NCT01275391

Brief Summary

In this project we will conduct a pilot study of a brief intervention to reduce teen tobacco, alcohol and drug use that primary care dental practitioners can provide in their offices.

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 Sep 2011

Typical duration for phase_1

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withdrawn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

January 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

January 11, 2011

Last Update Submit

October 6, 2016

Conditions

Tobacco AbuseAlcohol AbuseDrug Abuse

Keywords

Tobacco useAlcohol abuseDrug abuseSubstance usePreventionBrief interventionScreeningAdolescents

Outcome Measures

Primary Outcomes (1)

  • Percent days abstinent of tobacco, alcohol and drugs

    Past 90 days

Secondary Outcomes (1)

  • Prevalence of tobacco, alcohol and drug use

    Past 90 days

Study Arms (4)

Treatment as Usual Group 1

NO INTERVENTION

Participants will receive treatment as usual and will complete a baseline and 1-month post-visit assessment

Treatment as Usual Group 2

NO INTERVENTION

Participants will receive treatment as usual and complete only the 1-month post-visit assessment

Intervention Group 1

EXPERIMENTAL

Computer Screening, Brief Intervention, Referral toTreatment. Participants will receive the intervention and complete a baseline and 1-month post-visit assessment

Behavioral: Computer Screening, Brief Intervention, Referral toTreatment

Intervention Group 2

EXPERIMENTAL

Computer Screening, Brief Intervention, Referral toTreatment Participants will receive the intervention and complete only the 1-month post-visit assessment

Behavioral: Computer Screening, Brief Intervention, Referral toTreatment

Interventions

Computer Screening, Brief Intervention, Referral toTreatmentBEHAVIORAL

A computerized screening for tobacco, alcohol and drug use accompanied by 10-15 pages of health information regarding the risks of tobacco, alcohol and drug use. This is followed by a brief conversation with the primary care provider regarding the health risks of tobacco, alcohol and drug use and a referral to treatment for those at high risk of substance use problems.

Also known as: Brief Advice, SBIRT, Screen and Brief Advice
Intervention Group 1Intervention Group 2

Eligibility Criteria

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

You may qualify if:

  • years of age
  • arriving for routine care to dental office

You may not qualify if:

  • dentally, medically, or psychologically unstable at the time of the visit
  • cannot read or understand English at a 6th grade level
  • unavailable for 1-month post-visit assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.

    PMID: 33605440DERIVED

Related Links

MeSH Terms

Conditions

Tobacco Use DisorderAlcoholismSubstance-Related DisordersTobacco Use

Interventions

Crisis InterventionMass Screening

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related DisordersBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDiagnostic 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 Practice

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
SINGLE GROUP
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

January 11, 2011

First Posted

January 12, 2011

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

September 1, 2013

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)