Homeless Youth Study - Stepping Stone Project

• ClinicalTrials.gov Identifier: NCT03620682
• Recruitment Status: Completed
• First Posted: August 8, 2018
• Last Update Posted: August 8, 2018
• Sponsor: Rush University Medical Center
• Information provided by (Responsible Party): Alyson Zalta, Rush University Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Mental Health	Behavioral: Coaching sessions; Behavioral: Mobile applications	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Using Smartphone Technology to Provide Mental Health Interventions for Homeless Youth
• Actual Study Start Date: January 29, 2016
• Actual Primary Completion Date: December 11, 2017
• Actual Study Completion Date: May 11, 2018

Arms and Interventions

Arm

Intervention/treatment

Experimental: Mobile mental health intervention; Participants will receive emotional support and problem-solving / stress-management skills via over-the-phone coaching sessions and mobile applications.

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.; Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 23 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Rush University Medical Center

Investigators

• Principal Investigator: Alyson K Zalta, PhD; Rush University Medical Center

  Study Documents (Full-Text)

Documents provided by Alyson Zalta, Rush University Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] June 24, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Alyson Zalta, Assistant Professor, Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT03620682
• Other Study ID Numbers: 14112402
• First Posted: August 8, 2018
• Last Update Posted: August 8, 2018
• Last Verified: August 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No