NCT03855410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

February 15, 2019

Last Update Submit

February 25, 2019

Conditions

Tobacco UseDrug UseAdolescent BehaviorAlcohol UseSexual Risk Behavior

Keywords

mHealthpreventive interventionsubstance useyoutheHealthtechnology-basedHIV/STI

Outcome Measures

Primary Outcomes (1)

  • Change in Tobacco Use from baseline to 30 days

    Tobacco use will be measured at baseline and 30-days post intervention, to assess change in usage.

    baseline and 30 days post-baseline

Secondary Outcomes (8)

  • Change in Drug Use from baseline to 30 days

    baseline and 30 days post-baseline

  • Change in contraception (non-condom) use from baseline to 30 days

    baseline and 30 days post-baseline

  • Change in Number of sexual partners from baseline to 30 days

    baseline and 30 days post-baseline

  • Change in Alcohol Use from baseline to 30 days

    baseline and 30 days post-baseline

  • Change in Binge Drinking from baseline to 30 days

    baseline and 30 days post-baseline

  • +3 more secondary outcomes

Other Outcomes (4)

  • 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

  • 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

  • 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

  • +1 more other outcomes

Study Arms (2)

S4E App intervention

EXPERIMENTAL

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

Attention-Matched Control

EXPERIMENTAL

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

Interventions

S4EBEHAVIORAL

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.

S4E App intervention
Attention-Matched Control GroupBEHAVIORAL

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.

Attention-Matched Control

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Corner Health Center

Ypsilanti, Michigan, 48198, United States

Location

Related Publications (4)

  • Cordova D, Alers-Rojas F, Lua FM, Bauermeister J, Nurenberg R, Ovadje L, Fessler K, Delva J, Salas-Wright CP, Council YL. The Usability and Acceptability of an Adolescent mHealth HIV/STI and Drug Abuse Preventive Intervention in Primary Care. Behav Med. 2018 Jan-Mar;44(1):36-47. doi: 10.1080/08964289.2016.1189396. Epub 2016 Jul 15.

    PMID: 27223646BACKGROUND

  • Cordova D, Bauermeister JA, Fessler K, Delva J, Nelson A, Nurenberg R, Mendoza Lua F, Alers-Rojas F, Salas-Wright CP; Youth Leadership Council. A Community-Engaged Approach to Developing an mHealth HIV/STI and Drug Abuse Preventive Intervention for Primary Care: A Qualitative Study. JMIR Mhealth Uhealth. 2015 Dec 18;3(4):e106. doi: 10.2196/mhealth.4620.

    PMID: 26685288BACKGROUND

  • Cordova D, Lua FM, Ovadje L, Fessler K, Bauermeister JA, Salas-Wright CP, Vaughn MG, Leadership Council Y. Adolescent Experiences of Clinician-Patient HIV/STI Communication in Primary Care. Health Commun. 2018 Sep;33(9):1177-1183. doi: 10.1080/10410236.2017.1339379. Epub 2017 Jul 7.

    PMID: 28686489BACKGROUND

  • Cordova D, Munoz-Velazquez J, Mendoza Lua F, Fessler K, Warner S, Delva J, Adelman N; Youth Leadership Council; Fernandez A, Bauermeister J. Pilot Study of a Multilevel Mobile Health App for Substance Use, Sexual Risk Behaviors, and Testing for Sexually Transmitted Infections and HIV Among Youth: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 17;8(3):e16251. doi: 10.2196/16251.

    PMID: 32181747DERIVED

MeSH Terms

Conditions

Tobacco UseAdolescent BehaviorAlcohol DrinkingSubstance-Related Disorders

Condition Hierarchy (Ancestors)

BehaviorDrinking BehaviorChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 26, 2019

Study Start

October 27, 2016

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)