NCT01666496

Brief Summary

The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
333

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2016

Completed
Last Updated

June 27, 2017

Status Verified

February 1, 2017

Enrollment Period

3.5 years

First QC Date

August 9, 2012

Last Update Submit

June 26, 2017

Conditions

HIVRisk Reduction

Keywords

AdolescentriskHIVvideo games

Outcome Measures

Primary Outcomes (6)

  • Delay in the initiation of sexual activity

    The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.

    3 weeks

  • Delay in the initiation of sexual activity

    The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.

    6 weeks

  • Delay in the initiation of sexual activity

    The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.

    3 months

  • Delay in the initiation of sexual activity

    The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.

    6 months

  • Delay in the initiation of sexual activity

    The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.

    12 months

  • Delay in the initiation of sexual activity

    The primary outcome measure will be delay in initiating sexual activity. Delay in initiation of sexual activity will be defined as individuals who report having never had voluntary sexual intercourse prior to the baseline assessment and continue to not initiate sexual activity. Those who report initiating sex between baseline and the follow-up period are defined as having initiated sexual activity.

    24 months

Secondary Outcomes (36)

  • Knowledge about HIV/AIDS risk behaviors and transmission

    3 weeks

  • Level of social competency in using negotiating and refusal skills in the virtual environment

    3 weeks

  • Level of self-efficacy regarding negotiation around initiation of sexual activity

    3 weeks

  • Drug and alcohol use behaviors

    3 weeks

  • Level of self-efficacy in negotiating situations involving offers of drugs and alcohol

    3 weeks

  • +31 more secondary outcomes

Study Arms (2)

Experimental Video Game

EXPERIMENTAL

Participants will play the experimental videogame for 6 weeks. The intervention will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.

Behavioral: Experimental Video Game

Off the Shelf Video Game

OTHER

Participants will play the off the shelf videogame for 6 weeks. The intervention be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.

Behavioral: Off the Shelf Video Game

Interventions

Experimental Video GameBEHAVIORAL

Participants will play either the experimental or the control videogame for 6 weeks. Both interventions will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.

Experimental Video Game
Off the Shelf Video GameBEHAVIORAL

Participants will play either the experimental or the control videogame for 6 weeks. Both interventions will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.

Off the Shelf Video Game

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ages 11-14 years
  • Able to provide assent/parental/guardian consent
  • Agree to participate in a computer-based videogame (willing to sit at a computer for 75 minutes twice weekly to play the game)
  • English-speaking

You may not qualify if:

  • Not between the ages of 11-14 years
  • Not able to provide assent/parental/guardian consent
  • Not willing to sit at a computer for 75 minutes twice weekly to play the game
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Publications (2)

  • Fiellin LE, Hieftje KD, Pendergrass TM, Kyriakides TC, Duncan LR, Dziura JD, Sawyer BG, Mayes L, Crusto CA, Forsyth BW, Fiellin DA. Video Game Intervention for Sexual Risk Reduction in Minority Adolescents: Randomized Controlled Trial. J Med Internet Res. 2017 Sep 18;19(9):e314. doi: 10.2196/jmir.8148.

    PMID: 28923788DERIVED

  • Montanaro E, Fiellin LE, Fakhouri T, Kyriakides TC, Duncan LR. Using Videogame Apps to Assess Gains in Adolescents' Substance Use Knowledge: New Opportunities for Evaluating Intervention Exposure and Content Mastery. J Med Internet Res. 2015 Oct 28;17(10):e245. doi: 10.2196/jmir.4377.

    PMID: 26510775DERIVED

Related Links

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lynn E Fiellin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 9, 2012

First Posted

August 16, 2012

Study Start

January 1, 2013

Primary Completion

June 18, 2016

Study Completion

June 18, 2016

Last Updated

June 27, 2017

Record last verified: 2017-02

Locations

US(1)