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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02049710
Other study ID # TPP-TVS-01
Secondary ID 5 TP1AH000040
Status Completed
Phase N/A
First received
Last updated
Start date June 2012
Est. completion date August 2016

Study information

Verified date June 2021
Source Carnegie Mellon University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1317
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Female
Age group 14 Years to 19 Years
Eligibility 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

Study Design


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
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.

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio
United States West Virginia University Morgantown West Virginia
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Carnegie Mellon University University of Pittsburgh, West Virginia University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Self-efficacy for Condom Use 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. 6 months
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