PLANTS Pilot Trial

NCT05897827 | Completed Results

• 2 other identifiers: STUDY23040142K01AA027564
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Social Acceptance; Depressive Symptoms; Bullying

Keywords

Sexual and gender minority youth

Outcome Measures

Primary Outcomes (4)

• Mean Value of Acceptability of Intervention Measure

  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.

  Approximately 4 months after intervention deployment

• Mean Score on the System Usability Scale

  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.

  Approximately 4 months after intervention deployment

• Mean Value of Intervention Appropriateness Measure

  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.

  Approximately 4 months after intervention deployment

• Mean Value of Feasibility of Intervention Measure

  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.

  Approximately 4 months after intervention deployment

Secondary Outcomes (9)

• 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)

Study Arms (2)

PLANTS

EXPERIMENTAL

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

Behavioral: PLANTS

EMAILS

ACTIVE COMPARATOR

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

Behavioral: EMAILS

Interventions

PLANTS BEHAVIORAL

PLANTS intervention is an online-delivered training program, including asynchronous and synchronous activities. This intervention was informed by the Information-Motivation-Behavior theory to target skills, self-efficacy, knowledge, and outcome expectations. There are 3 asynchronous online modules that cover a variety of topics including lessons on LGBTQ+ terminology, names and pronouns, resources, antibullying, gender neutral bathrooms, student confidentiality, active empathic listening, and school policies. Module include recorded presentations, student testimonials, activities, and downloadable resources for future reference. Every month, 7-9 lessons are opened. There are 2 synchronous group events delivered via Zoom and are 1.5 hours each.

Also known as: Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety

PLANTS

EMAILS BEHAVIORAL

The active control arm is an email-based intervention, EMAILS, in which existing public resources for supporting, affirming, and protecting LGBTQ+ students are emailed to participants.

Also known as: E-learning to Maximize Academic Inclusion of LGBTQ+ Students

EMAILS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Does not interact with high school students at work

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Coulter RW, Mahal IK, Lin CA, Schneider SK, Mathias AS, Baral K, Miller E, Abebe KZ. Providing Lesbian, Gay, Bisexual, Transgender, Nonbinary, and Queer Adolescents With Nurturance, Trustworthiness, and Safety: Protocol for Pilot Cluster Randomized Controlled Trial Design. JMIR Res Protoc. 2024 Mar 19;13:e55210. doi: 10.2196/55210.

  PMID: 38502156 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Depression; Bullying; Coitus

Interventions

Safety

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Behavioral Symptoms; Aggression; Harassment, Non-Sexual; Social Behavior; Sexual Behavior

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health

Results Point of Contact

• Title: Robert W. S. Coulter
• Organization: University of Pittsburgh

robert.ws.coulter@pitt.edu

412-624-0647

Study Officials

• Robert Coulter, PhD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 9, 2023
• Study Start: June 28, 2023
• Primary Completion: February 9, 2024
• Study Completion: February 9, 2024
• Last Updated: April 4, 2025
• Results First Posted: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)