NCT01784627

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2013

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

February 4, 2013

Last Update Submit

October 6, 2016

Conditions

Keywords

substance usealcohol abusecannabis abusenicotine dependenceadolescents

Outcome Measures

Primary Outcomes (1)

  • Days of alcohol use

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

    12 months

Secondary Outcomes (3)

  • Drinking initiation

    12 months

  • Drinking cessation

    12 months

  • Driving/Riding risk

    12 months

Other Outcomes (2)

  • Cannabis use

    12 months

  • Tobacco use

    12 months

Study Arms (2)

Treatment at Usual

NO INTERVENTION

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.

c-ASBI

EXPERIMENTAL

Participants in this group will receive the computerized alcohol screening and brief intervention (c-ASBI).

Behavioral: c-ASBI

Interventions

c-ASBIBEHAVIORAL

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.

c-ASBI

Eligibility Criteria

Age9 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Arriving for well or non-emergent care at one of participating study sites
  • Have an email address
  • Have internet address

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Longwood Pediatrics

Boston, Massachusetts, 02115, United States

Location

East Boston Neighborhood Health Center

Boston, Massachusetts, 02128, United States

Location

Cambridge Pediatrics

Cambridge, Massachusetts, 02139, United States

Location

Lexington Pediatrics

Lexington, Massachusetts, 02421, United States

Location

MeSH Terms

Conditions

AlcoholismMarijuana AbuseTobacco Use DisorderSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • John R Knight, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 6, 2013

Study Start

January 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations