Homeless Youth Study - Stepping Stone Project

Mental Health Clinical Trial

Official title:

Using Smartphone Technology to Provide Mental Health Interventions for Homeless Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620682
• Other study ID #: 14112402
• Status: Completed
• Phase: N/A
• Start date: January 29, 2016
• Est. completion date: May 11, 2018

Study information

• Verified date: August 2018
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 11, 2018
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 23 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health

Intervention

Behavioral:
• Coaching sessions
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of mental health treatment	Attitudes toward the mental health system will be assessed using an author-developed measure.	Baseline (week 0) to Endpoint (week 4)
Other	Positive and negative affect	Current positive and negative emotions will be assessed using the Positive and Negative Affect Schedule.	Baseline (week 0) to Endpoint (week 4)
Primary	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).	Baseline (week 0) to Endpoint (week 4)
Primary	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.	Treatment endpoint (week 4)
Secondary	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.	Baseline (week 0) to Endpoint (week 4)
Secondary	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.	Baseline (week 0) to Endpoint (week 4)
Secondary	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.	Baseline (week 0) to Endpoint (week 4)
Secondary	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.	Baseline (week 0) to Endpoint (week 4)
Secondary	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).	Baseline (week 0) to Endpoint (week 4)
Secondary	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.	Endpoint (week 4)