NCT02049710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,317

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

February 14, 2022

Completed
Last Updated

February 14, 2022

Status Verified

June 1, 2021

Enrollment Period

4.2 years

First QC Date

December 18, 2013

Results QC Date

February 12, 2021

Last Update Submit

December 2, 2021

Conditions

Keywords

pregnancy prevention, condom use, self efficacy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Sexual Behavior Intervention

ACTIVE COMPARATOR

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

Behavioral: Seventeen Days

Driving behavior intervention

ACTIVE COMPARATOR

Video based intervention based on changing risky behavior associate with driving

Behavioral: Driving Skills for Life

Interventions

Seventeen DaysBEHAVIORAL

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

Sexual Behavior Intervention

Interactive video includes guidance and practice for safe driving techniques, driver and car care tips, an eco-driving learning module, and interactive driving games.

Driving behavior intervention

Eligibility Criteria

Age14 Years - 19 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only as the project is focusing on teen pregnancy prevention. (self-representation of gender)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient at participating healthcare facility
  • Unmarried at time of enrollment
  • Not pregnant at time of enrollment
  • Available for contact over ensuing 6 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related 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.

    PMID: 29126824BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Mandy Lanyon, Research Associate II
Organization
Carnegie Mellon University, Social and Decision Sciences

Study Officials

  • Julie S Downs, Ph.D.

    Carnegie Mellon University

    PRINCIPAL INVESTIGATOR
  • Pamela J Murray, MD, MHP

    West Virginia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2013

First Posted

January 30, 2014

Study Start

June 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 14, 2022

Results First Posted

February 14, 2022

Record last verified: 2021-06

Locations