NCT04884087

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

May 7, 2021

Last Update Submit

March 15, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (4)

EMA, 3x/day, fixed incentive

EXPERIMENTAL

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/dayBehavioral: Incentive Structure - fixed

EMA, 6x/day, fixed incentive

EXPERIMENTAL

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/dayBehavioral: Incentive Structure - fixed

EMA, 3x/day, prize-based incentive

EXPERIMENTAL

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/dayBehavioral: Incentive Structure - prize based

EMA, 6x/day, prized-based incentive

EXPERIMENTAL

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/dayBehavioral: Incentive Structure - prize based

Interventions

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

EMA, 3x/day, fixed incentiveEMA, 3x/day, prize-based incentive

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

EMA, 6x/day, fixed incentiveEMA, 6x/day, prized-based incentive

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.

EMA, 3x/day, fixed incentiveEMA, 6x/day, fixed incentive

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).

EMA, 3x/day, prize-based incentiveEMA, 6x/day, prized-based incentive

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Laura Chavez

    Abigail Wexner Research Institute at Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: 2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 12, 2021

Study Start

February 24, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations