Adolescent Behavior, Alcohol Use, Drug Use, Sexual Risk Behavior, Tobacco Use
Conditions
Keywords
mHealth, preventive intervention, substance use, youth, eHealth, technology-based, HIV/STI
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.
Interventions
BEHAVIORALS4E
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.
BEHAVIORALAttention-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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 |
| 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 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Youth Self-Efficacy as measured by the Condom Self-Efficacy Scale from baseline to immediately post-intervention and 30 days post-intervention | baseline, immediately post-intervention, and 30 days-post baseline | Youth's self-efficacy will be assessed using the Condom Self-Efficacy Scale (19 items, α =.85). Responses range from 1=not sure at all, to 4=definitely sure, on a four-point Likert scale. A sample question for the youth is, How sure are you that you can refuse if a friend offers you marijuana at a party and you do not want it? |
| Change in Youth Self-Efficacy as measured by Drug Use Resistance Self-Efficacy Scale from baseline to immediately post-intervention and 30 days post-intervention | baseline, immediately post-intervention, and 30 days-post baseline | Youth's self-efficacy will be assessed using the Drug Use Resistance Self-Efficacy (24 items, α =.98). Responses range from 1=not sure at all, to 4=definitely sure, on a four-point Likert scale. A sample question for the youth is, How sure are you that you can refuse if a friend offers you marijuana at a party and you do not want it? |
| Change in Clinician-Youth Communication for Clinicians from baseline to immediately post-intervention and 30 days post-intervention | baseline, immediately post-intervention, and 30 days-post baseline | Completed by the clinician, clinician-youth communication will be assessed post-baseline using items adapted from the Matched Pair Instrument (19 items; MPI). MPI assesses process and content of communication, including verbal and action-related behaviors performed by clinicians. Responses range from 1=strongly disagree, to 5=strongly agree, on a five-point Likert scale. A sample statement for clinicians and youths is, I encouraged the patient to express his or her thoughts concerning drug use behaviors. |
| Change in Clinician-Youth Communication for Youth from baseline to immediately post-intervention and 30 days post-intervention | baseline, immediately post-intervention, and 30 days-post baseline | Completed by the youth, clinician-youth communication will be assessed post-baseline using items adapted from the Matched Pair Instrument (19 items; MPI). MPI assesses process and content of communication, including verbal and action-related behaviors performed by clinicians. Responses range from 1=strongly disagree, to 5=strongly agree, on a five-point Likert scale. A sample statement for youths is, I was encouraged to express my thoughts concerning drug use behaviors. |
Countries
United States
Outcome results
None listed