NCT03776422

Brief Summary

Housing instability is both a cause and consequence of mental health problems. As such youth experiencing housing instability (e.g., homeless or marginally housed) have higher rates of mental health problems.Because of their circumstances, these youth also face significant barriers to mental health care and are therefore less likely to receive the treatment that they need. Mobile technology may offer a novel platform for increasing access to mental health care in this population. The primary goals of this pilot study are to (1) establish the feasibility and acceptability of delivering automated mental health interventions via smartphone technology, (2) examine the extent to which automated mental health interventions delivered via mobile technology improve mental health in homeless, marginally-housed, and exiting foster youth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

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

December 21, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

December 12, 2018

Last Update Submit

September 26, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Program adherence

    Program adherence will be assessed based on usage data determining how often participants utilized the study applications, and how often they completed daily surveys and rated daily tips.

    Baseline to Endpoint (6 months)

  • Program satisfaction

    Program satisfaction will be assessed using a self-report questionnaire that participants will be asked to complete at the midpoint and endpoint of the study. Participants will be asked to report the extent to which they benefited from the study, how helpful the mobile applications were, and if they would recommend the study to others. These responses are recorded on 5-point likert type scales with higher ratings indicating higher satisfaction.

    Midpoint (3 months) and Endpoint (6 months)

Secondary Outcomes (8)

  • Anxiety symptoms

    Baseline (0 months), Midpoint (3 months), Endpoint (6 months)

  • Depression symptoms

    Baseline (0 months), Midpoint (3 months), Endpoint (6 months)

  • Alcohol use

    Baseline (0 months), Midpoint (3 months), Endpoint (6 months)

  • Cannabis use

    Baseline (0 months), Midpoint (3 months), Endpoint (6 months)

  • Risky sexual behavior

    Baseline (0 months), Midpoint (3 months), Endpoint (6 months)

  • +3 more secondary outcomes

Study Arms (1)

Mobile self-help intervention

EXPERIMENTAL

This study uses automated self-help interventions designed as a kit of smartphone tools.

Behavioral: Mobile self-help intervention

Interventions

Participants receive several apps on their phone including IntelliCare apps, which are based on principles of cognitive-behavioral therapy. Participants also receive the Pocket Helper app, which has been designed for this study. The tools within the Pocket Helper app include a crisis text line that is available 24/7, the Illinois Warm Line which is available Monday through Friday from 8am to 5pm, directions to call 911 in the case of an emergency, the Koko web app that provides crowdsourced emotional support, brief cognitive-behavioral interventions, daily tips, and daily surveys. Phones will also include the StreetLight Chicago app, which provides homeless individuals with up-to-date information on shelters, health clinics, emergency contacts, mental health services, and more.

Mobile self-help intervention

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years
  • English-speaking
  • Youth must meet one of the following risk criteria
  • Experiencing housing instability as defined by:
  • lacking a fixed, regular, and adequate nighttime residence OR whose primary nighttime residence is a shelter, institution, or a "public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings"
  • sharing the housing of other persons due to loss of housing \[or\] economic hardship.
  • frequent moves, poor housing quality (e.g., living in severely overcrowded housing).
  • Imminently leaving the foster care system
  • Willingness and ability to comply with requirements of the study protocol

You may not qualify if:

  • \* Inability to understand study procedures and participate in the informed consent process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

  • Straka K, Blacketer AR, Martinez RL, Glover A, Winiarski DA, Karnik NS, Schueller SM, Zalta AK. Rates and correlates of well-being among youth experiencing homelessness. J Community Psychol. 2022 Sep;50(8):3746-3759. doi: 10.1002/jcop.22869. Epub 2022 Apr 23.

  • Glover AC, Schueller SM, Winiarski DA, Smith DL, Karnik NS, Zalta AK. Automated Mobile Phone-Based Mental Health Resource for Homeless Youth: Pilot Study Assessing Feasibility and Acceptability. JMIR Ment Health. 2019 Oct 11;6(10):e15144. doi: 10.2196/15144.

MeSH Terms

Conditions

DepressionPsychotic DisordersPersonality DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersChemically-Induced Disorders

Study Officials

  • Alyson K Zalta, PhD

    University of California, Irvine

    STUDY DIRECTOR

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

December 12, 2018

First Posted

December 14, 2018

Study Start

December 21, 2017

Primary Completion

July 8, 2019

Study Completion

July 8, 2019

Last Updated

September 27, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations