NCT00227877

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. 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. 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,695

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

September 21, 2018

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

September 27, 2005

Results QC Date

April 19, 2017

Last Update Submit

August 1, 2019

Conditions

Substance Related Disorders

Keywords

alcohol abusesubstance abusesubstance related disorders

Outcome Measures

Primary Outcomes (8)

  • 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-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.

    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

    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

    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

    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

    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

    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

    Past-12-months at 12 months post-baseline

Secondary Outcomes (4)

  • Any Risky Riding or Driving at 3 Months - New England, USA

    Past-90-days at 3 months post-baseline

  • Any Risky Riding or Driving at 12 Months - New England, USA

    Past-90-days at 12 months post-baseline

  • Any Risky Riding or Driving at 3 Months - Prague, CZR

    Past-90-days at 3 months post-baseline

  • Any Risky Riding or Driving at 12 Months - Prague, CZR

    Past-90-days at 12 months post-baseline

Study Arms (4)

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.

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.

Behavioral: cSBA - Prague, CZR

Interventions

cSBA - New England, USABEHAVIORAL

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.

Also known as: SBIRT
cSBA - New England, USA
cSBA - Prague, CZRBEHAVIORAL

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.

Also known as: SBIRT
cSBA - Prague, CZR

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Will not be available for 12 month follow-up period, Medically unstable at the time of the visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Tufts-New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Cambridge Pediatrics

Cambridge, Massachusetts, 02139, United States

Location

Fallon Clinic

Worcester, Massachusetts, 01605, United States

Location

Capital Region Family Health Center

Concord, New Hampshire, 03301, United States

Location

Milton Family Practice

Milton, Vermont, 05468, United States

Location

Center for the Evaluation, Prevention, and Research of Substance Abuse

Prague, Czechia

Location

Related Publications (13)

  • 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.

    PMID: 10357299BACKGROUND

  • 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.

    PMID: 12038895BACKGROUND

  • 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.

    PMID: 17448404BACKGROUND

  • 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.

    PMID: 17984404BACKGROUND

  • 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.

    PMID: 18077307BACKGROUND

  • 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.

    PMID: 30079877RESULT

  • 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.

    PMID: 29054734RESULT

  • 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.

    PMID: 28196680RESULT

  • 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.

    PMID: 27936375RESULT

  • 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.

    PMID: 24216313RESULT

  • 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.

    PMID: 22566420RESULT

  • 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.

    PMID: 34974918DERIVED

  • 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.

    PMID: 31225897DERIVED

Related Links

MeSH Terms

Conditions

Substance-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Limitations and Caveats

Use of non-randomized, asynchronous study design may have confounded results; 2 NE groups not equivalent in baseline substance use (but controlled for in analysis); self-report and interview-collected data prone to recall and social desirability bias

Results Point of Contact

Title
Sion Kim Harris, PhD
Organization
Boston Children's Hospital - Center for Adolescent Substance Use and Addiction Research
sion.harris@childrens.harvard.edu
857-218-4304

Study Officials

  • John R Knight, M.D.

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics, Harvard Medical School

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 28, 2005

Study Start

December 1, 2005

Primary Completion

December 1, 2008

Study Completion

February 1, 2010

Last Updated

August 14, 2019

Results First Posted

September 21, 2018

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)US(5)