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NCT03820609 · ClinicalTrials.gov registry record · NA

Interactive Digital Intervention to Prevent Violence Among Young Adults

A NA study of Sexual Assault, sponsored by Happy People Games.

Completed
Registry status
NA
Development phase
41
Enrollment target
2
Study locations

NCT03820609 is a NA study of Sexual Assault that has completed, run by Happy People Games. The registered enrollment target is 41 participants, below the 747-participant average among 12 other Sexual Assault trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03820609, a NA study of Sexual Assault, has completed, sponsored by Happy People Games.

COMPLETED
Registry status
NA
Development phase
41 participants
Enrollment target
2
Study locations

Study Summary

The primary aim of this Phase I SBIR is to create and test an alpha version of Make a Change for mobile devices, and to document the technical merit, commercial viability, and proof of concept of the product. Successful completion of this proposal will result in the creation of two assets: 1) an "Intervention Manual" that (similar to a logic model) will align key game mechanics with theory and behavior change goals and, 2) the digital application for mobile devices. Focus groups and interviews with students, as well as interviews with campus stakeholders, will be used to inform development of the digital application and ensure its commercial viability. A non-randomized open trial with a 1-month follow up will assess preliminary effects on attitudes and behaviors, and will establish procedures for assessing change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal. This line of research and development has the potential to develop a commercially viable product with high public health impact that can be disseminated to 1700+ community colleges and 3,000+ 4-year colleges, and readily adapted to high schools, clinics and military settings.

Conditions Studied

Interventions

  • BEHAVIORAL Digital Intervention

Study Locations (2)

Rhode Island

  • Community College of Rhode Island - Warwick

South Carolina

  • Clemson University - Clemson

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2018-06-05
Est. Completion 2018-08-15
Phase NA

Sponsor

Happy People Games

1 total trials

What the Registry Record Tells You About NCT03820609

The ClinicalTrials.gov registry entry for NCT03820609 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 747-participant average among 12 other Sexual Assault trials with a reported enrollment target (95% lower). The listed sponsor is Happy People Games, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sexual Assault appearing as the primary indexed condition, and to 1 intervention - of which Digital Intervention is the first listed.

NCT03820609 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Rhode Island, South Carolina.

Frequently Asked Questions

What is clinical trial NCT03820609 about?

NCT03820609 is a clinical study titled "Interactive Digital Intervention to Prevent Violence Among Young Adults". The primary aim of this Phase I SBIR is to create and test an alpha version of Make a Change for mobile devices, and to document the technical merit, commercial viability, and proof of concept of the product. Successful completion of this proposal will result in the creation of two assets: 1) an "In...

What is the current status of trial NCT03820609?

This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2018-06-05. Estimated completion is 2018-08-15.

What conditions does trial NCT03820609 study?

This clinical trial studies the following conditions: Sexual Assault.

What interventions are being tested in trial NCT03820609?

The interventions under investigation include: Digital Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT03820609?

This trial is sponsored by Happy People Games, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03820609 being conducted?

This trial has 2 study locations across Rhode Island, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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