Back to results

EMA of Substance Use in Homeless Youth

Primary Purpose

Substance Use

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day

Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day

Incentive Structure - fixed

Incentive Structure - prize based

About this trial

This is an interventional other trial for Substance Use

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

EMA, 3x/day, fixed incentive

EMA, 6x/day, fixed incentive

EMA, 3x/day, prize-based incentive

EMA, 6x/day, prized-based incentive

Arm Description

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.

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.

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).

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).

Outcomes

Primary Outcome Measures

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.

Percent Completion

Percent of EMA surveys completed (0-100%). Higher values represent a larger percentage of EMA surveys completed.

Secondary Outcome Measures

Full Information

NCT ID

NCT04884087

First Posted

May 7, 2021

Last Updated

March 15, 2023

Sponsor

Nationwide Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04884087

Brief Title

EMA of Substance Use in Homeless Youth

Official Title

Ecological Momentary Assessment of Substance Use in Homeless Youth

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

February 24, 2021 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nationwide Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Use

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EMA, 3x/day, fixed incentive

Arm Type

Experimental

Arm Description

Arm Title

EMA, 6x/day, fixed incentive

Arm Type

Experimental

Arm Description

Arm Title

EMA, 3x/day, prize-based incentive

Arm Type

Experimental

Arm Description

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).

Arm Title

EMA, 6x/day, prized-based incentive

Arm Type

Experimental

Arm Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day

Intervention Description

Participants receive 3 EMA survey prompts daily for the duration of the study.

Intervention Type

Behavioral

Intervention Name(s)

Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day

Intervention Description

Participants receive 6 EMA survey prompts daily for the duration of the study.

Intervention Type

Behavioral

Intervention Name(s)

Incentive Structure - fixed

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Incentive Structure - prize based

Intervention Description

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).

Primary Outcome Measure Information:

Title

Length of Time

Description

Total length of time in days using EMA (range: 1-14 days). Higher values represent greater length of time EMA was used.

Time Frame

Baseline to end of trial (day 14)

Title

Percent Completion

Description

Percent of EMA surveys completed (0-100%). Higher values represent a larger percentage of EMA surveys completed.

Time Frame

Baseline to end of trial (day 14)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura Chavez

Organizational Affiliation

Abigail Wexner Research Institute at Nationwide Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nationwide Children's Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

EMA of Substance Use in Homeless Youth

We'll reach out to this number within 24 hrs