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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborators:
West Virginia University
University of Pittsburgh
Information provided by (Responsible Party):
Carnegie Mellon University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Pregnancy
Sexually Transmitted Infections
Automobile Accidents
Interventions Behavioral: Seventeen Days
Behavioral: Driving Skills for Life
Enrollment 1317
Recruitment Details  
Pre-assignment Details Participants were randomized once they consented to participate and before the baseline survey.
Arm/Group Title Sexual Behavior Intervention Driving Behavior Intervention
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 653 664
Completed 334 340
Not Completed 319 324
Reason Not Completed
Lost to Follow-up             319             324
Arm/Group Title Sexual Behavior Intervention Driving Behavior Intervention Total
Hide Arm/Group Description 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. Total of all reporting groups
Overall Number of Baseline Participants 653 664 1317
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 653 participants 664 participants 1317 participants
<=18 years
503
  77.0%
505
  76.1%
1008
  76.5%
Between 18 and 65 years
150
  23.0%
159
  23.9%
309
  23.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 653 participants 664 participants 1317 participants
17.18
(14 to 19)
17.25
(14 to 19)
17.20
(14 to 19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 653 participants 664 participants 1317 participants
Female
653
 100.0%
664
 100.0%
1317
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 653 participants 664 participants 1317 participants
653 664 1317
1.Primary Outcome
Title Perceived Self-efficacy for Condom Use
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Sexually active female adolescents ages 14 to 19 years. The overall number of participants analyzed are those that completed the baseline survey, video component and the 6 month survey.
Arm/Group Title Sexual Behavior Intervention Driving Behavior Intervention
Hide Arm/Group Description:

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

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

Video based intervention based on changing risky behavior associate with driving

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.
Overall Number of Participants Analyzed 334 340
Mean (95% Confidence Interval)
Unit of Measure: summation score
13.00
(12.74 to 13.24)
12.48
(12.15 to 12.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sexual Behavior Intervention, Driving Behavior Intervention
Comments Summation scores are reported across 3 items measured on a 5-point scale from 1(not at all sure)to5(very sure), which loaded together on a principal components analysis of the baseline data.The summation score thus represents a theoretical range from 3 to 15.The 3 items were as follows:Indicate How Sure You are that You Would be Able to Perform Each of the Following:a)Get the money needed to buy condoms b)Walk into a store&buy condoms c)Find a place to get condoms for free(Cronbach alpha-0.72)
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.06
Confidence Interval (2-Sided) 95%
3 to 15
Estimation Comments [Not Specified]
Time Frame 6 months per participant
Adverse Event Reporting Description Low risk study - watching a video intervention on a computer/tablet.
 
Arm/Group Title Sexual Behavior Intervention Driving Behavior Intervention
Hide Arm/Group Description 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.
All-Cause Mortality
Sexual Behavior Intervention Driving Behavior Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/653 (0.00%)   0/664 (0.00%) 
Hide Serious Adverse Events
Sexual Behavior Intervention Driving Behavior Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/653 (0.00%)   0/664 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sexual Behavior Intervention Driving Behavior Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/653 (0.00%)   0/664 (0.00%) 
Because this intervention was a pregnancy prevention strategy, we recruited participants at risk for pregnancy(ie, female adolescents with recent sexual activity)&presented content targeted at heterosexual sexual behavior. Therefore, these findings are, by design, not generalizable to adolescent women having sex only with other women or to male adolescents. High overall attrition rates before as well as after randomization might limit generalizability of the findings.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mandy Lanyon, Research Associate II
Organization: Carnegie Mellon University, Social and Decision Sciences
Phone: 4122683249
EMail: mandy@cmu.edu
Publications:
Layout table for additonal information
Responsible Party: Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT02049710    
Other Study ID Numbers: TPP-TVS-01
5 TP1AH000040 ( Other Grant/Funding Number: Office of Adolescent Health, HSS )
First Submitted: December 18, 2013
First Posted: January 30, 2014
Results First Submitted: February 12, 2021
Results First Posted: February 14, 2022
Last Update Posted: February 14, 2022