Clinical trial NCT01784627: Trial of Computerized SBI to Reduce Teen Alcohol Use
Official title: Randomized Controlled Trial of Computerized SBI to Reduce Teen Alcohol Use
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Alcohol Abuse
Cannabis Abuse
Nicotine Dependence
Keywords: substance use
alcohol abuse
cannabis abuse
nicotine dependence
adolescents
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 9
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: The Specific Aims are to 1) Test the effects of c-ASBI on any alcohol use; 2) Test the effects of c-ASBI separately as a prevention, therapeutic, and risk-reduction intervention; 3) Test the effects of c-ASBI separately on cannabis and tobacco use; explore its effects on other drug use; and 4) Assess potential moderators (e.g., age, gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance use), mediators (e.g., Youth to Provider Connectedness,20 perceived harmfulness of alcohol and drug use), and explore c-ASBI's mechanism of action.

Eligibility 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

Primary outcomes:
measure: Days of alcohol use
timeFrame: 12 months
Secondary outcomes:
measure: Drinking initiation
timeFrame: 12 months
measure: Drinking cessation
timeFrame: 12 months
measure: Driving/Riding risk
timeFrame: 12 months
Other outcomes:
measure: Cannabis use
timeFrame: 12 months
measure: Tobacco use
timeFrame: 12 months
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Longwood Pediatrics
state: Massachusetts
city: Boston
country: United States
facility: East Boston Neighborhood Health Center
state: Massachusetts
city: Cambridge
country: United States
facility: Cambridge Pediatrics
state: Massachusetts
city: Lexington
country: United States
facility: Lexington Pediatrics
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John R Knight, MD
role: PRINCIPAL_INVESTIGATOR
References: