Substance Related Disorders
Conditions
Keywords
alcohol abuse, substance abuse, substance related disorders
Brief summary
The purpose of this study is to test the effectiveness of a brief intervention for alcohol and drug use in adolescents that a primary care doctor can give in his/her office. The study will be conducted in nine primary care offices in three New England states, and in ten pediatric offices in Prague, Czech Republic (CZR). We hypothesize that: 1. Among 12-18 year old well care patients who screen positive for drug/alcohol use, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing drug and alcohol use; 2. Among 12-18 year old well care patients who screen negative for drug/alcohol use, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing initiation of drug and alcohol use as measured by self-reports of substance use; 3. Among 12-18 year old well care patients who are at risk for riding with an impaired driver or driving while impaired, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing Riding/Driving risk behavior as measured by a standardized scale.
Detailed description
We are trying to find out the best way for doctors to talk with their adolescent patients about alcohol and drug use. Adolescents 12-18 who are coming to their doctor's office for a routine well-care or follow-up visit will be invited to participate in the study. Participants do not have to have ever used alcohol or drugs. All participants will answer a computerized questionnaire about alcohol and drug use three times. The first one will be at the time of a doctor's visit. The second time will be three months later and the third time a year later. Adolescents who agree to be in the study during the first year will be in the 'control' group. Their doctor will talk to them about drugs and alcohol the same as he/she usually does for all his/her patients. Those who agree to be in the study during the second year will be in the 'intervention' group. Everyone in the 'intervention' group will receive some advice on the computer about their alcohol and drug use. Their doctor will also give them some specific advice about drug and alcohol use. The researchers have chosen what that advice will be, and all doctors involved in the study will give advice according to the study protocol. Participants and their parents will also be given educational information about alcohol and drugs. We will test the effectiveness of the intervention by comparing drug and alcohol use between those who are in the 'control' group, and those who are in the 'intervention' group. We we will also validate the Czech version of the CRAFFT screen before conducting the effectiveness trial outlined above in the Czech Republic.
Interventions
BEHAVIORALcSBA - New England, USA
Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.
BEHAVIORALcSBA - Prague, CZR
Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.
Sponsors
Cambridge Health Alliance
Concord Hospital
Fallon Clinic
Tufts Medical Center
University of Vermont
Boston Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
In this before-/after- quasi-experimental trial, all sites first completed a treatment-as-usual phase with assessments only, followed by all sites undergoing training and completing a subsequent intervention phase.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
12-18 year old patients coming for well care or follow-up visits to one of the study sites, All levels of substance use, Able to read and understand English
Exclusion criteria
Will not be available for 12 month follow-up period, Medically unstable at the time of the visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR | Past-12-months at 12 months post-baseline | Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic |
| Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA | Past-12-months at 12 months post-baseline | Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA |
| Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR | Past-90-days at 3 months post-baseline | Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic |
| Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR | Past-90-days at 3 months post-baseline | Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic |
| Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR | Past-12-months at 12 months post-baseline | Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic |
| Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA | Past-90-days at 3 months post-baseline | Among the 12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment. |
| Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA | Past-90-days at 3 months post-baseline | Among the 12-18 year old primary care patients who did NOT report past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment. |
| Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA | Past-12-months at 12 months post-baseline | Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any Risky Riding or Driving at 12 Months - New England, USA | Past-90-days at 12 months post-baseline | Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - New England |
| Any Risky Riding or Driving at 3 Months - Prague, CZR | Past-90-days at 3 months post-baseline | Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - Prague, Czech Republic |
| Any Risky Riding or Driving at 12 Months - Prague, CZR | Past-90-days at 12 months post-baseline | Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - Prague, Czech Republic |
| Any Risky Riding or Driving at 3 Months - New England, USA | Past-90-days at 3 months post-baseline | Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - New England |
Countries
Czechia, United States
Participant flow
Recruitment details
Quasi-experimental, asynchronous study design with each site as its own control. From 2005 to 2008, 12- to 18-year-olds arriving for routine care at 9 medical offices in New England (n= 2096, 58% females) and 10 in Prague, Czech Republic (n = 589, 47% females) were recruited. Medically/emotionally stable, able to read, and available for follow-ups.
Participants by arm
| Arm | Count |
|---|---|
| Control - New England Control participants will receive care as usual from their provider | 1,068 |
| Computer Screen & Brief Physician Advice - New England Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking points which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.
Computer screen & brief physician advice: Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use. | 1,028 |
| Control - Czech Republic Control participants will receive care as usual from their provider | 297 |
| Computer Screen & Brief Physician Advice - Czech Republic Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking points which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.
Computer screen & brief physician advice: Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested talking point which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use. | 292 |
| Total | 2,685 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 12-months Follow-up | Completed late | 78 | 74 | 1 | 0 |
| 12-months Follow-up | Lost to Follow-up | 232 | 189 | 30 | 26 |
| 3-months Follow-up | Completed late | 135 | 128 | 34 | 8 |
| 3-months Follow-up | Lost to Follow-up | 178 | 139 | 18 | 13 |
| Post-visit Checklist | Lost to Follow-up | 24 | 13 | 1 | 0 |
| Pre-visit Assessment | Technical difficulties | 7 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Control - New England | Computer Screen & Brief Physician Advice - New England | Control - Czech Republic | Computer Screen & Brief Physician Advice - Czech Republic | Total |
|---|---|---|---|---|---|
| Age, Continuous Age | 15.9 years STANDARD_DEVIATION 2 | 15.6 years STANDARD_DEVIATION 2 | 15.0 years STANDARD_DEVIATION 1.6 | 15.0 years STANDARD_DEVIATION 1.6 | 15.8 years STANDARD_DEVIATION 2 |
| Parents at Home One parent or Other | 341 Participants | 294 Participants | 107 Participants | 97 Participants | 839 Participants |
| Parents at Home Two parents | 703 Participants | 721 Participants | 184 Participants | 195 Participants | 1803 Participants |
| Parents Highest Education Level College/university degree or higher | 451 Participants | 522 Participants | 92 Participants | 100 Participants | 1165 Participants |
| Parents Highest Education Level Did not complete high school/secondary school | 46 Participants | 33 Participants | 44 Participants | 46 Participants | 169 Participants |
| Parents Highest Education Level Don't know | 99 Participants | 42 Participants | 43 Participants | 38 Participants | 222 Participants |
| Parents Highest Education Level High school/Secondary school graduate | 427 Participants | 405 Participants | 111 Participants | 106 Participants | 1049 Participants |
| Parent Substance Use | 170 Participants | 152 Participants | 32 Participants | 32 Participants | 386 Participants |
| Peer substance abuse | 658 Participants | 607 Participants | 204 Participants | 192 Participants | 1661 Participants |
| Race/Ethnicity, Customized Asian non-Hispanic | 77 Participants | 74 Participants | 0 Participants | 0 Participants | 151 Participants |
| Race/Ethnicity, Customized Black non-Hispanic | 100 Participants | 117 Participants | 0 Participants | 0 Participants | 217 Participants |
| Race/Ethnicity, Customized Hispanic | 106 Participants | 124 Participants | 0 Participants | 0 Participants | 230 Participants |
| Race/Ethnicity, Customized Other non-Hispanic | 96 Participants | 49 Participants | 0 Participants | 0 Participants | 145 Participants |
| Race/Ethnicity, Customized White non-Hispanic | 689 Participants | 664 Participants | 297 Participants | 292 Participants | 1942 Participants |
| Sex: Female, Male Female | 659 Participants | 561 Participants | 139 Participants | 139 Participants | 1498 Participants |
| Sex: Female, Male Male | 409 Participants | 467 Participants | 158 Participants | 153 Participants | 1187 Participants |
| Sibling Substance Abuse | 205 Participants | 187 Participants | 41 Participants | 36 Participants | 469 Participants |
| Visit type Female provider No | 391 Participants | 335 Participants | 33 Participants | 33 Participants | 792 Participants |
| Visit type Female provider Yes | 663 Participants | 684 Participants | 263 Participants | 259 Participants | 1869 Participants |
| Visit type First visit No | 930 Participants | 914 Participants | 0 Participants | 0 Participants | 1844 Participants |
| Visit type First visit Yes | 115 Participants | 105 Participants | 0 Participants | 0 Participants | 220 Participants |
| Visit type Well visit No | 199 Participants | 51 Participants | 0 Participants | 0 Participants | 250 Participants |
| Visit type Well visit Yes | 851 Participants | 968 Participants | 297 Participants | 292 Participants | 2408 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1,068 | 0 / 1,028 | 0 / 297 | 0 / 292 |
| serious Total, serious adverse events | 0 / 1,068 | 0 / 1,028 | 0 / 297 | 0 / 292 |
Outcome results
Primary
Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic
Time frame: Past-12-months at 12 months post-baseline
Population: 12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in Prague, CZR
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR | 48 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR | 38 Participants |
p-value: 0.1395% CI: [0.51, 1.09]Regression, Logistic
Primary
Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA
Time frame: Past-12-months at 12 months post-baseline
Population: 12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in New England, USA
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA | 214 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA | 172 Participants |
p-value: 0.0595% CI: [0.99, 3.27]Regression, Logistic
Primary
Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic
Time frame: Past-12-months at 12 months post-baseline
Population: 12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in Prague, CZR
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR | 154 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR | 148 Participants |
p-value: 0.7895% CI: [0.27, 2.7]Regression, Logistic
Primary
Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA
Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA
Time frame: Past-12-months at 12 months post-baseline
Population: 12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in New England, USA
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA | 83 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA | 73 Participants |
p-value: 0.2395% CI: [0.53, 1.16]Regression, Logistic
Primary
Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA
Among the 12-18 year old primary care patients who did NOT report past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.
Time frame: Past-90-days at 3 months post-baseline
Population: 12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in New England, USA
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA | 24 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA | 15 Participants |
p-value: 0.3295% CI: [0.34, 1.42]Regression, Logistic
Primary
Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR
Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic
Time frame: Past-90-days at 3 months post-baseline
Population: 12-18 year old primary care patients who did not report past-12-month drug or alcohol use at baseline in Prague, CZR
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR | 10 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR | 13 Participants |
p-value: 0.9395% CI: [0.42, 2.21]Regression, Logistic
Primary
Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA
Among the 12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.
Time frame: Past-90-days at 3 months post-baseline
Population: 12-18 year old primary care patients who report past-12-month drug or alcohol use at baseline in New England, USA
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA | 162 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA | 121 Participants |
p-value: <0.0595% CI: [1.08, 1.8]Regression, Logistic
Primary
Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic
Time frame: Past-90-days at 3 months post-baseline
Population: 12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in Prague, CZR
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR | 118 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR | 114 Participants |
p-value: 0.0795% CI: [0.97, 2.36]Regression, Logistic
Secondary
Any Risky Riding or Driving at 12 Months - New England, USA
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - New England
Time frame: Past-90-days at 12 months post-baseline
Population: 12-18 year old primary care patients in New England, USA
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Any Risky Riding or Driving at 12 Months - New England, USA | 161 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Any Risky Riding or Driving at 12 Months - New England, USA | 125 Participants |
p-value: 0.3595% CI: [0.64, 1.17]Regression, Logistic
Secondary
Any Risky Riding or Driving at 12 Months - Prague, CZR
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - Prague, Czech Republic
Time frame: Past-90-days at 12 months post-baseline
Population: 12-18 year old primary care patients in Prague, CZR
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Any Risky Riding or Driving at 12 Months - Prague, CZR | 78 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Any Risky Riding or Driving at 12 Months - Prague, CZR | 61 Participants |
p-value: <0.0595% CI: [0.54, 0.98]Regression, Logistic
Secondary
Any Risky Riding or Driving at 3 Months - New England, USA
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - New England
Time frame: Past-90-days at 3 months post-baseline
Population: 12-18 year old primary care patients in New England, USA
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Any Risky Riding or Driving at 3 Months - New England, USA | 150 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Any Risky Riding or Driving at 3 Months - New England, USA | 88 Participants |
p-value: 0.6695% CI: [0.48, 0.91]Regression, Logistic
Secondary
Any Risky Riding or Driving at 3 Months - Prague, CZR
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - Prague, Czech Republic
Time frame: Past-90-days at 3 months post-baseline
Population: 12-18 year old primary care patients in Prague, CZR
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - New England, USA | Any Risky Riding or Driving at 3 Months - Prague, CZR | 245 Participants |
| Computer Screen & Brief Physician Advice - New England, USA | Any Risky Riding or Driving at 3 Months - Prague, CZR | 269 Participants |
p-value: <0.0195% CI: [0.46, 0.87]Regression, Logistic