Trial Outcomes & Findings for Feasibility of a Multi-Level School Intervention for LGBTQ Youth (NCT NCT04041414)
NCT ID: NCT04041414
Last Updated: 2021-07-28
Results Overview
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.
COMPLETED
NA
47 participants
Change between baseline and post-intervention/follow-up (12 weeks).
2021-07-28
Participant Flow
Participant milestones
| Measure |
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! 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.
|
Control Schools
Students in control schools will receive no intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
20
|
|
Overall Study
COMPLETED
|
26
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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! 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.
|
Control Schools
Students in control schools will receive no intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Feasibility of a Multi-Level School Intervention for LGBTQ Youth
Baseline characteristics by cohort
| Measure |
Intervention Schools
n=26 Participants
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.
|
Control Schools
n=18 Participants
Students in control schools will receive no intervention.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Gender Identity
Genderqueer or gender nonconforming
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Gender Identity
Transgender Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
13 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Customized
14 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
15 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Customized
16 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Customized
17 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino or Hispanic
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaksa Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Gender Identity
Female
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Gender Identity
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Gender Identity
Transgender Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sexual Orientation
Gay/Homosexual
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sexual Orientation
Lesbian/Homosexual
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sexual Orientation
Bisexual
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sexual Orientation
Pansexual
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sexual Orientation
Asexual
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sexual Orientation
Queer
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sexual Orientation
Straight/Heterosexual
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sexual Orientation
Decline to Answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Grade in School
9th Grade
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Grade in School
10th Grade
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Grade in School
11th Grade
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Grade in School
12th Grade
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Schools
n=26 Participants
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.
|
Control Schools
n=18 Participants
Students in control schools will not receive any intervention.
|
|---|---|---|
|
Sexual Minority Adolescent Stress Inventory (SMASI)
Time 2 (Post-intervention)
|
7.59 score on a scale
Standard Deviation 7.13
|
8.29 score on a scale
Standard Deviation 7.68
|
|
Sexual Minority Adolescent Stress Inventory (SMASI)
Time 1 (Baseline)
|
8.44 score on a scale
Standard Deviation 6.65
|
7.22 score on a scale
Standard Deviation 7.12
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Schools
n=26 Participants
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.
|
Control Schools
n=18 Participants
Students in control schools will not receive any intervention.
|
|---|---|---|
|
Beck Anxiety Inventory (BAI)
Time 1 (Baseline)
|
22.08 score on a scale
Standard Deviation 14.44
|
26.89 score on a scale
Standard Deviation 16.75
|
|
Beck Anxiety Inventory (BAI)
Time 2 (Post-intervention)
|
19.56 score on a scale
Standard Deviation 16.08
|
27.39 score on a scale
Standard Deviation 14.14
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Schools
n=26 Participants
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.
|
Control Schools
n=18 Participants
Students in control schools will not receive any intervention.
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
Time 2 (Post-intervention)
|
24.40 score on a scale
Standard Deviation 19.08
|
29.28 score on a scale
Standard Deviation 17.32
|
|
PTSD Checklist for DSM-5 (PCL-5)
Time 1 (Baseline)
|
21.81 score on a scale
Standard Deviation 18.30
|
26.78 score on a scale
Standard Deviation 20.34
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Schools
n=26 Participants
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.
|
Control Schools
n=18 Participants
Students in control schools will not receive any intervention.
|
|---|---|---|
|
Beck Depression Inventory
Time 1 (Baseline)
|
15.40 score on a scale
Standard Deviation 11.54
|
17.81 score on a scale
Standard Deviation 9.56
|
|
Beck Depression Inventory
Time 2 (Post-intervention)
|
15.68 score on a scale
Standard Deviation 11.96
|
18.65 score on a scale
Standard Deviation 12.77
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Schools
n=26 Participants
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.
|
Control Schools
n=18 Participants
Students in control schools will not receive any intervention.
|
|---|---|---|
|
Coping Strategies Inventory
Time 2 (Post-intervention)
|
47.64 score on a scale
Standard Deviation 16.25
|
49.26 score on a scale
Standard Deviation 14.22
|
|
Coping Strategies Inventory
Time 1 (Baseline)
|
49.96 score on a scale
Standard Deviation 15.23
|
47.85 score on a scale
Standard Deviation 12.48
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Schools
n=26 Participants
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.
|
Control Schools
n=18 Participants
Students in control schools will not receive any intervention.
|
|---|---|---|
|
Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)
Time 1 (Baseline)
|
0.63 score on a scale
Standard Deviation 1.31
|
0.5 score on a scale
Standard Deviation 1.34
|
|
Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)
Time 2 (Post-intervention)
|
.71 score on a scale
Standard Deviation 1.46
|
0.61 score on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intervention Schools
n=26 Participants
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.
|
Control Schools
n=18 Participants
Students in control schools will not receive any intervention.
|
|---|---|---|
|
Youth Risk Behavior Survey Substance Use Questions
Alcohol Use : Time 1 (Baseline)
|
11 participants
|
5 participants
|
|
Youth Risk Behavior Survey Substance Use Questions
Alcohol Use : Time 2 (Post-intervention)
|
12 participants
|
7 participants
|
|
Youth Risk Behavior Survey Substance Use Questions
Tobacco Use : Time 1 (Baseline)
|
6 participants
|
2 participants
|
|
Youth Risk Behavior Survey Substance Use Questions
Tobacco Use : Time 2 (Post-intervention)
|
5 participants
|
4 participants
|
|
Youth Risk Behavior Survey Substance Use Questions
Pain Relievers Use : Time 1 (Baseline)
|
3 participants
|
1 participants
|
|
Youth Risk Behavior Survey Substance Use Questions
Marijuana Use : Time 1 (Baseline)
|
9 participants
|
0 participants
|
|
Youth Risk Behavior Survey Substance Use Questions
Marijuana Use : Time 2 (Post-intervention)
|
10 participants
|
1 participants
|
|
Youth Risk Behavior Survey Substance Use Questions
Pain Relievers Use : Time 2 (Post-intervention)
|
1 participants
|
1 participants
|
|
Youth Risk Behavior Survey Substance Use Questions
Tranquilizers Use : Time 1 (Baseline)
|
0 participants
|
0 participants
|
|
Youth Risk Behavior Survey Substance Use Questions
Tranquilizers Use : Time 2 (Post-intervention)
|
0 participants
|
0 participants
|
|
Youth Risk Behavior Survey Substance Use Questions
Stimulants Use : Time 1 (Baseline)
|
0 participants
|
0 participants
|
|
Youth Risk Behavior Survey Substance Use Questions
Stimulants Use : Time 2 (Post-intervention)
|
1 participants
|
0 participants
|
Adverse Events
Intervention Schools
Control Schools
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeremy Goldbach, PhD, LMSW
University of Southern California
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place