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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083987
• Other study ID #: STUDY22070134
• Secondary ID: 5R21MD015806-02
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: Ana Radovic, MD, MSc
• Phone: 4126927227
• Email: ana.radovic[@]chp.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Anxiety
• Depression
• Depressive Disorder

Intervention

Behavioral:
• 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").
• 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").
• 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").
• 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").
• Control Group - No Interventions
Control Group - Will be given no interventions

Locations

Country	Name	City	State
United States	Virtual Social Media Based Recruitment	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - IP use proportion	Proportion of IP components completed	Over one month
Primary	Feasibility - IP use days	Proportion of days IP is used (number of sessions over total offered)	Over one month
Primary	Feasibility - IP use time	Average length of time IP is used (length of session)	Over one month
Primary	Usability	System Usability Scale, min: 0, Max: 100, higher scores mean better usability	1 month
Primary	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 )	1 month
Primary	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	1 month
Secondary	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.	1 month
Secondary	Perceived Need for Treatment	Open-ended question about whether adolescent thinks they need any mental health service	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	Depression	Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	Expectance of rejection due to SGM status	Single-item yes/no and open ended question	1 month
Secondary	Confidentiality Concerns	Confidentiality item from BASH-B scale, min: 1, max: 6, higher score means individual agrees that a therapist would not maintain confidentiality	1 month
Secondary	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	1 month
Secondary	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	1 month
Secondary	Social Isolation	4-item version of revised UCLA Loneliness Scale. min: 4, max: 16. Higher score means greater levels of loneliness	1 month
Secondary	Internalized Homophobia	Sexual Minority Adolescent Stress Inventory Internalized homonegativity subscale. min: 0, max: 7. Higher score indicates greater internalized homophobia	1 month
Secondary	Internalized Transphobia	Gender Minority Stress and Resilience Measure. min: 0, max: 40. Higher score indicates greater internalized transphobia	1 month