Clinical trial NCT04041414: Feasibility of a Multi-Level School Intervention for LGBTQ Youth
Official title: Feasibility of a Multi-Level School Intervention for LGBTQ Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Minority Stress Experiences Among LGBTQ Youth
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 47
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* LGBTQ student in one of four high schools

Exclusion Criteria:

* Not meeting inclusion criteria

Primary outcomes:
measure: Sexual Minority Adolescent Stress Inventory (SMASI)
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks).
measure: Beck Anxiety Inventory (BAI)
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks).
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks).
measure: Beck Depression Inventory
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks).
measure: Coping Strategies Inventory
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks).
measure: Adapted CSSRS Suicide Questions (Columbia Suicide Severity Rating Scale)
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks).
Secondary outcomes:
measure: Youth Risk Behavior Survey Substance Use Questions
timeFrame: Change between baseline and post-intervention/follow-up (12 weeks).
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: John Muir High School
state: California
city: Pasadena
country: United States
facility: Marshall Fundamental High School
state: California
city: Pasadena
country: United States
facility: Blair High School
state: California
city: Pasadena
country: United States
facility: Pasadena High School
state: California
Study officials:
References:
citation: 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.