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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
Sponsor:
Collaborators:
West Virginia University
University of Pittsburgh
Information provided by (Responsible Party):
Carnegie Mellon University

Study Description
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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.

Study Design
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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
Actual Study Start Date : June 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sexual Behavior Intervention
Video based intervention based on changing risky behavior associated with sexual behavior.
 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
Video based intervention based on changing risky behavior associate with driving
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females only as the project is focusing on teen pregnancy prevention. (self-representation of gender)
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 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
Contacts and Locations
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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
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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
Investigators
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Principal Investigator: Julie S Downs, Ph.D. Carnegie Mellon University
Principal Investigator: Pamela J Murray, MD, MHP West Virginia University
More Information
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Publications:

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Responsible Party: Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT02049710    
Other Study ID Numbers: TPP-TVS-01
5 TP1AH000040 ( Other Grant/Funding Number: Office of Adolescent Health, HSS )
First Posted: January 30, 2014    Key Record Dates
Results First Posted: February 14, 2022
Last Update Posted: February 14, 2022
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carnegie Mellon University:
pregnancy prevention, condom use, self efficacy
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Communicable Diseases
Infections
Genital Diseases
 Urogenital Diseases
Disease Attributes
Pathologic Processes