Mental HealthNCT03620682
Homeless Youth Study - Stepping Stone Project
A study testing Coaching sessions and Mobile applications in people with Mental Health, run by Rush University Medical Center.
Trial summary
Homelessness is associated with a multitude of negative consequences including an increased risk for mental health problems. Once homeless, these individuals face significant barriers to mental health care and are therefore less likely to receive the treatment they need. Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Coaching sessions and Mobile applications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 29 Jan 2016to 11 May 2018
- 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 18 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English-speaking
- Homeless as defined by lacking "a fixed, regular, and adequate nighttime residence," (Department of Education) including youth who temporarily share the housing of others due to financial hardship
- Currently sleeping in a Chicago-based shelter (at least 50% of nights in the past week)
- Willingness and ability to comply with requirements of the study protocol
Who cannot join
- Involvement in risky behaviors that could interfere with the ability to fully engage in the study, as determined by the Principal Investigator
- Current involvement in legal proceedings
- Mental retardation or significant cognitive impairment
- Significant suicidal ideation indicated by a BDI-II item 9 score ≥ 2 or enacted suicidal behaviors within 6 months prior to eligibility
- Any concurrent psychotherapy of any duration
- Inability to understand study procedures and participate in the informed consent process
About this study
Official title: Using Smartphone Technology to Provide Mental Health Interventions for Homeless Youth
Homelessness is associated with a multitude of negative consequences including an increased risk for mental health problems. Once homeless, these individuals face significant barriers to mental health care and are therefore less likely to receive the treatment they need. Mobile technology may offer a novel platform for increasing access to mental health care in this population. Thus, the primary goals of this pilot study are to (1) establish the feasibility and acceptability of delivering a brief cognitive-behavioral intervention to homeless youth via smartphone technology, (2) examine the extent to which brief cognitive-behavioral interventions delivered via mobile technology improve mental health and trauma-related psychological symptoms in homeless youth, and (3) establish smartphone usage patterns among homeless youth to inform future interventions.
- Conditions
- Mental Health
- Being tested
- Coaching sessions, Mobile applications
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching sessionsBehavioural
Participants receive three 30-minute phone sessions with a doctorate-level therapist over the course of one month. These sessions are skills-based and focus on improving participants' problem solving through cognitive-behavioral techniques. Participants are allowed to text the therapist between sessions for information and support.
Mobile applicationsBehavioural
Participants will have access to 3 mobile apps for the duration of the study, and after it ends. One app will push participants a daily, self-reflective survey to complete, and a daily motivational or instructional tip to rate. Other apps will provide education and exercises on various aspects of mental health and wellness, such as sleep and relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Mobile mental health intervention | Experimental | Participants will receive emotional support and problem-solving / stress-management skills via over-the-phone coaching sessions and mobile applications. Receives: Behavioral: Coaching sessions; Behavioral: Mobile applications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment adherence
Adherence will be assessed based on number of coaching sessions attended over the course of the 1 month treatment period (range of 0 to 3).
Measured: Baseline (week 0) to Endpoint (week 4)
Treatment satisfaction
Participants will be asked to report the extent to which they were satisfied with the study, the extent to which they thought the study was helpful, and whether they would recommend the study to someone else. These responses are recorded on 5-point likert type scales with higher ratings indicating higher satisfaction.
Measured: Treatment endpoint (week 4)
Secondary outcomes (6)
Depression symptoms
Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The range is from 0-27. Higher values represent worse depression symptoms.
Measured: Baseline (week 0) to Endpoint (week 4)
Posttraumatic Stress Disorder symptoms
PTSD symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5). The range is from 0-80. Higher values represent worse PTSD symptoms.
Measured: Baseline (week 0) to Endpoint (week 4)
Emotion Regulation
Ability to regulate emotion will be assessed using the Difficulties in Emotion Regulation Scale (DERS). Range is from 36 to 180. Higher scores suggest greater problems with emotion regulation.
Measured: Baseline (week 0) to Endpoint (week 4)
Anxiety symptoms
Current symptoms of anxiety will be assessed using the State Anxiety scale of the State Trait Anxiety Inventory. Scores range from 20 to 80. Higher scores indicate greater anxiety.
Measured: Baseline (week 0) to Endpoint (week 4)
Risky sexual behavior and substance use
Risky sexual behaviors and substance use will be assessed using the Centers for Disease Control and Prevention's Youth Risk Behavior Survey (2011).
Measured: Baseline (week 0) to Endpoint (week 4)
Acceptability of treatment components
At the end of the treatment period, participants will rate the extent to which they liked each of the different treatment components (coaching sessions, text messages, apps, tips). Participants will also be asked to report the extent to which they used the skills that they learned in the coaching sessions.
Measured: Endpoint (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start29 Jan 2016
- Primary completion11 Dec 2017
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyson Zalta, Rush University Medical Center
- Investigators
- Alyson K Zalta, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620682
- Sponsor's protocol ID
- 14112402
- Status last verified
- Aug 2018
- First submitted
- 24 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schueller SM, Glover AC, Rufa AK, Dowdle CL, Gross GD, Karnik NS, Zalta AK. A Mobile Phone-Based Intervention to Improve Mental Health Among Homeless Young Adults: Pilot Feasibility Trial. JMIR Mhealth Uhealth. 2019 Jul 2;7(7):e12347. doi: 10.2196/12347.
PubMed 31267980
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Smartphone Technology to Provide Mental Health Interventions for Homeless Youth
- ClinicalTrials.gov ID
- NCT03620682
- Acronym / sponsor ID
- 14112402
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 29 Jan 2016 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 8 Aug 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.
Homelessness is associated with a multitude of negative consequences including an increased risk for mental health problems. Once homeless, these individuals face significant barriers to mental health care and are therefore less likely to receive the treatment they need. Mobile technology may offer a novel platform for increasing access to mental health care in this population. Thus, the primary goals of this pilot study are to (1) establish the feasibility and acceptability of delivering a brief cognitive-behavioral intervention to homeless youth via smartphone technology, (2) examine the extent to which brief cognitive-behavioral interventions delivered via mobile technology improve mental health and trauma-related psychological symptoms in homeless youth, and (3) establish smartphone usage patterns among homeless youth to inform future interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile mental health intervention | Experimental | Behavioral: Coaching sessions, Behavioral: Mobile applicationsParticipants will receive emotional support and problem-solving / stress-management skills via over-the-phone coaching sessions and mobile applications. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- English-speaking
- Homeless as defined by lacking "a fixed, regular, and adequate nighttime residence," (Department of Education) including youth who temporarily share the housing of others due to financial hardship
- Currently sleeping in a Chicago-based shelter (at least 50% of nights in the past week)
- Willingness and ability to comply with requirements of the study protocol
Key exclusion criteria (6 listed)
- Involvement in risky behaviors that could interfere with the ability to fully engage in the study, as determined by the Principal Investigator
- Current involvement in legal proceedings
- Mental retardation or significant cognitive impairment
- Significant suicidal ideation indicated by a BDI-II item 9 score ≥ 2 or enacted suicidal behaviors within 6 months prior to eligibility
- Any concurrent psychotherapy of any duration
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 |
|---|---|---|
| Coaching sessionsParticipants receive three 30-minute phone sessions with a doctorate-level therapist over the course of one month. These sessions are skills-based and focus on improving participants' problem solving through cognitive-behavioral techniques. Participants are allowed to text the therapist between sessions for information and support. | Behavioural | Mobile mental health intervention |
| Mobile applicationsParticipants will have access to 3 mobile apps for the duration of the study, and after it ends. One app will push participants a daily, self-reflective survey to complete, and a daily motivational or instructional tip to rate. Other apps will provide education and exercises on various aspects of mental health and wellness, such as sleep and relaxation. | Behavioural | Mobile mental health intervention |
Primary outcome
Treatment adherence
Time frame: Baseline (week 0) to Endpoint (week 4)
Adherence will be assessed based on number of coaching sessions attended over the course of the 1 month treatment period (range of 0 to 3).
Treatment satisfaction
Time frame: Treatment endpoint (week 4)
Participants will be asked to report the extent to which they were satisfied with the study, the extent to which they thought the study was helpful, and whether they would recommend the study to someone else. These responses are recorded on 5-point likert type scales with higher ratings indicating higher satisfaction.
6 secondary outcomes
Depression symptoms
Time frame: Baseline (week 0) to Endpoint (week 4)
Posttraumatic Stress Disorder symptoms
Time frame: Baseline (week 0) to Endpoint (week 4)
Emotion Regulation
Time frame: Baseline (week 0) to Endpoint (week 4)
Anxiety symptoms
Time frame: Baseline (week 0) to Endpoint (week 4)
Risky sexual behavior and substance use
Time frame: Baseline (week 0) to Endpoint (week 4)
Acceptability of treatment components
Time frame: Endpoint (week 4)
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 8 Aug 2018.
- Derived from this study: PubMed 31267980Schueller SM, Glover AC, Rufa AK, Dowdle CL, Gross GD, Karnik NS, Zalta AK. A Mobile Phone-Based Intervention to Improve Mental Health Among Homeless Young Adults: Pilot Feasibility Trial. JMIR Mhealth Uhealth. 2019 Jul 2;7(7):e12347. doi: 10.2196/12347.
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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 principal investigator
Rush University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Coaching sessions and Mobile applications in people with Mental Health, run by Rush University Medical Center.
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 4 inclusion and 6 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Treatment adherence (time frame: Baseline (week 0) to Endpoint (week 4)). 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 NCT03620682, which also lists 1 linked publication.
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 8 Aug 2018; AzTrials last refreshed its copy on 29 Oct 2026.