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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00227877
Other study ID # NIDA-R01DA0118848
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2005
Est. completion date February 2010

Study information

Verified date August 2019
Source Boston Children’s Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 (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.


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.


Other known NCT identifiers
  • NCT00592878
  • NCT00592956

Recruitment information / eligibility

Status Completed
Enrollment 2695
Est. completion date February 2010
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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

Study Design


Intervention

Behavioral:
cSBA - 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.
cSBA - 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.

Locations

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

Sponsors (6)

Lead Sponsor Collaborator
Boston Children’s Hospital Cambridge Health Alliance, Concord Hospital, Fallon Clinic, Tufts Medical Center, University of Vermont

Countries where clinical trial is conducted

United States,  Czechia, 

References & Publications (11)

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. — View Citation

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 tri — View 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. — View 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. 2 — View 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. — View 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. — View 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 — View 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. — View 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. — View 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 — View 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. Epub 2007 Feb 15. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
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. Past-90-days at 3 months post-baseline
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. Past-90-days at 3 months post-baseline
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 Past-12-months at 12 months post-baseline
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 Past-12-months at 12 months post-baseline
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 Past-90-days at 3 months post-baseline
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 Past-90-days at 3 months post-baseline
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 Past-12-months at 12 months post-baseline
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 Past-12-months at 12 months post-baseline
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 Past-90-days at 3 months post-baseline
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 Past-90-days at 12 months post-baseline
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 Past-90-days at 3 months post-baseline
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 Past-90-days at 12 months post-baseline
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