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Adaptive Interventions for Prevention/Intervention for Youth Substance Abuse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03928756
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Maureen A Walton, University of Michigan

Study Description
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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).

Condition or disease Intervention/treatment Phase
Substance Use Behavioral: Push Notifications with Tailored Intervention Content Behavioral: Push Notifications with Engaging, Non-therapeutic Content Behavioral: No Push Notifications Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Adaptive Interventions for Prevention/Intervention for Youth Substance Abuse
Actual Study Start Date : August 12, 2019
Actual Primary Completion Date : October 17, 2019
Actual Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Experimental: Within-participant randomization
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 Content
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.

Behavioral: Push Notifications with Engaging, Non-therapeutic Content
Participants will receive a push notification with an engaging, non-therapeutic message (e.g., fun facts).

Behavioral: No Push Notifications
Participants will not receive a push notification.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Intentions to Reduce Alcohol Use [ Time Frame: 1-month post-app start ]
    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)

  2. Change in Importance of Reducing Alcohol Use [ Time Frame: 1-month post-app start ]
    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)

  3. Change in Intentions to Reduce Marijuana Use [ Time Frame: 1-month post-app start ]
    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)

  4. Change in Importance of Reducing Marijuana Use [ Time Frame: 1-month post-app start ]
    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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928756


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48108
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Maureen Walton, MPH, PHD University of Michigan
  Study Documents (Full-Text)

Documents provided by Maureen A Walton, University of Michigan:
Informed Consent Form  [PDF] June 16, 2019

More Information
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Responsible Party: Maureen A Walton, Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT03928756    
Other Study ID Numbers: HUM00148393
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maureen A Walton, University of Michigan:
substance use
mobile health
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders