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Completed

NCT Number: NCT03776422

Homeless Youth Study - Stepping Stone 2.0

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.

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Key information

Conditions

Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Personality Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile self-help intervention

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. Cannabis use

    Time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)

    Cannabis use will be assessed using the Cannabis Use Disorder Identification Test - Revised (CUDIT-R).

  5. Risky sexual behavior

    Time frame: Baseline (0 months), Midpoint (3 months), Endpoint (6 months)

    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).

  6. 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).

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Illinois Department of Human Services
  • Sparrow Mobile

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2018
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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