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

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT03855410

Collaborator

(none)

Enrollment

Locations

Arms

10.1

Actual Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Drug Use Adolescent Behavior Alcohol Use Sexual Risk Behavior	Behavioral: S4E Behavioral: Attention-Matched Control Group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Preventing Substance Use and HIV/STI Among Urban Youth Via an M-Health Primary Care Preventive Intervention

Actual Study Start Date :

Oct 27, 2016

Actual Primary Completion Date :

Aug 31, 2017

Actual Study Completion Date :

Aug 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

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

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 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 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

Other Outcome Measures

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."
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?"

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 21 Years

Sexes Eligible for Study:

All

Accepts 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.