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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-27

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Development of a Mobile Health Intervention for Electronic Cigarette Use Among Young Adults

NCT06395415

Electronic Nicotine Delivery Systems Tobacco Products Cigarette Smoking

RECRUITING NA

Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

NCT04020718

Tobacco Use Cessation

COMPLETED PHASE4

Addressing Tobacco Use Disparities in Rural Older Adults Through an Innovative Mobile Phone Intervention

NCT02510716

Tobacco Cessation

COMPLETED NA

Electronic Cigarette Use in Young Adult Men and Women

NCT03089541

Cigarette Smoking Tobacco Use

COMPLETED NA

Identify the Usefulness of Peer-facilitated Versus Self-navigated Quit Tobacco Program for Youths.

NCT06053762

Tobacco Product Use

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Drug Use Adolescent Behavior Alcohol Use Sexual Risk Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

To test the preliminary efficacy of S4E, we will conduct a stage 1 randomized control trial (RCT) and use a mixed between/within-subjects design with two levels of intervention (S4E and Attention-Matched Control) as the between-subjects factor and a repeated measure assessment at 30 days post-Baseline as the within-subject factor.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

S4E App intervention

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.

Group Type EXPERIMENTAL

S4E

Intervention Type BEHAVIORAL

The face-to-face version of S4E (i.e., Storytelling for Empowerment) is registered as a best-practice with the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Evidence-Based Practices and Programs.The S4E mHealth app was developed in collaboration with youth in Southeast Michigan. Content produced for the application is based on scientific prevention principles in conjunction with youth input. To date, we have developed modules focused on youth alcohol and drug use, HIV and STIs. We now propose to develop modules focused on tobacco prevention and cessation. S4E aims to increase self-efficacy and communication about health risk behaviors. The face-to-face version of S4E has been shown to prevent and reduce substance use, including cigarette use, as well as increase (1) substance use prevention knowledge, (2) communication about health risk behaviors, and (3) perception of harm and self-efficacy in refusing licit and illicit substances.

Attention-Matched Control

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.

Group Type EXPERIMENTAL

Attention-Matched Control Group

Intervention Type BEHAVIORAL

Participants in the Attention-Matched Control group will receive a PDF version of the tobacco module material, an enhancement to the usual care they would receive should they not join the study. Participants in this group will also receive usual care. The Clinic's usual care includes standard risk behaviors intake form, pamphlets highlighting resources on sexual, physical, and mental health, and other healthcare services.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

S4E

The face-to-face version of S4E (i.e., Storytelling for Empowerment) is registered as a best-practice with the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Evidence-Based Practices and Programs.The S4E mHealth app was developed in collaboration with youth in Southeast Michigan. Content produced for the application is based on scientific prevention principles in conjunction with youth input. To date, we have developed modules focused on youth alcohol and drug use, HIV and STIs. We now propose to develop modules focused on tobacco prevention and cessation. S4E aims to increase self-efficacy and communication about health risk behaviors. The face-to-face version of S4E has been shown to prevent and reduce substance use, including cigarette use, as well as increase (1) substance use prevention knowledge, (2) communication about health risk behaviors, and (3) perception of harm and self-efficacy in refusing licit and illicit substances.

Intervention Type BEHAVIORAL

Attention-Matched Control Group

Participants in the Attention-Matched Control group will receive a PDF version of the tobacco module material, an enhancement to the usual care they would receive should they not join the study. Participants in this group will also receive usual care. The Clinic's usual care includes standard risk behaviors intake form, pamphlets highlighting resources on sexual, physical, and mental health, and other healthcare services.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes