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Adaptive Interventions for Prevention/Intervention for Youth Substance Abuse

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Push Notifications with Tailored Intervention Content
Push Notifications with Engaging, Non-therapeutic Content
No Push Notifications
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use focused on measuring substance use, mobile health

Eligibility Criteria

16 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Have an iPhone smartphone on which the app can be downloaded
  2. 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
  3. Meet study verification criteria (i.e., use of CAPTCHA, IP address checks, social media checks).

Exclusion Criteria:

1. Unable to understand English

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Within-participant randomization

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
April 23, 2019
Last Updated
October 21, 2019
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03928756
Brief Title
Adaptive Interventions for Prevention/Intervention for Youth Substance Abuse
Official Title
Adaptive Interventions for Prevention/Intervention for Youth Substance Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
October 17, 2019 (Actual)
Study Completion Date
October 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Previously, the study team developed a prototype mobile application which utilized novel engagement strategies to enhance user adherence with daily and weekly survey assessments. The new app developed for this study extends the previous app by featuring the capability to also deliver tailored health intervention. As part of the app, users are prompted to complete brief daily and weekly assessments for 30 days. For each completed assessment, users earn small financial rewards and points to unlock new fish that populate a virtual aquarium in the app. The app also features push notifications with survey reminders and life insights (or graphs plotting data collected over time) to increase user engagement with the app. Additionally, each day, users are randomized to receive intervention content (see the "Interventions" section for more information) tailored on their recent assessment responses. After 30 days of using the app, participants will be asked to complete a follow-up survey; data collected will provide preliminary feedback regarding the feasibility and effectiveness of using the app to deliver substance use intervention content to affected youth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
substance use, mobile health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Within-participant randomization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Push Notifications with Tailored Intervention Content
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Push Notifications with Engaging, Non-therapeutic Content
Intervention Description
Participants will receive a push notification with an engaging, non-therapeutic message (e.g., fun facts).
Intervention Type
Behavioral
Intervention Name(s)
No Push Notifications
Intervention Description
Participants will not receive a push notification.
Primary Outcome Measure Information:
Title
Change in Intentions to Reduce Alcohol Use
Description
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)
Time Frame
1-month post-app start
Title
Change in Importance of Reducing Alcohol Use
Description
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)
Time Frame
1-month post-app start
Title
Change in Intentions to Reduce Marijuana Use
Description
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)
Time Frame
1-month post-app start
Title
Change in Importance of Reducing Marijuana Use
Description
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)
Time Frame
1-month post-app start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 1. Unable to understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Walton, MPH, PHD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adaptive Interventions for Prevention/Intervention for Youth Substance Abuse

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