Male | 242 Participants | 89 Participants | 331 Participants |
| Sex: Female, Male Participants who reported past-12-month use of alcohol or other drugs at baseline Female | 80 Participants | 34 Participants | 114 Participants |
| Sex: Female, Male Participants who reported past-12-month use of alcohol or other drugs at baseline Male | 68 Participants | 29 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 626 | 0 / 243 |
| other Total, other adverse events | 0 / 626 | 0 / 243 |
| serious Total, serious adverse events | 0 / 626 | 0 / 243 |
Outcome results
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
Time frame: 12-months follow-up
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Time to First Post-visit Drinking Day | Participants who reported past-12-month use of alcohol or other drugs at baseline | 97 days |
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Time to First Post-visit Drinking Day | Participants who reported no past-12-month use of alcohol or other drugs at baseline | 366 days |
| Computerized Screening With Treatment as Usual (TAU) | Time to First Post-visit Drinking Day | Participants who reported past-12-month use of alcohol or other drugs at baseline | 44 days |
| Computerized Screening With Treatment as Usual (TAU) | Time to First Post-visit Drinking Day | Participants who reported no past-12-month use of alcohol or other drugs at baseline | 366 days |
Comparison: Participants who reported past-12-month use of alcohol or other drugs at baseline95% CI: [0.47, 1.02]
Comparison: Participants who reported no past-12-month use of alcohol or other drugs at baseline95% CI: [0.57, 1.31]
Primary
Time to First Post-visit Heavy Episodic Drinking Day
The number of days post-visit to first reported heavy episodic drinking day
Time frame: 12-months follow-up
Population: Participants who reported past-12-month use of alcohol or other drugs at baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Time to First Post-visit Heavy Episodic Drinking Day | 366 days |
| Computerized Screening With Treatment as Usual (TAU) | Time to First Post-visit Heavy Episodic Drinking Day | 213 days |
Comparison: Participants who reported past-12-month use of alcohol or other drugs at baseline95% CI: [0.4, 1.1]
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
Time frame: 12 months follow-up
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Past-3-month Riding Risk | Riding risk at baseline : Baseline, No. | 64 participants |
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Past-3-month Riding Risk | Riding risk at baseline : 6 months | 20 participants |
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Past-3-month Riding Risk | Riding risk at baseline : 9 months | 16 participants |
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Past-3-month Riding Risk | Riding risk at baseline : 12 months | 18 participants |
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Past-3-month Riding Risk | No riding risk at baseline : Baseline, No. | 561 participants |
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Past-3-month Riding Risk | No riding risk at baseline : 6 months | 35 participants |
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Past-3-month Riding Risk | No riding risk at baseline : 9 months | 33 participants |
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Past-3-month Riding Risk | No riding risk at baseline : 12 months | 28 participants |
| Computerized Screening With Treatment as Usual (TAU) | Past-3-month Riding Risk | No riding risk at baseline : 12 months | 11 participants |
| Computerized Screening With Treatment as Usual (TAU) | Past-3-month Riding Risk | Riding risk at baseline : Baseline, No. | 35 participants |
| Computerized Screening With Treatment as Usual (TAU) | Past-3-month Riding Risk | No riding risk at baseline : Baseline, No. | 208 participants |
| Computerized Screening With Treatment as Usual (TAU) | Past-3-month Riding Risk | Riding risk at baseline : 6 months | 12 participants |
| Computerized Screening With Treatment as Usual (TAU) | Past-3-month Riding Risk | No riding risk at baseline : 9 months | 10 participants |
| Computerized Screening With Treatment as Usual (TAU) | Past-3-month Riding Risk | Riding risk at baseline : 9 months | 13 participants |
| Computerized Screening With Treatment as Usual (TAU) | Past-3-month Riding Risk | No riding risk at baseline : 6 months | 19 participants |
| Computerized Screening With Treatment as Usual (TAU) | Past-3-month Riding Risk | Riding risk at baseline : 12 months | 13 participants |
Comparison: 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.95% CI: [0.5, 1.34]
Comparison: 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.95% CI: [0.44, 1.19]
Comparison: 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.95% CI: [0.37, 0.91]
Comparison: 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.95% CI: [0.43, 1.23]
Comparison: 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.95% CI: [0.67, 2.66]
Comparison: 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.95% CI: [0.5, 1.99]
Secondary
Time to First Post-visit Cannabis Use Day
The number of days post-visit to first reported cannabis use day.
Time frame: 12-months follow-up
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Time to First Post-visit Cannabis Use Day | Participants who reported past-12-month use of alcohol or other drugs at baseline | 101 Days |
| Computerized Screening w/ Provider Brief Intervention (cSBI) | Time to First Post-visit Cannabis Use Day | Participants who reported no past-12-month use of alcohol or other drugs at baseline | 366 Days |
| Computerized Screening With Treatment as Usual (TAU) | Time to First Post-visit Cannabis Use Day | Participants who reported past-12-month use of alcohol or other drugs at baseline | 83 Days |
| Computerized Screening With Treatment as Usual (TAU) | Time to First Post-visit Cannabis Use Day | Participants who reported no past-12-month use of alcohol or other drugs at baseline | 366 Days |
95% CI: [0.41, 0.94]
Comparison: Participants who reported no past-12-month use of alcohol or other drugs at baseline95% CI: [0.44, 1.32]