Feasibility of a Multi-Level School Intervention for LGBTQ Youth

NCT04041414 | Completed Results

• 1 other identifier: 1R21MD013971
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 4

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.

Conditions

Sexual Minority Stress Experiences Among LGBTQ Youth

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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 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.

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

Secondary Outcomes (1)

• Youth Risk Behavior Survey Substance Use Questions

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

Study Arms (2)

Intervention schools

EXPERIMENTAL

Schools will be assigned to either intervention or control schools. Students in intervention schools will receive the intervention in semester 1.

Other: Proud & Empowered!

Control schools

ACTIVE COMPARATOR

Students in control schools will receive no intervention

Other: Proud & Empowered!

Interventions

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.

Control schools; Intervention schools

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• LGBTQ student in one of four high schools

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (4)

John Muir High School

Pasadena, California, 91103, United States

Location

Marshall Fundamental High School

Pasadena, California, 91104, United States

Location

Blair High School

Pasadena, California, 91106, United States

Location

Pasadena High School

Pasadena, California, 91107, United States

Location

Related Publications (1)

• 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.

  PMID: 34949171 DERIVED

Results Point of Contact

• Title: Jeremy Goldbach, PhD, LMSW
• Organization: University of Southern California

goldbach@usc.edu

(213) 821-6460

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: August 1, 2019
• Study Start: September 4, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: July 28, 2021
• Results First Posted: July 27, 2021

Record last verified: 2021-07

Locations

US (4)