NCT03928756

Brief Summary

The main aim of this formative study is to test and iteratively refine a new mobile phone app, which delivers assessments and tailored intervention content. The study will use social media advertisements to recruit a total of 40 youth between the ages of 16-24 years. Those screening positive for past-month binge drinking or marijuana use will be invited to complete a baseline survey, download and use the app for 30 days, and complete a follow-up survey about the app functionality, design and content, and preliminary outcomes (intentions and importance of reducing use).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 12, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2019

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

April 23, 2019

Last Update Submit

October 21, 2019

Conditions

Substance Use

Keywords

substance usemobile health

Outcome Measures

Primary Outcomes (4)

  • Change in Intentions to Reduce Alcohol Use

    Change in intentions to reduce alcohol use will be assessed using a 10-point validated Likert item which asks participants to rate their current likelihood of cutting back on their alcohol use. (a score of 1 is equivalent to not at all likely and a score of 10 is very likely)

    1-month post-app start

  • Change in Importance of Reducing Alcohol Use

    Change in importance of reducing alcohol use will be assessed using a 10-point validated Likert item which asks participants to rate how important it is to them to cut back on their alcohol use. (a score of 1 is equivalent to not at all important and a score of 10 is very important)

    1-month post-app start

  • Change in Intentions to Reduce Marijuana Use

    Change in intentions to reduce marijuana use will be assessed using a 10-point validated Likert item which asks participants to rate their current likelihood of cutting back on their marijuana use. (a score of 1 is equivalent to not at all likely and a score of 10 is very likely)

    1-month post-app start

  • Change in Importance of Reducing Marijuana Use

    Change in importance of reducing alcohol use will be assessed using a 10-point validated Likert item which asks participants to rate how important it is to them to cut back on their marijuana use. (a score of 1 is equivalent to not at all important and a score of 10 is very important)

    1-month post-app start

Study Arms (1)

Within-participant randomization

EXPERIMENTAL

Each day, each available participant will be randomly assigned to receive either: a push notification with tailored intervention content; a push notification with engaging, nontherapeutic content; or no push notification.

Behavioral: Push Notifications with Tailored Intervention ContentBehavioral: Push Notifications with Engaging, Non-therapeutic ContentBehavioral: No Push Notifications

Interventions

Push Notifications with Tailored Intervention ContentBEHAVIORAL

Participants will receive a push notification with a therapeutic message (e.g., about stress, mood, substance use motives, tools to reduce risky substance use) tailored to their recent daily or weekly survey responses. Messages include visual (memes, images, videos) and written content.

Within-participant randomization
Push Notifications with Engaging, Non-therapeutic ContentBEHAVIORAL

Participants will receive a push notification with an engaging, non-therapeutic message (e.g., fun facts).

Within-participant randomization
No Push NotificationsBEHAVIORAL

Participants will not receive a push notification.

Within-participant randomization

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Have an iPhone smartphone on which the app can be downloaded
  • Self-reported past-month binge drinking (4/5 or more drinks on one occasion, tailored by sex) OR any past-month marijuana use without a medical marijuana card
  • Meet study verification criteria (i.e., use of CAPTCHA, IP address checks, social media checks).

You may not qualify if:

  • \. Unable to understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Maureen Walton, MPH, PHD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 26, 2019

Study Start

August 12, 2019

Primary Completion

October 17, 2019

Study Completion

October 17, 2019

Last Updated

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)