This trial is active, not recruiting.

Conditions pregnancy, sexually transmitted infections, automobile accidents
Treatments seventeen days, driving skills for life
Sponsor Carnegie Mellon University
Collaborator West Virginia University
Start date June 2012
End date August 2016
Trial size 1317 participants
Trial identifier NCT02049710, 5 TP1AH000040, TPP-TVS-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, investigator, outcomes assessor)
Primary purpose prevention
(Active Comparator)
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 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.

Primary Outcomes

Pregnancy change over time
time frame: baseline and 6 months
STI incidence change over time
time frame: baseline and 6 months
Automobile collisions and injuries change over time
time frame: baseline and 6 months

Secondary Outcomes

Self-reported sexual behavior change over time
time frame: baseline, 3 and 6 months

Eligibility Criteria

Female participants from 14 years up to 19 years old.

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

Additional Information

Official title Randomized Controlled Trial Evaluating the Effectiveness of Interactive Video Interventions to Reduce Teen Pregnancy and Teen Automobile Injuries
Principal investigator Julie S Downs, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Carnegie Mellon University.