NCT03501264

Brief Summary

The purpose of this research study is to conduct a pilot randomized controlled trial of a game-based intervention is able to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among sexual and gender minority (SGM) youth. The goals of the proposed study are to: (1) Test the feasibility and acceptability of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors among SGM youth; and (2) Using a randomized controlled trial, test the efficacy of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among SGM youth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

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

March 13, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 17, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 7, 2019

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

March 13, 2018

Results QC Date

August 7, 2019

Last Update Submit

October 4, 2019

Conditions

Bullying of Child

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Changes in Help Seeking Scores

    A measure of help-seeking intentions for emotional/mental distress from different sources of help. Options range from 1= never, 2=rarely, 3=occasionally, 4=a moderate amount, 5=a great deal. Total scale is out of 105 with higher scores indicating greater health seeking intentions. Questions were asked about: parents/guardians, relatives/family member, teacher, friend, mental health professional, nurse or doctor, and phone/chat line. Mean scores will be calculated at baseline and 1-month post intervention. These scores will then be compared to determine change over the intervention period.

    Baseline and 1-month post intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

This group receives the game

Behavioral: Online Game

Control Group

ACTIVE COMPARATOR

This group receives LGBTQ resources only

Behavioral: LGBTQ Resources

Interventions

Online GameBEHAVIORAL

LGBTQ Bullying game

Intervention group
LGBTQ ResourcesBEHAVIORAL

This group receives LGBTQ Resources

Control Group

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Must identify as lesbian, gay, bisexual, queer, transgender or another sexual or gender minority
  • must have bullying experience
  • must have access to a computer and email

You may not qualify if:

  • Residence outside of United States
  • Not within the age range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Coulter RW, Sang JM, Louth-Marquez W, Henderson ER, Espelage D, Hunter SC, DeLucas M, Abebe KZ, Miller E, Morrill BA, Hieftje K, Friedman MS, Egan JE. Pilot Testing the Feasibility of a Game Intervention Aimed at Improving Help Seeking and Coping Among Sexual and Gender Minority Youth: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Feb 15;8(2):e12164. doi: 10.2196/12164.

    PMID: 30767903DERIVED

Results Point of Contact

Title
James Egan
Organization
University of Pittsburgh, Graduate School of Public Health
jee48@pitt.edu
412-624-2255

Study Officials

  • James E Egan, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 13, 2018

First Posted

April 18, 2018

Study Start

April 17, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

October 7, 2019

Results First Posted

October 7, 2019

Record last verified: 2019-10

Locations

US(1)