Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)NCT03776422
Homeless Youth Study - Stepping Stone 2.0
A study testing Mobile self-help intervention in people with Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), run by Rush University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
- What is being tested?
- Mobile self-help intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2017to 8 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- Inability to understand study procedures and participate in the informed consent process.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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.
- Being tested
- Mobile self-help intervention
- Medical subject headings
- Depression, Psychotic Disorders, Personality Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile self-help interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile self-help intervention | Experimental | This study uses automated self-help interventions designed as a kit of smartphone tools. Receives: Behavioral: Mobile self-help intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Endpoint (6 months)
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.
Measured: Midpoint (3 months) and Endpoint (6 months)
Secondary outcomes (8)
Anxiety symptoms
Anxiety symptoms will be assessed using the adaptive PROMIS Bank v1.0 for anxiety.
Measured: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Depression symptoms
Depression symptoms will be assessed using the adaptive PROMIS Bank v1.0 for depression.
Measured: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Alcohol use
Alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT-C).
Measured: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Cannabis use
Cannabis use will be assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R).
Measured: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
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).
Measured: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
PTSD symptoms
PTSD symptoms will be assessed using the The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
Measured: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
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.
Measured: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
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.
Measured: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start21 Dec 2017
- Primary completion8 Jul 2019
- Study completion8 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Illinois Department of Human Services, Sparrow Mobile
- Responsible party
- Principal investigator, Alyson Zalta, University of California, Irvine
- Investigators
- Alyson K Zalta, PhD, Study director, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776422
- Sponsor's protocol ID
- 17072403
- Status last verified
- Sep 2019
- First submitted
- 12 Dec 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35460583Glover 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.
PubMed 31605516
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homeless Youth Study - Stepping Stone 2.0
- ClinicalTrials.gov ID
- NCT03776422
- Acronym / sponsor ID
- 17072403
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Illinois Department of Human Services, Sparrow Mobile
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile self-help intervention | Experimental | Behavioral: Mobile self-help interventionThis study uses automated self-help interventions designed as a kit of smartphone tools. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 16-25 years
- English-speaking
- Youth must meet one of the following risk criteria
- Willingness and ability to comply with requirements of the study protocol
Key exclusion criteria (1 listed)
- Inability to understand study procedures and participate in the informed consent process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile self-help interventionParticipants 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. | Behavioural | Mobile self-help intervention |
Primary outcome
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.
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.
8 secondary outcomes
Anxiety symptoms
Time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Depression symptoms
Time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Alcohol use
Time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Cannabis use
Time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Risky sexual behavior
Time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
PTSD symptoms
Time frame: 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)
Psychosocial flourishing
Time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Derived from this study: PubMed 35460583Straka 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.
- Derived from this study: PubMed 31605516Glover 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.
- Individual participant dataSharing planned: No
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Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyson K Zalta, PhD study director
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile self-help intervention in people with Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program adherence (time frame: Baseline to Endpoint (6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03776422, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.