跳至主要内容
临床试验/NCT05541406
NCT05541406招募中不适用

Efficacy of a Multi-level School Intervention for LGBTQ Youth

Washington University School of Medicine66 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2022年9月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
228
试验地点
66
主要终点
Beck Anxiety Inventory (BAI)

研究概览

简要总结

Efficacy of a Multi-level School Intervention for LGBTQ Youth

详细描述

The goal of this R01 grant is to test the efficacy of a theoretically informed, LGBTQ-affirming intervention (Proud & Empowered; P&E) alongside a school climate intervention (Make Space).

Sexual and gender minority adolescents (SGMA) experience victimization in schools at much higher rates than their peers, and although SGMA experience disparities in behavioral health outcomes compared to their heterosexual peers, interventions are scarce.

The investigators P&E intervention aims to allow youth participants to discuss their experiences of bullying and victimization, to build coping skills and to plan stress management strategies, while the investigators Make Space intervention is an indirect, environmental strategy aimed at improving overall school climate. The investigators goal will be achieved by completing three specific aims: 1) Determine participant-level efficacy of the intervention in an RCT with 24 schools (6-10 schools each year over 4 years); 2) Determine the school-wide intervention effects on (a) reporting of minority stress and behavioral health outcomes among all SGMA students and (b) perceptions of school climate (norms, attitudes, beliefs, bullying behaviors toward SGM youth, policies) among all students, and; 3) Examine factors that may affect intervention success (e.g., fidelity of implementation, barriers or facilitators to implementation, school or student characteristics) to prepare the intervention for future dissemination. This intervention has been tested in a previous, smaller, Feasibility study with 4 high schools.

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
12 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • LGBTQ student in one of 24 high schools

排除标准

  • Not meeting inclusion criteria

研究组 & 干预措施

Intervention schools

Experimental

Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1.

干预措施: Proud & Empowered (Behavioral)

Control schools

Active Comparator

Students in control schools will receive no intervention

干预措施: Control Group (Behavioral)

结局指标

主要结局

Beck Anxiety Inventory (BAI)

时间窗: Change between baseline and post-intervention/follow-up (12 weeks)

21-item self-report assessment of anxiety symptoms. The total score is calculated by taking the sum of the 21 items. There are five responses an individual can choose from for each item, these being "Not at all" which is scored as a 1, "Mildly, but it didn't bother me much" which is scored as a 2, "Moderately -- It wasn't pleasant at times" which is scored as a 3, "Severely -- It bothered me a lot" which is scored as a 4, and "Decline to answer" which is scored as a 5. The total score ranges from 0-63. Higher values indicate higher self-reported anxiety: Score of 0-21 indicates low anxiety, Score of 22-35 indicates moderate anxiety, Scores of 36+ indicates potentially concerning levels of anxiety. Subscales are calculated through summation.

Coping Strategies Inventory

时间窗: Change between baseline and post-intervention/follow-up (12 weeks)

16-item assessment measuring specific coping strategies people use in response to stressful events. Individuals respond to 16 items, with each item assessing components of Problem Solving, Cognitive Restructuring, Social Support, Express Emotions, Problem Avoidance, Wishful Thinking, and Social Withdrawal. Individuals can respond in 5 different ways, these being "Never", "Seldom", "Sometimes", "Often", or "Almost Always". These responses are scored from 1-5 with "Never" being a 1 and "Almost Always" being a 5. The total score is a summation of item scores with a range from 16-80. Higher scores in a particular primary scale indicates that the individual implements that form of coping strategy more often.

Sexual Minority Stress Inventory

时间窗: Change between baseline and post-intervention/follow-up (12 weeks)

54-item survey across 10 domains of minority stress. Assesses experiences of minority stress among adolescents. Each statement reflects past-30-day thoughts, feelings, and situations a person may have experienced, with response options of 1 = yes and 0 = no. A total score was calculated by summing the 54 items. The total score ranged from 0-54. Higher values correspond to a worse outcome, meaning the individual in question has had more stressful experiences.

Beck Depression Inventory

时间窗: Change between baseline and post-intervention/follow-up (12 weeks)

21-item self-report assessment of depression symptoms and severity of depression. The items are rated on a 4-point scale ranging from 0-3 based on the severity of each item (e.g., 0=I do not feel sad, 1=I feel sad much of the time, 2=I am sad all the time, and 3=I am so sad or unhappy that I can't stand it). The total range of scores is from 0-63. Higher values indicate a worse outcome and indicates a greater severity of depression. Scores of 0-13 indicates minimal depression, scores of 14-19 indicates mild depression, scores of 20-28 indicates moderate depression, scores of 29-63 indicates severe depression. Subscale values are achieved through summation.

Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)

时间窗: Change between baseline and post-intervention/follow-up (12 weeks)

Six items assessing current suicidality that were adapted from the longer, treatment-based Columbia Suicide Severity Rating Scale. The first two items ask about passive ideation and active ideation, and affirmative responses link to follow-up questions about methods, intent, plans, and attempts. The scale is scored as follows: 0 = no to passive ideation and no to active ideation; 1 = yes to passive ideation (but no to active ideation); 2 = yes to active ideation (but no method, intent, plan); 3 = yes to method (but no intent or plan); 4 = yes to intent (but no plan); 5 = yes to plan; Attempts can be scored on its own or added to the overall scale for a risk score of 6 if participant has a recent suicide attempt.

PTSD Checklist for DSM-5 (PCL-5)

时间窗: Change between baseline and post-intervention/follow-up (12 weeks)

20-item self-report assessment of post-traumatic stress disorder (PTSD) symptoms which addresses all 20 DSM-5 symptoms of PTSD. A total symptom severity score can be calculated by summing the scores for each of the 20 items. Each item has five possible responses including "Not at all" which is scored as a 0, "A little bit" which is scored as a 1, "Moderately" which is scored as 2, "Quite a bit" which is scored as a 3, and "Extremely" which is scored as a 4. The potential range of scores is 0-80. Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.

次要结局

  • Youth Risk Behavior Survey Substance Use Questions(Change between baseline and post-intervention/follow-up (12 weeks))
  • California Healthy Kids Survey General Bullying and Gender Identity/Sexual Orientation-Based Harassment Module(Change between baseline and post-intervention/follow-up (12 weeks))

研究者

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

Harmony Rhoades

Research Associate Professor

Washington University School of Medicine

研究点 (66)

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