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临床试验/NCT06083987
NCT06083987已完成不适用

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

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2024年3月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
Usability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Control Group - No Interventions

Active Comparator

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

干预措施: Control Group - No Interventions (Behavioral)

Intervention 1 - Intersectionality and Identity

Experimental

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

干预措施: Intersectionality and Identity (Behavioral)

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

Experimental

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

干预措施: Intersectionality and Identity (Behavioral)

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

Experimental

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

干预措施: Confidentiality (Behavioral)

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

Experimental

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

干预措施: Confidentiality (Behavioral)

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

Experimental

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

干预措施: Educating Your Community (Behavioral)

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

Experimental

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

干预措施: Intersectionality and Identity (Behavioral)

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

Experimental

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

干预措施: How to find Affirming Caregivers (Behavioral)

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

Experimental

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

干预措施: Intersectionality and Identity (Behavioral)

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

Experimental

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

干预措施: Confidentiality (Behavioral)

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

Experimental

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

干预措施: Intersectionality and Identity (Behavioral)

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

Experimental

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

干预措施: Confidentiality (Behavioral)

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

Experimental

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

干预措施: Educating Your Community (Behavioral)

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

Experimental

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

干预措施: How to find Affirming Caregivers (Behavioral)

Interventions 1 and 3 - Intersectionality and Identity/Educational Tools

Experimental

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

干预措施: Intersectionality and Identity (Behavioral)

Interventions 1 and 3 - Intersectionality and Identity/Educational Tools

Experimental

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

干预措施: Educating Your Community (Behavioral)

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

Experimental

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.

干预措施: Intersectionality and Identity (Behavioral)

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

Experimental

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.

干预措施: Educating Your Community (Behavioral)

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

Experimental

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.

干预措施: How to find Affirming Caregivers (Behavioral)

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

Experimental

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.

干预措施: Intersectionality and Identity (Behavioral)

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

Experimental

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.

干预措施: How to find Affirming Caregivers (Behavioral)

Intervention 2 - Confidentiality and Privacy

Experimental

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

干预措施: Confidentiality (Behavioral)

Interventions 2 and 3 - Confidentiality and Privacy/Educational Tools

Experimental

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

干预措施: Confidentiality (Behavioral)

Interventions 2 and 3 - Confidentiality and Privacy/Educational Tools

Experimental

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

干预措施: Educating Your Community (Behavioral)

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

Experimental

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.

干预措施: Confidentiality (Behavioral)

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

Experimental

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.

干预措施: Educating Your Community (Behavioral)

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

Experimental

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.

干预措施: How to find Affirming Caregivers (Behavioral)

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

Experimental

Arm 13 will be given access to interventions 2 and 4. Video and text content will focus on confidentiality and determining if caregivers are affirming.

干预措施: Confidentiality (Behavioral)

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

Experimental

Arm 13 will be given access to interventions 2 and 4. Video and text content will focus on confidentiality and determining if caregivers are affirming.

干预措施: How to find Affirming Caregivers (Behavioral)

Intervention 3 - Educational Tools

Experimental

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

干预措施: Educating Your Community (Behavioral)

Interventions 3 and 4 - Educational Tools/Finding Affirming Care

Experimental

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.

干预措施: Educating Your Community (Behavioral)

Interventions 3 and 4 - Educational Tools/Finding Affirming Care

Experimental

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.

干预措施: How to find Affirming Caregivers (Behavioral)

Intervention 4 - Finding Affirming Care

Experimental

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

干预措施: How to find Affirming Caregivers (Behavioral)

结局指标

主要结局

Usability

时间窗: 1 month

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

Acceptability of the Intervention Principle

时间窗: 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 )

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

时间窗: 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

Feasibility - IP Use Proportion

时间窗: 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)

Feasibility - IP Use Days

时间窗: Over one month

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

Feasibility - IP Use Time

时间窗: Over one month

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

Usability

时间窗: 1 month

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

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

时间窗: 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

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

时间窗: 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

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

时间窗: 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

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

时间窗: 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

次要结局

  • Depression Symptoms Intervention 3 vs Not 3(1 month)
  • Confidentiality Concerns Intervention 3 vs Not 3(1 month)
  • Social Support - TAU vs Not TAU(1 month)
  • Social Support - Intervention 1 vs. Not 1(1 month)
  • Social Support - Intervention 2 vs. Not 2(1 month)
  • Confidentiality Concerns Intervention 4 vs Not 4(1 month)
  • Social Support - Intervention 3 vs. Not 3(1 month)
  • Social Support - Intervention 4 vs. Not 4(1 month)
  • Internalized Homophobia - TAU vs Not TAU(1 month)
  • Internalized Homophobia - Intervention 1 vs Not 1(1 month)
  • Internalized Homophobia - Intervention 2 vs Not 2(1 month)
  • Internalized Homophobia - Intervention 3 vs Not 3(1 month)
  • Internalized Homophobia - Intervention 4 vs Not 4(1 month)
  • Internalized Transphobia - TAU vs Not TAU(1 month)
  • Internalized Transphobia - Intervention 1 vs Not 1(1 month)
  • Internalized Transphobia - Intervention 2 vs Not 2(1 month)
  • Internalized Transphobia - Intervention 3 vs Not 3(1 month)
  • Internalized Transphobia - Intervention 4 vs Not 4(1 month)
  • Expectance of Rejection Due to SGM Status TAU vs Not TAU(1 month)
  • Expectance of Rejection Due to SGM Status Intervention 1 vs Not 1(1 month)
  • Expectance of Rejection Due to SGM Status Intervention 2 vs Not 2(1 month)
  • Expectance of Rejection Due to SGM Status Intervention 3 vs Not 3(1 month)
  • Expectance of Rejection Due to SGM Status Intervention 4 vs Not 4(1 month)
  • Confidentiality Concerns TAU vs Not TAU(1 month)
  • Confidentiality Concerns Intervention 1 vs Not 1(1 month)
  • Confidentiality Concerns Intervention 2 vs Not 2(1 month)
  • Receipt of Any Mental Health Treatment in Past 4 Weeks TAU vs Not TAU(1 month)
  • Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 1 vs Not 1(1 month)
  • Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 2 vs Not 2(1 month)
  • Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 3 vs Not 3(1 month)
  • Receipt of Any Mental Health Treatment in Past 4 Weeks Intervention 4 vs Not 4(1 month)
  • Depression Symptoms TAU vs Not TAU(1 month)
  • Depression Symptoms Intervention 1 vs Not 1(1 month)
  • Depression Symptoms Intervention 2 vs Not 2(1 month)
  • Depression Symptoms Intervention 4 vs Not 4(1 month)
  • Anxiety Symptoms - TAU vs Not TAU(1 month)
  • Anxiety Symptoms - Intervention 1 vs Not 1(1 month)
  • Anxiety Symptoms - Intervention 2 vs Not 2(1 month)
  • Anxiety Symptoms - Intervention 3 vs Not 3(1 month)
  • Anxiety Symptoms - Intervention 4 vs Not 4(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Radovic

Assistant professor

University of Pittsburgh

研究点 (1)

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