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Feasibility of a Multi-Level School Intervention for LGBTQ Youth

Feasibility of a Multi-Level School Intervention for LGBTQ Youth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04041414
Enrollment
47
Registered
2019-08-01
Start date
2019-09-04
Completion date
2020-04-30
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Minority Stress Experiences Among LGBTQ Youth

Brief 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. 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.

Interventions

OTHERProud & 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.

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
Yes

Inclusion criteria

* LGBTQ student in one of four high schools

Exclusion criteria

* Not meeting inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
PTSD Checklist for DSM-5 (PCL-5)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.
Sexual Minority Adolescent Stress Inventory (SMASI)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)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.
Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)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.
Beck Depression InventoryChange 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 InventoryChange 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.

Secondary

MeasureTime frameDescription
Youth Risk Behavior Survey Substance Use QuestionsChange between baseline and post-intervention/follow-up (12 weeks).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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention Schools
Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1. 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.
26
Control Schools
Students in control schools will receive no intervention.
18
Total44

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up12

Baseline characteristics

CharacteristicIntervention SchoolsControl SchoolsTotal
Age, Customized
13 years
4 Participants0 Participants4 Participants
Age, Customized
14 years
4 Participants3 Participants7 Participants
Age, Customized
15 years
4 Participants7 Participants11 Participants
Age, Customized
16 years
7 Participants5 Participants12 Participants
Age, Customized
17 years
6 Participants3 Participants9 Participants
Age, Customized
18 years
1 Participants0 Participants1 Participants
Gender Identity
Female
19 Participants8 Participants27 Participants
Gender Identity
Genderqueer or gender nonconforming
0 Participants3 Participants3 Participants
Gender Identity
Male
5 Participants6 Participants11 Participants
Gender Identity
Transgender Female
1 Participants0 Participants1 Participants
Gender Identity
Transgender Male
1 Participants1 Participants2 Participants
Grade in School
10th Grade
5 Participants8 Participants13 Participants
Grade in School
11th Grade
4 Participants5 Participants9 Participants
Grade in School
12th Grade
10 Participants4 Participants14 Participants
Grade in School
9th Grade
7 Participants1 Participants8 Participants
Race/Ethnicity, Customized
American Indian or Alaksa Native
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Asian
2 Participants7 Participants9 Participants
Race/Ethnicity, Customized
Black or African American
6 Participants1 Participants7 Participants
Race/Ethnicity, Customized
Latino or Hispanic
13 Participants10 Participants23 Participants
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
White
9 Participants6 Participants15 Participants
Sex: Female, Male
Female
20 Participants12 Participants32 Participants
Sex: Female, Male
Male
6 Participants6 Participants12 Participants
Sexual Orientation
Asexual
1 Participants1 Participants2 Participants
Sexual Orientation
Bisexual
14 Participants4 Participants18 Participants
Sexual Orientation
Decline to Answer
0 Participants1 Participants1 Participants
Sexual Orientation
Gay/Homosexual
5 Participants3 Participants8 Participants
Sexual Orientation
Lesbian/Homosexual
4 Participants2 Participants6 Participants
Sexual Orientation
Pansexual
1 Participants4 Participants5 Participants
Sexual Orientation
Queer
1 Participants2 Participants3 Participants
Sexual Orientation
Straight/Heterosexual
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 20
other
Total, other adverse events
0 / 270 / 20
serious
Total, serious adverse events
0 / 270 / 20

Outcome results

Primary

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 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.

Time frame: Change between baseline and post-intervention/follow-up (12 weeks).

Population: All participants who completed the Proud \& Empowered intervention. Participants were from four high schools within Los Angeles County. Two schools were assigned to the intervention condition while the other two were assigned to the control condition. Participants were in 9th through 12th grade, and identified as sexual and/or gender minority.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention SchoolsAdapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)Time 1 (Baseline)0.63 score on a scaleStandard Deviation 1.31
Intervention SchoolsAdapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)Time 2 (Post-intervention).71 score on a scaleStandard Deviation 1.46
Control SchoolsAdapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)Time 1 (Baseline)0.5 score on a scaleStandard Deviation 1.34
Control SchoolsAdapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)Time 2 (Post-intervention)0.61 score on a scaleStandard Deviation 1.24
Primary

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.

Time frame: Change between baseline and post-intervention/follow-up (12 weeks).

Population: All participants who completed the Proud \& Empowered intervention. Participants were from four high schools within Los Angeles County. Two schools were assigned to the intervention condition while the other two were assigned to the control condition. Participants were in 9th through 12th grade, and identified as sexual and/or gender minority.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention SchoolsBeck Anxiety Inventory (BAI)Time 1 (Baseline)22.08 score on a scaleStandard Deviation 14.44
Intervention SchoolsBeck Anxiety Inventory (BAI)Time 2 (Post-intervention)19.56 score on a scaleStandard Deviation 16.08
Control SchoolsBeck Anxiety Inventory (BAI)Time 1 (Baseline)26.89 score on a scaleStandard Deviation 16.75
Control SchoolsBeck Anxiety Inventory (BAI)Time 2 (Post-intervention)27.39 score on a scaleStandard Deviation 14.14
Primary

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.

Time frame: Change between baseline and post-intervention/follow-up (12 weeks).

Population: All participants who completed the Proud \& Empowered intervention. Participants were from four high schools within Los Angeles County. Two schools were assigned to the intervention condition while the other two were assigned to the control condition. Participants were in 9th through 12th grade, and identified as sexual and/or gender minority.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention SchoolsBeck Depression InventoryTime 1 (Baseline)15.40 score on a scaleStandard Deviation 11.54
Intervention SchoolsBeck Depression InventoryTime 2 (Post-intervention)15.68 score on a scaleStandard Deviation 11.96
Control SchoolsBeck Depression InventoryTime 1 (Baseline)17.81 score on a scaleStandard Deviation 9.56
Control SchoolsBeck Depression InventoryTime 2 (Post-intervention)18.65 score on a scaleStandard Deviation 12.77
Primary

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.

Time frame: Change between baseline and post-intervention/follow-up (12 weeks).

Population: All participants who completed the Proud \& Empowered intervention. Participants were from four high schools within Los Angeles County. Two schools were assigned to the intervention condition while the other two were assigned to the control condition. Participants were in 9th through 12th grade, and identified as sexual and/or gender minority.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention SchoolsCoping Strategies InventoryTime 1 (Baseline)49.96 score on a scaleStandard Deviation 15.23
Intervention SchoolsCoping Strategies InventoryTime 2 (Post-intervention)47.64 score on a scaleStandard Deviation 16.25
Control SchoolsCoping Strategies InventoryTime 1 (Baseline)47.85 score on a scaleStandard Deviation 12.48
Control SchoolsCoping Strategies InventoryTime 2 (Post-intervention)49.26 score on a scaleStandard Deviation 14.22
Primary

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.

Time frame: Change between baseline and post-intervention/follow-up (12 weeks).

Population: All participants who completed the Proud \& Empowered intervention. Participants were from four high schools within Los Angeles County. Two schools were assigned to the intervention condition while the other two were assigned to the control condition. Participants were in 9th through 12th grade, and identified as sexual and/or gender minority.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention SchoolsPTSD Checklist for DSM-5 (PCL-5)Time 1 (Baseline)21.81 score on a scaleStandard Deviation 18.3
Intervention SchoolsPTSD Checklist for DSM-5 (PCL-5)Time 2 (Post-intervention)24.40 score on a scaleStandard Deviation 19.08
Control SchoolsPTSD Checklist for DSM-5 (PCL-5)Time 1 (Baseline)26.78 score on a scaleStandard Deviation 20.34
Control SchoolsPTSD Checklist for DSM-5 (PCL-5)Time 2 (Post-intervention)29.28 score on a scaleStandard Deviation 17.32
Primary

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.

Time frame: Change between baseline and post-intervention/follow-up (12 weeks).

Population: All participants who completed the Proud \& Empowered intervention. Participants were from four high schools within Los Angeles County. Two schools were assigned to the intervention condition while the other two were assigned to the control condition. Participants were in 9th through 12th grade, and identified as sexual and/or gender minority.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention SchoolsSexual Minority Adolescent Stress Inventory (SMASI)Time 1 (Baseline)8.44 score on a scaleStandard Deviation 6.65
Intervention SchoolsSexual Minority Adolescent Stress Inventory (SMASI)Time 2 (Post-intervention)7.59 score on a scaleStandard Deviation 7.13
Control SchoolsSexual Minority Adolescent Stress Inventory (SMASI)Time 1 (Baseline)7.22 score on a scaleStandard Deviation 7.12
Control SchoolsSexual Minority Adolescent Stress Inventory (SMASI)Time 2 (Post-intervention)8.29 score on a scaleStandard Deviation 7.68
Secondary

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.

Time frame: Change between baseline and post-intervention/follow-up (12 weeks).

Population: All participants who completed the Proud \& Empowered intervention. Participants were from four high schools within Los Angeles County. Two schools were assigned to the intervention condition while the other two were assigned to the control condition. Participants were in 9th through 12th grade, and identified as sexual and/or gender minority.

ArmMeasureGroupValue (NUMBER)
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsAlcohol Use : Time 1 (Baseline)11 participants
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsTranquilizers Use : Time 1 (Baseline)0 participants
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsMarijuana Use : Time 1 (Baseline)9 participants
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsTranquilizers Use : Time 2 (Post-intervention)0 participants
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsTobacco Use : Time 1 (Baseline)6 participants
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsStimulants Use : Time 1 (Baseline)0 participants
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsAlcohol Use : Time 2 (Post-intervention)12 participants
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsStimulants Use : Time 2 (Post-intervention)1 participants
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsTobacco Use : Time 2 (Post-intervention)5 participants
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsMarijuana Use : Time 2 (Post-intervention)10 participants
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsPain Relievers Use : Time 2 (Post-intervention)1 participants
Intervention SchoolsYouth Risk Behavior Survey Substance Use QuestionsPain Relievers Use : Time 1 (Baseline)3 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsPain Relievers Use : Time 2 (Post-intervention)1 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsAlcohol Use : Time 2 (Post-intervention)7 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsTobacco Use : Time 1 (Baseline)2 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsTobacco Use : Time 2 (Post-intervention)4 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsPain Relievers Use : Time 1 (Baseline)1 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsStimulants Use : Time 2 (Post-intervention)0 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsAlcohol Use : Time 1 (Baseline)5 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsTranquilizers Use : Time 1 (Baseline)0 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsTranquilizers Use : Time 2 (Post-intervention)0 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsStimulants Use : Time 1 (Baseline)0 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsMarijuana Use : Time 1 (Baseline)0 participants
Control SchoolsYouth Risk Behavior Survey Substance Use QuestionsMarijuana Use : Time 2 (Post-intervention)1 participants

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026