Adolescent Behavior Clinical Trial
Official title:
Preventing Substance Use and HIV/STI Among Urban Youth Via an M-Health Primary Care Preventive Intervention
Verified date | February 2019 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 31, 2017 |
Est. primary completion date | August 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 21 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Corner Health Center | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
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. — View Citation
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. — View Citation
Córdova 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Clinician-Youth Communication for Clinicians from baseline to immediately post-intervention and 30 days post-intervention | 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." | baseline, immediately post-intervention, and 30 days-post baseline | |
Other | Change in Clinician-Youth Communication for Youth from baseline to immediately post-intervention and 30 days post-intervention | 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." | baseline, immediately post-intervention, and 30 days-post baseline | |
Other | Change in Youth Self-Efficacy as measured by the Condom Self-Efficacy Scale from baseline to immediately post-intervention and 30 days post-intervention | Youth's self-efficacy will be assessed using the Condom Self-Efficacy Scale (19 items, a =.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?" | baseline, immediately post-intervention, and 30 days-post baseline | |
Other | 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 | Youth's self-efficacy will be assessed using the Drug Use Resistance Self-Efficacy (24 items, a =.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?" | baseline, immediately post-intervention, and 30 days-post baseline | |
Primary | 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 | Change in Drug Use from baseline to 30 days | 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. | baseline and 30 days post-baseline | |
Secondary | Change in contraception (non-condom) use from baseline to 30 days | 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. | baseline and 30 days post-baseline | |
Secondary | Change in Number of sexual partners from baseline to 30 days | 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. | baseline and 30 days post-baseline | |
Secondary | Change in Alcohol Use from baseline to 30 days | 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. | baseline and 30 days post-baseline | |
Secondary | Change in Binge Drinking from baseline to 30 days | 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. | baseline and 30 days post-baseline | |
Secondary | Change in Unprotected sex from baseline to 30 days | 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. | baseline and 30 days post-baseline | |
Secondary | Change in alcohol or drug use before sex from baseline to 30 days | 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. | baseline and 30 days post-baseline | |
Secondary | Change in HIV/STI testing from baseline to immediately post-intervention and 30 day 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 | baseline, immediately post-intervention, and 30 days post-intervention |
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