search
Back to results

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

Primary Purpose

Anxiety, Depression, Adolescent Behavior

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intersectionality and Identity
Confidentiality
Educating Your Community
How to find Affirming Caregivers
Control Group - No Interventions
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anxiety

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm 13

    Arm 14

    Arm 15

    Arm 16

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Control Group - No Interventions

    Intervention 1 - Intersectionality and Identity

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

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

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

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

    Interventions 1 and 3 - Intersectionality and Identity/Educational Tools

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

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

    Intervention 2 - Confidentiality and Privacy

    Interventions 2 and 3 - Confidentiality and Privacy/Educational Tools

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

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

    Intervention 3 - Educational Tools

    Interventions 3 and 4 - Educational Tools/Finding Affirming Care

    Intervention 4 - Finding Affirming Care

    Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

    Arm 13 will be given access to interventions 1, 3, and 4. Video and text content will focus on confidentiality and determining if caregivers are affirming.

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

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

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

    Outcomes

    Primary Outcome Measures

    Feasibility - IP use proportion
    Proportion of IP components completed
    Feasibility - IP use days
    Proportion of days IP is used (number of sessions over total offered)
    Feasibility - IP use time
    Average length of time IP is used (length of session)
    Usability
    System Usability Scale, min: 0, Max: 100, higher scores mean better usability
    Acceptability of the intervention Principle
    Open-ended questions about whether IP was 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 )
    Help-Seeking Intention from Counselor or Therapist
    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

    Secondary Outcome Measures

    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.
    Perceived Need for Treatment
    Open-ended question about whether adolescent thinks they need any mental health service
    Social Support
    The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. This subscale ranges from 0-100, with higher levels associated with greater support. We will use the emotional/informational subscale from this report.
    Anxiety
    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.
    Depression
    Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.
    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.
    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.
    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.
    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.
    Expectance of rejection due to SGM status
    Single-item yes/no and open ended question
    Confidentiality Concerns
    Confidentiality 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
    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
    12 Item Short Form Survay 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
    Social Isolation
    4-item version of revised UCLA Loneliness Scale. min: 4, max: 16. Higher score means greater levels of loneliness
    Internalized Homophobia
    Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. min: 0, max: 7. Higher score indicates greater internalized homophobia
    Internalized Transphobia
    Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia

    Full Information

    First Posted
    September 27, 2023
    Last Updated
    October 10, 2023
    Sponsor
    University of Pittsburgh
    Collaborators
    National Institute on Minority Health and Health Disparities (NIMHD)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06083987
    Brief Title
    Sexual and Gender Minority Youth (SGMY) and Online Interventions to Increase Help-seeking for Anxiety and/or Depression
    Official Title
    Optimizing Technology Interventions for Help-Seeking for Depression and Suicidality in Sexual and Gender Minority Youth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 23, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pittsburgh
    Collaborators
    National Institute on Minority Health and Health Disparities (NIMHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Depression, Adolescent Behavior, Sexual and Gender Minorities

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    96 participants randomly assigned to one of the 16 combinations of the four study intervention principles
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group - No Interventions
    Arm Type
    Active Comparator
    Arm Description
    Arm 1 will have not be given any of the interventions and will be a control group.
    Arm Title
    Intervention 1 - Intersectionality and Identity
    Arm Type
    Experimental
    Arm Description
    Arm 2 will be given access to intervention 1. It will have video and text content focused on identity and intersectionality.
    Arm Title
    Interventions 1 and 2 - Intersectionality and Identity/Confidentiality and Privacy
    Arm Type
    Experimental
    Arm Description
    Arm 3 will be given access to with the video and text content focused on intersectionality and confidentiality
    Arm Title
    Interventions 1, 2, and 3 - Intersectionality/Confidentiality/Educational Tools
    Arm Type
    Experimental
    Arm Description
    Arm 4 will be given access to with the video and text content focused on intersectionality, confidentiality, and education about identity
    Arm Title
    Interventions 1, 2, and 4 - Intersectionality/Confidentiality/Finding Affirming Care
    Arm Type
    Experimental
    Arm Description
    Arm 5 will be given access to interventions 1, 2, and 4, with the video and text content focused on intersectionality, confidentiality, and determining if caregivers are affirming
    Arm Title
    Interventions 1, 2, 3 and 4 - Intersectionality/Confidentiality/Educational Tools/Affirming Care
    Arm Type
    Experimental
    Arm Description
    Arm 6 will be given access to all 4 interventions, with the video and text content focused on intersectionality, confidentiality, education about identity, and determining if caregivers are affirming
    Arm Title
    Interventions 1 and 3 - Intersectionality and Identity/Educational Tools
    Arm Type
    Experimental
    Arm Description
    Arm 7 will be given access to interventions 1 and 3, with the video and text content focused on intersectionality and education about identity
    Arm Title
    Interventions 1, 3, and 4 - Intersectionality and Identity/Educational Tools/Finding Affirming Care
    Arm Type
    Experimental
    Arm Description
    Arm 8 will be given access to interventions 1, 3, and 4, with the video and text content focused on intersectionality, education about identity and determining if caregivers are affirming.
    Arm Title
    Interventions 1 and 4 - Intersectionality and Identity/Finding Affirming Care
    Arm Type
    Experimental
    Arm Description
    Arm 9 will be given access to interventions 1 and 4, with the video and text content focused on intersectionality and determining if caregivers are affirming.
    Arm Title
    Intervention 2 - Confidentiality and Privacy
    Arm Type
    Experimental
    Arm Description
    Arm 10 will be given access to intervention 2, with the video and text content focused on confidentiality
    Arm Title
    Interventions 2 and 3 - Confidentiality and Privacy/Educational Tools
    Arm Type
    Experimental
    Arm Description
    Arm 11 will be given access to interventions 2, and 3. Video and text content will focus on confidentiality and education about identity.
    Arm Title
    Interventions 2, 3 and 4 - Confidentiality and Privacy/Educational Tools/Finding Affirming Care
    Arm Type
    Experimental
    Arm Description
    Arm 12 will be given access to interventions 2, 3, and 4. Video and text content will focus on confidentiality, education about identity, and determine if caregivers are affirming.
    Arm Title
    Interventions 2 and 4 - Confidentiality and Privacy/Finding Affirming Care
    Arm Type
    Experimental
    Arm Description
    Arm 13 will be given access to interventions 1, 3, and 4. Video and text content will focus on confidentiality and determining if caregivers are affirming.
    Arm Title
    Intervention 3 - Educational Tools
    Arm Type
    Experimental
    Arm Description
    Arm 14 will be given access to intervention 3. Video and text content will focus on education about identity
    Arm Title
    Interventions 3 and 4 - Educational Tools/Finding Affirming Care
    Arm Type
    Experimental
    Arm Description
    Arm 15 will be given access to interventions 3 and 4. Video and text content will focus on educational tools about identity and determining if caregivers are affirming.
    Arm Title
    Intervention 4 - Finding Affirming Care
    Arm Type
    Experimental
    Arm Description
    Arm 16 will be given access to intervention 4, with video and text content focusing on determining if caregivers are affirming.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intersectionality and Identity
    Intervention Description
    Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of intersectionality and identity. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").
    Intervention Type
    Behavioral
    Intervention Name(s)
    Confidentiality
    Intervention Description
    Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on Confidentiality for caregivers. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educating Your Community
    Intervention Description
    Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of the education of family and friends about identity. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").
    Intervention Type
    Behavioral
    Intervention Name(s)
    How to find Affirming Caregivers
    Intervention Description
    Participants will use the computer application, Discord, a social media site that allows for sharing of content and interaction with other people in a variety of forms (video chat, direct messaging, and talking in group chat areas). We will be using the group chat function to set up discussion forums where there will be video and text resources focused on matters of finding affirming caregivers. Participants will do at least one activity from three types each week for four weeks. The three activity types will have the participants engage with the content and then either discuss it in the forum ("Talk about it"), write a review about the content discussing why/why not they like it ("Rate it"), or Attempt to use the knowledge or skills to accomplish a task offline ("Try it").
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control Group - No Interventions
    Intervention Description
    Control Group - Will be given no interventions
    Primary Outcome Measure Information:
    Title
    Feasibility - IP use proportion
    Description
    Proportion of IP components completed
    Time Frame
    Over one month
    Title
    Feasibility - IP use days
    Description
    Proportion of days IP is used (number of sessions over total offered)
    Time Frame
    Over one month
    Title
    Feasibility - IP use time
    Description
    Average length of time IP is used (length of session)
    Time Frame
    Over one month
    Title
    Usability
    Description
    System Usability Scale, min: 0, Max: 100, higher scores mean better usability
    Time Frame
    1 month
    Title
    Acceptability of the intervention Principle
    Description
    Open-ended questions about whether IP was 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
    Title
    Help-Seeking Intention from Counselor or Therapist
    Description
    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
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Help-Seeking Intention from Multiple Sources
    Description
    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
    Title
    Perceived Need for Treatment
    Description
    Open-ended question about whether adolescent thinks they need any mental health service
    Time Frame
    1 month
    Title
    Social Support
    Description
    The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. This subscale ranges from 0-100, with higher levels associated with greater support. We will use the emotional/informational subscale from this report.
    Time Frame
    1 month
    Title
    Anxiety
    Description
    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
    Title
    Depression
    Description
    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
    Title
    Mental Health Stigma, Personal and Perceived
    Description
    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
    Title
    Antidepressant Outcome Expectations
    Description
    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
    Title
    Beliefs about therapy
    Description
    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
    Title
    Depression and Anxiety Knowledge
    Description
    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
    Title
    Expectance of rejection due to SGM status
    Description
    Single-item yes/no and open ended question
    Time Frame
    1 month
    Title
    Confidentiality Concerns
    Description
    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
    Title
    Receipt of any mental health treatment in past 4 weeks
    Description
    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
    Title
    12 Item Short Form Survay from the RAND Medical Outcomes Study (SF-12)
    Description
    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
    Title
    Social Isolation
    Description
    4-item version of revised UCLA Loneliness Scale. min: 4, max: 16. Higher score means greater levels of loneliness
    Time Frame
    1 month
    Title
    Internalized Homophobia
    Description
    Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. min: 0, max: 7. Higher score indicates greater internalized homophobia
    Time Frame
    1 month
    Title
    Internalized Transphobia
    Description
    Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ana Radovic, MD, MSc
    Phone
    4126927227
    Email
    ana.radovic@chp.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Caia Smith, MSW
    Email
    smithc77@upmc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana Radovic, MD, MSc
    Organizational Affiliation
    University of Pittsburgh/UPMC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Trial outcome data can be accessed by contacting the study principal investigator.
    IPD Sharing Time Frame
    Upon Completion of the study (estimated June 2024) and it will be available indefinitely via contacting Dr. Radovic
    IPD Sharing Access Criteria
    Completed Data and results will be fully available upon request to any interested parties via email

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs