Preventing Cigarette Use Among Urban Youth Via an M-Health Primary Care Preventive Intervention

Not Applicable

Completed

• Conditions: Drug Use; Tobacco Use; Sexual Risk Behavior; Adolescent Behavior; Alcohol Use
• Interventions: Behavioral: S4E; Behavioral: Attention-Matched Control Group

• Registration Number: NCT03855410
• Lead Sponsor: University of Michigan

Brief Summary

The study aims to develop tobacco modules to be included in an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) and to determine the feasibility and preliminary efficacy of the updated version of S4E in an urban youth-centered community health clinic in Southeast Michigan.

Detailed Description

Tobacco use remains a significant public health concern in the US, and youth are disproportionately affected. Among high school youth , 38% report lifetime cigarette use, and 9.3% report having smoked a whole cigarette before the age of 13. In Southeast Michigan, African-American youth are at disproportionate risk of engaging in tobacco use and co-occuring substance use and other risk behaviors. To address these significant public health concerns, we developed Storytelling 4 Empowerment (S4E), a targeted and tailored mobile-health (mHealth) application (app) intervention to be delivered in health clinic settings. The proposed research aims to develop culturally congruent and developmentally appropriate modules focused on tobacco use prevention and risk reduction to be included as part of the S4E mHealth app. The proposed research will also determine the preliminary efficacy of S4E in reducing tobacco use, alcohol and other drug use, sexual risk behaviors, and improving HIV/STI testing in a sample (n=50) of youth ages 13-21 living in Southeast Michigan.

Study Timeline

• Study Start: 2016-10-27
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2019-02
• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-25
• Last Update Submitted: 2019-02-25
• Study First Posted: 2019-02-26
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Female, Male, and Transgender adolescents
• Adolescents 13-21 years of age
• Adolescents must live in Southeast Michigan
• Adolescents must provide assent and consent

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Exclusion Criteria

• Report of a prior psychiatric hospitalization by adolescent or caregiver
• Adolescent reports (tentative or firm) plans to move out of the Southeast Michigan area during the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S4E App intervention	S4E	Participants in the S4E group will receive the tobacco modules via iPads in a private room. The intervention will last approximately 20 minutes. Content includes the theoretically driven components of S4E: (a)Storytelling scenarios, (b) an introduction video, tobacco use knowledge development, (c) interactive activities, (d) increasing self-efficacy to prevent tobacco use, (e) clinician-youth communication, and (f) highlighting prevention principles. Participants in this group also receive usual care. The Clinic's usual care includes a standard risk behaviors intake form, pamphlets highlighting resources on sexual, physical, and mental health, and other healthcare services. Adolescents will be compensated $20 at baseline and $40 at 30-day follow-up. To minimize bias, randomization will occur prior to baseline assessment.
Attention-Matched Control	Attention-Matched Control Group	Participants in the Attention-Matched Control group will receive a portable document format (PDF) version of the tobacco module content, an enhancement to the care they would receive should they not join the study. Participants in this group also receive usual care. The Clinic's usual care includes a standard risk behaviors intake form, pamphlets highlighting resources on sexual, physical, and mental health, and other healthcare services. Adolescents will be compensated $20 at baseline and $40 at 30-day follow-up. To minimize bias, randomization will occur prior to baseline assessment.

Primary Outcome Measures

Name	Time	Method
Change in Tobacco Use from baseline to 30 days	baseline and 30 days post-baseline	Tobacco use will be measured at baseline and 30-days post intervention, to assess change in usage.

Secondary Outcome Measures

Name	Time	Method
Change in contraception (non-condom) use from baseline to 30 days	baseline and 30 days post-baseline	Adolescent contraception (non-condom) use will be measured using items extracted from Jemmott, Jemmott, and Fong's Sexual Behavior instrument. This gated instrument will assess the adolescent's past contraceptive use (non-condom) use.
Change in Number of sexual partners from baseline to 30 days	baseline and 30 days post-baseline	Adolescent number of sexual partners will be measured using items extracted from Jemmott, Jemmott, and Fong's Sexual Behavior instrument. This gated instrument will assess the adolescent's past number of sexual partners.
Change in Alcohol Use from baseline to 30 days	baseline and 30 days post-baseline	Past 30-day alcohol use behaviors will be assessed using items from the Monitoring the Future study. Youth will be asked whether or not they have used alcohol in their lifetime and the past 30 days. Youth who report "YES" to past 30-day alcohol use will be asked to report the frequency of alcohol use. These measures have been used in our formative research.
Change in Drug Use from baseline to 30 days	baseline and 30 days post-baseline	Licit and illicit drug use behaviors will be assessed using items from the Monitoring the Future study. Youth will be asked whether or not they have used licit or illicit drugs in their lifetime and the past 30 days. Youth who report "YES" to past 30-day drug use will be asked to report the frequency of drug use. These measures have been used in our formative research.
Change in alcohol or drug use before sex from baseline to 30 days	baseline and 30 days post-baseline	Alcohol or drug use before sex will be assessed. Youth will be asked whether they have used alcohol or drugs before sex in their lifetime and past-30 days. Youth who report "YES" will be asked to report the frequency of alcohol and drug use before sex. These measures have been used in our formative research.
Change in Unprotected sex from baseline to 30 days	baseline and 30 days post-baseline	Condom use behaviors will be assessed. Youth will be asked whether they are sexually active or not. Youth who report "YES" to being sexually active will be asked to report whether or not they have had unprotected sex in their lifetime and past 30-days and the frequency of unprotected sex, if they used condoms the last time they had sex, and if they plan on using condoms next time. These measures have been used in our formative research.
Change in Binge Drinking from baseline to 30 days	baseline and 30 days post-baseline	Past 2-weeks binge drinking behaviors will be assessed using items from the Monitoring the Future study. Youth will be asked whether or not they have had 5 or more drinks of alcohol in a row within a couple of hours in the past 2-weeks. Youth who report "YES" to past binge drinking will be asked to report the frequency of binge drinking. These measures have been used in our formative research.
Change in HIV/STI testing from baseline to immediately post-intervention and 30 day post-intervention	baseline, immediately post-intervention, and 30 days post-intervention	HIV/STI testing will be assessed. Youth will be asked to report lifetime HIV and STI testing, whether or not they received an HIV or STI test during the clinic visit, and HIV or STI testing in the past 30-days. Additionally, clinicians will be asked whether or not their youth participant received an HIV or STI test during the clinic visit. These measures have been used in our formative research

Trial Locations

Locations (2)

Corner Health Center; 🇺🇸 Ypsilanti, Michigan, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States