Back to resultsHomeless Youth Study - Stepping Stone 2.0
Primary Purpose
Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile self-help intervention
Sponsored by
About this trial
This is an interventional treatment trial for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Eligibility Criteria
Inclusion Criteria:
- 16-25 years
- English-speaking
Youth must meet one of the following risk criteria
Experiencing housing instability as defined by:
- lacking a fixed, regular, and adequate nighttime residence OR whose primary nighttime residence is a shelter, institution, or a "public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings"
- sharing the housing of other persons due to loss of housing [or] economic hardship.
- frequent moves, poor housing quality (e.g., living in severely overcrowded housing).
- Imminently leaving the foster care system
- Willingness and ability to comply with requirements of the study protocol
Exclusion Criteria:
* Inability to understand study procedures and participate in the informed consent process.
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobile self-help intervention
Arm Description
This study uses automated self-help interventions designed as a kit of smartphone tools.
Outcomes
Primary Outcome Measures
Program adherence
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.
Program satisfaction
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.
Secondary Outcome Measures
Anxiety symptoms
Anxiety symptoms will be assessed using the adaptive PROMIS Bank v1.0 for anxiety.
Depression symptoms
Depression symptoms will be assessed using the adaptive PROMIS Bank v1.0 for depression.
Alcohol use
Alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT-C).
Cannabis use
Cannabis use will be assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R).
Risky sexual behavior
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).
PTSD symptoms
PTSD symptoms will be assessed using the The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
Satisfaction with life: Satisfaction with Life Scale (SWLS)
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.
Psychosocial flourishing
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.
Full Information
NCT ID
NCT03776422
First Posted
December 12, 2018
Last Updated
September 26, 2019
Sponsor
Rush University Medical Center
Collaborators
Illinois Department of Human Services, Sparrow Mobile
1. Study Identification
Unique Protocol Identification Number
NCT03776422
Brief Title
Homeless Youth Study - Stepping Stone 2.0
Official Title
Homeless Youth Study - Stepping Stone 2.0
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
July 8, 2019 (Actual)
Study Completion Date
July 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
Illinois Department of Human Services, Sparrow Mobile
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile self-help intervention
Arm Type
Experimental
Arm Description
This study uses automated self-help interventions designed as a kit of smartphone tools.
Intervention Type
Behavioral
Intervention Name(s)
Mobile self-help intervention
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.
Primary Outcome Measure Information:
Title
Program adherence
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.
Time Frame
Baseline to Endpoint (6 months)
Title
Program satisfaction
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.
Time Frame
Midpoint (3 months) and Endpoint (6 months)
Secondary Outcome Measure Information:
Title
Anxiety symptoms
Description
Anxiety symptoms will be assessed using the adaptive PROMIS Bank v1.0 for anxiety.
Time Frame
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Title
Depression symptoms
Description
Depression symptoms will be assessed using the adaptive PROMIS Bank v1.0 for depression.
Time Frame
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Title
Alcohol use
Description
Alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT-C).
Time Frame
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Title
Cannabis use
Description
Cannabis use will be assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R).
Time Frame
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Title
Risky sexual behavior
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).
Time Frame
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Title
PTSD symptoms
Description
PTSD symptoms will be assessed using the The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
Time Frame
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Title
Satisfaction with life: Satisfaction with Life Scale (SWLS)
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.
Time Frame
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Title
Psychosocial flourishing
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.
Time Frame
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
16-25 years
English-speaking
Youth must meet one of the following risk criteria
Experiencing housing instability as defined by:
lacking a fixed, regular, and adequate nighttime residence OR whose primary nighttime residence is a shelter, institution, or a "public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings"
sharing the housing of other persons due to loss of housing [or] economic hardship.
frequent moves, poor housing quality (e.g., living in severely overcrowded housing).
Imminently leaving the foster care system
Willingness and ability to comply with requirements of the study protocol
Exclusion Criteria:
* Inability to understand study procedures and participate in the informed consent process.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alyson K Zalta, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Study Director
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35460583
Citation
Straka K, Blacketer AR, Martinez RL, Glover A, Winiarski DA, Karnik NS, Schueller SM, Zalta AK. Rates and correlates of well-being among youth experiencing homelessness. J Community Psychol. 2022 Sep;50(8):3746-3759. doi: 10.1002/jcop.22869. Epub 2022 Apr 23.
Results Reference
derived
PubMed Identifier
31605516
Citation
Glover AC, Schueller SM, Winiarski DA, Smith DL, Karnik NS, Zalta AK. Automated Mobile Phone-Based Mental Health Resource for Homeless Youth: Pilot Study Assessing Feasibility and Acceptability. JMIR Ment Health. 2019 Oct 11;6(10):e15144. doi: 10.2196/15144.
Results Reference
derived
Learn more about this trial
Homeless Youth Study - Stepping Stone 2.0
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