Homeless Youth Study - Stepping Stone Project

August 6, 2018 updated by: Alyson Zalta, Rush University Medical Center

Using Smartphone Technology to Provide Mental Health Interventions for Homeless Youth

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 23 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline (week 0) to Endpoint (week 4)
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.
Treatment endpoint (week 4)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0) to Endpoint (week 4)
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.
Baseline (week 0) to Endpoint (week 4)
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.
Baseline (week 0) to Endpoint (week 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.
Baseline (week 0) to Endpoint (week 4)
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).
Baseline (week 0) to Endpoint (week 4)
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.
Endpoint (week 4)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0) to Endpoint (week 4)
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.
Baseline (week 0) to Endpoint (week 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rush University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alyson K Zalta, PhD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14112402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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