Clinical trial NCT06083987: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Adolescent Behavior
Sexual and Gender Minorities
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-10-16
Enrollment: 96
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 96 participants randomly assigned to one of the 16 combinations of the four study intervention principles
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Feasibility - IP use proportion
timeFrame: Over one month
measure: Feasibility - IP use days
timeFrame: Over one month
measure: Feasibility - IP use time
timeFrame: Over one month
measure: Usability
timeFrame: 1 month
measure: Acceptability of the intervention Principle
timeFrame: 1 month
measure: Help-Seeking Intention from Counselor or Therapist
timeFrame: 1 month
Secondary outcomes:
measure: Help-Seeking Intention from Multiple Sources
timeFrame: 1 month
measure: Perceived Need for Treatment
timeFrame: 1 month
measure: Social Support
timeFrame: 1 month
measure: Anxiety
timeFrame: 1 month
measure: Depression
timeFrame: 1 month
measure: Mental Health Stigma, Personal and Perceived
timeFrame: 1 month
measure: Antidepressant Outcome Expectations
timeFrame: 1 month
measure: Beliefs about therapy
timeFrame: 1 month
measure: Depression and Anxiety Knowledge
timeFrame: 1 month
measure: Expectance of rejection due to SGM status
timeFrame: 1 month
measure: Confidentiality Concerns
timeFrame: 1 month
measure: Receipt of any mental health treatment in past 4 weeks
timeFrame: 1 month
measure: 12 Item Short Form Survay from the RAND Medical Outcomes Study (SF-12)
timeFrame: 1 month
measure: Social Isolation
timeFrame: 1 month
measure: Internalized Homophobia
timeFrame: 1 month
measure: Internalized Transphobia
timeFrame: 1 month
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Virtual Social Media Based Recruitment
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh/UPMC
name: Ana Radovic, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: