Bullying of ChildNCT03501264
Evaluation of an Online Intervention to Help LGBTQ Youth Cope With Bullying
A study testing Online Game and LGBTQ Resources in people with Bullying of Child, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Bullying of Child
- What is being tested?
- Online Game and LGBTQ Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Residence outside of United States
- Not within the age range
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Bullying of Child
- Being tested
- Online Game, LGBTQ Resources
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online GameBehavioural
LGBTQ Bullying game
LGBTQ ResourcesBehavioural
This group receives LGBTQ Resources
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group receives the game Receives: Behavioral: Online Game |
| Control Group | Active comparator | This group receives LGBTQ resources only Receives: Behavioral: LGBTQ Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start17 Apr 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bullying of ChildStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, James Egan, University of Pittsburgh
- Investigators
- James E Egan, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501264
- Sponsor's protocol ID
- PRO17060347
- Other IDs
- 5R21HD083561-02
- Status last verified
- Oct 2019
- First submitted
- 13 Mar 2018
- Last updated
- 7 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30767903
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online Intervention to Help LGBTQ Youth Cope With Bullying
- ClinicalTrials.gov ID
- NCT03501264
- Acronym / sponsor ID
- PRO17060347
- Conditions
- Bullying of Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 7 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Online GameThis group receives the game |
| Control Group | Active comparator | Behavioral: LGBTQ ResourcesThis group receives LGBTQ resources only |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Residence outside of United States
- Not within the age range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online GameLGBTQ Bullying game | Behavioural | Intervention group |
| LGBTQ ResourcesThis group receives LGBTQ Resources | Behavioural | Control Group |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30767903Coulter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James E Egan, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Game and LGBTQ Resources in people with Bullying of Child, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Changes in Help Seeking Scores (time frame: Baseline and 1-month post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.