- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04884087
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
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
Participants receive 3 EMA survey prompts daily for the duration of the study.
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.
|
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.
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).
|
Participants receive 3 EMA survey prompts daily for the duration of the study.
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).
|
Participants receive 6 EMA survey prompts daily for the duration of the study.
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
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
Investigators
- 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)
February 24, 2021
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
May 7, 2021
First Submitted That Met QC Criteria
May 7, 2021
First Posted (Actual)
May 12, 2021
Study Record Updates
Last Update Posted (Actual)
March 17, 2023
Last Update Submitted That Met QC Criteria
March 15, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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