Clinical trial NCT04004520: Feasibility of Collecting Stress Biomarkers Among Youth Experiencing Homelessness
Official title: Feasibility of Collecting Stress Biomarkers Among Youth Experiencing Homelessness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Physiological
Keywords: stress
cortisol
alpha-amylase
homelessness
biomarkers
virtual reality
meditation
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will examine changes in acute stress (biological and psychological) via salivary cortisol and alpha amylase levels as well as survey measures of self-reported anxiety in response to either (a) a free online guided mindfulness meditation available at (https://www.uclahealth.org/marc/mindful-meditations); (b) a guided mindfulness meditation via virtual reality (https://guidedmeditationvr.com/) or (c) a virtual reality platform of historic photographs and written narratives (https://lookingglassvr.com/). Participants will also complete an interviewer administered survey to measure sociodemographic factors, mental and physical health status, substance use, and medication use and provide a hair sample to measure cortisol.

Detailed description: Homeless youth experience many daily stressors, including hunger, poor sleep, harassment, and violence. Many also have been victims of child abuse and/or neglect, witnessed family and/or community violence, and/or lived in foster care prior to leaving the home setting - exposures labeled as adverse childhood experiences known to increase the risk for poor physical and mental health. Because homeless youth are often disconnected from families, friends and institutions (e.g. health care, schools, jobs), they are at greater risk for "toxic stress" resulting in impaired biological stress responses with high or low levels of the stress hormone, cortisol, and increased inflammation in the cells of the body. High levels of inflammation are associated with sickness behavior syndrome (e.g. fatigue), depression, and suicidal thoughts, which may lead youth to engage in risky behaviors (e.g. substance use, HIV risk behaviors) in an attempt to reduce symptoms. However, few studies have collected biological measures of stress among homeless youth despite prior research linking exposure to violence and trauma to impaired biological stress responses in the general population. Because homeless youth experience a greater number of adverse exposures and with higher levels of severity on a daily basis and across their lifetime than youth in the general population, our lack of understanding of the biological impact that these exposures have on homeless youths' physical and mental health in the short-term as well as across their life span limits understanding of which youth are most vulnerable to poor outcomes. This study's purpose is to test the feasibility of collecting acute and chronic stress response biomarkers in homeless youth for use with future planned research. The study will also assess changes in acute stress (biological and psychological) via salivary cortisol and alpha amylase levels as well as survey measures of self-reported anxiety in response to either (a) a free online guided mindfulness meditation available at (https://www.uclahealth.org/marc/mindful-meditations); (b) a guided mindfulness meditation via virtual reality (https://guidedmeditationvr.com/) or (c) a virtual reality platform of historic photographs and written narratives (https://lookingglassvr.com/). Participants will also complete an interviewer administered survey to measure sociodemographic factors, mental and physical health status, substance use, and medication use and provide a hair sample to measure cortisol.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 to 24 years
* Meets the criteria for homelessness as defined by the federal McKinney-Vento Act as "lacking a fixed, regular, stable, and adequate nighttime residence" and includes "living in a publicly or privately operated shelter designed to provide temporary living accommodations, or a public or private place not designed for, or ordinarily used as, regular sleeping accommodations for human beings"
* speaks and understands the English language

Exclusion Criteria:

* 17 years and younger
* 25 years and older
* non-English speakers

Primary outcomes:
measure: Change in Stress Reactivity
timeFrame: Baseline, 5 minutes, 20 minutes, 35 minutes
Secondary outcomes:
measure: Change in Self-reported Anxiety as measured by the Spielberger State-Trait Anxiety Inventory
timeFrame: 5 minutes, 35 minutes
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jodi L Ford, PhD
role: STUDY_CHAIR
References:
citation: Chavez LJ, Kelleher K, Slesnick N, Holowacz E, Luthy E, Moore L, Ford J. Virtual Reality Meditation Among Youth Experiencing Homelessness: Pilot Randomized Controlled Trial of Feasibility. JMIR Ment Health. 2020 Sep 24;7(9):e18244. doi: 10.2196/18244.