NCT05875467

Brief Summary

The goal of this clinical trial is to test a prototype of a new educational game about environmental health literacy with middle school age youth. The main questions it aims to answer are:

  • Does playing the game increase knowledge about environmental health?
  • Does playing the game improve environmental health literacy?
  • Does playing the game increase interest and confidence in science? Participants will be asked to:
  • Take a survey at the beginning of the study
  • Play the game for a minimum of 50 minutes
  • Take a survey at the end of the study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

2 active sites

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

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 12, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

May 16, 2023

Results QC Date

November 19, 2024

Last Update Submit

March 6, 2025

Conditions

Keywords

environmental healthgameair qualitySTEMhealth literacy

Outcome Measures

Primary Outcomes (1)

  • Change in Environmental Health Indoor Air Pollution Knowledge Score

    Based on a scale created for this study the Environmental Health Indoor Air Pollution Knowledge Score is comprised of a series of questions about indoor environmental pollution. The scores from the question are summed to create a total score. The scale ranges from 0 to 17 with a higher score indicating greater knowledge.

    Day 1 to Day 7

Secondary Outcomes (3)

  • Change in Environmental Health Mitigation Knowledge Score

    Day 1 to Day 7

  • Change in Environmental Health Interest Score

    Day 1 to Day 7

  • Change in Science Interest and Confidence Score

    Day 1 to Day 7

Study Arms (1)

Single Arm, Intervention with SE3 Game

EXPERIMENTAL

This is a single arm study. This arm will receive the intervention. This intervention is a prototype of online game, about 50 minutes in duration. The online game provides gameplay that allows the user, with a gameplay narrative, to identify and remove sources of environmental hazards in the home environment. Participants play the prototype game for about 50 minutes at which time the intervention is complete.

Other: SE3 Game

Interventions

A prototype online game designed to increase environmental health literacy

Single Arm, Intervention with SE3 Game

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • In middle school.
  • Ability to use a mobile tablet.
  • Have access to wifi in location of intervention implementation.
  • Reside in the geographic areas of implementation: California, Michigan, Florida

You may not qualify if:

  • Age not within middle school range.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Monroe Middle School

San Jose, California, 95128, United States

Location

Virtual Study

Scotts Valley, California, 95066, United States

Location

Results Point of Contact

Title
Chief Executive Officer
Organization
dfusion Inc

Study Officials

  • Tamara Kuhn, MA

    dfusion Inc

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

May 30, 2023

Primary Completion

July 3, 2023

Study Completion

July 3, 2023

Last Updated

March 12, 2025

Results First Posted

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

The research is being conducted under a Small Business Innovation Grant (SBIR) in support of product development and is considered proprietary to the business.

Locations