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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04884087
Other study ID # STUDY00000809
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2021
Est. completion date June 30, 2021

Study information

Verified date March 2023
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day
Participants receive 3 EMA survey prompts daily for the duration of the study.
Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day
Participants receive 6 EMA survey prompts daily for the duration of the study.
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.
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).

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of Time 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)
Primary Percent Completion Percent of EMA surveys completed (0-100%). Higher values represent a larger percentage of EMA surveys completed. Baseline to end of trial (day 14)
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