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Completed

NCT Number: NCT06083987

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

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.

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Key information

Conditions

Anxiety Adolescent Behavior Anxiety Disorders Behavior Behavioral Symptoms Coitus Depression Mental Disorders Sexual Behavior Sexual and Gender Minorities

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virtual Social Media Based Recruitment

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intersectionality and Identity

Behavioral

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").

Confidentiality

Behavioral

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").

Educating Your Community

Behavioral

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").

How to find Affirming Caregivers

Behavioral

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").

Control Group - No Interventions

Behavioral

Control Group - Will be given no interventions

Primary outcomes

  1. Feasibility - IP Use Proportion

    Time frame: Over one month

    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)

  2. Feasibility - IP Use Days

    Time frame: Over one month

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

  3. Feasibility - IP Use Time

    Time frame: Over one month

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

  4. Usability

    Time frame: 1 month

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

  5. Acceptability of the Intervention Principle

    Time frame: 1 month

    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 )

  6. Help-Seeking Intention From Counselor or Therapist - TAU vs Not TAU

    Time frame: 1 month

    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

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

    Time frame: 1 month

    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

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

    Time frame: 1 month

    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

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

    Time frame: 1 month

    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

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

    Time frame: 1 month

    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

Secondary outcomes

  1. Social Support - TAU vs Not TAU

    Time frame: 1 month

    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.

  2. Social Support - Intervention 1 vs. Not 1

    Time frame: 1 month

    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.

  3. Social Support - Intervention 2 vs. Not 2

    Time frame: 1 month

    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.

  4. Social Support - Intervention 3 vs. Not 3

    Time frame: 1 month

    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.

  5. Social Support - Intervention 4 vs. Not 4

    Time frame: 1 month

    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.

  6. Internalized Homophobia - TAU vs Not TAU

    Time frame: 1 month

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

  7. Internalized Homophobia - Intervention 1 vs Not 1

    Time frame: 1 month

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

  8. Internalized Homophobia - Intervention 2 vs Not 2

    Time frame: 1 month

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

  9. Internalized Homophobia - Intervention 3 vs Not 3

    Time frame: 1 month

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

  10. Internalized Homophobia - Intervention 4 vs Not 4

    Time frame: 1 month

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

  11. Internalized Transphobia - TAU vs Not TAU

    Time frame: 1 month

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

  12. Internalized Transphobia - Intervention 1 vs Not 1

    Time frame: 1 month

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

  13. Internalized Transphobia - Intervention 2 vs Not 2

    Time frame: 1 month

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

  14. Internalized Transphobia - Intervention 3 vs Not 3

    Time frame: 1 month

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

  15. Internalized Transphobia - Intervention 4 vs Not 4

    Time frame: 1 month

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

  16. Expectance of Rejection Due to SGM Status TAU vs Not TAU

    Time frame: 1 month

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

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

    Time frame: 1 month

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

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

    Time frame: 1 month

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

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

    Time frame: 1 month

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

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

    Time frame: 1 month

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

  21. Confidentiality Concerns TAU vs Not TAU

    Time frame: 1 month

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

  22. Confidentiality Concerns Intervention 1 vs Not 1

    Time frame: 1 month

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

  23. Confidentiality Concerns Intervention 2 vs Not 2

    Time frame: 1 month

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

  24. Confidentiality Concerns Intervention 3 vs Not 3

    Time frame: 1 month

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

  25. Confidentiality Concerns Intervention 4 vs Not 4

    Time frame: 1 month

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

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

    Time frame: 1 month

    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

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

    Time frame: 1 month

    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

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

    Time frame: 1 month

    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

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

    Time frame: 1 month

    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

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

    Time frame: 1 month

    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

  31. Depression Symptoms TAU vs Not TAU

    Time frame: 1 month

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

  32. Depression Symptoms Intervention 1 vs Not 1

    Time frame: 1 month

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

  33. Depression Symptoms Intervention 2 vs Not 2

    Time frame: 1 month

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

  34. Depression Symptoms Intervention 3 vs Not 3

    Time frame: 1 month

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

  35. Depression Symptoms Intervention 4 vs Not 4

    Time frame: 1 month

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

  36. Anxiety Symptoms - TAU vs Not TAU

    Time frame: 1 month

    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.

  37. Anxiety Symptoms - Intervention 1 vs Not 1

    Time frame: 1 month

    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.

  38. Anxiety Symptoms - Intervention 2 vs Not 2

    Time frame: 1 month

    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.

  39. Anxiety Symptoms - Intervention 3 vs Not 3

    Time frame: 1 month

    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.

  40. Anxiety Symptoms - Intervention 4 vs Not 4

    Time frame: 1 month

    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.

Other outcomes

  1. Social Isolation

    Time frame: 1 month

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

  2. Antidepressant Outcome Expectations

    Time frame: 1 month

    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.

  3. Beliefs About Therapy

    Time frame: 1 month

    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.

  4. 12 Item Short Form Survey From the RAND Medical Outcomes Study (SF-12)

    Time frame: 1 month

    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

  5. Mental Health Stigma, Personal and Perceived

    Time frame: 1 month

    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.

  6. Perceived Need for Treatment

    Time frame: 1 month

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

  7. Help-Seeking Intention From Multiple Sources

    Time frame: 1 month

    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.

  8. Depression and Anxiety Knowledge

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 16, 2023
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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