Trial of Computerized SBI to Reduce Teen Alcohol Use

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01784627
• Collaborator: (none)
• Enrollment: 0
• Locations: 6
• Arms: 2
• Duration (Months): 33
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Alcohol Abuse; Cannabis Abuse; Nicotine Dependence	Behavioral: c-ASBI	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized Controlled Trial of Computerized SBI to Reduce Teen Alcohol Use
• Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Oct 1, 2017
• Anticipated Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Days of alcohol use [12 months]

   We will compare rates of any alcohol use over the past twelve months between the groups.

Secondary Outcome Measures

1. Drinking initiation [12 months]

   We will compare rates of drinking initiation over the past 12-months between groups.

2. Drinking cessation [12 months]

   We will compare rates of drinking cessation over the past 12 months between groups.

3. Driving/Riding risk [12 months]

   We will compare the rates of driving under the influence or riding with a driver under the influence between groups.

Other Outcome Measures

1. Cannabis use [12 months]

   We will compare the rates of cannabis use over the past twelve months between groups.

2. Tobacco use [12 months]

   We will compare the rates of tobacco use over the past twelve months between groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111
2	Boston Children's Hospital	Boston	Massachusetts	United States	02115
3	Longwood Pediatrics	Boston	Massachusetts	United States	02115
4	East Boston Neighborhood Health Center	Boston	Massachusetts	United States	02128
5	Cambridge Pediatrics	Cambridge	Massachusetts	United States	02139
6	Lexington Pediatrics	Lexington	Massachusetts	United States	02421

Sponsors and Collaborators

• Boston Children's Hospital

Investigators

• Principal Investigator: John R Knight, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John R Knight, MD, Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT01784627
• Other Study ID Numbers: JK R01 PA-12-031
• First Posted: Feb 6, 2013
• Last Update Posted: Oct 7, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by John R Knight, MD, Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital, Boston Children's Hospital: substance use; alcohol abuse; cannabis abuse; nicotine dependence; adolescents
• Additional relevant MeSH terms: Marijuana Abuse; Tobacco Use Disorder; Alcoholism

Study Results

No Results Posted as of Oct 7, 2016