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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.
ClinicalTrials.gov Identifier: NCT02049710
Recruitment Status : Completed
First Posted : January 30, 2014
Results First Posted : February 14, 2022
Last Update Posted : February 14, 2022
West Virginia University
University of Pittsburgh
Information provided by (Responsible Party):
Carnegie Mellon University

Tracking Information
First Submitted Date  ICMJE December 18, 2013
First Posted Date  ICMJE January 30, 2014
Results First Submitted Date  ICMJE February 12, 2021
Results First Posted Date  ICMJE February 14, 2022
Last Update Posted Date February 14, 2022
Actual Study Start Date  ICMJE June 2012
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2021)
Perceived Self-efficacy for Condom Use [ Time Frame: 6 months ]
To assess the effects of the Seventeen Days interactive video on young women's perceived self-efficacy for using condoms 6 months after being offered the intervention, relative to a control.
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
  • Pregnancy change over time [ Time Frame: baseline, 6 and 15 months ]
    Pregnancy urine test will be conducted, and health records will be reviewed for other pregnancy tests provided as part of clinic care
  • STI incidence change over time [ Time Frame: baseline, 6 and 15 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
  • Automobile collisions and injuries change over time [ Time Frame: baseline, 6 and 15 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
Self-reported sexual behavior change over time [ Time Frame: baseline, 3, 6 and 15 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Teen Video Study to Reduce Risky Driving and Sexual Behavior in Adolescents
Official Title  ICMJE Randomized Controlled Trial Evaluating the Effectiveness of Interactive Video Interventions to Reduce Teen Pregnancy and Teen Automobile Injuries
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pregnancy
  • Sexually Transmitted Infections
  • Automobile Accidents
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: Sexual Behavior Intervention
    Video based intervention based on changing risky behavior associated with sexual behavior.
    Intervention: Behavioral: Seventeen Days
  • Active Comparator: Driving behavior intervention
    Video based intervention based on changing risky behavior associate with driving
    Intervention: Behavioral: Driving Skills for Life
Publications * Downs JS, Ashcraft AM, Murray PJ, Berlan ED, Bruine de Bruin W, Eichner J, Fischhoff B, Leary JM, McCall RB, Miller E, Salaway J, Smith-Jones J, Sucato GS. Video Intervention to Increase Perceived Self-Efficacy for Condom Use in a Randomized Controlled Trial of Female Adolescents. J Pediatr Adolesc Gynecol. 2018 Jun;31(3):291-298.e2. doi: 10.1016/j.jpag.2017.10.008. Epub 2017 Nov 7.

*   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: October 27, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2014)
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient at participating healthcare facility
  • Unmarried at time of enrollment
  • Not pregnant at time of enrollment
  • Available for contact over ensuing 6 months

Exclusion Criteria:

  • Apparent or stated inability to comprehend consent or assent form (e.g., language barrier or cognitive ability)
  • No ability to provide at least 2 methods of contact
  • Married or pregnant at time of enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Females only as the project is focusing on teen pregnancy prevention. (self-representation of gender)
Ages  ICMJE 14 Years to 19 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 NCT02049710
Other Study ID Numbers  ICMJE TPP-TVS-01
5 TP1AH000040 ( Other Grant/Funding Number: Office of Adolescent Health, HSS )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Carnegie Mellon University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Carnegie Mellon University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • West Virginia University
  • University of Pittsburgh
Investigators  ICMJE
Principal Investigator: Julie S Downs, Ph.D. Carnegie Mellon University
Principal Investigator: Pamela J Murray, MD, MHP West Virginia University
PRS Account Carnegie Mellon University
Verification Date June 2021

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