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Teen Video Study to Reduce Risky Driving and Sexual Behavior in Adolescents (TVS)

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. Identifier: NCT02049710
Recruitment Status : Unknown
Verified October 2015 by Carnegie Mellon University.
Recruitment status was:  Active, not recruiting
First Posted : January 30, 2014
Last Update Posted : October 29, 2015
West Virginia University
University of Pittsburgh
Information provided by (Responsible Party):
Carnegie Mellon University

Brief Summary:
The purpose of this study is to measure the effects of an interactive video on adolescent risky behaviors and outcomes, with one video intended to reduce teen pregnancies and the other intended to reduce automobile accidents.

Condition or disease Intervention/treatment Phase
Pregnancy Sexually Transmitted Infections Automobile Accidents Behavioral: Seventeen Days Behavioral: Driving Skills for Life Not Applicable

Detailed Description:

Motor vehicle crashes cause one-third of teenage deaths and many serious injuries. Teen drivers ages 16 to 19 are four times more likely than older drivers to crash. Death and injuries could be reduced with a change in behaviors that include improved visual and attention skills while driving, more seat belt use, appropriate speed control, and not combining drinking or texting with driving. Sexually transmitted infections (STIs) and unplanned pregnancies are particularly common among adolescents. The U.S. adolescent birthrate is by far the highest among industrialized nations. These problems can be decreased by less sexual activity and better protection.

This study uses a randomized controlled trial to measure how well interactive video interventions can reduce these common risks to adolescents. Adolescent females will be invited to participate if they are currently seeking care at a participating clinic. They will answer survey questions about their driving and sexual behaviors, and then a computer will determine whether they will be given a video about driving or a video about sexual behavior. Participants will have unlimited access to their video, which they can watch at their clinic or from any Internet-enabled computer, and will be followed for 6 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Evaluating the Effectiveness of Interactive Video Interventions to Reduce Teen Pregnancy and Teen Automobile Injuries
Study Start Date : June 2012
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Arm Intervention/treatment
Active Comparator: Sexual Behavior Intervention Behavioral: Seventeen Days
Interactive video includes highlighting salience of active choices in sexual decision making, modeling different responses to sexual situations, cognitive rehearsal of preventive behaviors, and information about hormonal and non-hormonal contraception

Active Comparator: Driving behavior intervention Behavioral: Driving Skills for Life
Interactive video includes guidance and practice for safe driving techniques, driver and car care tips, an eco-driving learning module, and interactive driving games.

Primary Outcome Measures :
  1. Pregnancy change over time [ Time Frame: baseline and 6 months ]
    Pregnancy urine test will be conducted, and health records will be reviewed for other pregnancy tests provided as part of clinic care

  2. STI incidence change over time [ Time Frame: baseline and 6 months ]
    Vaginal swab test for chlamydia and gonorrhea will be conducted, and health records will be reviewed for other STI test results provided as part of clinic care

  3. Automobile collisions and injuries change over time [ Time Frame: baseline and 6 months ]
    Reports of automobile collisions and injuries will be collected by self-report, and augmented by news searches for participants who do not follow up

Secondary Outcome Measures :
  1. Self-reported sexual behavior change over time [ Time Frame: baseline, 3 and 6 months ]
    Number of sexual partners, proportion of condom use for each partner and type of sexual behavior, and use of other contraceptives will be assessed using a timeline follow back calendar methodology

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient at participating healthcare facility
  • Unmarried at time of enrollment
  • Not pregnant at time of enrollment
  • Available for contact over ensuing 15 months

Exclusion Criteria:

  • Apparent or stated inability to comprehend consent or assent form (e.g., language barrier or cognitive ability)
  • In ability to provide at least 2 methods of contact
  • Married or pregnant at time of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02049710

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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Carnegie Mellon University
West Virginia University
University of Pittsburgh
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Principal Investigator: Julie S Downs, Ph.D. Carnegie Mellon University
Principal Investigator: Pamela J Murray, MD, MHP West Virginia University
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Responsible Party: Carnegie Mellon University Identifier: NCT02049710    
Other Study ID Numbers: TPP-TVS-01
5 TP1AH000040 ( Other Grant/Funding Number: Office of Adolescent Health, Department of Health and Human Services )
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Virus Diseases