- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01170260
Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents (MARS)
Study Overview
Status
Detailed Description
During baseline assessment, a computer questionnaire is administered, including questions about participants' attitudes, beliefs, and behaviors regarding sexual behavior, condom use, and drug use. A saliva sample is provided as well. A "Time-Line Follow-Back" is conducted, noting on which days certain activities occurred, such as sexual intercourse, alcohol use, marijuana use, and cigarette use. A urine sample is also collected in order to test for the STD's chlamydia and gonorrhea (if results are positive, we schedule a meeting with the participant to administer medication to treat the STD).
In the second session, a 3-hour interventional health class is held with groups of same-gender participants. There are 3 different health classes (one focusing just on sex risk reduction, one focusing on sex and alcohol risk reduction, and one focusing on sex, alcohol, and marijuana risk reduction); participants are randomly assigned to one.
Participants are contacted 3 months after the intervention, 6 months after, 9 months after, and 12 months after, in order to meet. These meetings entail completing another Time-Line Follow-Back and completing another questionnaire. At the final 12 month meeting, we collect another urine sample to again test for chlamydia and gonorrhea. As before, if results are positive, we schedule a meeting with the participant to administer medical treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
New Mexico
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Albuquerque, New Mexico, United States, 87107
- Juvenile Detention Center (JDC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 14-18
- Involved in Juvenile Justice System (living in the Detention Center when recruited)
Exclusion Criteria:
- Currently taking anti-psychotics
- Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Info-only sexual risk reduction
Corresponding intervention gives information only on STDs/HIV
|
Intervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion
Other Names:
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Experimental: Sex plus alcohol risk reduction
Corresponding intervention gives info focusing on sex and alcohol risk reduction only
|
Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussion
Other Names:
|
|
Experimental: Sex + alcohol + marijuana risk reduction
Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction
|
Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants With Risky Sexual Behavior Measured for 1 Year
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Computer questionnaire
Time Frame: used at Baseline
|
Questionnaire completed by participant assesses sexual activity/consequences/attitudes, alcohol use/consequences/attitudes, marijuana use/consequences/attitudes, cigarette use/consequences/attitudes, particularly within past few months
|
used at Baseline
|
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Computer questionnaire
Time Frame: used at 3 months post-intervention
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Questionnaire completed by participant assesses sexual activity/consequences/attitudes, alcohol use/consequences/attitudes, marijuana use/consequences/attitudes, cigarette use/consequences/attitudes, particularly within past few months
|
used at 3 months post-intervention
|
|
Computer questionnaire
Time Frame: used at 6 months post-intervention
|
Questionnaire completed by participant assesses sexual activity/consequences/attitudes, alcohol use/consequences/attitudes, marijuana use/consequences/attitudes, cigarette use/consequences/attitudes, particularly within past few months
|
used at 6 months post-intervention
|
|
Computer questionnaire
Time Frame: used at 9 months post-intervention
|
Questionnaire completed by participant assesses sexual activity/consequences/attitudes, alcohol use/consequences/attitudes, marijuana use/consequences/attitudes, cigarette use/consequences/attitudes, particularly within past few months
|
used at 9 months post-intervention
|
|
Computer questionnaire
Time Frame: used at 12 months post-intervention
|
Questionnaire completed by participant assesses sexual activity/consequences/attitudes, alcohol use/consequences/attitudes, marijuana use/consequences/attitudes, cigarette use/consequences/attitudes, particularly within past few months
|
used at 12 months post-intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Schmiege SJ, Magnan RE, Yeater EA, Feldstein Ewing SW, Bryan AD. Randomized Trial to Reduce Risky Sexual Behavior Among Justice-Involved Adolescents. Am J Prev Med. 2021 Jan;60(1):47-56. doi: 10.1016/j.amepre.2020.07.009.
- Bryan AD, Magnan RE, Gillman AS, Yeater EA, Feldstein Ewing SW, Kong AS, Schmiege SJ. Effect of Including Alcohol and Cannabis Content in a Sexual Risk-Reduction Intervention on the Incidence of Sexually Transmitted Infections in Adolescents: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2018 Apr 2;172(4):e175621. doi: 10.1001/jamapediatrics.2017.5621. Epub 2018 Apr 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAA RO1 AA013844-05
- R01AA013844-05 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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