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

University of Michigan

Status: Completed

Conditions: Alcohol Use; Sexual Risk Behavior; Adolescent Behavior; Drug Use; Tobacco Use

Treatments: Behavioral: S4E; Behavioral: Attention-Matched Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03855410

HUM00097290

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 13 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

S4E App intervention

Experimental group

Description:

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.

Treatment:

Behavioral: S4E

Attention-Matched Control

Experimental group

Description:

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.

Treatment:

Behavioral: Attention-Matched Control Group