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

Primary Purpose

Pregnancy, Sexually Transmitted Infections, Automobile Accidents

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Seventeen Days
Driving Skills for Life
Sponsored by
Carnegie Mellon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring pregnancy prevention, condom use, self efficacy

Eligibility Criteria

14 Years - 19 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nationwide Children's Hospital
  • Children's Hospital of Pittsburgh
  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sexual Behavior Intervention

Driving behavior intervention

Arm Description

Video based intervention based on changing risky behavior associated with sexual behavior.

Video based intervention based on changing risky behavior associate with driving

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2013
Last Updated
December 2, 2021
Sponsor
Carnegie Mellon University
Collaborators
West Virginia University, University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02049710
Brief Title
Teen Video Study to Reduce Risky Driving and Sexual Behavior in Adolescents
Acronym
TVS
Official Title
Randomized Controlled Trial Evaluating the Effectiveness of Interactive Video Interventions to Reduce Teen Pregnancy and Teen Automobile Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carnegie Mellon University
Collaborators
West Virginia University, University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Sexually Transmitted Infections, Automobile Accidents
Keywords
pregnancy prevention, condom use, self efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sexual Behavior Intervention
Arm Type
Active Comparator
Arm Description
Video based intervention based on changing risky behavior associated with sexual behavior.
Arm Title
Driving behavior intervention
Arm Type
Active Comparator
Arm Description
Video based intervention based on changing risky behavior associate with driving
Intervention Type
Behavioral
Intervention Name(s)
Seventeen Days
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Driving Skills for Life
Intervention Description
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 Outcome Measure Information:
Title
Perceived Self-efficacy for Condom Use
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females only as the project is focusing on teen pregnancy prevention. (self-representation of gender)
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie S Downs, Ph.D.
Organizational Affiliation
Carnegie Mellon University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela J Murray, MD, MHP
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29126824
Citation
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.
Results Reference
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Teen Video Study to Reduce Risky Driving and Sexual Behavior in Adolescents

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