Clinical trial NCT05897827: PLANTS Pilot Trial
Official title: Providing LGBTQ+ Adolescents With Nurturance, Trustworthiness, and Safety (PLANTS): Pilot Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Social Acceptance
Depressive Symptoms
Bullying
Keywords: Sexual and gender minority youth
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-06-09
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-armed cluster-randomized controlled pilot trial of the PLANTS intervention versus an active control group, the EMAILS intervention. The investigators will randomize schools in an equal 1:1 ratio, stratified by large versus small schools, into intervention or active control conditions. The investigators will use block randomization with block sizes of 2, which will be stratified by large schools versus not, where large is ≥1000 students. The investigators use block size of 2 because there are only 4 schools in this pilot trial.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Currently employed by an enrolled school in the MetroWest Region of Boston, Massachusetts
* Age 18 years old or older
* Consents to participate

Exclusion Criteria:

• Does not interact with high school students at work

Primary outcomes:
measure: Mean Value of Acceptability of Intervention Measure
timeFrame: Approximately 4 months after intervention deployment
measure: Mean Score on the System Usability Scale
timeFrame: Approximately 4 months after intervention deployment
measure: Mean Value of Intervention Appropriateness Measure
timeFrame: Approximately 4 months after intervention deployment
measure: Mean Value of Feasibility of Intervention Measure
timeFrame: Approximately 4 months after intervention deployment
Secondary outcomes:
measure: Trial Participation Rate
timeFrame: Baseline
measure: Trial Retention Rate
timeFrame: At follow-up (approximately 4 months after baseline)
measure: Intervention Demand
timeFrame: At follow-up (approximately 4 months after baseline)
measure: Change in Mean Scores on the Active-Empathic Listening Scale
timeFrame: Baseline and follow-up (approximately 4 months after baseline)
measure: Change in Mean Scores on Self-efficacy Change Objectives for Providing LGBTQ+ Adolescents With Nurturance, Trustworthiness, and Safety
timeFrame: Baseline and follow-up (approximately 4 months after baseline)
measure: Change in Mean Scores on the Teacher Bystander Intervention Model in Traditional Bullying Scale
timeFrame: Baseline and follow-up (approximately 4 months after baseline)
measure: Change in Mean Scores on the Teacher Bystander Intervention Model in Cyberbullying Scale
timeFrame: Baseline and follow-up (approximately 4 months after baseline)
measure: Change in Mean Scores on the Modified Gay Affirmative Practice Scale
timeFrame: Baseline and follow-up (approximately 4 months after baseline)
measure: Safety Outcomes
timeFrame: At follow-up (approximately 4 months after baseline)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Robert Coulter, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: