EMA of Substance Use in Homeless Youth

March 15, 2023 updated by: Laura Chavez, Nationwide Children's Hospital

Ecological Momentary Assessment of Substance Use in Homeless Youth

The proposed study will provide critical information on Ecological Momentary Assessment (EMA) design characteristics that promote retention in a vulnerable and under-represented population in research-youth experiencing homelessness. The study will use an EMA app to collect substance use, mood, craving, social surroundings, and trauma measures over a 14-day period in youth age 18-24 (n=40) recruited from Star House, a homeless youth drop-in center. Youth will be randomized in 2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day).

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.
40

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

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 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • currently homeless, defined as lacking a fixed, regular, and adequate nighttime residence.
  • report any of the following past-month frequencies of substance use (NIDA ASSIST screen) used in prior EMA studies: a) heavy episodic or "binge" drinking (≥4 drinks per day for women/≥5 drinks for men) ≥2 days per month ; b) marijuana use ≥2 days per week; or c) any illicit drug use.

Exclusion Criteria:

-

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: Other
  • Allocation: Randomized
  • Interventional Model: Factorial 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: EMA, 3x/day, fixed incentive
Ecological Momentary Assessment (EMA; Metricwire). Participants randomized to this group will be sent prompts through the EMA app to complete brief EMA survey at 3 random times per day. Participants randomized to this group will earn a fixed bonus/incentive based on completion of the EMA surveys (50-74%=$3; 75-89%=$5; ≥90%=$10) each week.
Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day
Participants receive 3 EMA survey prompts daily for the duration of the study.
Behavioral: Incentive Structure - fixed
Those assigned to the "fixed" incentive condition will earn a fixed bonus based on EMA completion (50-74%=$3; 75-89%=$5; ≥90%=$10) each week.
Experimental: EMA, 6x/day, fixed incentive
Ecological Momentary Assessment (EMA; Metricwire). Participants randomized to this group will be sent prompts through the EMA app to complete brief EMA survey at 6 random times per day. Participants randomized to this group will earn a fixed bonus/incentive based on completion of the EMA surveys (50-74%=$3; 75-89%=$5; ≥90%=$10) each week.
Behavioral: Incentive Structure - fixed
Those assigned to the "fixed" incentive condition will earn a fixed bonus based on EMA completion (50-74%=$3; 75-89%=$5; ≥90%=$10) each week.
Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day
Participants receive 6 EMA survey prompts daily for the duration of the study.
Experimental: EMA, 3x/day, prize-based incentive
Ecological Momentary Assessment (EMA; Metricwire). Participants randomized to this group will be sent prompts through the EMA app to complete brief EMA survey at 3 random times per day. Participants randomized to this group will be rewarded for high survey completion with increasing numbers of "draws" for prizes depending on their level of response each week (50-74%=1 draw, 75-89%=2 draws, ≥90%=3 draws).
Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day
Participants receive 3 EMA survey prompts daily for the duration of the study.
Behavioral: Incentive Structure - prize based
Those assigned to the "prize-based" incentive will be rewarded for high survey completion with increasing numbers of "draws" depending on their level of response to EMA prompts each week (50-74%=1 draw, 75-89%=2 draws, ≥90%=3 draws). For each draw, individuals will use the EMA app to "spin the wheel" to see which prize amount they earn. Out of a total of 500 total draws, 50% will be $1, 43.6% will be $3, 6% will be medium prizes ($5), and 0.4% will be a "jumbo" prize ($90).
Experimental: EMA, 6x/day, prized-based incentive
Ecological Momentary Assessment (EMA; Metricwire). Participants randomized to this group will be sent prompts through the EMA app to complete brief EMA survey at 6 random times per day. Participants randomized to this group will be rewarded for high survey completion with increasing numbers of "draws" for prizes depending on their level of response each week (50-74%=1 draw, 75-89%=2 draws, ≥90%=3 draws).
Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day
Participants receive 6 EMA survey prompts daily for the duration of the study.
Behavioral: Incentive Structure - prize based
Those assigned to the "prize-based" incentive will be rewarded for high survey completion with increasing numbers of "draws" depending on their level of response to EMA prompts each week (50-74%=1 draw, 75-89%=2 draws, ≥90%=3 draws). For each draw, individuals will use the EMA app to "spin the wheel" to see which prize amount they earn. Out of a total of 500 total draws, 50% will be $1, 43.6% will be $3, 6% will be medium prizes ($5), and 0.4% will be a "jumbo" prize ($90).

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
Length of Time
Time Frame: Baseline to end of trial (day 14)
Total length of time in days using EMA (range: 1-14 days). Higher values represent greater length of time EMA was used.
Baseline to end of trial (day 14)
Percent Completion
Time Frame: Baseline to end of trial (day 14)
Percent of EMA surveys completed (0-100%). Higher values represent a larger percentage of EMA surveys completed.
Baseline to end of trial (day 14)

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.
Nationwide Children's Hospital

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: Laura Chavez, Abigail Wexner Research Institute at Nationwide Children's Hospital

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.
February 24, 2021

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.
June 30, 2021

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.
June 30, 2021

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).
May 7, 2021

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.
May 7, 2021

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.
May 12, 2021

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.
March 17, 2023

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.
March 15, 2023

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.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • STUDY00000809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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