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Sexual and Gender Minority Youth (SGMY) and Online Interventions to Increase Help-seeking for Anxiety and/or Depression

Optimizing Technology Interventions for Help-Seeking for Depression and Suicidality in Sexual and Gender Minority Youth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06083987
Enrollment
81
Registered
2023-10-16
Start date
2024-03-08
Completion date
2024-06-01
Last updated
2025-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Anxiety, Depression, Sexual and Gender Minorities

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.

Detailed description

Only one-third of adolescents access treatment for depression, and many fail to interact with clinic-based mental health resources. Sexual and gender minority youth (SGMY) are at greater risk for severe mental health disorders and suicidality but even less likely to access mental health services, even when access is available. Widespread factors - stigma, negative beliefs about treatment, lack of mental health knowledge - contribute to not seeking services. Mainstream mental health interventions fail to address unique factors to SGMY that inhibit help-seeking: double stigma (stigma around mental health as well as internalized homophobia and transphobia), concern about revealing SGM status, low family support, lack of access to SGM affirming mental health professionals. Despite being hard-to-reach, SGMY at risk for depression are quite active online. Yet SGMY-specific evidence-based online interventions are lacking and community interventions do not enhance mental health help-seeking. Targeted online interventions are needed to address unique factors which prevent help-seeking but are themselves usable and engaging. The current proposal will use a user-informed efficient approach to technology intervention design considering the heterogeneity and specific needs of SGMY. The investigators will use the Behavioral Intervention Technology Model to design and study several intervention principles (IPs), or theoretical concepts including intervention aims and behavioral strategies, to understand which mechanisms of action hold promise while being iterating design and potential modalities. The investigators will use human computer interaction (HCI) framework, Discover, Design/Build, and Test to develop and study several IPs. Specifically, will use HCI techniques to develop initial prototypes and seek iterative user feedback and evaluate 4 finalized low-fidelity prototypes using a factorial trial to understand each IP prototype's individual and combined feasibility, usability, acceptability, and change in help-seeking intention in an online sample of diverse (racially, ethnically, age, gender identity, sexual orientation) SGMY. This will inform the development of a high-fidelity intervention which may include different components for specific SGMY subgroups to be evaluated in a larger clinical trial. The PI, Dr. Radovic, is a physician researcher in adolescent medicine and has conducted years of research using stakeholder-informed methods and HCI techniques to inform intervention development. By working with experts in SGM health, stakeholder engagement, intervention design, qualitative analysis, HCI design, and BIT development and testing, the investigators have an exciting opportunity to bridge the gap for SGM adolescents with depression and suicidality to motivate and equip adolescents with the tools needed to access treatment. This proposal is responsive to NOT-MH-18-031 by conducting nimble iterative testing and NOT-MD-19-001 - testing stigma reduction interventions. Adolescents who are sexual and gender minority (or LGBTQ) have rising rates of depression, anxiety, and suicidality but are less likely to get mental health treatment than other adolescents due to stigma and low family support. These adolescents are quite active online. This study aims to understand what types of technology interventions are most promising for helping them to seek mental health help when indicated. Due to the exploratory nature of this clinical trial, we originally considered multiple secondary outcomes. As we proceeded with the study and obtained formative information from qualitative interviews to inform initial prototypes, we further clarified our conceptual model regarding our interests in the main outcome of mental health help-seeking and subsequent improvement in depression and anxiety symptoms. This help-seeking we hypothesized may be influenced by help-seeking intention, social support, internalized stigmatization of identity (internalized homophobia, internalized transphobia), confidentiality concerns, and expectations of rejection by mental healthcare providers. These measures therefore remained as secondary outcomes which we examined, and all others were moved to Other Pre-specified outcome measures. With regards to statistical analysis, due to limitations in sample size, and non-normality of data, we used non-parametric tests of statistical significance within the primary outcome of mental health help-seeking intention between each intervention compared to not that intervention and adjusted for multiple tests using false-discovery rate q-value calculated with the Yekutieli method in Stata.

Interventions

BEHAVIORALIntersectionality and Identity

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).

BEHAVIORALConfidentiality

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).

BEHAVIORALEducating Your Community

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).

BEHAVIORALHow to find Affirming Caregivers

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).

BEHAVIORALControl Group - No Interventions

Control Group - Will be given no interventions

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

96 participants randomly assigned to one of the 16 combinations of the four study intervention principles

Eligibility

Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
Yes

Inclusion criteria

List the inclusion criteria: 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: 50% 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 List the

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Help-Seeking Intention From Counselor or Therapist - Intervention 1 vs. Not 11 monthsingle 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
Help-Seeking Intention From Counselor or Therapist - TAU vs Not TAU1 monthsingle 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
Acceptability of the Intervention Principle1 monthOpen-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 )
Usability1 monthSystem Usability Scale, min: 0, Max: 100, higher scores mean better usability
Feasibility - IP Use TimeOver one monthAverage length of time IP is used (length of session)
Help-Seeking Intention From Counselor or Therapist - Intervention 4 vs. Not 41 monthsingle 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
Help-Seeking Intention From Counselor or Therapist - Intervention 3 vs. Non-31 monthsingle 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
Help-Seeking Intention From Counselor or Therapist - Intervention 2 vs. Not 21 monthsingle 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
Feasibility - IP Use ProportionOver one monthAverage 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)
Feasibility - IP Use DaysOver one monthAverage Proportion of days IP is used per individual (number of days session accessed over total offered which is 28 days)

Secondary

MeasureTime frameDescription
Internalized Homophobia - Intervention 2 vs Not 21 monthSexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia
Internalized Homophobia - Intervention 3 vs Not 31 monthSexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia
Internalized Homophobia - Intervention 4 vs Not 41 monthSexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia
Internalized Transphobia - TAU vs Not TAU1 monthGender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia
Internalized Transphobia - Intervention 1 vs Not 11 monthGender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia
Internalized Transphobia - Intervention 2 vs Not 21 monthGender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia
Internalized Transphobia - Intervention 3 vs Not 31 monthGender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia
Internalized Transphobia - Intervention 4 vs Not 41 monthGender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia
Expectance of Rejection Due to SGM Status Intervention 2 vs Not 21 monthSingle-item yes/no and open ended question - asked about past 30 days
Expectance of Rejection Due to SGM Status Intervention 3 vs Not 31 monthSingle-item yes/no and open ended question - asked about past 30 days
Expectance of Rejection Due to SGM Status Intervention 4 vs Not 41 monthSingle-item yes/no and open ended question - asked about past 30 days
Confidentiality Concerns TAU vs Not TAU1 monthConfidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality
Confidentiality Concerns Intervention 1 vs Not 11 monthConfidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality
Confidentiality Concerns Intervention 2 vs Not 21 monthConfidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality
Confidentiality Concerns Intervention 3 vs Not 31 monthConfidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality
Confidentiality Concerns Intervention 4 vs Not 41 monthConfidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality
Receipt of Any Mental Health Treatment in Past 4 Weeks TAU vs Not TAU1 monthActual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 1 vs Not 11 monthActual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 2 vs Not 21 monthActual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 4 vs Not 41 monthActual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns
Depression Symptoms TAU vs Not TAU1 monthPatient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.
Depression Symptoms Intervention 1 vs Not 11 monthPatient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.
Depression Symptoms Intervention 2 vs Not 21 monthPatient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.
Depression Symptoms Intervention 3 vs Not 31 monthPatient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.
Depression Symptoms Intervention 4 vs Not 41 monthPatient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.
Anxiety Symptoms - TAU vs Not TAU1 monthGeneralized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Anxiety Symptoms - Intervention 1 vs Not 11 monthGeneralized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Anxiety Symptoms - Intervention 2 vs Not 21 monthGeneralized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Anxiety Symptoms - Intervention 3 vs Not 31 monthGeneralized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Anxiety Symptoms - Intervention 4 vs Not 41 monthGeneralized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 3 vs Not 31 monthActual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns
Expectance of Rejection Due to SGM Status TAU vs Not TAU1 monthSingle-item yes/no and open ended question - asked about past 30 days
Social Support - TAU vs Not TAU1 monthThe Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.
Social Support - Intervention 1 vs. Not 11 monthThe Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.
Social Support - Intervention 2 vs. Not 21 monthThe Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.
Social Support - Intervention 3 vs. Not 31 monthThe Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.
Expectance of Rejection Due to SGM Status Intervention 1 vs Not 11 monthSingle-item yes/no and open ended question - asked about past 30 days
Social Support - Intervention 4 vs. Not 41 monthThe Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.
Internalized Homophobia - TAU vs Not TAU1 monthSexual Minority Adolescent Stress Inventory Internalized homonegativity subscale for the past 30 days. min: 0, max: 7. Higher score indicates greater internalized homophobia
Internalized Homophobia - Intervention 1 vs Not 11 monthSexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia

Other

MeasureTime frameDescription
Social Isolation1 month4-item version of revised UCLA Loneliness Scale. min: 4, max: 16. Higher score means greater levels of loneliness
Depression and Anxiety Knowledge1 monthThe Depression and Anxiety literacy questionnaires (Gulliver 2012) measures knowledge about depression and anxiety diagnosis and treatment. The total score ranges from 0-22, with a higher score indicating greater knowledge of depression. We will use a brief version of this scale.
Help-Seeking Intention From Multiple Sources1 monthThe General Help Seeking Questionnaire (Rickwood, 2005) asks the likelihood of seeking help from a potential individual for a personal or emotional problem. A higher score per individual indicates a higher likelihood and intention to seek help from this source.
Perceived Need for Treatment1 monthOpen-ended question about whether adolescent thinks they need any mental health service
Mental Health Stigma, Personal and Perceived1 monthThe Depression Stigma Scale (Griffiths 2004) measures stigmatizing attitudes toward depression treatment. It is a continuous measure and the total score ranges from 0-36. There are two subscales: the personal stigma subscale which totals 0-18 and the perceived stigma subscale which totals 0-18. These two are summed for the total stigma score. A higher score indicates a worse outcome.
12 Item Short Form Survey From the RAND Medical Outcomes Study (SF-12)1 monthSF-12 (Jenkinson 1997). SF-12 survey generates two summary scores: a physical component score (pcs-12) and a mental component score (mcs-12). These scores are calculated using an algorithm that weighs the responses according to their contribution to the physical or mental health dimensions. The scores are then standardized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health status and lower scores worse health status. PCS-12 raw scores min is -3.37 and max is 69.68. MCS-12 raw scores min is -10.64 and max is 73.18
Beliefs About Therapy1 monthBarriers to Adolescents Seeking Help Scale-Brief Version (Wilson 2005/Kuhl 1997) measures perceptions about seeking treatment from a mental health provider. The total score ranges from 1 to 11, a higher score indicated greater barriers.
Antidepressant Outcome Expectations1 monthThe Antidepressant Meanings Scale (Cohane, 2008) measures an individual's level of negative attitudes toward taking an antidepressant medication if prescribed. It is a continuous measure and the total score ranges from 0 to 24, with a higher score indicating more negative attitudes.

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1: Attention Control Group
Individuals in this group are individuals who are in Arm 1 and will only receive the control intervention. Individuals in the Attention Control Group will not be given any of the intervention content (1-4) and will receive video and text content focused on interest in research. Control group: 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 participating in research studies. Participants will receive one new video a week and will be asked to share their thoughts on research and past experiences with research.
4
Arm 2: Intervention 1 - Intersectionality and Identity
Individuals in Arm 2 will receive Intervention 1 and will be exposed to video and text content focused on identity and intersectionality. Intersectionality and Identity: 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).
5
Arm 3: Intervention 1 + 2
Individuals in Arm 3 will receive both Intervention 1 (description in Arm 2 description box) and Intervention 2 (description in Arm 10 description box).
5
Arm 4: Intervention 1 + 2 + 3
Individuals in Arm 4 will receive Intervention 1 (description in Arm 2 description box), Intervention 2 (description in Arm 10 description box) and Intervention 3 (description in Arm 14 description box).
5
Arm 5: Intervention 1 + 2 + 4
Individuals in Arm 5 will receive Intervention 1 (description in Arm 2 description box), Intervention 2 (description in Arm 10 description box) and Intervention 4 (description in Arm 16 description box).
5
Arm 6: Intervention 1 + 2 + 3 + 4
Individuals in Arm 6 will receive Intervention 1 (description in Arm 2 description box), Intervention 2 (description in Arm 10 description box) and Intervention 3 (description in Arm 14 description box) and Intervention 4 (description in Arm 16 description box).
6
Arm 7: Intervention 1 + 3
Individuals in Arm 7 will receive Intervention 1 (description in Arm 2 description box), and Intervention 3 (description in Arm 14 description box).
6
Arm 8: Intervention 1 + 3 + 4
Individuals in Arm 8 will receive Intervention 1 (description in Arm 2 description box), and Intervention 3 (description in Arm 14 description box) and Intervention 4 (description in Arm 16 description box).
5
Arm 9: Intervention 1 + 4
Individuals in Arm 9 will receive Intervention 1 (description in Arm 2 description box), and Intervention 4 (description in Arm 16 description box).
4
Arm 10: Intervention 2 - Confidentiality and Privacy
Arm 10 will be given access to intervention 2, with the video and text content focused on confidentiality Confidentiality: 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).
6
Arm 11: Intervention 2 + 3
Individuals in Arm 11 will receive Intervention 2 (description in Arm 10 description box) and Intervention 3 (description in Arm 14 description box).
5
Arm 12: Intervention 2 + 3 + 4
Individuals in Arm 12 will receive Intervention 2 (description in Arm 10 description box) and Intervention 3 (description in Arm 14 description box) and Intervention 4 (description in Arm 16 description box).
4
Arm 13: Intervention 2 + 4
Individuals in Arm 13 will receive Intervention 2 (description in Arm 10 description box) and Intervention 4 (description in Arm 16 description box).
5
Arm 14: Intervention 3 - Educational Tools
Arm 14 will be given access to intervention 3. Video and text content will focus on education about identity Educating Your Community: 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).
5
Arm 15: Intervention 3 + 4
Individuals in Arm 15 will receive Intervention 3 (description in Arm 14 description box) and Intervention 4 (description in Arm 16 description box).
6
Arm 16: Intervention 4 - Finding Affirming Care
Arm 16 will be given access to intervention 4, with video and text content focusing on determining if caregivers are affirming. How to find Affirming Caregivers: 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).
5
Total81

Baseline characteristics

CharacteristicTotalArm 16: Intervention 4 - Finding Affirming CareArm 15: Intervention 3 + 4Arm 14: Intervention 3 - Educational ToolsArm 13: Intervention 2 + 4Arm 12: Intervention 2 + 3 + 4Arm 11: Intervention 2 + 3Arm 10: Intervention 2 - Confidentiality and PrivacyArm 9: Intervention 1 + 4Arm 8: Intervention 1 + 3 + 4Arm 7: Intervention 1 + 3Arm 6: Intervention 1 + 2 + 3 + 4Arm 5: Intervention 1 + 2 + 4Arm 4: Intervention 1 + 2 + 3Arm 3: Intervention 1 + 2Arm 2: Intervention 1 - Intersectionality and IdentityArm 1: Attention Control Group
Access to Health Insurance60 Participants3 Participants4 Participants4 Participants4 Participants4 Participants5 Participants5 Participants3 Participants4 Participants4 Participants5 Participants2 Participants4 Participants3 Participants3 Participants3 Participants
Age, Continuous18.0 years
STANDARD_DEVIATION 0.1
18.4 years
STANDARD_DEVIATION 0.9
18.3 years
STANDARD_DEVIATION 0.5
17.8 years
STANDARD_DEVIATION 1.1
18.2 years
STANDARD_DEVIATION 0.8
17.3 years
STANDARD_DEVIATION 2.2
18.4 years
STANDARD_DEVIATION 0.6
17.5 years
STANDARD_DEVIATION 0.8
18.2 years
STANDARD_DEVIATION 0.5
17.8 years
STANDARD_DEVIATION 1.3
18.5 years
STANDARD_DEVIATION 0.6
18.3 years
STANDARD_DEVIATION 0.5
18.2 years
STANDARD_DEVIATION 0.4
17.4 years
STANDARD_DEVIATION 1.3
17.6 years
STANDARD_DEVIATION 0.9
18.2 years
STANDARD_DEVIATION 1.3
17.3 years
STANDARD_DEVIATION 0.1
Easy Access to Transportation75 Participants4 Participants5 Participants5 Participants4 Participants4 Participants5 Participants6 Participants4 Participants5 Participants6 Participants6 Participants4 Participants5 Participants5 Participants3 Participants4 Participants
Education
Graduated High School
14 Participants1 Participants0 Participants1 Participants2 Participants0 Participants0 Participants0 Participants1 Participants0 Participants2 Participants2 Participants2 Participants1 Participants0 Participants2 Participants0 Participants
Education
High School (9-12th grade)
51 Participants3 Participants4 Participants4 Participants2 Participants2 Participants5 Participants4 Participants2 Participants5 Participants4 Participants2 Participants1 Participants4 Participants2 Participants3 Participants4 Participants
Education
Middle School (7-8th grade)
16 Participants1 Participants2 Participants0 Participants1 Participants2 Participants0 Participants2 Participants1 Participants0 Participants0 Participants2 Participants2 Participants0 Participants3 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
77 Participants5 Participants6 Participants4 Participants5 Participants4 Participants5 Participants6 Participants4 Participants5 Participants6 Participants6 Participants5 Participants5 Participants5 Participants3 Participants3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Ever Received Medication25 Participants3 Participants1 Participants1 Participants1 Participants1 Participants1 Participants4 Participants2 Participants1 Participants1 Participants2 Participants0 Participants2 Participants2 Participants1 Participants2 Participants
Ever Received Therapy24 Participants2 Participants1 Participants1 Participants1 Participants2 Participants1 Participants3 Participants0 Participants1 Participants1 Participants3 Participants0 Participants2 Participants1 Participants2 Participants3 Participants
Have Primary Care Provider70 Participants4 Participants5 Participants4 Participants4 Participants4 Participants5 Participants6 Participants3 Participants4 Participants6 Participants6 Participants3 Participants4 Participants4 Participants4 Participants4 Participants
MacArthur scale of subjective social status - United States5.5 units on a scale
STANDARD_DEVIATION 0.2
5.4 units on a scale
STANDARD_DEVIATION 1.7
5.2 units on a scale
STANDARD_DEVIATION 1.3
5.0 units on a scale
STANDARD_DEVIATION 1.2
6.2 units on a scale
STANDARD_DEVIATION 1.3
5.3 units on a scale
STANDARD_DEVIATION 2.2
5.2 units on a scale
STANDARD_DEVIATION 1.6
6.3 units on a scale
STANDARD_DEVIATION 1.5
4.3 units on a scale
STANDARD_DEVIATION 1.5
4.2 units on a scale
STANDARD_DEVIATION 2.4
4.5 units on a scale
STANDARD_DEVIATION 1.5
6.0 units on a scale
STANDARD_DEVIATION 2.4
6.0 units on a scale
STANDARD_DEVIATION 0.7
6.2 units on a scale
STANDARD_DEVIATION 1.9
6.2 units on a scale
STANDARD_DEVIATION 0.4
6.0 units on a scale
STANDARD_DEVIATION 2.7
6 units on a scale
STANDARD_DEVIATION 0.7
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
61 Participants3 Participants5 Participants3 Participants4 Participants3 Participants3 Participants5 Participants4 Participants3 Participants6 Participants3 Participants5 Participants4 Participants4 Participants2 Participants4 Participants
Race (NIH/OMB)
More than one race
2 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
15 Participants2 Participants0 Participants0 Participants1 Participants1 Participants2 Participants0 Participants0 Participants2 Participants0 Participants3 Participants0 Participants1 Participants1 Participants2 Participants0 Participants
Sex: Female, Male
Female
24 Participants2 Participants1 Participants3 Participants2 Participants2 Participants0 Participants1 Participants1 Participants1 Participants1 Participants2 Participants3 Participants1 Participants0 Participants3 Participants1 Participants
Sex: Female, Male
Male
57 Participants3 Participants5 Participants2 Participants3 Participants2 Participants5 Participants5 Participants3 Participants4 Participants5 Participants4 Participants2 Participants4 Participants5 Participants2 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 81
other
Total, other adverse events
0 / 81
serious
Total, serious adverse events
0 / 81

Outcome results

Primary

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 )

Time frame: 1 month

Population: For this outcome all groups are combined - for the full sample completing this follow-up measure. This was acceptability metric was of the entire pilot study population as a whole and not intended to compare across arms to answer the question, what is the acceptability rating of the entire online intervention?

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention 1Acceptability of the Intervention PrincipleFelt Discord Server and Tools were Helpful72 Participants
Intervention 1Acceptability of the Intervention PrincipleFelt Content was Appropriate74 Participants
Intervention 1Acceptability of the Intervention PrincipleTiming of Posting/Receiving Content Appropriate73 Participants
Intervention 1Acceptability of the Intervention PrincipleFelt Affirmed (received emotional support or encouragement) about your sexuality or gender73 Participants
Intervention 1Acceptability of the Intervention PrincipleFelt Privacy and Confidentiality were Maintained74 Participants
Intervention 1Acceptability of the Intervention PrincipleExperienced any Negative Consequences from Participation0 Participants
Primary

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)

Time frame: Over one month

Population: Total sample who enrolled in the study; for this outcome all groups are combined because this was a feasibility metric of the entire pilot study population as a whole and not intended to compare across arms to answer the question, what proportion of days the study participants would access the online intervention?

ArmMeasureValue (MEAN)Dispersion
Intervention 1Feasibility - IP Use Days0.04 Mean proportion total days used per partStandard Deviation 0.06
Primary

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)

Time frame: Over one month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Feasibility - IP Use Proportion0.10 average proportionStandard Deviation 0.17
Intervention 2Feasibility - IP Use Proportion0.11 average proportionStandard Deviation 0.21
Intervention 3Feasibility - IP Use Proportion0.10 average proportionStandard Deviation 0.16
Intervention 4Feasibility - IP Use Proportion0.08 average proportionStandard Deviation 0.13
Total SampleFeasibility - IP Use Proportion0.11 average proportionStandard Deviation 0.19
Primary

Feasibility - IP Use Time

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

Time frame: Over one month

Population: We do not have access to this data. Prior to starting the study, we had the understanding that we would be able to extract this level of data from the Discord platform. Upon beginning the study and collecting data, and after multiple iterative attempts, we were not able to obtain that data due to Discord regulations.

Primary

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

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Help-Seeking Intention From Counselor or Therapist - Intervention 1 vs. Not 14.19 units on a scaleStandard Deviation 1.19
Intervention 2Help-Seeking Intention From Counselor or Therapist - Intervention 1 vs. Not 13.79 units on a scaleStandard Deviation 1.36
p-value: 0.31Wilcoxon (Mann-Whitney)
Primary

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

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Help-Seeking Intention From Counselor or Therapist - Intervention 2 vs. Not 24.05 units on a scaleStandard Deviation 1.37
Intervention 2Help-Seeking Intention From Counselor or Therapist - Intervention 2 vs. Not 23.92 units on a scaleStandard Deviation 1.21
p-value: 0.34Wilcoxon (Mann-Whitney)
Primary

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

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Help-Seeking Intention From Counselor or Therapist - Intervention 3 vs. Non-34.26 units on a scaleStandard Deviation 1.14
Intervention 2Help-Seeking Intention From Counselor or Therapist - Intervention 3 vs. Non-33.69 units on a scaleStandard Deviation 1.39
p-value: 0.04Wilcoxon (Mann-Whitney)
Primary

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

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Help-Seeking Intention From Counselor or Therapist - Intervention 4 vs. Not 44.24 units on a scaleStandard Deviation 1.05
Intervention 2Help-Seeking Intention From Counselor or Therapist - Intervention 4 vs. Not 43.72 units on a scaleStandard Deviation 1.47
p-value: 0.22Wilcoxon (Mann-Whitney)
Primary

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

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Help-Seeking Intention From Counselor or Therapist - TAU vs Not TAU4.00 units on a scaleStandard Deviation 1
Intervention 2Help-Seeking Intention From Counselor or Therapist - TAU vs Not TAU3.99 units on a scaleStandard Deviation 1.3
p-value: 0.86Wilcoxon (Mann-Whitney)
Primary

Usability

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

Time frame: 1 month

Population: For this outcome all groups are combined - for the full sample completing this follow-up measure. This was a usability metric of the entire pilot study population as a whole and not intended to compare across arms to answer the question, what is the usability rating of the entire online intervention?

ArmMeasureValue (MEAN)Dispersion
Intervention 1Usability77.4 units on a scaleStandard Deviation 13.6
Secondary

Anxiety Symptoms - Intervention 1 vs Not 1

Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Anxiety Symptoms - Intervention 1 vs Not 14.95 score on a scaleStandard Deviation 3.74
Intervention 2Anxiety Symptoms - Intervention 1 vs Not 15.65 score on a scaleStandard Deviation 3.82
Secondary

Anxiety Symptoms - Intervention 2 vs Not 2

Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Anxiety Symptoms - Intervention 2 vs Not 25.63 score on a scaleStandard Deviation 4.46
Intervention 2Anxiety Symptoms - Intervention 2 vs Not 24.94 score on a scaleStandard Deviation 2.91
Secondary

Anxiety Symptoms - Intervention 3 vs Not 3

Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Anxiety Symptoms - Intervention 3 vs Not 34.97 score on a scaleStandard Deviation 3.66
Intervention 2Anxiety Symptoms - Intervention 3 vs Not 35.64 score on a scaleStandard Deviation 3.91
Secondary

Anxiety Symptoms - Intervention 4 vs Not 4

Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Anxiety Symptoms - Intervention 4 vs Not 45.00 score on a scaleStandard Deviation 3.81
Intervention 2Anxiety Symptoms - Intervention 4 vs Not 45.61 score on a scaleStandard Deviation 3.77
Secondary

Anxiety Symptoms - TAU vs Not TAU

Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Anxiety Symptoms - TAU vs Not TAU4.67 score on a scaleStandard Deviation 3.21
Intervention 2Anxiety Symptoms - TAU vs Not TAU5.23 score on a scaleStandard Deviation 3.81
Secondary

Confidentiality Concerns Intervention 1 vs Not 1

Confidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Confidentiality Concerns Intervention 1 vs Not 12.43 units on a scaleStandard Deviation 1.24
Intervention 2Confidentiality Concerns Intervention 1 vs Not 12.66 units on a scaleStandard Deviation 1.07
Secondary

Confidentiality Concerns Intervention 2 vs Not 2

Confidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Confidentiality Concerns Intervention 2 vs Not 22.42 units on a scaleStandard Deviation 1.15
Intervention 2Confidentiality Concerns Intervention 2 vs Not 22.68 units on a scaleStandard Deviation 1.16
Secondary

Confidentiality Concerns Intervention 3 vs Not 3

Confidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Confidentiality Concerns Intervention 3 vs Not 32.59 units on a scaleStandard Deviation 1.23
Intervention 2Confidentiality Concerns Intervention 3 vs Not 32.50 units on a scaleStandard Deviation 1.08
Secondary

Confidentiality Concerns Intervention 4 vs Not 4

Confidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Confidentiality Concerns Intervention 4 vs Not 42.50 units on a scaleStandard Deviation 1.16
Intervention 2Confidentiality Concerns Intervention 4 vs Not 42.59 units on a scaleStandard Deviation 1.17
Secondary

Confidentiality Concerns TAU vs Not TAU

Confidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Confidentiality Concerns TAU vs Not TAU3 units on a scaleStandard Deviation 1
Intervention 2Confidentiality Concerns TAU vs Not TAU2.53 units on a scaleStandard Deviation 1.16
Secondary

Depression Symptoms Intervention 1 vs Not 1

Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Depression Symptoms Intervention 1 vs Not 15.76 score on a scaleStandard Deviation 4.03
Intervention 2Depression Symptoms Intervention 1 vs Not 16.13 score on a scaleStandard Deviation 4.39
Secondary

Depression Symptoms Intervention 2 vs Not 2

Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Depression Symptoms Intervention 2 vs Not 26.13 score on a scaleStandard Deviation 4.69
Intervention 2Depression Symptoms Intervention 2 vs Not 25.76 score on a scaleStandard Deviation 3.66
Secondary

Depression Symptoms Intervention 3 vs Not 3

Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Depression Symptoms Intervention 3 vs Not 35.38 score on a scaleStandard Deviation 3.51
Intervention 2Depression Symptoms Intervention 3 vs Not 36.56 score on a scaleStandard Deviation 4.8
Secondary

Depression Symptoms Intervention 4 vs Not 4

Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Depression Symptoms Intervention 4 vs Not 46.00 score on a scaleStandard Deviation 4.12
Intervention 2Depression Symptoms Intervention 4 vs Not 45.89 score on a scaleStandard Deviation 4.32
Secondary

Depression Symptoms TAU vs Not TAU

Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Depression Symptoms TAU vs Not TAU4.33 score on a scaleStandard Deviation 3.51
Intervention 2Depression Symptoms TAU vs Not TAU6.01 score on a scaleStandard Deviation 4.22
Secondary

Expectance of Rejection Due to SGM Status Intervention 1 vs Not 1

Single-item yes/no and open ended question - asked about past 30 days

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention 1Expectance of Rejection Due to SGM Status Intervention 1 vs Not 18 Participants
Intervention 2Expectance of Rejection Due to SGM Status Intervention 1 vs Not 110 Participants
Secondary

Expectance of Rejection Due to SGM Status Intervention 2 vs Not 2

Single-item yes/no and open ended question - asked about past 30 days

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention 1Expectance of Rejection Due to SGM Status Intervention 2 vs Not 29 Participants
Intervention 2Expectance of Rejection Due to SGM Status Intervention 2 vs Not 29 Participants
Secondary

Expectance of Rejection Due to SGM Status Intervention 3 vs Not 3

Single-item yes/no and open ended question - asked about past 30 days

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention 1Expectance of Rejection Due to SGM Status Intervention 3 vs Not 310 Participants
Intervention 2Expectance of Rejection Due to SGM Status Intervention 3 vs Not 38 Participants
Secondary

Expectance of Rejection Due to SGM Status Intervention 4 vs Not 4

Single-item yes/no and open ended question - asked about past 30 days

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention 1Expectance of Rejection Due to SGM Status Intervention 4 vs Not 49 Participants
Intervention 2Expectance of Rejection Due to SGM Status Intervention 4 vs Not 49 Participants
Secondary

Expectance of Rejection Due to SGM Status TAU vs Not TAU

Single-item yes/no and open ended question - asked about past 30 days

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention 1Expectance of Rejection Due to SGM Status TAU vs Not TAU1 Participants
Intervention 2Expectance of Rejection Due to SGM Status TAU vs Not TAU17 Participants
Secondary

Internalized Homophobia - Intervention 1 vs Not 1

Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Internalized Homophobia - Intervention 1 vs Not 10.68 score on a scaleStandard Deviation 0.97
Intervention 2Internalized Homophobia - Intervention 1 vs Not 10.74 score on a scaleStandard Deviation 1.06
Secondary

Internalized Homophobia - Intervention 2 vs Not 2

Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Internalized Homophobia - Intervention 2 vs Not 20.76 score on a scaleStandard Deviation 1
Intervention 2Internalized Homophobia - Intervention 2 vs Not 20.65 score on a scaleStandard Deviation 1.03
Secondary

Internalized Homophobia - Intervention 3 vs Not 3

Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Internalized Homophobia - Intervention 3 vs Not 30.77 score on a scaleStandard Deviation 1.09
Intervention 2Internalized Homophobia - Intervention 3 vs Not 30.64 score on a scaleStandard Deviation 0.93
Secondary

Internalized Homophobia - Intervention 4 vs Not 4

Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. - asked about past 30 days min: 0, max: 7. Higher score indicates greater internalized homophobia

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Internalized Homophobia - Intervention 4 vs Not 40.68 score on a scaleStandard Deviation 0.93
Intervention 2Internalized Homophobia - Intervention 4 vs Not 40.73 score on a scaleStandard Deviation 1.1
Secondary

Internalized Homophobia - TAU vs Not TAU

Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale for the past 30 days. min: 0, max: 7. Higher score indicates greater internalized homophobia

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Internalized Homophobia - TAU vs Not TAU1.00 score on a scaleStandard Deviation 1.73
Intervention 2Internalized Homophobia - TAU vs Not TAU0.69 score on a scaleStandard Deviation 0.99
Secondary

Internalized Transphobia - Intervention 1 vs Not 1

Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia

Time frame: 1 month

Population: this is the population which identified as transgender/nonbinary/gender-diverse

ArmMeasureValue (MEAN)Dispersion
Intervention 1Internalized Transphobia - Intervention 1 vs Not 17.59 score on a scaleStandard Deviation 5.78
Intervention 2Internalized Transphobia - Intervention 1 vs Not 110.86 score on a scaleStandard Deviation 8.88
Secondary

Internalized Transphobia - Intervention 2 vs Not 2

Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia

Time frame: 1 month

Population: this is the population which identified as transgender/nonbinary/gender-diverse

ArmMeasureValue (MEAN)Dispersion
Intervention 1Internalized Transphobia - Intervention 2 vs Not 210.62 score on a scaleStandard Deviation 7.94
Intervention 2Internalized Transphobia - Intervention 2 vs Not 27.88 score on a scaleStandard Deviation 7.42
Secondary

Internalized Transphobia - Intervention 3 vs Not 3

Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia

Time frame: 1 month

Population: this is the population which identified as transgender/nonbinary/gender-diverse

ArmMeasureValue (MEAN)Dispersion
Intervention 1Internalized Transphobia - Intervention 3 vs Not 311.8 score on a scaleStandard Deviation 9.72
Intervention 2Internalized Transphobia - Intervention 3 vs Not 37.83 score on a scaleStandard Deviation 5.82
Secondary

Internalized Transphobia - Intervention 4 vs Not 4

Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia

Time frame: 1 month

Population: this is the population which identified as transgender/nonbinary/gender-diverse

ArmMeasureValue (MEAN)Dispersion
Intervention 1Internalized Transphobia - Intervention 4 vs Not 48.89 score on a scaleStandard Deviation 8.51
Intervention 2Internalized Transphobia - Intervention 4 vs Not 49.85 score on a scaleStandard Deviation 7.15
Secondary

Internalized Transphobia - TAU vs Not TAU

Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia

Time frame: 1 month

Population: this is the population which identified as transgender/nonbinary/gender-diverse

ArmMeasureValue (MEAN)Dispersion
Intervention 1Internalized Transphobia - TAU vs Not TAU7.00 score on a scaleStandard Deviation 1.41
Intervention 2Internalized Transphobia - TAU vs Not TAU9.53 score on a scaleStandard Deviation 7.92
Secondary

Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 1 vs Not 1

Actual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention 1Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 1 vs Not 115 Participants
Intervention 2Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 1 vs Not 116 Participants
Secondary

Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 2 vs Not 2

Actual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention 1Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 2 vs Not 216 Participants
Intervention 2Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 2 vs Not 215 Participants
Secondary

Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 3 vs Not 3

Actual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention 1Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 3 vs Not 318 Participants
Intervention 2Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 3 vs Not 313 Participants
Secondary

Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 4 vs Not 4

Actual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention 1Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 4 vs Not 416 Participants
Intervention 2Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 4 vs Not 415 Participants
Secondary

Receipt of Any Mental Health Treatment in Past 4 Weeks TAU vs Not TAU

Actual Help Seeking Questionnaire (Rickwood 2005) which does not involve scoring; list of whether help-seeking was sought from different individuals for mental health concerns

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention 1Receipt of Any Mental Health Treatment in Past 4 Weeks TAU vs Not TAU1 Participants
Intervention 2Receipt of Any Mental Health Treatment in Past 4 Weeks TAU vs Not TAU30 Participants
Secondary

Social Support - Intervention 1 vs. Not 1

The Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Social Support - Intervention 1 vs. Not 13.57 units on a scaleStandard Deviation 0.78
Intervention 2Social Support - Intervention 1 vs. Not 13.35 units on a scaleStandard Deviation 0.78
Secondary

Social Support - Intervention 2 vs. Not 2

The Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Social Support - Intervention 2 vs. Not 23.41 units on a scaleStandard Deviation 0.78
Intervention 2Social Support - Intervention 2 vs. Not 23.51 units on a scaleStandard Deviation 0.79
Secondary

Social Support - Intervention 3 vs. Not 3

The Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Social Support - Intervention 3 vs. Not 33.38 units on a scaleStandard Deviation 0.77
Intervention 2Social Support - Intervention 3 vs. Not 33.53 units on a scaleStandard Deviation 0.79
Secondary

Social Support - Intervention 4 vs. Not 4

The Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Social Support - Intervention 4 vs. Not 43.61 units on a scaleStandard Deviation 0.82
Intervention 2Social Support - Intervention 4 vs. Not 43.30 units on a scaleStandard Deviation 0.72
Secondary

Social Support - TAU vs Not TAU

The Medical Outcome Study Social Support Scale measures types of social support. Per item, options range from 1 to 5 with higher levels are associated with greater support. We will use the emotional/informational subscale from this report and instead of transforming to 0-100 like the original, we will use the untransformed mean score of the items which can range 1 to 5.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Intervention 1Social Support - TAU vs Not TAU3.54 units on a scaleStandard Deviation 1.08
Intervention 2Social Support - TAU vs Not TAU3.45 units on a scaleStandard Deviation 0.78
Other Pre-specified

12 Item Short Form Survey From the RAND Medical Outcomes Study (SF-12)

SF-12 (Jenkinson 1997). SF-12 survey generates two summary scores: a physical component score (pcs-12) and a mental component score (mcs-12). These scores are calculated using an algorithm that weighs the responses according to their contribution to the physical or mental health dimensions. The scores are then standardized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health status and lower scores worse health status. PCS-12 raw scores min is -3.37 and max is 69.68. MCS-12 raw scores min is -10.64 and max is 73.18

Time frame: 1 month

Other Pre-specified

Antidepressant Outcome Expectations

The Antidepressant Meanings Scale (Cohane, 2008) measures an individual's level of negative attitudes toward taking an antidepressant medication if prescribed. It is a continuous measure and the total score ranges from 0 to 24, with a higher score indicating more negative attitudes.

Time frame: 1 month

Other Pre-specified

Beliefs About Therapy

Barriers to Adolescents Seeking Help Scale-Brief Version (Wilson 2005/Kuhl 1997) measures perceptions about seeking treatment from a mental health provider. The total score ranges from 1 to 11, a higher score indicated greater barriers.

Time frame: 1 month

Other Pre-specified

Depression and Anxiety Knowledge

The Depression and Anxiety literacy questionnaires (Gulliver 2012) measures knowledge about depression and anxiety diagnosis and treatment. The total score ranges from 0-22, with a higher score indicating greater knowledge of depression. We will use a brief version of this scale.

Time frame: 1 month

Other Pre-specified

Help-Seeking Intention From Multiple Sources

The General Help Seeking Questionnaire (Rickwood, 2005) asks the likelihood of seeking help from a potential individual for a personal or emotional problem. A higher score per individual indicates a higher likelihood and intention to seek help from this source.

Time frame: 1 month

Other Pre-specified

Mental Health Stigma, Personal and Perceived

The Depression Stigma Scale (Griffiths 2004) measures stigmatizing attitudes toward depression treatment. It is a continuous measure and the total score ranges from 0-36. There are two subscales: the personal stigma subscale which totals 0-18 and the perceived stigma subscale which totals 0-18. These two are summed for the total stigma score. A higher score indicates a worse outcome.

Time frame: 1 month

Other Pre-specified

Perceived Need for Treatment

Open-ended question about whether adolescent thinks they need any mental health service

Time frame: 1 month

Other Pre-specified

Social Isolation

4-item version of revised UCLA Loneliness Scale. min: 4, max: 16. Higher score means greater levels of loneliness

Time frame: 1 month

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026