Adaptive Interventions for Prevention/Intervention for Youth Substance Abuse

Substance Use Clinical Trial

Official title:

Adaptive Interventions for Prevention/Intervention for Youth Substance Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928756
• Other study ID #: HUM00148393
• Status: Completed
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: October 17, 2019

Study information

• Verified date: October 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 17, 2019
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

Intervention

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.
• Push Notifications with Engaging, Non-therapeutic Content
Participants will receive a push notification with an engaging, non-therapeutic message (e.g., fun facts).
• No Push Notifications
Participants will not receive a push notification.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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