Trial record 4 of 32 for:
alcohol [CONDITION] AND (adolescent OR teen) [ALL-FIELDS] | Open Studies
Trial of Computerized SBI to Reduce Teen Alcohol Use
This study is not yet open for participant recruitment.
Verified February 2013 by Children's Hospital Boston
Sponsor:
Children's Hospital Boston
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01784627
First received: February 4, 2013
Last updated: February 5, 2013
Last verified: February 2013
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Purpose
The goal of this project is to test the effectiveness of a computer-facilitated alcohol screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to Treatment As Usual (TAU).
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Abuse Cannabis Abuse Nicotine Dependence |
Behavioral: c-ASBI |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Randomized Controlled Trial of Computerized SBI to Reduce Teen Alcohol Use |
Resource links provided by NLM:
Further study details as provided by Children's Hospital Boston:
Primary Outcome Measures:
- Days of alcohol use [ Time Frame: 12 months ] [ Designated as safety issue: No ]We will compare rates of any alcohol use over the past twelve months between the groups.
Secondary Outcome Measures:
- Drinking initiation [ Time Frame: 12 months ] [ Designated as safety issue: No ]We will compare rates of drinking initiation over the past 12-months between groups.
- Drinking cessation [ Time Frame: 12 months ] [ Designated as safety issue: No ]We will compare rates of drinking cessation over the past 12 months between groups.
- Driving/Riding risk [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]We will compare the rates of driving under the influence or riding with a driver under the influence between groups.
Other Outcome Measures:
- Cannabis use [ Time Frame: 12 months ] [ Designated as safety issue: No ]We will compare the rates of cannabis use over the past twelve months between groups.
- Tobacco use [ Time Frame: 12 months ] [ Designated as safety issue: No ]We will compare the rates of tobacco use over the past twelve months between groups.
| Estimated Enrollment: | 2500 |
| Study Start Date: | October 2013 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Treatment at Usual
Participants in this group will receive treatment as usual (TAU) from their provider, which may or may not include screening and brief advice regarding alcohol use.
|
|
|
Experimental: c-ASBI
Participants in this group will receive the computerized alcohol screening and brief intervention (c-ASBI).
|
Behavioral: c-ASBI
Participants in the c-ASBI group will complete a computerized screen for alcohol, cannabis, tobacco and other drugs, then view their screen score and 10 pages of information about the health effects of substance use and true-life stories on the computer. Their provider will see a report of their screen results and provide advice to stop or decrease their use, or, for those at high risk, referral to complete a computerized motivational enhancement therapy intervention.
|
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Arriving for well or non-emergent care at one of participating study sites
- Have an email address
- Have internet address
Exclusion Criteria:
- Unable to read or understand English
- Living away at college at the time of the recruitment visit
- Not available for computer/telephone follow-ups
- Judged by the provider to be medically or emotionally unstable at time of visit
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784627
Contacts
| Contact: John R Knight, MD | 617-355-5433 | john.knight@childrens.harvard.edu |
| Contact: Shari Van Hook, MPH | 857-218-4317 | shari.vanhook@childrens.harvard.edu |
Locations
| United States, Massachusetts | |
| Boston Children's Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: John R Knight, MD | |
| Sub-Investigator: Sion K Harris, PhD | |
Sponsors and Collaborators
Children's Hospital Boston
Investigators
| Principal Investigator: | John R Knight, MD | Boston Children's Hospital |
More Information
No publications provided
| Responsible Party: | Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT01784627 History of Changes |
| Other Study ID Numbers: | JK R01 PA-12-031 |
| Study First Received: | February 4, 2013 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Boston:
|
substance use alcohol abuse cannabis abuse nicotine dependence adolescents |
Additional relevant MeSH terms:
|
Alcohol Drinking Alcohol-Related Disorders Marijuana Abuse Tobacco Use Disorder Alcoholism Drinking Behavior Substance-Related Disorders Mental Disorders |
Ethanol Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013