NCT03620682

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

July 24, 2018

Last Update Submit

August 6, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (6)

  • Depression symptoms

    Baseline (week 0) to Endpoint (week 4)

  • Posttraumatic Stress Disorder symptoms

    Baseline (week 0) to Endpoint (week 4)

  • Emotion Regulation

    Baseline (week 0) to Endpoint (week 4)

  • Anxiety symptoms

    Baseline (week 0) to Endpoint (week 4)

  • Risky sexual behavior and substance use

    Baseline (week 0) to Endpoint (week 4)

  • +1 more secondary outcomes

Other Outcomes (2)

  • Acceptability of mental health treatment

    Baseline (week 0) to Endpoint (week 4)

  • Positive and negative affect

    Baseline (week 0) to Endpoint (week 4)

Study Arms (1)

Mobile mental health intervention

EXPERIMENTAL

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

Behavioral: Coaching sessionsBehavioral: Mobile applications

Interventions

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 mental health intervention

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.

Mobile mental health intervention

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Alyson K Zalta, PhD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 8, 2018

Study Start

January 29, 2016

Primary Completion

December 11, 2017

Study Completion

May 11, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08