Dental and Medical Office iMET to Reduce Teen Tobacco, Al... | NCT00907309

Studies
Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use

NCT00907309

Sponsor

Boston Children's Hospital

Status

Completed

Last Update Posted

Oct 7, 2016Estimated

Enrollment

121Actual

Phase

Phase 1Phase 2

Conditions

Use; Tobacco, Harmful
Alcohol Abuse
Drug Abuse

Interventions

iMET
iMET/TE

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

May 20, 2009

First Submission Date that Met QC Criteria

May 21, 2009

First Posted Date

May 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2016

Last Update Posted Date

Oct 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 HospitalPrincipal Investigator

Lead Sponsor

Boston Children's HospitalOTHER

Collaborators

Name	Class
Cambridge Health Alliance	OTHER
Tufts Medical Center	OTHER
Harvard School of Dental Medicine	OTHER
Fallon Clinic

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the project is to improve adolescent behavioral counseling services in healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy (iMET) intervention that targets the use of tobacco, alcohol, and other drugs.

Detailed Description

We have previously developed and tested in a treatment population a promising MET program for alcohol and drug use. We will broaden the MET intervention to also target tobacco use and convert the new materials into a self-administered format.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment as usual	No Intervention	Participants will receive treatment as usual from their provider.
iMET	Experimental	Participants will receive the iMET intervention.	Behavioral: iMET
iMET/TE	Experimental	Participants will receive the iMET intervention and Technological Extenders (TEs).	Behavioral: iMET/TE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iMET	Behavioral	Participants will receive the iMET intervention	iMET

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of tobacco, alcohol, marijuana, and other drug use		3 months, 6 months

Secondary Outcomes

Measure	Description	Time Frame
Rates of initiation and cessation of tobacco, alcohol, marijuana and other drug use		3 months, 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

12-21 years old
Coming for routine care

Exclusion Criteria:

Medically or emotionally unstable day of visit
Already receiving behavioral health services
Cannot read/understand English
Will not be available for post-tests

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John R. Knight, MD	Boston Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Boston		Boston	Massachusetts	02115	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33605440	Derived	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.

ID	Term
D000437	Alcoholism
D019966	Substance-Related Disorders
D002189	Marijuana Abuse
D064424	Tobacco Use
D014029	Tobacco Use Disorder

ID	Term
D019973	Alcohol-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D001519	Behavior