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A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01813123
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Traci M. Schwinn, Columbia University

Tracking Information
First Submitted Date  ICMJE March 8, 2013
First Posted Date  ICMJE March 18, 2013
Last Update Posted Date June 27, 2019
Study Start Date  ICMJE March 2013
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)		 30-day alcohol and drug use [ Time Frame: Up to 3 years ]
Measures will ask girls to report, for the past 30 days, the number of: drinks of alcohol consumed, cigarettes smoked, puffs of marijuana, and times they consumed four or more drinks within 2 hours. Girls will also report past 30-day use of: inhalants, ecstasy, club drugs, prescription drugs for recreational use, heroin, and hallucinogens.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls
Official Title  ICMJE A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls
Brief Summary

This study is designed to develop and test a gender-specific, web-based drug abuse prevention program. Study participants will be adolescent girls aged 13 and 14 years who will complete all measures online. Randomly assigned girls will also interact online with a skills-based program and subsequent annual booster sessions.

The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower among girls assigned to receive the intervention.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Drug Abuse Prevention
Intervention  ICMJE Behavioral: RealTeen
A web-based, gender-specific program intended improve girls' cognitive and behavioral skills. Each of the 9 sessions requires approximately 20 minutes. After initial intervention, girls will receive two annual booster sessions (i.e., a 20-minute review of previously learned material indexed to new age).
Study Arms  ICMJE
  • No Intervention: Control
  • Experimental: Intervention
    RealTeen
    Intervention: Behavioral: RealTeen
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: July 14, 2014)		 788
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2013)		 750
Actual Study Completion Date  ICMJE January 30, 2019
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • resident of USA
  • speaks English
  • have private computer with Internet

Exclusion Criteria:

-
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 13 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01813123
Other Study ID Numbers  ICMJE AAAJ3409
R01DA031782 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Traci M. Schwinn, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Traci M Schwinn, PhD Columbia University
PRS Account Columbia University
Verification Date June 2019

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