Providing LGBTQ+ Adolescents With Nurturance, Trustworthiness, and Safety (PLANTS): Pilot Cluster-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Mean Value of Acceptability of Intervention Measure
研究概览
简要总结
This pilot cluster-randomized controlled trial will evaluate the PLANTS (Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety) course among high school staff. The primary hypotheses are that the PLANTS course will have high acceptability, usability, appropriateness, and feasibility as reported by high school staff.
详细描述
The intervention being studied, PLANTS, is an online-delivered training program, including asynchronous and synchronous activities targeting high school staff. This intervention is informed by the Information-Motivation-Behavior theory to target high school staffs' skills, self-efficacy, knowledge, and outcome expectations. Members of the study population as well as collaborators invested in Sexual and Gender Minority Youth (SGMY) well-being provided valuable feedback on PLANTS throughout its development. Comparison schools will receive the email-based control intervention, E-learning to Maximize Academic Inclusion of LGBTQ+ Students (EMAILS). Staff will receive periodic emails with publicly available resources on similar topics to those of PLANTS.
Regarding the intervention's targeted behavioral outcomes, upon completion of the PLANTS program, high school staff will: provide interpersonal support and affirmation to SGMY; provide educational resources that are inclusive of SGMY; provide safe spaces for SGMY; promote acceptance of SGMY among cisgender heterosexual youth; prevent and reduce bullying, cyberbullying, and harassment of SGMY; evaluate and advocate for SGMY inclusivity and protections in school policies; and maintain the confidentiality of SGMY. By having high school staff achieve these behavioral outcomes, the investigators hypothesize that SGMY will experience less risk factors (e.g., bullying victimization) and more protective factors (e.g., school-based adult support), which will in turn reduce SGMY's substance use and mental health problems.
The primary aim of this clinical trial is to rigorously test the acceptability, usability, appropriateness, and feasibility of the PLANTS intervention using a 2-armed cluster-randomized controlled trial. The investigators will also examine the efficacy of intervention in improving high school staff outcomes as well as implementation and safety outcomes related to the intervention and trial. Results from this pilot trial will provide necessary information to conduct a fully powered trial of the efficacy of PLANTS for reducing the ultimate health outcome of SGMY alcohol use.
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
盲法说明
This is an unblinded study. This is an educational intervention that cannot be blinded because study participants will be able to tell which condition they are in based on the content they receive.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently employed by an enrolled school in the MetroWest Region of Boston, Massachusetts
- •Age 18 years old or older
- •Consents to participate
排除标准
- •Does not interact with high school students at work
研究组 & 干预措施
PLANTS
Schools will receive the online-delivered PLANTS intervention, which includes 3 asynchronous training modules and 3 synchronous group events.
干预措施: PLANTS (Behavioral)
EMAILS
Comparison schools will receive emails with publicly available resources for supporting LGBTQ+ students as a control intervention.
干预措施: EMAILS (Behavioral)
结局指标
主要结局
Mean Value of Acceptability of Intervention Measure
时间窗: Approximately 4 months after intervention deployment
At follow-up, participants will complete the four-question Acceptability of Intervention Measure (AIM) about PLANTS. Each question uses a five-point Likert scale for responses, coded with a value from 1 (Completely disagree) to 5 (Completely agree) and averaged to produce the mean acceptability value. The minimum possible mean value is 1 and the maximum mean value is 5. The higher the computed mean value, the more acceptable the intervention.
Mean Score on the System Usability Scale
时间窗: Approximately 4 months after intervention deployment
At follow-up, participants will complete the ten-question System Usability Scale (SUS) about PLANTS. Each question uses a five-point Likert scale for responses, coded with a value from 1 (Strongly agree) to 5 (Strongly disagree). The odd-numbered question responses will be reverse coded. All items will be summed and that sum will be multiplied by 2.5 to produce the final SUS value (ranging from 0-100). The higher the computed value, the more useable the intervention.
Mean Value of Intervention Appropriateness Measure
时间窗: Approximately 4 months after intervention deployment
At follow-up, participants will complete the four-question Intervention Appropriateness Measure (IAM) about PLANTS. Each question uses a five-point Likert scale for responses, coded with a value from 1 (Completely disagree) to 5 (Completely agree) and averaged to produce the mean appropriateness value. The minimum possible mean value is 1 and the maximum mean value is 5. The higher the computed mean value, the more appropriate the intervention.
Mean Value of Feasibility of Intervention Measure
时间窗: Approximately 4 months after intervention deployment
At follow-up, participants will complete the four-question Feasibility of Intervention Measure (FIM) about PLANTS. Each question uses a five-point Likert scale for responses, coded with a value from 1 (Completely disagree) to 5 (Completely agree) and averaged to produce the mean feasibility value. The minimum possible mean value is 1 and the maximum mean value is 5. The higher the computed mean value, the more feasible the intervention.
次要结局
- Trial Participation Rate(Baseline)
- Trial Retention Rate(At follow-up (approximately 4 months after baseline))
- Intervention Demand(At follow-up (approximately 4 months after baseline))
- Change in Mean Scores on the Active-Empathic Listening Scale(Baseline and follow-up (approximately 4 months after baseline))
- Change in Mean Scores on Self-efficacy Change Objectives for Providing LGBTQ+ Adolescents With Nurturance, Trustworthiness, and Safety(Baseline and follow-up (approximately 4 months after baseline))
- Change in Mean Scores on the Teacher Bystander Intervention Model in Traditional Bullying Scale(Baseline and follow-up (approximately 4 months after baseline))
- Change in Mean Scores on the Teacher Bystander Intervention Model in Cyberbullying Scale(Baseline and follow-up (approximately 4 months after baseline))
- Change in Mean Scores on the Modified Gay Affirmative Practice Scale(Baseline and follow-up (approximately 4 months after baseline))
- Safety Outcomes(At follow-up (approximately 4 months after baseline))
研究者
Robert Coulter
Assistant Professor
University of Pittsburgh