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Completed

NCT Number: NCT04004520

Feasibility of Collecting Stress Biomarkers Among Youth Experiencing Homelessness

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.

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Key information

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality with Meditation

Behavioral

The Guided Meditation Virtual Reality is a mindfulness meditation app provided on a virtual reality platform that includes a 10 minute audio meditation for relaxation along with a 3D visualization of natural settings (e.g. forest, beach, mountain).

Other names: Guided Meditation Virtual Reality

Audio Control

Behavioral

The UCLA Mindful App is an audio only mindfulness meditation for relaxation called Breath, Sound, Body Meditation that is 12 minutes in length.

Other names: UCLA Mindful App

Virtual reality Control

Behavioral

The Looking Glass Virtual Reality is a stereographic 3D photo viewer provided on a virtual reality platform featuring photos from around the world dating back to approximately a century ago that participants will view for 10 minutes.

Other names: Looking Glass Virtual Reality

Primary outcomes

  1. Change in Stress Reactivity

    Time frame: Baseline, 5 minutes, 20 minutes, 35 minutes

    Participant gives the first saliva sample at arrival, then the second saliva sample 5 minutes after arrival prior to the intervention. The intervention is administered (approximately 10-15 minutes in length). The participant will give the third saliva sample immediately after the intervention and then a fourth saliva sample 15 minutes after the intervention.

Secondary outcomes

  1. Change in Self-reported Anxiety as measured by the Spielberger State-Trait Anxiety Inventory

    Time frame: 5 minutes, 35 minutes

    The Spielberger State-Trait Anxiety Inventory survey which has six-item short-form of the state(STAI: Y-6 score.

    To calculate the total STAI score (range 20 - 80):

    • reverse scoring of the positive items (calm, relaxed, content) so 1=4, 2=3, 3=2 and 4=1;
    • sum all six scores;
    • multiply total score by 20/6;
    • refer to Spielberger's manuals to interpret scores (a 'normal' score is approx. 34 - 36)

    Participant will complete the survey 5 minutes prior to the intervention and then 15 minutes after the intervention.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2019
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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