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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Carnegie Mellon University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02049710
First Posted: January 30, 2014
Last Update Posted: October 29, 2015
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.
Collaborators:
West Virginia University
University of Pittsburgh
Information provided by (Responsible Party):
Carnegie Mellon University
  Purpose
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 Intervention
Pregnancy Sexually Transmitted Infections Automobile Accidents Behavioral: Seventeen Days Behavioral: Driving Skills for Life

Study Type: Interventional
Study Design: 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

Further study details as provided by Carnegie Mellon University:

Primary Outcome Measures:
  • 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

  • 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

  • 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:
  • 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


Enrollment: 1317
Study Start Date: June 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02049710


Locations
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
Investigators
Principal Investigator: Julie S Downs, Ph.D. Carnegie Mellon University
Principal Investigator: Pamela J Murray, MD, MHP West Virginia University
  More Information

Additional Information:
Responsible Party: Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT02049710     History of Changes
Other Study ID Numbers: TPP-TVS-01
5 TP1AH000040 ( Other Grant/Funding Number: Office of Adolescent Health, Department of Health and Human Services )
First Submitted: December 18, 2013
First Posted: January 30, 2014
Last Update Posted: October 29, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female