NCT00849589

Brief Summary

The goal of this project is to adapt a computerized Screening and Brief Advice (SBA) protocol that has demonstrated efficacy in reducing underage drinking among adolescent primary care patients and then to test it in a multi-site randomized controlled trial (RCT).

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 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

February 23, 2009

Last Update Submit

October 6, 2016

Conditions

Alcohol AbuseRisk Behavior

Keywords

ScreeningBrief interventionUnderage drinking

Outcome Measures

Primary Outcomes (1)

  • Initiation of underage drinking

    Baseline, 3-months, 6-months, 12-months

Secondary Outcomes (1)

  • Cessation of underage drinking

    Baseline, 3-months, 6-months, 12-months

Study Arms (3)

1

NO INTERVENTION

Treatment as Usual (TAU)

2

EXPERIMENTAL

Computerized Screening and Brief Physician Advice (SBA)

Behavioral: Computerized screening and brief physician advice

3

EXPERIMENTAL

Computerized screening and brief physician advice with technological extenders (SBA/TE)

Behavioral: Computerized SBA with technological extenders

Interventions

Computerized screening and brief physician adviceBEHAVIORAL

Participants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors

Also known as: Screening, Brief advice, Brief intervention, Underage drinking
2
Computerized SBA with technological extendersBEHAVIORAL

Participants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors. In addition, the provider sends them a brief email or text message at 4 months and 9 months after study entry to reinforce the brief advice.

Also known as: Screening, Brief advice, Brief intervention, Underage drinking
3

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old
  • patients arriving for routine medical care
  • provide informed assent (for those \<18) or informed consent (for those 18-21)

You may not qualify if:

  • medically or psychologically unstable at time of visit
  • receiving behavioral health services
  • cannot read or understand English at a 6th grade reading level
  • unavailable for follow-up assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Links

MeSH Terms

Conditions

AlcoholismRisk-TakingUnderage Drinking

Interventions

Mass ScreeningCrisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorAdolescent BehaviorAlcohol DrinkingDrinking Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health PracticePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • John R. Knight, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
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 23, 2009

First Posted

February 24, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2014

Study Completion

December 1, 2014

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)