- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03501264
Evaluation of an Online Intervention to Help LGBTQ Youth Cope With Bullying
October 4, 2019 updated by: James Egan, University of Pittsburgh
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Residence outside of United States
- Not within the age range
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
This group receives the game
|
LGBTQ Bullying game
|
ACTIVE_COMPARATOR: Control Group
This group receives LGBTQ resources only
|
This group receives LGBTQ Resources
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Changes in Help Seeking Scores
Time Frame: Baseline and 1-month post intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James E Egan, PhD, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 17, 2018
Primary Completion (ACTUAL)
August 1, 2019
Study Completion (ACTUAL)
August 1, 2019
Study Registration Dates
First Submitted
March 13, 2018
First Submitted That Met QC Criteria
April 9, 2018
First Posted (ACTUAL)
April 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 7, 2019
Last Update Submitted That Met QC Criteria
October 4, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO17060347
- 5R21HD083561-02 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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