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Trial record 6 of 10 for:    Open Studies | "Pregnancy in Adolescence"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Carnegie Mellon University
Sponsor:
Collaborators:
West Virginia University
University of Pittsburgh
Information provided by (Responsible Party):
Carnegie Mellon University
ClinicalTrials.gov Identifier:
NCT02049710
First received: December 18, 2013
Last updated: January 28, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Carnegie Mellon University:

Primary Outcome Measures:
  • Pregnancy change over time [ Time Frame: baseline, 6 and 15 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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, 6 and 15 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 3000
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 18 months.

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049710

Contacts
Contact: Vanessa Veltre vveltre@andrew.cmu.edu
Contact: Cory Campbell cjcampbell@gmail.com

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Modupeore Shenbanjo       Modupeore.Shenbanjo@nationwidechildrens.org   
Principal Investigator: Elise D Berlan, M.D.         
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ashley F Baskin    412-692-6656    Ashley.Baskin@chp.edu   
Principal Investigator: Gina Sucato, M.D.         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Amie Ashcraft, PhD, MPH    304-293-2321    AMASHCRAFT@hsc.wvu.edu   
Principal Investigator: Pamela J Murray, M.D.         
Sponsors and Collaborators
Carnegie Mellon University
West Virginia University
University of Pittsburgh
Investigators
Principal Investigator: Julie S Downs, Ph.D. Carnegie Mellon University
Study Director: Vanessa Veltre Carnegie Mellon University
  More Information

Additional Information:
No publications provided

Responsible Party: Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT02049710     History of Changes
Other Study ID Numbers: TPP-TVS-01, 5 TP1AH000040
Study First Received: December 18, 2013
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014