Screening and Brief Advice to Reduce Teen Substance Use
| Tracking Information | |||||
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| First Received Date ICMJE | September 27, 2005 | ||||
| Last Updated Date | June 16, 2011 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percent days abstinent from substance use [ Time Frame: past 90 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Drug and alcohol use | ||||
| Change History | Complete list of historical versions of study NCT00227877 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Screening and Brief Advice to Reduce Teen Substance Use | ||||
| Official Title ICMJE | Screening and Brief Advice to Reduce Teen Substance Use | ||||
| 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:
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Substance Related Disorders | ||||
| Intervention ICMJE | Behavioral: Computerized CRAFFT screen and brief physician advice
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 |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2145 | ||||
| Completion Date | February 2010 | ||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 12 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Czech Republic | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00227877 | ||||
| Other Study ID Numbers ICMJE | NIDA-R01DA0118848 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | John R. Knight, MD, Children's Hospital Boston | ||||
| Study Sponsor ICMJE | Children's Hospital Boston | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Children's Hospital Boston | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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