Clinical trial NCT00227877: Screening and Brief Advice to Reduce Teen Substance Use
Official title: Screening and Brief Advice to Reduce Teen Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Related Disorders
Keywords: alcohol abuse
substance abuse
substance related disorders
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Cambridge Health Alliance
name: Concord Hospital
name: Fallon Clinic
name: Tufts Medical Center
name: University of Vermont
First posted: 2005-09-28
Enrollment: 2695
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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. 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.

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.

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

Primary outcomes:
measure: Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA
timeFrame: Past-90-days at 3 months post-baseline
measure: Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA
timeFrame: Past-90-days at 3 months post-baseline
measure: Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA
timeFrame: Past-12-months at 12 months post-baseline
measure: Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA
timeFrame: Past-12-months at 12 months post-baseline
measure: Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR
timeFrame: Past-90-days at 3 months post-baseline
measure: Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR
timeFrame: Past-90-days at 3 months post-baseline
measure: Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR
timeFrame: Past-12-months at 12 months post-baseline
measure: Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR
timeFrame: Past-12-months at 12 months post-baseline
Secondary outcomes:
measure: Any Risky Riding or Driving at 3 Months - New England, USA
timeFrame: Past-90-days at 3 months post-baseline
measure: Any Risky Riding or Driving at 12 Months - New England, USA
timeFrame: Past-90-days at 12 months post-baseline
measure: Any Risky Riding or Driving at 3 Months - Prague, CZR
timeFrame: Past-90-days at 3 months post-baseline
measure: Any Risky Riding or Driving at 12 Months - Prague, CZR
timeFrame: Past-90-days at 12 months post-baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts-New England Medical Center
state: Massachusetts
city: Cambridge
country: United States
facility: Cambridge Pediatrics
state: Massachusetts
city: Worcester
country: United States
facility: Fallon Clinic
state: Massachusetts
city: Concord
country: United States
facility: Capital Region Family Health Center
state: New Hampshire
city: Milton
country: United States
facility: Milton Family Practice
state: Vermont
city: Prague
country: Czechia
facility: Center for the Evaluation, Prevention, and Research of Substance Abuse
Study officials:
affiliation: Boston Children's Hospital
name: John R Knight, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.