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

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ClinicalTrials.gov Identifier: NCT00907309
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : October 7, 2016
Sponsor:
Collaborators:
Cambridge Health Alliance
Tufts Medical Center
Harvard School of Dental Medicine
Fallon Clinic
Information provided by (Responsible Party):
John R Knight, MD, Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE May 20, 2009
First Posted Date  ICMJE May 22, 2009
Last Update Posted Date October 7, 2016
Study Start Date  ICMJE September 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
Frequency of tobacco, alcohol, marijuana, and other drug use [ Time Frame: 3 months, 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00907309 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
Rates of initiation and cessation of tobacco, alcohol, marijuana and other drug use [ Time Frame: 3 months, 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use
Official Title  ICMJE Dental and Medical Office Internet/Intranet Motivational Enhancement Therapy to Reduce Teen Tobacco, Alcohol, and Drug Use
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Use; Tobacco, Harmful
  • Alcohol Abuse
  • Drug Abuse
Intervention  ICMJE
  • Behavioral: iMET
    Participants will receive the iMET intervention
  • Behavioral: iMET/TE
    Participants will receive the iMET intervention and also receive TEs (Technological Extenders)
Study Arms  ICMJE
  • No Intervention: Treatment as usual
    Participants will receive treatment as usual from their provider.
  • Experimental: iMET
    Participants will receive the iMET intervention.
    Intervention: Behavioral: iMET
  • Experimental: iMET/TE
    Participants will receive the iMET intervention and Technological Extenders (TEs).
    Intervention: Behavioral: iMET/TE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2013)
121
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2009)
695
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907309
Other Study ID Numbers  ICMJE iMET RFA-OD-09-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John R Knight, MD, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE
  • Cambridge Health Alliance
  • Tufts Medical Center
  • Harvard School of Dental Medicine
  • Fallon Clinic
Investigators  ICMJE
Principal Investigator: John R. Knight, MD Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP