Risk Reduction BehaviorMARSNCT01170260
Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents
A study testing INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY), SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH) and SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION in people with Risk Reduction Behavior and Health Behavior, run by University of New Mexico at 1 site in United States.
Trial summary
This research is studying behaviors that young people engage in that may place them at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational program works best to reduce these risky behaviors. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction Behavior, Health Behavior, Sexual Behavior
- What is being tested?
- INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY), SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH) and SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 14-18
- Involved in Juvenile Justice System (living in the Detention Center when recruited)
Who cannot join
- Currently taking anti-psychotics
- Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)
Trial locations and contacts
1 site in 1 country.
United States1 site
Juvenile Detention Center (JDC)
Albuquerque, New Mexico, 87107
About this study
This research is studying behaviors that young people engage in that may place them at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational program works best to reduce these risky behaviors.
Read the 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.
- Being tested
- INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY), SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH), SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION
- Medical subject headings
- Risk Reduction Behavior, Health Behavior, Sexual Behavior, Adolescent Behavior, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)Behavioural
Also called INFO-ONLY
Intervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion
SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH)Behavioural
Also called (SRRI+ETOH)
Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussion
SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTIONBehavioural
Also called (SRRI+ETOH+THC)
Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion
| Study group | Role | What they receive |
|---|---|---|
| Info-only sexual risk reduction | Active comparator | Corresponding intervention gives information only on STDs/HIV Receives: Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY) |
| Sex plus alcohol risk reduction | Experimental | Corresponding intervention gives info focusing on sex and alcohol risk reduction only Receives: Behavioral: SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH) |
| Sex + alcohol + marijuana risk reduction | Experimental | Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction Receives: Behavioral: SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Risky Sexual Behavior Measured for 1 Year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Risk Reduction BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170260
- Sponsor's protocol ID
- NIAAA RO1 AA013844-05
- Acronym
- MARS
- Status last verified
- Apr 2024
- First submitted
- 23 Jul 2010
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 33341180Bryan 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.
PubMed 29435591
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents
- ClinicalTrials.gov ID
- NCT01170260
- Acronym / sponsor ID
- MARS / NIAAA RO1 AA013844-05
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Aug 2010 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Posted 23 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is studying behaviors that young people engage in that may place them at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational program works best to reduce these risky behaviors.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Info-only sexual risk reduction | Active comparator | Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)Corresponding intervention gives information only on STDs/HIV |
| Sex plus alcohol risk reduction | Experimental | Behavioral: SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH)Corresponding intervention gives info focusing on sex and alcohol risk reduction only |
| Sex + alcohol + marijuana risk reduction | Experimental | Behavioral: SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTIONCorresponding intervention gives info on sex, alcohol, and marijuana risk reduction |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ages 14-18
- Involved in Juvenile Justice System (living in the Detention Center when recruited)
Key exclusion criteria (2 listed)
- Currently taking anti-psychotics
- Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)Also: INFO-ONLYIntervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion | Behavioural | Info-only sexual risk reduction |
| SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH)Also: (SRRI+ETOH)Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussion | Behavioural | Sex plus alcohol risk reduction |
| SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTIONAlso: (SRRI+ETOH+THC)Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion | Behavioural | Sex + alcohol + marijuana risk reduction |
Primary outcome
Number of Participants With Risky Sexual Behavior Measured for 1 Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33341180Schmiege 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.
- Derived from this study: PubMed 29435591Bryan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY), SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH) and SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION in people with Risk Reduction Behavior and Health Behavior, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Risky Sexual Behavior Measured for 1 Year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01170260, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.