Alcohol DrinkingPLANTSNCT05897827
PLANTS Pilot Trial
A study testing PLANTS and EMAILS in people with Alcohol Drinking and Social Acceptance, run by University of Pittsburgh at 1 site in United States.
Trial summary
This pilot cluster-randomized controlled trial will evaluate the PLANTS (Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety) course among high school staff. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Social Acceptance, Depressive Symptoms
- What is being tested?
- PLANTS and EMAILS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2023to 9 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently employed by an enrolled school in the MetroWest Region of Boston, Massachusetts
- Age 18 years old or older
- Consents to participate
Who cannot join
- Does not interact with high school students at work
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Providing LGBTQ+ Adolescents With Nurturance, Trustworthiness, and Safety (PLANTS): Pilot Cluster-Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Alcohol Drinking, Social Acceptance, Depressive Symptoms, Bullying
- Being tested
- PLANTS, EMAILS
- Keywords
- Sexual and gender minority youth
- Medical subject headings
- Alcohol Drinking, Depression, Bullying, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLANTSBehavioural
Also called Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and Safety
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.
EMAILSBehavioural
Also called E-learning to Maximize Academic Inclusion of LGBTQ+ Students
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.
| Study group | Role | What they receive |
|---|---|---|
| PLANTS | Experimental | Schools will receive the online-delivered PLANTS intervention, which includes 3 asynchronous training modules and 3 synchronous group events. Receives: Behavioral: PLANTS |
| EMAILS | Active comparator | Comparison schools will receive emails with publicly available resources for supporting LGBTQ+ students as a control intervention. Receives: Behavioral: EMAILS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 4 months after intervention deployment
Secondary outcomes (9)
Trial Participation Rate
The investigators will divide the number of school staff who consent to participate by the total number of school staff who are invited, then multiply by 100 to get a percentage.
Measured: Baseline
Trial Retention Rate
The investigators will divide the number of school staff who complete the follow-up survey by the total number of school staff who were enrolled, then multiply by 100 to get a percentage.
Measured: At follow-up (approximately 4 months after baseline)
Intervention Demand
The investigators will divide the number of participants who adhere to the PLANTS intervention by the total number of school staff who were enrolled at schools randomly assigned the PLANTS intervention and multiply by 100 to obtain a percentage. Adherence is a composite variable ranging from 0-100% comprised of: 55% for online module completion (based on the number of completed items divided by the total number of items offered); 45% for Live Zoom Event attendance (where each event is 15%).
Measured: At follow-up (approximately 4 months after baseline)
Change in Mean Scores on the Active-Empathic Listening Scale
Participants will complete the eleven-item Active-Empathic Listening Scale at baseline and follow-up. Each item uses a seven-point Likert scale for responses, coded from 1 ("never or almost never true") to 7 ("Always or almost always true"). Mean scores will be calculated for all eleven items at each time point. The minimum possible mean value is 1 and the maximum mean value is 7. Higher values represent greater active-empathic listening. The mean scores from baseline will be subtracted from the mean scores from follow-up to produce the change in mean scores. Higher values represent greater increases in active-empathic listening from baseline to follow-up.
Measured: 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
The investigators have developed items pertaining directly to PLANTS' self-efficacy change objectives. Participants will complete each item using a five-point Likert scale, where 1 represents "not at all certain" and 5 represents "extremely certain." Mean scores will be calculated for all items at each time point. The minimum possible mean value is 1 and the maximum mean value is 5. Higher values represent greater self-efficacy. The mean scores from baseline will be subtracted from the mean scores from follow-up to produce the change in mean scores. Higher values represent greater increases in self-efficacy from baseline to follow-up.
Measured: Baseline and follow-up (approximately 4 months after baseline)
Change in Mean Scores on the Teacher Bystander Intervention Model in Traditional Bullying Scale
Participants will complete the 16-item Teacher Bystander Intervention Model in Traditional Bullying scale, which has five subscales. Each response will be coded on a scale of 1 to 5, with 1 representing "strongly disagree" and 5 representing "strongly agree." Mean scores will be calculated for all items at each time point. The minimum possible mean value is 1 and the maximum mean value is 5. Higher values represent greater skills related to bystander intervention in bullying. The mean scores from baseline will be subtracted from the mean scores from follow-up to produce the change in mean scores. Higher values represent greater increases in bystander intervention skills from baseline to follow-up.
Measured: Baseline and follow-up (approximately 4 months after baseline)
Change in Mean Scores on the Teacher Bystander Intervention Model in Cyberbullying Scale
Participants will complete the 16-item Teacher Bystander Intervention Model in Cyberbullying scale, which has five subscales. Each response will be coded on a scale of 1 to 5, with 1 representing "strongly disagree" and 5 representing "strongly agree." Mean scores will be calculated for all items at each time point. The minimum possible mean value is 1 and the maximum mean value is 5. Higher values represent greater skills related to bystander intervention in cyberbulling. The mean scores from baseline will be subtracted from the mean scores from follow-up to produce the change in mean scores. Higher values represent greater increases in bystander intervention skills from baseline to follow-up.
Measured: Baseline and follow-up (approximately 4 months after baseline)
Change in Mean Scores on the Modified Gay Affirmative Practice Scale
The investigators have modified the language of the Gay Affirmative Practice Scale to incorporate school-oriented words instead of therapy-oriented words to measure self-efficacy for school staff working with SGMY. Participants will complete the nine-item scale at baseline and follow-up, with each item using a five-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (5). Mean scores will be calculated for all items at each time point. The minimum possible mean value is 1 and the maximum mean value is 5. Higher values represent greater self-efficacy. The mean scores from baseline will be subtracted from the mean scores from follow-up to produce the change in mean scores. Higher values represent greater increases in self-efficacy from baseline to follow-up.
Measured: Baseline and follow-up (approximately 4 months after baseline)
Safety Outcomes
Investigators assess myriad safety outcomes including parent backlash, social media backlash, school board backlash, suspension or removal from employment, censorship of LGBTQ+ literature/history/stories or removal of books with LGBTQ+ representation from school libraries, and emotional discomfort with intervention and control conditions at follow-up. Response options include frequency of each event occurrence (none, once, twice, 3-9 times, and 10 or more times). Investigators will report the overall frequency of events, frequency of each type of event, and percentage of school staff reporting any event.
Measured: At follow-up (approximately 4 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start28 Jun 2023
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Robert Coulter, University of Pittsburgh
- Investigators
- Robert Coulter, PhD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897827
- Sponsor's protocol ID
- STUDY23040142
- Other IDs
- K01AA027564
- Acronym
- PLANTS
- Status last verified
- Mar 2025
- First submitted
- 1 Jun 2023
- Last updated
- 4 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38502156
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing LGBTQ+ Adolescents With Nurturance, Trustworthiness, and Safety (PLANTS): Pilot Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05897827
- Acronym / sponsor ID
- PLANTS / STUDY23040142
- Conditions
- Alcohol Drinking, Social Acceptance, Depressive Symptoms, Bullying
- Keywords
- Sexual and gender minority youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Posted 4 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PLANTS | Experimental | Behavioral: PLANTSSchools will receive the online-delivered PLANTS intervention, which includes 3 asynchronous training modules and 3 synchronous group events. |
| EMAILS | Active comparator | Behavioral: EMAILSComparison schools will receive emails with publicly available resources for supporting LGBTQ+ students as a control intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently employed by an enrolled school in the MetroWest Region of Boston, Massachusetts
- Age 18 years old or older
- Consents to participate
Key exclusion criteria (1 listed)
- Does not interact with high school students at work
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLANTSAlso: Providing LGBTQ+ Adolescents with Nurturance, Trustworthiness, and SafetyPLANTS 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. | Behavioural | PLANTS |
| EMAILSAlso: E-learning to Maximize Academic Inclusion of LGBTQ+ StudentsThe 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. | Behavioural | EMAILS |
Primary outcome
Mean Value of Acceptability of Intervention Measure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
9 secondary outcomes
Trial Participation Rate
Time frame: Baseline
Trial Retention Rate
Time frame: At follow-up (approximately 4 months after baseline)
Intervention Demand
Time frame: At follow-up (approximately 4 months after baseline)
Change in Mean Scores on the Active-Empathic Listening Scale
Time frame: 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
Time frame: Baseline and follow-up (approximately 4 months after baseline)
Change in Mean Scores on the Teacher Bystander Intervention Model in Traditional Bullying Scale
Time frame: Baseline and follow-up (approximately 4 months after baseline)
Change in Mean Scores on the Teacher Bystander Intervention Model in Cyberbullying Scale
Time frame: Baseline and follow-up (approximately 4 months after baseline)
Change in Mean Scores on the Modified Gay Affirmative Practice Scale
Time frame: Baseline and follow-up (approximately 4 months after baseline)
Safety Outcomes
Time frame: At follow-up (approximately 4 months after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38502156Coulter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Coulter, PhD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLANTS and EMAILS in people with Alcohol Drinking and Social Acceptance, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Value of Acceptability of Intervention Measure (time frame: Approximately 4 months after intervention deployment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05897827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.