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Completed

NCT Number: NCT03620682

Homeless Youth Study - Stepping Stone Project

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.

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Key information

Conditions

Mental Health Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Coaching Sessions

Behavioral

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 applications

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Depression symptoms

    Time frame: Baseline (week 0) to Endpoint (week 4)

    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.

  2. Posttraumatic Stress Disorder symptoms

    Time frame: Baseline (week 0) to Endpoint (week 4)

    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.

  3. Emotion Regulation

    Time frame: Baseline (week 0) to Endpoint (week 4)

    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.

  4. Anxiety symptoms

    Time frame: Baseline (week 0) to Endpoint (week 4)

    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.

  5. Risky sexual behavior and substance use

    Time frame: Baseline (week 0) to Endpoint (week 4)

    Risky sexual behaviors and substance use will be assessed using the Centers for Disease Control and Prevention's Youth Risk Behavior Survey (2011).

  6. Acceptability of treatment components

    Time frame: Endpoint (week 4)

    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.

Other outcomes

  1. Acceptability of mental health treatment

    Time frame: Baseline (week 0) to Endpoint (week 4)

    Attitudes toward the mental health system will be assessed using an author-developed measure.

  2. Positive and negative affect

    Time frame: Baseline (week 0) to Endpoint (week 4)

    Current positive and negative emotions will be assessed using the Positive and Negative Affect Schedule.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Using Smartphone Technology to Provide Mental Health Interventions for Homeless Youth

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 8, 2018
Registry last updated
Aug 8, 2018

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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