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Screening and Brief Advice to Reduce Teen Substance Use

Primary Purpose

Substance Related Disorders

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
cSBA - New England, USA
cSBA - Prague, CZR
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Related Disorders focused on measuring alcohol abuse, substance abuse, substance related disorders

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tufts-New England Medical Center
  • Cambridge Pediatrics
  • Fallon Clinic
  • Capital Region Family Health Center
  • Milton Family Practice
  • Center for the Evaluation, Prevention, and Research of Substance Abuse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

Control - New England, USA

cSBA - New England, USA

Control - Prague, CZR

cSBA - Prague, CZR

Arm Description

Control participants will receive "care as usual" from their provider

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.

Control participants will receive "care as usual" from their provider

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.

Outcomes

Primary Outcome Measures

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.
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.
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
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
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
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
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
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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
September 27, 2005
Last Updated
August 1, 2019
Sponsor
Boston Children's Hospital
Collaborators
Cambridge Health Alliance, Concord Hospital, Fallon Clinic, Tufts Medical Center, University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT00227877
Brief Title
Screening and Brief Advice to Reduce Teen Substance Use
Official Title
Screening and Brief Advice to Reduce Teen Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2005 (Actual)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Cambridge Health Alliance, Concord Hospital, Fallon Clinic, Tufts Medical Center, University of Vermont

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Related Disorders
Keywords
alcohol abuse, substance abuse, substance related disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
2695 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control - New England, USA
Arm Type
No Intervention
Arm Description
Control participants will receive "care as usual" from their provider
Arm Title
cSBA - New England, USA
Arm Type
Experimental
Arm Description
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.
Arm Title
Control - Prague, CZR
Arm Type
No Intervention
Arm Description
Control participants will receive "care as usual" from their provider
Arm Title
cSBA - Prague, CZR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
cSBA - New England, USA
Other Intervention Name(s)
SBIRT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
cSBA - Prague, CZR
Other Intervention Name(s)
SBIRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA
Description
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
Title
Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA
Description
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
Title
Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA
Description
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
Title
Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA
Description
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
Title
Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR
Description
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
Title
Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR
Description
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
Title
Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR
Description
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
Title
Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR
Description
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
Secondary Outcome Measure Information:
Title
Any Risky Riding or Driving at 3 Months - New England, USA
Description
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
Title
Any Risky Riding or Driving at 12 Months - New England, USA
Description
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
Title
Any Risky Riding or Driving at 3 Months - Prague, CZR
Description
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
Title
Any Risky Riding or Driving at 12 Months - Prague, CZR
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Knight, M.D.
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts-New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Cambridge Pediatrics
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02139
Country
United States
Facility Name
Fallon Clinic
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Capital Region Family Health Center
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Milton Family Practice
City
Milton
State/Province
Vermont
ZIP/Postal Code
05468
Country
United States
Facility Name
Center for the Evaluation, Prevention, and Research of Substance Abuse
City
Prague
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10357299
Citation
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.
Results Reference
background
PubMed Identifier
12038895
Citation
Knight 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.
Results Reference
background
PubMed Identifier
17448404
Citation
Van 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.
Results Reference
background
PubMed Identifier
17984404
Citation
Knight 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.
Results Reference
background
PubMed Identifier
18077307
Citation
Knight 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 Reference
background
PubMed Identifier
30079877
Citation
Knight 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 Reference
result
PubMed Identifier
29054734
Citation
Knight 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 Reference
result
PubMed Identifier
28196680
Citation
Hadland 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 Reference
result
PubMed Identifier
27936375
Citation
Harris 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 Reference
result
PubMed Identifier
24216313
Citation
Louis-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 Reference
result
PubMed Identifier
22566420
Citation
Harris SK, Csemy L, Sherritt L, Starostova O, Van Hook S, Johnson J, Boulter S, Brooks T, Carey P, Kossack R, Kulig JW, Van Vranken N, Knight JR. Computer-facilitated substance use screening and brief advice for teens in primary care: an international trial. Pediatrics. 2012 Jun;129(6):1072-82. doi: 10.1542/peds.2011-1624. Epub 2012 May 7.
Results Reference
result
PubMed Identifier
34974918
Citation
Byregowda 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.
Results Reference
derived
PubMed Identifier
31225897
Citation
Knight 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.
Results Reference
derived
Links:
URL
http://www.crafft.org
Description
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.

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Screening and Brief Advice to Reduce Teen Substance Use

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