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

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

Tracking Information

• First Submitted Date: December 18, 2013
• First Posted Date: January 30, 2014
• Results First Submitted Date: February 12, 2021
• Results First Posted Date: February 14, 2022
• Last Update Posted Date: February 14, 2022
• Actual Study Start Date: June 2012
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: Teen Video Study to Reduce Risky Driving and Sexual Behavior in Adolescents
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Pregnancy
• Sexually Transmitted Infections
• Automobile Accidents

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
• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 27, 2015): 1317
• Original Estimated Enrollment (submitted: January 28, 2014): 3000
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• 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: 14 Years to 19 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02049710
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Carnegie Mellon University
• Original Responsible Party: Same as current
• Current Study Sponsor: Carnegie Mellon University
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: Carnegie Mellon University
• Verification Date: June 2021