PLANTS Pilot Trial

University of Pittsburgh

Status: Completed

Conditions: Depressive Symptoms; Social Acceptance; Bullying; Alcohol Drinking

Treatments: Behavioral: PLANTS; Behavioral: EMAILS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05897827

K01AA027564 (U.S. NIH Grant/Contract)

STUDY23040142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

PLANTS

Experimental group

Description:

Schools will receive the online-delivered PLANTS intervention, which includes 3 asynchronous training modules and 3 synchronous group events.

Treatment:

Behavioral: PLANTS

EMAILS

Active Comparator group

Description:

Comparison schools will receive emails with publicly available resources for supporting LGBTQ+ students as a control intervention.

Treatment:

Behavioral: EMAILS