Homeless Youth Study - Stepping Stone 2.0

Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) Clinical Trial

Official title:

Homeless Youth Study - Stepping Stone 2.0

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776422
• Other study ID #: 17072403
• Status: Completed
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: July 8, 2019

Study information

• Verified date: September 2019
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 8, 2019
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
• Personality Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Mobile self-help intervention
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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	Illinois Department of Human Services, Sparrow Mobile

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Endpoint (6 months)
Primary	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.	Midpoint (3 months) and Endpoint (6 months)
Secondary	Anxiety symptoms	Anxiety symptoms will be assessed using the adaptive PROMIS Bank v1.0 for anxiety.	Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Secondary	Depression symptoms	Depression symptoms will be assessed using the adaptive PROMIS Bank v1.0 for depression.	Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Secondary	Alcohol use	Alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT-C).	Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Secondary	Cannabis use	Cannabis use will be assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R).	Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Secondary	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).	Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Secondary	PTSD symptoms	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)
Secondary	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.	Baseline (0 months), Midpoint (3 months), Endpoint (6 months)
Secondary	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.	Baseline (0 months), Midpoint (3 months), Endpoint (6 months)