跳至主要内容
临床试验/NCT06587139
NCT06587139已完成不适用

An Online Mentoring Program to Prevent Adversities Among Trans and Other Gender Minority Youth (PILOT RCT PHASE)

University of Michigan2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年7月22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
56
试验地点
2
主要终点
Alcohol Use (Youth-reported)

研究概览

简要总结

The purpose of this project is to develop and evaluate an online mentoring and skill-building program for transgender and/or gender minority youth (TGMY) ages 14 to 18, the Teen Connection Project (TCP). The TCP includes seven 90-minute sessions facilitated by transgender and/or gender minority (TGM) adults (who are also mentors). TGMY will be paired with a TGM adult mentor, based on their shared interests. Mentors and mentees will participate together in each session along with other mentors and mentees. Mentors will direct activities and discussion to promote TGMY social-emotional skills. The TCP sessions will include one-on-one mentor-mentee break-out sessions.

详细描述

Transgender and/or gender minority youth (TGMY) (i.e., any identity other than cisgender) experience concerning rates of mental health problems, self-harm, alcohol and drug use, sexual risk-taking, and violence victimization and perpetration. Minority stress theory states that peer and family rejection and internalized transphobia predict negative health outcomes in TGMY. This highlights the urgent need to identify effective programs that prevent psychosocial and behavioral health issues among TGMY. Mentoring programs may be especially impactful for TGMY, given that these programs may help alleviate adverse outcomes associated with peer and family rejection, and promote self-acceptance among TGMY. However, few mentoring programs exist specifically for TGMY, and those that do have not been rigorously evaluated; often require guardian permission; generally occur in person via community organizations--which excludes TGMY in high stigma, rural areas of the United States from participating; and rarely include evidence-based skill-building components (e.g., social-emotional skills).

The specific aims of this trial are as follow:

  1. Assess acceptability and feasibility of the Teen Connection Project (TCP) through observations (to evaluate program delivery and observe mentor-mentee interactions), post-session surveys, and exit interviews with participants.
  2. Generate preliminary data on the TCP's efficacy in reducing psychosocial and behavioral health issues facing TGMY, including mental health problems, self-harm, alcohol and drug use, sexual risk-taking, and teen dating violence.
  3. Identify treatment options for TGMY.

The purpose of this project is to develop and evaluate an online mentoring and skill-building program for transgender and/or gender minority youth (TGMY) ages 14 to 18, the Teen Connection Project (TCP). The TCP includes seven 90-minute sessions facilitated by transgender and/or gender minority (TGM) adults (who are also mentors). TGMY will be paired with a TGM adult mentors, based on their shared interests. Mentors and mentees will participate together in each session, along with other mentors and mentees. Mentors will direct activities and discussion to promote TGMY social-emotional skills. The TCP sessions will include one-on-one mentor-mentee break-out sessions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • identify as transgender and/or gender minority youth (TGMY) (i.e., any identity other than cisgender)
  • be between the ages of 14 to 18 years
  • read and speak English
  • live in the United States
  • report consistent access to a phone, tablet, and/or computer with high-speed internet access/Wi-Fi (which represents 90+% of youth in the United States)
  • report an ability to attend seven, 90-minute online sessions at pre-determined times
  • pass an assent quiz
  • report moderate to high levels of internalized transphobia

排除标准

  • be at imminent risk for suicide (e.g., intent to kill themselves in the immediate future) as determined by an initial online suicide screening regarding their past month suicide risk (the Suicide Behaviors Questionnaire-Revised [SBQ-R]; modified to assess past month risk)
  • demonstrate current psychosis as determined by the Prodromal Questionnaire; modified to just focus on visual and auditory symptoms
  • Inclusion Criteria for Mentors:
  • be 30 years old or older
  • identify as transgender and/or gender minority (i.e., any identity other than cisgender)
  • Exclusion Criteria for Mentors:
  • not be currently experiencing substance use disorder or mental health challenges

研究组 & 干预措施

Treatment

Experimental

The Teen Connection Project (TCP) is theoretically grounded, and follows best practices for effective health behavior prevention. It includes seven 90-minute sessions with group and one-on-one mentoring components. The intervention is facilitated by transgender and/or gender minority adults (i.e., any identity other than cisgender).

干预措施: Teen Connection Project (TCP) (Behavioral)

Waitlist control

No Intervention

Provide check-ins, provide resources, and offer program after intervention and measurement has been completed.

Mentors

No Intervention

Mentors complete a two-day training and post-training survey, facilitate programming, and complete post-session surveys. A subset of the mentors will complete exit interviews.

结局指标

主要结局

Alcohol Use (Youth-reported)

时间窗: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Youth Risk Behavior Survey Questionnaire (YRBSS). Minimum Value = 0, Maximum Value = 6, Higher scores = worse outcomes

Drug Use (Youth-reported)

时间窗: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

YRBSS. Minimum Value = 0, Maximum Value = 5, Higher scores = worse outcomes

Sexual Risk-Taking (Youth-reported)

时间窗: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Researcher-created items, adapted items with input from a youth advisory board from, YRBSS, and Sexual Risk Taking Survey. Minimum Value = 1, Maximum Value = 7, Higher scores = worse outcomes

Dating and Sexual Violence (DSV) victimization-1 (Youth-reported)

时间窗: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Measure of Adolescent Relationship Harassment and Abuse (MARSHA). Minimum Value = 0, Maximum Value = 3, Higher scores = worse outcomes

DSV perpetration-1 (Youth-reported)

时间窗: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

MARSHA. Minimum Value = 0, Maximum Value = 3, Higher scores = worse outcomes

DSV victimization-2 (Youth-reported)

时间窗: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

CTS-2: SGM-Specific Intimate partner Violence (IPV) Tactics Scale \[CTS = Conflict Tactics Scale, SGM = sexual and gender minority\]. Minimum Value = 0, Maximum value = 3, Higher scores = worse outcomes

DSV perpetration-2 (Youth-reported)

时间窗: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

CTS-2: SGM-Specific IPV Tactics Scale. Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes

Depressive symptoms (Youth-reported)

时间窗: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Patient Health Questionnaire for Adolescents (PHQ-9). Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes

Anxiety symptoms (Youth-reported)

时间窗: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Generalized Anxiety Disorder Screener (GAD-7). Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes

Suicidality (Youth-reported)

时间窗: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Suicidal Ideation Attributes Scale (SIDAS). Minimum Value = 0, Maximum Value = 10, Higher scores = Better outcomes

次要结局

未报告次要终点

研究者

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

Katie M Edwards

Professor, School of Social Work Director, Interpersonal Violence Research Laboratory (IVRL)

University of Michigan

研究点 (2)

Loading locations...

相似试验