<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03776422</url>
  </required_header>
  <id_info>
    <org_study_id>17072403</org_study_id>
    <nct_id>NCT03776422</nct_id>
  </id_info>
  <brief_title>Homeless Youth Study - Stepping Stone 2.0</brief_title>
  <official_title>Homeless Youth Study - Stepping Stone 2.0</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Illinois Department of Human Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sparrow Mobile</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Housing instability is both a cause and consequence of mental health problems. As such youth&#xD;
      experiencing housing instability (e.g., homeless or marginally housed) have higher rates of&#xD;
      mental health problems.Because of their circumstances, these youth also face significant&#xD;
      barriers to mental health care and are therefore less likely to receive the treatment that&#xD;
      they need. Mobile technology may offer a novel platform for increasing access to mental&#xD;
      health care in this population. The primary goals of this pilot study are to (1) establish&#xD;
      the feasibility and acceptability of delivering automated mental health interventions via&#xD;
      smartphone technology, (2) examine the extent to which automated mental health interventions&#xD;
      delivered via mobile technology improve mental health in homeless, marginally-housed, and&#xD;
      exiting foster youth.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2017</start_date>
  <completion_date type="Actual">July 8, 2019</completion_date>
  <primary_completion_date type="Actual">July 8, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Program adherence</measure>
    <time_frame>Baseline to Endpoint (6 months)</time_frame>
    <description>Program adherence will be assessed based on usage data determining how often participants utilized the study applications, and how often they completed daily surveys and rated daily tips.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Program satisfaction</measure>
    <time_frame>Midpoint (3 months) and Endpoint (6 months)</time_frame>
    <description>Program satisfaction will be assessed using a self-report questionnaire that participants will be asked to complete at the midpoint and endpoint of the study. Participants will be asked to report the extent to which they benefited from the study, how helpful the mobile applications were, and if they would recommend the study to others. These responses are recorded on 5-point likert type scales with higher ratings indicating higher satisfaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>Baseline (0 months), Midpoint (3 months), Endpoint (6 months)</time_frame>
    <description>Anxiety symptoms will be assessed using the adaptive PROMIS Bank v1.0 for anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression symptoms</measure>
    <time_frame>Baseline (0 months), Midpoint (3 months), Endpoint (6 months)</time_frame>
    <description>Depression symptoms will be assessed using the adaptive PROMIS Bank v1.0 for depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol use</measure>
    <time_frame>Baseline (0 months), Midpoint (3 months), Endpoint (6 months)</time_frame>
    <description>Alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT-C).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cannabis use</measure>
    <time_frame>Baseline (0 months), Midpoint (3 months), Endpoint (6 months)</time_frame>
    <description>Cannabis use will be assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risky sexual behavior</measure>
    <time_frame>Baseline (0 months), Midpoint (3 months), Endpoint (6 months)</time_frame>
    <description>Risky sexual behaviors will be assessed using the sexual behavior items from the Centers for Disease Control and Prevention's Youth Risk Behavior Survey (2011).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD symptoms</measure>
    <time_frame>Baseline (0 months), Midpoint (3 months), Endpoint (6 months)</time_frame>
    <description>PTSD symptoms will be assessed using the The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with life: Satisfaction with Life Scale (SWLS)</measure>
    <time_frame>Baseline (0 months), Midpoint (3 months), Endpoint (6 months)</time_frame>
    <description>General satisfaction with life will be assessed using the Satisfaction with Life Scale (SWLS). This measure is 5 items, with each item rated on a scale from 1-7. All 5 items are summed to achieve a total score of 5-35. Higher scores indicate higher satisfaction with one's life circumstances.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial flourishing</measure>
    <time_frame>Baseline (0 months), Midpoint (3 months), Endpoint (6 months)</time_frame>
    <description>Psychological resources and strengths will be assessed using the Flourishing Scale (FS). This measure is 8 items, with each item rated on a scale from 1-7. All 8 items are summed to achieve a total score of 8-56. Higher scores indicate that an individual has more psychological resources and strengths.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)</condition>
  <arm_group>
    <arm_group_label>Mobile self-help intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This study uses automated self-help interventions designed as a kit of smartphone tools.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile self-help intervention</intervention_name>
    <description>Participants receive several apps on their phone including IntelliCare apps, which are based on principles of cognitive-behavioral therapy. Participants also receive the Pocket Helper app, which has been designed for this study. The tools within the Pocket Helper app include a crisis text line that is available 24/7, the Illinois Warm Line which is available Monday through Friday from 8am to 5pm, directions to call 911 in the case of an emergency, the Koko web app that provides crowdsourced emotional support, brief cognitive-behavioral interventions, daily tips, and daily surveys. Phones will also include the StreetLight Chicago app, which provides homeless individuals with up-to-date information on shelters, health clinics, emergency contacts, mental health services, and more.</description>
    <arm_group_label>Mobile self-help intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  16-25 years&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Youth must meet one of the following risk criteria&#xD;
&#xD;
               -  Experiencing housing instability as defined by:&#xD;
&#xD;
                    -  lacking a fixed, regular, and adequate nighttime residence OR whose primary&#xD;
                       nighttime residence is a shelter, institution, or a &quot;public or private place&#xD;
                       not designed for, or ordinarily used as, a regular sleeping accommodation&#xD;
                       for human beings&quot;&#xD;
&#xD;
                    -  sharing the housing of other persons due to loss of housing [or] economic&#xD;
                       hardship.&#xD;
&#xD;
                    -  frequent moves, poor housing quality (e.g., living in severely overcrowded&#xD;
                       housing).&#xD;
&#xD;
               -  Imminently leaving the foster care system&#xD;
&#xD;
          -  Willingness and ability to comply with requirements of the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        * Inability to understand study procedures and participate in the informed consent process.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alyson K Zalta, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of California, Irvine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>September 26, 2019</last_update_submitted>
  <last_update_submitted_qc>September 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Irvine</investigator_affiliation>
    <investigator_full_name>Alyson Zalta</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Personality Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03776422/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03776422
org study id: 17072403
nct id: NCT03776422
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Housing instability is both a cause and consequence of mental health problems. As such youth
      experiencing housing instability (e.g., homeless or marginally housed) have higher rates of
      mental health problems.Because of their circumstances, these youth also face significant
      barriers to mental health care and are therefore less likely to receive the treatment that
      they need. Mobile technology may offer a novel platform for increasing access to mental
      health care in this population. The primary goals of this pilot study are to (1) establish
      the feasibility and acceptability of delivering automated mental health interventions via
      smartphone technology, (2) examine the extent to which automated mental health interventions
      delivered via mobile technology improve mental health in homeless, marginally-housed, and
      exiting foster youth.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Program adherence
time frame: Baseline to Endpoint (6 months)
description: Program adherence will be assessed based on usage data determining how often participants utilized the study applications, and how often they completed daily surveys and rated daily tips.
measure: Program satisfaction
time frame: Midpoint (3 months) and Endpoint (6 months)
description: Program satisfaction will be assessed using a self-report questionnaire that participants will be asked to complete at the midpoint and endpoint of the study. Participants will be asked to report the extent to which they benefited from the study, how helpful the mobile applications were, and if they would recommend the study to others. These responses are recorded on 5-point likert type scales with higher ratings indicating higher satisfaction.
measure: Anxiety symptoms
time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
description: Anxiety symptoms will be assessed using the adaptive PROMIS Bank v1.0 for anxiety.
measure: Depression symptoms
time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
description: Depression symptoms will be assessed using the adaptive PROMIS Bank v1.0 for depression.
measure: Alcohol use
time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
description: Alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT-C).
measure: Cannabis use
time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
description: Cannabis use will be assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R).
measure: Risky sexual behavior
time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
description: Risky sexual behaviors will be assessed using the sexual behavior items from the Centers for Disease Control and Prevention's Youth Risk Behavior Survey (2011).
measure: PTSD symptoms
time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
description: PTSD symptoms will be assessed using the The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
measure: Satisfaction with life: Satisfaction with Life Scale (SWLS)
time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
description: General satisfaction with life will be assessed using the Satisfaction with Life Scale (SWLS). This measure is 5 items, with each item rated on a scale from 1-7. All 5 items are summed to achieve a total score of 5-35. Higher scores indicate higher satisfaction with one's life circumstances.
measure: Psychosocial flourishing
time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
description: Psychological resources and strengths will be assessed using the Flourishing Scale (FS). This measure is 8 items, with each item rated on a scale from 1-7. All 8 items are summed to achieve a total score of 8-56. Higher scores indicate that an individual has more psychological resources and strengths.
arm group label: Mobile self-help intervention
arm group type: Experimental
description: This study uses automated self-help interventions designed as a kit of smartphone tools.
intervention type: Behavioral
intervention name: Mobile self-help intervention
description: Participants receive several apps on their phone including IntelliCare apps, which are based on principles of cognitive-behavioral therapy. Participants also receive the Pocket Helper app, which has been designed for this study. The tools within the Pocket Helper app include a crisis text line that is available 24/7, the Illinois Warm Line which is available Monday through Friday from 8am to 5pm, directions to call 911 in the case of an emergency, the Koko web app that provides crowdsourced emotional support, brief cognitive-behavioral interventions, daily tips, and daily surveys. Phones will also include the StreetLight Chicago app, which provides homeless individuals with up-to-date information on shelters, health clinics, emergency contacts, mental health services, and more.
arm group label: Mobile self-help intervention
criteria: 
gender: All
minimum age: 16 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alyson K Zalta, PhD
role: Study Director
affiliation: University of California, Irvine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Irvine
investigator full name: Alyson Zalta
investigator title: Assistant Professor
mesh term: Substance-Related Disorders
mesh term: Personality Disorders
sharing ipd: No
provided document: 