EMA of Substance Use in Homeless Youth

Sponsor
Nationwide Children's Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04884087
Collaborator
(none)
40
1
4
16.2
2.5

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day
  • Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day
  • Behavioral: Incentive Structure - fixed
  • Behavioral: Incentive Structure - prize based
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day)2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day)
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Ecological Momentary Assessment of Substance Use in Homeless Youth
Actual Study Start Date :
Feb 24, 2021
Actual Primary Completion Date :
May 31, 2021
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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.

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: Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day
Participants receive 6 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, 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).

Outcome Measures

Primary Outcome Measures

  1. Length of Time [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.

  2. Percent Completion [Baseline to end of trial (day 14)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nationwide Children's Hospital Columbus Ohio United States 43205

Sponsors and Collaborators

  • Nationwide Children's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laura Chavez, Senior Research Scientist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT04884087
Other Study ID Numbers:
  • STUDY00000809
First Posted:
May 12, 2021
Last Update Posted:
Aug 16, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2021