Substance UseNCT04884087

EMA of Substance Use in Homeless Youth

A study testing Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day, Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day and Incentive Structure - fixed in people with Substance Use, run by Nationwide Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 24 years
Conditions the study is for: Substance Use
What is being tested?: Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day, Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day and Incentive Structure - fixed
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 24 Feb 2021to 30 Jun 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

Official title: 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).

Conditions: Substance Use
Being tested: Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day, Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day, Incentive Structure - fixed, Incentive Structure - prize based
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/dayBehavioural
Participants receive 3 EMA survey prompts daily for the duration of the study.
Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/dayBehavioural
Participants receive 6 EMA survey prompts daily for the duration of the study.
Incentive Structure - fixedBehavioural
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 basedBehavioural
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).

Study groups in NCT04884087
Study group	Role	What they receive
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. Receives: Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day; Behavioral: 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. Receives: Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day; Behavioral: 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). Receives: Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day; Behavioral: 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). Receives: Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day; Behavioral: Incentive Structure - prize based

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline to end of trial (day 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 202130 Jun 2021

First posted12 May 2021
Study start24 Feb 2021
Primary completion30 Jun 2021
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Substance UseStudies of the same condition, open and under way.
More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Factorial
Model description: 2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day)
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04884087
Sponsor's protocol ID: STUDY00000809
Status last verified: Mar 2023
First submitted: 7 May 2021
Last updated: 17 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Substance Use trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ecological Momentary Assessment of Substance Use in Homeless Youth
ClinicalTrials.gov ID: NCT04884087
Acronym / sponsor ID: STUDY00000809
Conditions: Substance Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Nationwide Children's HospitalUniversity, hospital or other
Study start: 24 Feb 2021 (actual)
Primary completion: 30 Jun 2021 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 12 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4
Model description: 2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day)

Arm	Type	Receives
EMA, 3x/day, fixed incentive	Experimental	Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day, Behavioral: Incentive Structure - fixedEcological 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.
EMA, 6x/day, fixed incentive	Experimental	Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day, Behavioral: Incentive Structure - fixedEcological 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.
EMA, 3x/day, prize-based incentive	Experimental	Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day, Behavioral: Incentive Structure - prize basedEcological 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).
EMA, 6x/day, prized-based incentive	Experimental	Behavioral: Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day, Behavioral: Incentive Structure - prize basedEcological 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).

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/dayParticipants receive 3 EMA survey prompts daily for the duration of the study.	Behavioural	EMA, 3x/day, fixed incentive, EMA, 3x/day, prize-based incentive
Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/dayParticipants receive 6 EMA survey prompts daily for the duration of the study.	Behavioural	EMA, 6x/day, fixed incentive, EMA, 6x/day, prized-based incentive
Incentive Structure - fixedThose 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.	Behavioural	EMA, 3x/day, fixed incentive, EMA, 6x/day, fixed incentive
Incentive Structure - prize basedThose 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).	Behavioural	EMA, 3x/day, prize-based incentive, EMA, 6x/day, prized-based incentive

Primary outcome

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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
Individual participant dataSharing planned: No

Related trials for Substance Use

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Structural Stressors, Reward Related Decision Making and Substance Use Risk
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Enrolling by invitationObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura Chavez principal investigator

Abigail Wexner Research Institute at Nationwide Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Time (time frame: Baseline to end of trial (day 14)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04884087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.