Homeless Youth Study - Stepping Stone Project

NCT ID: NCT03620682

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-29
• Study Completion Date: 2018-05-11

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.

Conditions

Mental Health

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mobile mental health intervention

Participants will receive emotional support and problem-solving / stress-management skills via over-the-phone coaching sessions and mobile applications.

Group Type: EXPERIMENTAL

Coaching sessions

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alyson Zalta

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alyson K Zalta, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

References

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.

Reference Type: DERIVED

PMID: 31267980 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14112402

Identifier Type: -

Identifier Source: org_study_id