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| ID | Type | Description | Link |
|---|---|---|---|
| 5 TP1AH000040 | Other Grant/Funding Number | Office of Adolescent Health, HSS |
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| Name | Class |
|---|---|
| West Virginia University | OTHER |
| University of Pittsburgh | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sexual Behavior Intervention | Active Comparator | Video based intervention based on changing risky behavior associated with sexual behavior. |
|
| Driving behavior intervention | Active Comparator | Video based intervention based on changing risky behavior associate with driving |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seventeen Days | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
Females only as the project is focusing on teen pregnancy prevention. (self-representation of gender)
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| Name | Affiliation | Role |
|---|---|---|
| Julie S Downs, Ph.D. | Carnegie Mellon University | Principal Investigator |
| Pamela J Murray, MD, MHP | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States | ||
| Children's Hospital of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29126824 | Background | 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. |
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Participants were randomized once they consented to participate and before the baseline survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sexual Behavior Intervention | 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 |
| FG001 | Driving Behavior Intervention | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sexual Behavior Intervention | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | summation score | 6 months |
|
6 months per participant
Low risk study - watching a video intervention on a computer/tablet.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sexual Behavior Intervention | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mandy Lanyon, Research Associate II | Carnegie Mellon University, Social and Decision Sciences | 4122683249 | mandy@cmu.edu |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
| Driving Skills for Life | Behavioral | Interactive video includes guidance and practice for safe driving techniques, driver and car care tips, an eco-driving learning module, and interactive driving games. |
|
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| Driving Behavior Intervention |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Driving Behavior Intervention | 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. |
|
|
|
| 0 |
| 653 |
| 0 |
| 653 |
| 0 |
| 653 |
| EG001 | Driving Behavior Intervention | 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. | 0 | 664 | 0 | 664 | 0 | 664 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |