Efficacy of a Multi-level School Intervention for LGBTQ Youth

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-20
SponsorWashington University School of Medicine

About this trial

Efficacy of a Multi-level School Intervention for LGBTQ Youth

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

LGBTQ student in one of 24 high schools

Disqualifiers

Not meeting inclusion criteria

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proud & Empowered

    Behavioral

    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 Group

    Behavioral

    Schools in this condition will not receive the Proud \& Empowered intervention. Students in this condition will provide data spaced to align with the timing of the intervention delivered to schools in the other study arm.

Treatment groups

228 Participants
are divided into 2 treatment groups
Group A: Intervention schoolsExperimental treatment 1 intervention
Group B: Control schoolsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sexual Minority Stress Inventory

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)
2

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)
3

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)
4

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)

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.

Time frame
Change between baseline and post-intervention/follow-up (12 weeks)
2

California Healthy Kids Survey General Bullying and Gender Identity/Sexual Orientation-Based Harassment Module

Assesses students' perceptions of harassment experiences on school campus among the general student population in addition to bullying and harassment experiences on school campus specific of students who identify as, or are perceived to be, lesbian, gay, bisexual, transgender, questioning, or gender nonconforming.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

University of Southern California

Collaborator