Sexual and Gender Minority Youth (SGMY) and Online Interventions to Increase Help-seeking for Anx… (NCT06083987) | Clinical Trial Compass
CompletedNot Applicable
Sexual and Gender Minority Youth (SGMY) and Online Interventions to Increase Help-seeking for Anxiety and/or Depression
United States81 participantsStarted 2024-03-08
Plain-language 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.
Who can participate
Age range
14 Years – 19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility - IP Use Proportion
Timeframe: Over one month
2
Feasibility - IP Use Days
Timeframe: Over one month
3
Feasibility - IP Use Time
Timeframe: Over one month
4
Usability
Timeframe: 1 month
5
Acceptability of the Intervention Principle
Timeframe: 1 month
6
Help-Seeking Intention From Counselor or Therapist - TAU vs Not TAU
Timeframe: 1 month
7
Help-Seeking Intention From Counselor or Therapist - Intervention 1 vs. Not 1
Timeframe: 1 month
8
Help-Seeking Intention From Counselor or Therapist - Intervention 2 vs. Not 2