Screening and Brief Advice to Reduce Teen Substance Use

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ClinicalTrials.gov Identifier: NCT00227877

Recruitment Status : Completed

First Posted : September 28, 2005

Results First Posted : September 21, 2018

Last Update Posted : September 21, 2018

Sponsor:

Collaborators:

Cambridge Health Alliance

Concord Hospital

Fallon Clinic

Tufts Medical Center

University of Vermont

Information provided by (Responsible Party):

John R Knight, MD, Boston Children’s Hospital

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 driving/riding while impaired (DRWI), the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing DRWI risk behavior as measured by a standardized scale.

Condition or disease	Intervention/treatment	Phase
Substance Related Disorders	Behavioral: cSBA - New England Behavioral: cSBA - Czech Republic	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2695 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
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.
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Screening and Brief Advice to Reduce Teen Substance Use
Actual Study Start Date :	December 2005
Actual Primary Completion Date :	December 2008
Actual Study Completion Date :	February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control - New England Control participants will receive "care as usual" from their provider
Experimental: cSBA - 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.	Behavioral: cSBA - 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 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. Other Name: SBIRT
No Intervention: Control - Czech Republic Control participants will receive "care as usual" from their provider
Experimental: cSBA - 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.	Behavioral: cSBA - 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 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. Other Name: SBIRT

Outcome Measures

Primary Outcome Measures :

Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England [ 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 New England, USA
Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England [ 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 New England, USA
Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England [ 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 [ 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 [ 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, CZ [ 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, CZ [ 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, CZ [ 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

Secondary Outcome Measures :

Any Risky DRWI at 3 Months - New England [ Time Frame: Past-90-days at 3 months post-baseline ]
Any past-90-day reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs (DRWI) at 3 months post-baseline assessment - New England
Any Risky DRWI at 12 Months - New England [ Time Frame: Past-90-days at 12 months post-baseline ]
Any past-90-day reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs (DRWI) at 12 months post-baseline assessment - New England
Any Risky DRWI at 3 Months - Prague, CZR [ Time Frame: Past-90-days at 3 months post-baseline ]
Any past-90-day reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs (DRWI) at 3 months post-baseline assessment - Prague, Czech Republic
Any Risky DRWI at 12 Months - Prague, CZR [ Time Frame: Past-90-days at 12 months post-baseline ]
Any past-90-day reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs (DRWI) at 12 months post-baseline assessment - Prague, Czech Republic

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227877

Locations

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United States, Massachusetts
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111
Cambridge Pediatrics
Cambridge, Massachusetts, United States, 02139
Fallon Clinic
Worcester, Massachusetts, United States, 01605
United States, New Hampshire
Capital Region Family Health Center
Concord, New Hampshire, United States, 03301
United States, Vermont
Milton Family Practice
Milton, Vermont, United States, 05468
Czechia
Center for the Evaluation, Prevention, and Research of Substance Abuse
Prague, Czechia

Sponsors and Collaborators

Boston Children’s Hospital

Cambridge Health Alliance

Concord Hospital

Fallon Clinic

Tufts Medical Center

University of Vermont

Investigators

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Principal Investigator:	John R Knight, M.D.	Boston Children’s Hospital

More Information

Additional Information:

This is the web site of the Center for Adolescent Substance Abuse Research (CeASAR) at Children's Hospital Boston. CeASAR is the research center funded to direct this project. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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.

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.

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. Epub 2007 Feb 15.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Harris SK, Csémy L, Sherritt L, Starostova O, Van Hook S, Johnson J, Boulter S, Brooks T, Carey P, Kossack R, Kulig JW, Van Vranken N, Knight JR. Computer-facilitated substance use screening and brief advice for teens in primary care: an international trial. Pediatrics. 2012 Jun;129(6):1072-82. doi: 10.1542/peds.2011-1624. Epub 2012 May 7.

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.

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Responsible Party:	John R Knight, MD, Associate Professor of Pediatrics, Harvard Medical School, Boston Children’s Hospital
ClinicalTrials.gov Identifier:	NCT00227877 History of Changes
Obsolete Identifiers:	NCT00592878, NCT00592956
Other Study ID Numbers:	NIDA-R01DA0118848
First Posted:	September 28, 2005 Key Record Dates
Results First Posted:	September 21, 2018
Last Update Posted:	September 21, 2018
Last Verified:	December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by John R Knight, MD, Boston Children’s Hospital:


alcohol abuse substance abuse substance related disorders

Additional relevant MeSH terms:

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Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Ethanol	Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs

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