Substance Related DisordersNCT00227877
Screening and Brief Advice to Reduce Teen Substance Use
A study testing cSBA - New England, USA and cSBA - Prague, CZR in people with Substance Related Disorders, run by Boston Children's Hospital at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Substance Related Disorders
- What is being tested?
- cSBA - New England, USA and cSBA - Prague, CZR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,695 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Dec 2005to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Will not be available for 12 month follow-up period, Medically unstable at the time of the visit
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Tufts-New England Medical Center
Boston, Massachusetts, 02111
Cambridge Pediatrics
Cambridge, Massachusetts, 02139
Capital Region Family Health Center
Concord, New Hampshire, 03301
Milton Family Practice
Milton, Vermont, 05468
Fallon Clinic
Worcester, Massachusetts, 01605
Czechia1 site
Center for the Evaluation, Prevention, and Research of Substance Abuse
Prague
About this study
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:
- 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;
- 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;
- 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.
Read the 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.
- Conditions
- Substance Related Disorders
- Being tested
- cSBA - New England, USA, cSBA - Prague, CZR
- Keywords
- alcohol abuse, substance abuse, substance related disorders
- Medical subject headings
- Substance-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cSBA - New England, USABehavioural
Also called SBIRT
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.
cSBA - Prague, CZRBehavioural
Also called SBIRT
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.
| Study group | Role | What they receive |
|---|---|---|
| Control - New England, USA | No intervention | Control participants will receive "care as usual" from their provider |
| cSBA - New England, USA | Experimental | 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. Receives: Behavioral: cSBA - New England, USA |
| Control - Prague, CZR | No intervention | Control participants will receive "care as usual" from their provider |
| cSBA - Prague, CZR | Experimental | 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. Receives: Behavioral: cSBA - Prague, CZR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Past-90-days at 3 months post-baseline
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.
Measured: Past-90-days at 3 months post-baseline
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
Measured: Past-12-months at 12 months post-baseline
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
Measured: Past-12-months at 12 months post-baseline
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
Measured: Past-90-days at 3 months post-baseline
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
Measured: Past-90-days at 3 months post-baseline
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
Measured: Past-12-months at 12 months post-baseline
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
Measured: Past-12-months at 12 months post-baseline
Secondary outcomes (4)
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
Measured: Past-90-days at 3 months post-baseline
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
Measured: Past-90-days at 12 months post-baseline
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
Measured: Past-90-days at 3 months post-baseline
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
Measured: Past-90-days at 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2008
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Substance Related DisordersStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 2,695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge Health Alliance, Concord Hospital, Fallon Clinic, Tufts Medical Center, University of Vermont
- Responsible party
- Principal investigator, John R Knight, MD, Boston Children's Hospital
- Investigators
- John R Knight, M.D., Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227877
- Sponsor's protocol ID
- NIDA-R01DA0118848
- Status last verified
- Aug 2019
- First submitted
- 27 Sep 2005
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Knight JR, Shrier LA, Bravender TD, Farrell M, Vander Bilt J, Shaffer HJ. A new brief screen for adolescent substance abuse. Arch Pediatr Adolesc Med. 1999 Jun;153(6):591-6. doi: 10.1001/archpedi.153.6.591.
PubMed 10357299Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002 Jun;156(6):607-14. doi: 10.1001/archpedi.156.6.607.
PubMed 12038895Van Hook S, Harris SK, Brooks T, Carey P, Kossack R, Kulig J, Knight JR; New England Partnership for Substance Abuse Research. The "Six T's": barriers to screening teens for substance abuse in primary care. J Adolesc Health. 2007 May;40(5):456-61. doi: 10.1016/j.jadohealth.2006.12.007. Epub 2007 Feb 15.
PubMed 17448404Knight JR, Harris SK, Sherritt L, Van Hook S, Lawrence N, Brooks T, Carey P, Kossack R, Kulig J. Prevalence of positive substance abuse screen results among adolescent primary care patients. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1035-41. doi: 10.1001/archpedi.161.11.1035.
PubMed 17984404Knight JR, Harris SK, Sherritt L, Van Hook S, Lawrence N, Brooks T, Carey P, Kossack R, Kulig J. Adolescents' preference for substance abuse screening in primary care practice. Subst Abus. 2007;28(4):107-17. doi: 10.1300/J465v28n04_03.
PubMed 18077307Knight JR, Csemy L, Sherritt L, Starostova O, Van Hook S, Bacic J, Finlay C, Tauber J, Brooks T, Kossack R, Kulig JW, Shaw J, Harris SK. Screening and Brief Advice to Reduce Adolescents' Risk of Riding With Substance-Using Drivers. J Stud Alcohol Drugs. 2018 Jul;79(4):611-616. doi: 10.15288/jsad.2018.79.611.
PubMed 30079877Knight JR, Kuzubova K, Csemy L, Sherritt L, Copelas S, Harris SK. Computer-Facilitated Screening and Brief Advice to Reduce Adolescents' Heavy Episodic Drinking: A Study in Two Countries. J Adolesc Health. 2018 Jan;62(1):118-120. doi: 10.1016/j.jadohealth.2017.08.013. Epub 2017 Oct 17.
PubMed 29054734Hadland SE, Copelas SH, Harris SK. Trajectories of Substance Use Frequency among Adolescents Seen in Primary Care: Implications for Screening. J Pediatr. 2017 May;184:178-185. doi: 10.1016/j.jpeds.2017.01.033. Epub 2017 Feb 10.
PubMed 28196680Harris SK, Johnson JK, Sherritt L, Copelas S, Rappo MA, Wilson CR. Putting Adolescents at Risk: Riding With Drinking Drivers Who Are Adults in the Home. J Stud Alcohol Drugs. 2017 Jan;78(1):146-151. doi: 10.15288/jsad.2017.78.146.
PubMed 27936375Louis-Jacques J, Knight JR, Sherritt L, Van Hook S, Harris SK. Do risky friends change the efficacy of a primary care brief intervention for adolescent alcohol use? J Adolesc Health. 2014 Apr;54(4):449-53. doi: 10.1016/j.jadohealth.2013.09.012. Epub 2013 Nov 8.
PubMed 24216313Harris 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.
PubMed 22566420Byregowda H, Flynn AL, Knight JR, Harris SK. Perceived Risk of Harm Mediates the Effects of Primary Care Alcohol Use Screening and Brief Advice in Adolescents. J Adolesc Health. 2022 Mar;70(3):442-449. doi: 10.1016/j.jadohealth.2021.09.029. Epub 2021 Dec 31.
PubMed 34974918Knight JR, Sherritt L, Gibson EB, Levinson JA, Grubb LK, Samuels RC, Silva T, Vernacchio L, Wornham W, Harris SK. Effect of Computer-Based Substance Use Screening and Brief Behavioral Counseling vs Usual Care for Youths in Pediatric Primary Care: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2019 Jun 5;2(6):e196258. doi: 10.1001/jamanetworkopen.2019.6258.
PubMed 31225897
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Brief Advice to Reduce Teen Substance Use
- ClinicalTrials.gov ID
- NCT00227877
- Acronym / sponsor ID
- NIDA-R01DA0118848
- Conditions
- Substance Related Disorders
- Keywords
- alcohol abuse, substance abuse, substance related disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,695 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Cambridge Health Alliance, Concord Hospital, Fallon Clinic, Tufts Medical Center, University of Vermont
- Study start
- Dec 2005 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 28 Sep 2005 (estimated)
- Results
- Posted 21 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control - New England, USA | No intervention | –Control participants will receive "care as usual" from their provider |
| cSBA - New England, USA | Experimental | Behavioral: cSBA - New England, USAParticipants 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. |
| Control - Prague, CZR | No intervention | –Control participants will receive "care as usual" from their provider |
| cSBA - Prague, CZR | Experimental | Behavioral: cSBA - Prague, CZRParticipants 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Will not be available for 12 month follow-up period, Medically unstable at the time of the visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cSBA - New England, USAAlso: SBIRTParticipants 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. | Behavioural | cSBA - New England, USA |
| cSBA - Prague, CZRAlso: SBIRTParticipants 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. | Behavioural | cSBA - Prague, CZR |
Primary outcome
Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA
Time frame: 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
Time frame: 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
Time frame: 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
Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Among Baseline Substance Non-Users - Prague, CZR
Time frame: 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
4 secondary outcomes
Any Risky Riding or Driving at 3 Months - New England, USA
Time frame: Past-90-days at 3 months post-baseline
Any Risky Riding or Driving at 12 Months - New England, USA
Time frame: Past-90-days at 12 months post-baseline
Any Risky Riding or Driving at 3 Months - Prague, CZR
Time frame: Past-90-days at 3 months post-baseline
Any Risky Riding or Driving at 12 Months - Prague, CZR
Time frame: Past-90-days at 12 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10357299Knight JR, Shrier LA, Bravender TD, Farrell M, Vander Bilt J, Shaffer HJ. A new brief screen for adolescent substance abuse. Arch Pediatr Adolesc Med. 1999 Jun;153(6):591-6. doi: 10.1001/archpedi.153.6.591.
- Background: PubMed 12038895Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002 Jun;156(6):607-14. doi: 10.1001/archpedi.156.6.607.
- Background: PubMed 17448404Van Hook S, Harris SK, Brooks T, Carey P, Kossack R, Kulig J, Knight JR; New England Partnership for Substance Abuse Research. The "Six T's": barriers to screening teens for substance abuse in primary care. J Adolesc Health. 2007 May;40(5):456-61. doi: 10.1016/j.jadohealth.2006.12.007. Epub 2007 Feb 15.
- Background: PubMed 17984404Knight JR, Harris SK, Sherritt L, Van Hook S, Lawrence N, Brooks T, Carey P, Kossack R, Kulig J. Prevalence of positive substance abuse screen results among adolescent primary care patients. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1035-41. doi: 10.1001/archpedi.161.11.1035.
- Background: PubMed 18077307Knight JR, Harris SK, Sherritt L, Van Hook S, Lawrence N, Brooks T, Carey P, Kossack R, Kulig J. Adolescents' preference for substance abuse screening in primary care practice. Subst Abus. 2007;28(4):107-17. doi: 10.1300/J465v28n04_03.
- Results publication: PubMed 30079877Knight JR, Csemy L, Sherritt L, Starostova O, Van Hook S, Bacic J, Finlay C, Tauber J, Brooks T, Kossack R, Kulig JW, Shaw J, Harris SK. Screening and Brief Advice to Reduce Adolescents' Risk of Riding With Substance-Using Drivers. J Stud Alcohol Drugs. 2018 Jul;79(4):611-616. doi: 10.15288/jsad.2018.79.611.
- Results publication: PubMed 29054734Knight JR, Kuzubova K, Csemy L, Sherritt L, Copelas S, Harris SK. Computer-Facilitated Screening and Brief Advice to Reduce Adolescents' Heavy Episodic Drinking: A Study in Two Countries. J Adolesc Health. 2018 Jan;62(1):118-120. doi: 10.1016/j.jadohealth.2017.08.013. Epub 2017 Oct 17.
- Results publication: PubMed 28196680Hadland SE, Copelas SH, Harris SK. Trajectories of Substance Use Frequency among Adolescents Seen in Primary Care: Implications for Screening. J Pediatr. 2017 May;184:178-185. doi: 10.1016/j.jpeds.2017.01.033. Epub 2017 Feb 10.
- Results publication: PubMed 27936375Harris SK, Johnson JK, Sherritt L, Copelas S, Rappo MA, Wilson CR. Putting Adolescents at Risk: Riding With Drinking Drivers Who Are Adults in the Home. J Stud Alcohol Drugs. 2017 Jan;78(1):146-151. doi: 10.15288/jsad.2017.78.146.
- Results publication: PubMed 24216313Louis-Jacques J, Knight JR, Sherritt L, Van Hook S, Harris SK. Do risky friends change the efficacy of a primary care brief intervention for adolescent alcohol use? J Adolesc Health. 2014 Apr;54(4):449-53. doi: 10.1016/j.jadohealth.2013.09.012. Epub 2013 Nov 8.
- Results publication: PubMed 22566420Harris 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.
- Derived from this study: PubMed 34974918Byregowda H, Flynn AL, Knight JR, Harris SK. Perceived Risk of Harm Mediates the Effects of Primary Care Alcohol Use Screening and Brief Advice in Adolescents. J Adolesc Health. 2022 Mar;70(3):442-449. doi: 10.1016/j.jadohealth.2021.09.029. Epub 2021 Dec 31.
- This is the web site of the Center for Adolescent Substance Use and Addiction Research (CeASAR) at Children's Hospital Boston. CeASAR is the research center funded to direct this project.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Knight, M.D. principal investigator
Boston Children's Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cSBA - New England, USA and cSBA - Prague, CZR in people with Substance Related Disorders, run by Boston Children's Hospital at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA (time frame: Past-90-days at 3 months post-baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00227877, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.