Sexual Minority Stress Experiences Among LGBTQ YouthNCT04041414
Feasibility of a Multi-Level School Intervention for LGBTQ Youth
A study testing Proud & Empowered! in people with Sexual Minority Stress Experiences Among LGBTQ Youth, run by University of Southern California at 4 sites in United States.
Trial summary
The goal of this R21 grant is to test the feasibility of a theoretically informed, LGBTQ-affirming intervention (Proud \& Empowered; P\&E). Although LGBTQ adolescents experience disparities in behavioral health outcomes compared to their heterosexual peers, interventions are scarce. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Minority Stress Experiences Among LGBTQ Youth
- What is being tested?
- Proud & Empowered!
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Sep 2019to 30 Apr 2020
- 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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- LGBTQ student in one of four high schools
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
4 sites in 1 country.
United States4 sites
John Muir High School
Pasadena, California, 91103
Marshall Fundamental High School
Pasadena, California, 91104
Blair High School
Pasadena, California, 91106
Pasadena High School
Pasadena, California, 91107
About this study
The goal of this R21 grant is to test the feasibility of a theoretically informed, LGBTQ-affirming intervention (Proud \& Empowered; P\&E). Although LGBTQ adolescents experience disparities in behavioral health outcomes compared to their heterosexual peers, interventions are scarce. For example, LGBTQ adolescents are 3 to 4 times more likely to meet criteria for an internalizing disorder and 2 to 5 times more likely to meet criteria for externalizing disorders than their heterosexual peers. Our intervention seeks to address disparate behavioral health problems such as depression, anxiety and trauma symptomology. Our goal will be achieved by completing two specific aims: 1) Assess the feasibility, including recruitment, enrollment, fidelity of service delivery, satisfaction, safety, and retention, of the intervention in a randomized control trial with four schools, 2) Obtain preliminary estimates of intervention effects on key behavioral health symptoms for LGBTQ youth and school climate (norms, attitudes, beliefs, behaviors) at the school level in preparation for a larger efficacy trial. This innovative R21 application brings together a team of nationally recognized minority stress and prevention science experts and responds to a nationally established public health need for research from the Institute of Medicine, the National Institutes of Health, and the National Gay and Lesbian Task Force.
- Being tested
- Proud & Empowered!
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proud & Empowered!Other
Proud \& Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention schools | Experimental | Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1. Receives: Other: Proud & Empowered! |
| Control schools | Active comparator | Students in control schools will receive no intervention Receives: Other: Proud & Empowered! |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Minority Adolescent Stress Inventory (SMASI)
54-item survey across 10 domains of minority stress. Assesses experiences of minority stress among adolescents. Each statement reflects past-30-day thoughts, feelings, and situations a person may have experienced, with response options of 1 = yes and 0 = no. A total score was calculated by summing the 54 items. The total score ranged from 0-54. Higher values correspond to a worse outcome, meaning the individual in question has had more stressful experiences.
Measured: Change between baseline and post-intervention/follow-up (12 weeks).
Beck Anxiety Inventory (BAI)
21-item self-report assessment of anxiety symptoms. The total score is calculated by taking the sum of the 21 items. There are five responses an individual can choose from for each item, these being "Not at all" which is scored as a 1, "Mildly, but it didn't bother me much" which is scored as a 2, "Moderately -- It wasn't pleasant at times" which is scored as a 3, "Severely -- It bothered me a lot" which is scored as a 4, and "Decline to answer" which is scored as a 5. The total score ranges from 0-63. Higher values indicate higher self-reported anxiety: Score of 0-21 indicates low anxiety, Score of 22-35 indicates moderate anxiety, Scores of 36+ indicates potentially concerning levels of anxiety. Subscales are calculated through summation.
Measured: Change between baseline and post-intervention/follow-up (12 weeks).
PTSD Checklist for DSM-5 (PCL-5)
20-item self-report assessment of post-traumatic stress disorder (PTSD) symptoms which addresses all 20 DSM-5 symptoms of PTSD. A total symptom severity score can be calculated by summing the scores for each of the 20 items. Each item has five possible responses including "Not at all" which is scored as a 0, "A little bit" which is scored as a 1, "Moderately" which is scored as 2, "Quite a bit" which is scored as a 3, and "Extremely" which is scored as a 4. The potential range of scores is 0-80. Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.
Measured: Change between baseline and post-intervention/follow-up (12 weeks).
Beck Depression Inventory
21-item self-report assessment of depression symptoms and severity of depression. The items are rated on a 4-point scale ranging from 0-3 based on the severity of each item (e.g., 0=I do not feel sad, 1=I feel sad much of the time, 2=I am sad all the time, and 3=I am so sad or unhappy that I can't stand it). The total range of scores is from 0-63. Higher values indicate a worse outcome and indicates a greater severity of depression. Scores of 0-13 indicates minimal depression, scores of 14-19 indicates mild depression, scores of 20-28 indicates moderate depression, scores of 29-63 indicates severe depression. Subscale values are achieved through summation.
Measured: Change between baseline and post-intervention/follow-up (12 weeks).
Coping Strategies Inventory
16-item assessment measuring specific coping strategies people use in response to stressful events. Individuals respond to 16 items, with each item assessing components of Problem Solving, Cognitive Restructuring, Social Support, Express Emotions, Problem Avoidance, Wishful Thinking, and Social Withdrawal. Individuals can respond in 5 different ways, these being "Never", "Seldom", "Sometimes", "Often", or "Almost Always". These responses are scored from 1-5 with "Never" being a 1 and "Almost Always" being a 5. The total score is a summation of item scores with a range from 16-80. Higher scores in a particular primary scale indicates that the individual implements that form of coping strategy more often.
Measured: Change between baseline and post-intervention/follow-up (12 weeks).
Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)
Six items assessing current suicidality that were adapted from the longer, treatment-based Columbia Suicide Severity Rating Scale. The first two items ask about passive ideation and active ideation, and affirmative responses link to follow-up questions about methods, intent, plans, and attempts. The scale is scored as follows: 0 = no to passive ideation and no to active ideation
- = yes to passive ideation (but no to active ideation)
- = yes to active ideation (but no method, intent, plan)
- = yes to method (but no intent or plan)
- = yes to intent (but no plan)
- = yes to plan Attempts can be scored on its own or added to the overall scale for a risk score of 6 if participant has a recent suicide attempt.
Measured: Change between baseline and post-intervention/follow-up (12 weeks).
Secondary outcomes (1)
Youth Risk Behavior Survey Substance Use Questions
Measures individual's usage of various substances in their lifetime and within the past 30 days as well as the ways in which individuals have used marijuana, tobacco, or nicotine in the past 30 days. Each substance is individually analyzed for both lifetime usage and past 30 day usage. Individuals can answer Yes or No for both lifetime usage and past 30 day usage. Each substance can range from 0 to the maximum number of survey responses. In addition, for marijuana, students can specify the way in which they used it with response options of smoking, vaping, edible or beverage form, or other. For nicotine and tobacco, students can specify the way in which they used it with the response options of smoking, vaping, or other. "Yes" responses indicate a worse outcome indicating that individuals have used or are currently using the substance in question.
Measured: Change between baseline and post-intervention/follow-up (12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start4 Sep 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
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 Sexual Minority Stress Experiences Among LGBTQ YouthStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Goldbach, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041414
- Sponsor's protocol ID
- 1R21MD013971
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2019
- Last updated
- 28 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Goldbach JT, Rhoades H, Mamey MR, Senese J, Karys P, Marsiglia FF. Reducing behavioral health symptoms by addressing minority stressors in LGBTQ adolescents: a randomized controlled trial of Proud & Empowered. BMC Public Health. 2021 Dec 23;21(1):2315. doi: 10.1186/s12889-021-12357-5.
PubMed 34949171
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Multi-Level School Intervention for LGBTQ Youth
- ClinicalTrials.gov ID
- NCT04041414
- Acronym / sponsor ID
- 1R21MD013971
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Posted 27 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this R21 grant is to test the feasibility of a theoretically informed, LGBTQ-affirming intervention (Proud \& Empowered; P\&E). Although LGBTQ adolescents experience disparities in behavioral health outcomes compared to their heterosexual peers, interventions are scarce. For example, LGBTQ adolescents are 3 to 4 times more likely to meet criteria for an internalizing disorder and 2 to 5 times more likely to meet criteria for externalizing disorders than their heterosexual peers. Our intervention seeks to address disparate behavioral health problems such as depression, anxiety and trauma symptomology. Our goal will be achieved by completing two specific aims: 1) Assess the feasibility, including recruitment, enrollment, fidelity of service delivery, satisfaction, safety, and retention, of the intervention in a randomized control trial with four schools, 2) Obtain preliminary estimates of intervention effects on key behavioral health symptoms for LGBTQ youth and school climate (norms, attitudes, beliefs, behaviors) at the school level in preparation for a larger efficacy trial. This innovative R21 application brings together a team of nationally recognized minority stress and prevention science experts and responds to a nationally established public health need for research from the Institute of Medicine, the National Institutes of Health, and the National Gay and Lesbian Task Force.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention schools | Experimental | Other: Proud & Empowered!Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1. |
| Control schools | Active comparator | Other: Proud & Empowered!Students in control schools will receive no intervention |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- LGBTQ student in one of four high schools
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 |
|---|---|---|
| Proud & Empowered!Proud \& Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers. | Other | Control schools, Intervention schools |
Primary outcome
Sexual Minority Adolescent Stress Inventory (SMASI)
Time frame: Change between baseline and post-intervention/follow-up (12 weeks).
54-item survey across 10 domains of minority stress. Assesses experiences of minority stress among adolescents. Each statement reflects past-30-day thoughts, feelings, and situations a person may have experienced, with response options of 1 = yes and 0 = no. A total score was calculated by summing the 54 items. The total score ranged from 0-54. Higher values correspond to a worse outcome, meaning the individual in question has had more stressful experiences.
Beck Anxiety Inventory (BAI)
Time frame: Change between baseline and post-intervention/follow-up (12 weeks).
21-item self-report assessment of anxiety symptoms. The total score is calculated by taking the sum of the 21 items. There are five responses an individual can choose from for each item, these being "Not at all" which is scored as a 1, "Mildly, but it didn't bother me much" which is scored as a 2, "Moderately -- It wasn't pleasant at times" which is scored as a 3, "Severely -- It bothered me a lot" which is scored as a 4, and "Decline to answer" which is scored as a 5. The total score ranges from 0-63. Higher values indicate higher self-reported anxiety: Score of 0-21 indicates low anxiety, Score of 22-35 indicates moderate anxiety, Scores of 36+ indicates potentially concerning levels of anxiety. Subscales are calculated through summation.
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Change between baseline and post-intervention/follow-up (12 weeks).
20-item self-report assessment of post-traumatic stress disorder (PTSD) symptoms which addresses all 20 DSM-5 symptoms of PTSD. A total symptom severity score can be calculated by summing the scores for each of the 20 items. Each item has five possible responses including "Not at all" which is scored as a 0, "A little bit" which is scored as a 1, "Moderately" which is scored as 2, "Quite a bit" which is scored as a 3, and "Extremely" which is scored as a 4. The potential range of scores is 0-80. Higher scores indicate a worse outcome where the individual has higher severity of PTSD symptoms.
Beck Depression Inventory
Time frame: Change between baseline and post-intervention/follow-up (12 weeks).
21-item self-report assessment of depression symptoms and severity of depression. The items are rated on a 4-point scale ranging from 0-3 based on the severity of each item (e.g., 0=I do not feel sad, 1=I feel sad much of the time, 2=I am sad all the time, and 3=I am so sad or unhappy that I can't stand it). The total range of scores is from 0-63. Higher values indicate a worse outcome and indicates a greater severity of depression. Scores of 0-13 indicates minimal depression, scores of 14-19 indicates mild depression, scores of 20-28 indicates moderate depression, scores of 29-63 indicates severe depression. Subscale values are achieved through summation.
Coping Strategies Inventory
Time frame: Change between baseline and post-intervention/follow-up (12 weeks).
16-item assessment measuring specific coping strategies people use in response to stressful events. Individuals respond to 16 items, with each item assessing components of Problem Solving, Cognitive Restructuring, Social Support, Express Emotions, Problem Avoidance, Wishful Thinking, and Social Withdrawal. Individuals can respond in 5 different ways, these being "Never", "Seldom", "Sometimes", "Often", or "Almost Always". These responses are scored from 1-5 with "Never" being a 1 and "Almost Always" being a 5. The total score is a summation of item scores with a range from 16-80. Higher scores in a particular primary scale indicates that the individual implements that form of coping strategy more often.
Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)
Time frame: Change between baseline and post-intervention/follow-up (12 weeks).
Six items assessing current suicidality that were adapted from the longer, treatment-based Columbia Suicide Severity Rating Scale. The first two items ask about passive ideation and active ideation, and affirmative responses link to follow-up questions about methods, intent, plans, and attempts. The scale is scored as follows: 0 = no to passive ideation and no to active ideation 1. = yes to passive ideation (but no to active ideation) 2. = yes to active ideation (but no method, intent, plan) 3. = yes to method (but no intent or plan) 4. = yes to intent (but no plan) 5. = yes to plan Attempts can be scored on its own or added to the overall scale for a risk score of 6 if participant has a recent suicide attempt.
1 secondary outcome
Youth Risk Behavior Survey Substance Use Questions
Time frame: Change between baseline and post-intervention/follow-up (12 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34949171Goldbach JT, Rhoades H, Mamey MR, Senese J, Karys P, Marsiglia FF. Reducing behavioral health symptoms by addressing minority stressors in LGBTQ adolescents: a randomized controlled trial of Proud & Empowered. BMC Public Health. 2021 Dec 23;21(1):2315. doi: 10.1186/s12889-021-12357-5.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proud & Empowered! in people with Sexual Minority Stress Experiences Among LGBTQ Youth, run by University of Southern California at 4 sites 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 1 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 27 Jul 2021). 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?
Sexual Minority Adolescent Stress Inventory (SMASI) (time frame: Change between baseline and post-intervention/follow-up (12 weeks).). The study lists 6 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 NCT04041414, 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 28 Jul 2021.