- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03776422
Homeless Youth Study - Stepping Stone 2.0
September 26, 2019 updated by: Alyson Zalta, Rush University Medical Center
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile self-help intervention
This study uses automated self-help interventions designed as a kit of smartphone tools.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Program adherence
Time Frame: Baseline to Endpoint (6 months)
|
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.
|
Baseline to Endpoint (6 months)
|
|
Program satisfaction
Time Frame: Midpoint (3 months) and Endpoint (6 months)
|
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.
|
Midpoint (3 months) and Endpoint (6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety symptoms
Time Frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
Anxiety symptoms will be assessed using the adaptive PROMIS Bank v1.0 for anxiety.
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Depression symptoms
Time Frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
Depression symptoms will be assessed using the adaptive PROMIS Bank v1.0 for depression.
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Alcohol use
Time Frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
Alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT-C).
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Cannabis use
Time Frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
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Cannabis use will be assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R).
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Risky sexual behavior
Time Frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
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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).
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
PTSD symptoms
Time Frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
PTSD symptoms will be assessed using the The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Satisfaction with life: Satisfaction with Life Scale (SWLS)
Time Frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
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.
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
|
Psychosocial flourishing
Time Frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
|
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.
|
Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Alyson K Zalta, PhD, University of California, Irvine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2017
Primary Completion (Actual)
July 8, 2019
Study Completion (Actual)
July 8, 2019
Study Registration Dates
First Submitted
December 12, 2018
First Submitted That Met QC Criteria
December 12, 2018
First Posted (Actual)
December 14, 2018
Study Record Updates
Last Update Posted (Actual)
September 27, 2019
Last Update Submitted That Met QC Criteria
September 26, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17072403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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