Evaluation of an Online Intervention to Help LGBTQ Youth Cope With Bullying

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT03501264
• Collaborator: National Institutes of Health (NIH) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 240
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.5
• Patients Per Site Per Month: 15.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bullying of Child	Behavioral: Online Game; Behavioral: LGBTQ Resources	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Evaluation of an Online Intervention to Help LGBTQ Youth Cope With Bullying
• Actual Study Start Date: Apr 17, 2018
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group This group receives the game	Behavioral: Online Game; LGBTQ Bullying game
Active Comparator: Control Group This group receives LGBTQ resources only	Behavioral: LGBTQ Resources; This group receives LGBTQ Resources

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Changes in Help Seeking Scores [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• National Institutes of Health (NIH)
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: James E Egan, PhD, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 25, 2018

More Information

Publications

None provided.

• Responsible Party: James Egan, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03501264
• Other Study ID Numbers: PRO17060347; 5R21HD083561-02
• First Posted: Apr 18, 2018
• Last Update Posted: Oct 7, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bullying

Study Results

Participant Flow

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	This group receives the game Online Game: LGBTQ Bullying game	This group receives LGBTQ resources only LGBTQ Resources: This group receives LGBTQ Resources
Period Title: Overall Study
STARTED	120	120
COMPLETED	120	120
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention Group	Control Group	Total
Arm/Group Description	This group receives the game Online Game: LGBTQ Bullying game	This group receives LGBTQ resources only LGBTQ Resources: This group receives LGBTQ Resources	Total of all reporting groups
Overall Participants	120	120	240
Age, Customized (Count of Participants)
14	16 13.3%	19 15.8%	35 14.6%
15	33 27.5%	33 27.5%	66 27.5%
16	37 30.8%	34 28.3%	71 29.6%
17	28 23.3%	28 23.3%	56 23.3%
18	6 5%	6 5%	12 5%
Sex/Gender, Customized (Count of Participants)
cisgender boys	18 15%	21 17.5%	39 16.3%
cisgender girls	39 32.5%	49 40.8%	88 36.7%
gender minority	63 52.5%	50 41.7%	113 47.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	28 23.3%	21 17.5%	49 20.4%
Not Hispanic or Latino	92 76.7%	99 82.5%	191 79.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	4 3.3%	4 1.7%
Native Hawaiian or Other Pacific Islander	3 2.5%	5 4.2%	8 3.3%
Black or African American	9 7.5%	3 2.5%	12 5%
White	86 71.7%	85 70.8%	171 71.3%
More than one race	14 11.7%	19 15.8%	33 13.8%
Unknown or Not Reported	8 6.7%	4 3.3%	12 5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Changes in Help Seeking Scores
Description	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.
Time Frame	Baseline and 1-month post intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	This group receives the game Online Game: LGBTQ Bullying game	This group receives LGBTQ resources only LGBTQ Resources: This group receives LGBTQ Resources
Measure Participants	72	83
Positive Change - yes	28 23.3%	28 23.3%
Positive Change - no	44 36.7%	55 45.8%

Adverse Events

Time Frame	4 months
Arm/Group Title	Intervention Group		Control Group
Arm/Group Description	This group receives the game Online Game: LGBTQ Bullying game		This group receives LGBTQ resources only LGBTQ Resources: This group receives LGBTQ Resources
All Cause Mortality
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/120 (0%)		0/120 (0%)
Serious Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/120 (0%)		0/120 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/120 (0%)		0/120 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.