NCT06083987

Brief Summary

the investigators will use 4 technology based tools (combinations of youtube videos, links to online resources, tiktok videos, and other media) in a study of 96 Sexual and Gender Minority Youth (SGMY) to determine the effectiveness of them in helping youth to seek out mental health help. Participants will be divided into 1 of 16 groups and will interact with other participants anonymously on Discord. Each group will have access to 1, 2, 3, or all 4 of the tools which are categorized by a specific subject (except for one group who will have no access to the tools in order to compare this outcome against those who use the tools). There will be a survey before starting the Discord portion which will last 4 weeks, and a survey afterwards.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable anxiety

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

September 27, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 8, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 21, 2025

Completed
Last Updated

October 21, 2025

Status Verified

October 1, 2025

Enrollment Period

3 months

First QC Date

September 27, 2023

Results QC Date

May 30, 2025

Last Update Submit

October 5, 2025

Conditions

Outcome Measures

Primary Outcomes (10)

  • Feasibility - IP Use Proportion

    Average proportions of IP components completed out of IP components available per individual participant (IP component defined as opportunity offered to interact with the intervention - some individuals will have more opportunities offered than others due to factorial randomization)

    Over one month

  • Feasibility - IP Use Days

    Average Proportion of days IP is used per individual (number of days session accessed over total offered which is 28 days)

    Over one month

  • Feasibility - IP Use Time

    Average length of time IP is used (length of session)

    Over one month

  • Usability

    System Usability Scale, min: 0, Max: 100, higher scores mean better usability

    1 month

  • Acceptability of the Intervention Principle

    Open-ended questions about whether the Discord server and the tools used were: helpful; whether it was affirming of SGM status; if timing and amount of content were appropriate, if privacy and confidentiality were maintained, and if they had any negative consequences of participation (e.g. parent questioning them )

    1 month

  • Help-Seeking Intention From Counselor or Therapist - TAU vs Not TAU

    single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help

    1 month

  • Help-Seeking Intention From Counselor or Therapist - Intervention 1 vs. Not 1

    single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help

    1 month

  • Help-Seeking Intention From Counselor or Therapist - Intervention 2 vs. Not 2

    single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help

    1 month

  • Help-Seeking Intention From Counselor or Therapist - Intervention 3 vs. Non-3

    single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help

    1 month

  • Help-Seeking Intention From Counselor or Therapist - Intervention 4 vs. Not 4

    single help-seeking intention ruler-based question (i.e. 'I intend to seek help from a counselor or therapist for my mental health problems' scale 1-7, a higher number signifying a higher intent to seek help

    1 month

Secondary Outcomes (40)

  • Social Support - TAU vs Not TAU

    1 month

  • Social Support - Intervention 1 vs. Not 1

    1 month

  • Social Support - Intervention 2 vs. Not 2

    1 month

  • Social Support - Intervention 3 vs. Not 3

    1 month

  • Social Support - Intervention 4 vs. Not 4

    1 month

  • +35 more secondary outcomes

Other Outcomes (8)

  • Social Isolation

    1 month

  • Antidepressant Outcome Expectations

    1 month

  • Beliefs About Therapy

    1 month

  • +5 more other outcomes

Study Arms (16)

Control Group - No Interventions

ACTIVE COMPARATOR

Arm 1 will have not be given any of the interventions and will be a control group.

Behavioral: Control Group - No Interventions

Intervention 1 - Intersectionality and Identity

EXPERIMENTAL

Arm 2 will be given access to intervention 1. It will have video and text content focused on identity and intersectionality.

Behavioral: Intersectionality and Identity

Interventions 1 and 2 - Intersectionality and Identity/Confidentiality and Privacy

EXPERIMENTAL

Arm 3 will be given access to with the video and text content focused on intersectionality and confidentiality

Behavioral: Intersectionality and IdentityBehavioral: Confidentiality

Interventions 1, 2, and 3 - Intersectionality/Confidentiality/Educational Tools

EXPERIMENTAL

Arm 4 will be given access to with the video and text content focused on intersectionality, confidentiality, and education about identity

Behavioral: Intersectionality and IdentityBehavioral: ConfidentialityBehavioral: Educating Your Community

Interventions 1, 2, and 4 - Intersectionality/Confidentiality/Finding Affirming Care

EXPERIMENTAL

Arm 5 will be given access to interventions 1, 2, and 4, with the video and text content focused on intersectionality, confidentiality, and determining if caregivers are affirming

Behavioral: Intersectionality and IdentityBehavioral: ConfidentialityBehavioral: How to find Affirming Caregivers

Interventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming Care

EXPERIMENTAL

Arm 6 will be given access to all 4 interventions, with the video and text content focused on intersectionality, confidentiality, education about identity, and determining if caregivers are affirming

Behavioral: Intersectionality and IdentityBehavioral: ConfidentialityBehavioral: Educating Your CommunityBehavioral: How to find Affirming Caregivers

Interventions 1 and 3 - Intersectionality and Identity/Educational Tools

EXPERIMENTAL

Arm 7 will be given access to interventions 1 and 3, with the video and text content focused on intersectionality and education about identity

Behavioral: Intersectionality and IdentityBehavioral: Educating Your Community

Interventions 1, 3, and 4 - Intersectionality and Identity/Educational Tools/Finding Affirming Care

EXPERIMENTAL

Arm 8 will be given access to interventions 1, 3, and 4, with the video and text content focused on intersectionality, education about identity and determining if caregivers are affirming.

Behavioral: Intersectionality and IdentityBehavioral: Educating Your CommunityBehavioral: How to find Affirming Caregivers

Interventions 1 and 4 - Intersectionality and Identity/Finding Affirming Care

EXPERIMENTAL

Arm 9 will be given access to interventions 1 and 4, with the video and text content focused on intersectionality and determining if caregivers are affirming.

Behavioral: Intersectionality and IdentityBehavioral: How to find Affirming Caregivers

Intervention 2 - Confidentiality and Privacy

EXPERIMENTAL

Arm 10 will be given access to intervention 2, with the video and text content focused on confidentiality

Behavioral: Confidentiality

Interventions 2 and 3 - Confidentiality and Privacy/Educational Tools

EXPERIMENTAL

Arm 11 will be given access to interventions 2, and 3. Video and text content will focus on confidentiality and education about identity.

Behavioral: ConfidentialityBehavioral: Educating Your Community

Interventions 2, 3 and 4 - Confidentiality and Privacy/Educational Tools/Finding Affirming Care

EXPERIMENTAL

Arm 12 will be given access to interventions 2, 3, and 4. Video and text content will focus on confidentiality, education about identity, and determine if caregivers are affirming.

Behavioral: ConfidentialityBehavioral: Educating Your CommunityBehavioral: How to find Affirming Caregivers

Interventions 2 and 4 - Confidentiality and Privacy/Finding Affirming Care

EXPERIMENTAL

Arm 13 will be given access to interventions 2 and 4. Video and text content will focus on confidentiality and determining if caregivers are affirming.

Behavioral: ConfidentialityBehavioral: How to find Affirming Caregivers

Intervention 3 - Educational Tools

EXPERIMENTAL

Arm 14 will be given access to intervention 3. Video and text content will focus on education about identity

Behavioral: Educating Your Community

Interventions 3 and 4 - Educational Tools/Finding Affirming Care

EXPERIMENTAL

Arm 15 will be given access to interventions 3 and 4. Video and text content will focus on educational tools about identity and determining if caregivers are affirming.

Behavioral: Educating Your CommunityBehavioral: How to find Affirming Caregivers

Intervention 4 - Finding Affirming Care

EXPERIMENTAL

Arm 16 will be given access to intervention 4, with video and text content focusing on determining if caregivers are affirming.

Behavioral: How to find Affirming Caregivers

Interventions

Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of intersectionality and identity. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").

Intervention 1 - Intersectionality and IdentityInterventions 1 and 2 - Intersectionality and Identity/Confidentiality and PrivacyInterventions 1 and 3 - Intersectionality and Identity/Educational ToolsInterventions 1 and 4 - Intersectionality and Identity/Finding Affirming CareInterventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming CareInterventions 1, 2, and 3 - Intersectionality/Confidentiality/Educational ToolsInterventions 1, 2, and 4 - Intersectionality/Confidentiality/Finding Affirming CareInterventions 1, 3, and 4 - Intersectionality and Identity/Educational Tools/Finding Affirming Care
ConfidentialityBEHAVIORAL

Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on Confidentiality for caregivers. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").

Intervention 2 - Confidentiality and PrivacyInterventions 1 and 2 - Intersectionality and Identity/Confidentiality and PrivacyInterventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming CareInterventions 1, 2, and 3 - Intersectionality/Confidentiality/Educational ToolsInterventions 1, 2, and 4 - Intersectionality/Confidentiality/Finding Affirming CareInterventions 2 and 3 - Confidentiality and Privacy/Educational ToolsInterventions 2 and 4 - Confidentiality and Privacy/Finding Affirming CareInterventions 2, 3 and 4 - Confidentiality and Privacy/Educational Tools/Finding Affirming Care

Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of the education of family and friends about identity. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").

Intervention 3 - Educational ToolsInterventions 1 and 3 - Intersectionality and Identity/Educational ToolsInterventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming CareInterventions 1, 2, and 3 - Intersectionality/Confidentiality/Educational ToolsInterventions 1, 3, and 4 - Intersectionality and Identity/Educational Tools/Finding Affirming CareInterventions 2 and 3 - Confidentiality and Privacy/Educational ToolsInterventions 2, 3 and 4 - Confidentiality and Privacy/Educational Tools/Finding Affirming CareInterventions 3 and 4 - Educational Tools/Finding Affirming Care

Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of finding affirming caregivers. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").

Intervention 4 - Finding Affirming CareInterventions 1 and 4 - Intersectionality and Identity/Finding Affirming CareInterventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming CareInterventions 1, 2, and 4 - Intersectionality/Confidentiality/Finding Affirming CareInterventions 1, 3, and 4 - Intersectionality and Identity/Educational Tools/Finding Affirming CareInterventions 2 and 4 - Confidentiality and Privacy/Finding Affirming CareInterventions 2, 3 and 4 - Confidentiality and Privacy/Educational Tools/Finding Affirming CareInterventions 3 and 4 - Educational Tools/Finding Affirming Care

Control Group - Will be given no interventions

Control Group - No Interventions

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • have access to a smartphone; have finished 6th grade; have access to and intellectual and physical ability to use the internet; fit demographic criteria (SGMY); and have symptoms of depression and/or anxiety that are mild or more severe (PHQ-8 and/or GAD-7 = 5 or above)
  • We will routinely monitor the sample to attempt to reach the following proportions:
  • % ages 14-16 and 50% ages 17-19 50% identify as sexual minority but cisgender and 50% identify as not cisgender at least 40% identify as a racial or ethnic minority
  • If any of the proportions are reached (e.g. if 60% of recruited sample identify as not belonging to a racial or ethnic minority we will change screen settings to exclude those who are not

You may not qualify if:

  • no access to smart phone or internet, did not complete the 6th grade, not able to use internet, depression and anxiety are less than mild (PHQ-8 and GAD-7 scores \<5); presently are in ongoing psychotherapy (i.e. have attended or plan to attend more than 1 session).
  • If they have been in therapy within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virtual Social Media Based Recruitment

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionAdolescent BehaviorCoitus

Interventions

Confidentiality

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSexual Behavior

Intervention Hierarchy (Ancestors)

Forensic PsychiatryPsychiatryBehavioral SciencesBehavioral Disciplines and ActivitiesPatient RightsHuman RightsSocial Control, FormalHealth Care Economics and OrganizationsJurisprudence

Results Point of Contact

Title
Dr. Ana Radovic
Organization
University of Pittsburgh

Study Officials

  • Ana Radovic, MD, MSc

    University of Pittsburgh/UPMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: 96 participants randomly assigned to one of the 16 combinations of the four study intervention principles
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 16, 2023

Study Start

March 8, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

October 21, 2025

Results First Posted

October 21, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Trial outcome data can be accessed by contacting the study principal investigator.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Upon Completion of the study (estimated June 2024) and it will be available indefinitely via contacting Dr. Radovic
Access Criteria
Completed Data and results will be fully available upon request to any interested parties via email

Locations