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CompletedNCT01170260MARSUpdated Apr 23, 2024Results posted

Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents

An interventional study of INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY) and SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH) in Risk Reduction Behavior, Health Behavior and Sexual Behavior, sponsored by University of New Mexico. Completed at 1 site in United States. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
460
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
All
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Study 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 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.

02

Conditions studied

  • Risk Reduction Behavior
  • Health Behavior
  • Sexual Behavior
  • Adolescent Behavior
  • Cannabis

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03

In context

Marijuana Abuse

517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.

This study's enrollment of 460 is above the median of 60 across 421 interventional studies indexed under Marijuana Abuse.

Browse Marijuana Abuse studies →

Lead sponsor

University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Ages 14-18
  • Involved in Juvenile Justice System (living in the Detention Center when recruited)

Exclusion criteria

Exclusion Criteria:

  • Currently taking anti-psychotics
  • Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
460 participants (actual)

Study arms

  • Active comparator
    Info-only sexual risk reduction

    Corresponding intervention gives information only on STDs/HIV

    Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)

  • Experimental
    Sex plus alcohol risk reduction

    Corresponding intervention gives info focusing on sex and alcohol risk reduction only

    Behavioral: SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH)

  • Experimental
    Sex + alcohol + marijuana risk reduction

    Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction

    Behavioral: SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION

Interventions

  • BehavioralINFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)

    Intervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion

    Also known as: INFO-ONLY

  • BehavioralSEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH)

    Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussion

    Also known as: (SRRI+ETOH)

  • BehavioralSEXUAL + ALCOHOL + 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

    Also known as: (SRRI+ETOH+THC)

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What researchers measure

Primary outcomes

  1. Number of Participants With Risky Sexual Behavior Measured for 1 Year

    Time frame: 1 year

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Results

Posted Apr 23, 2024

Participant flow

Participant flow — Overall Study
MilestoneRandomized to Alcohol ContentSex Plus Alcohol Risk ReductionSexual + Alcohol + Cannabis Content
Started143155162
Completed143155162
Not completed000

Outcome measures

PrimaryNumber of Participants With Risky Sexual Behavior Measured for 1 Year
Time frame:
1 year
Reported as:
Count of participants · Participants
Number of Participants With Risky Sexual Behavior Measured for 1 Year
ParticipantsRandomized to Alcohol ContentSex Plus Alcohol Risk ReductionSexual + Alcohol + Cannabis Content
Number of Participants With Risky Sexual Behavior Measured for 1 Year143155162

Adverse events

Collected over Every 3 months for 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Randomized to Alcohol Content0/143 (0%)0/143 (0%)0/143 (0%)
Sex Plus Alcohol Risk Reduction1/155 (0.6%)0/155 (0%)0/155 (0%)
Sexual + Alcohol + Cannabis Content0/162 (0%)0/162 (0%)0/162 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Info-only Sexual Risk ReductionSex Plus Alcohol Risk ReductionSex + Alcohol + Marijuana Risk ReductionTotal
Mean15.85 (15.7 to 16)15.82 (15.6 to 16)15.78 (15.6 to 16)15.81 (15.6 to 16)
Sex: Female, Male
Sex: Female, Male(Participants)Info-only Sexual Risk ReductionSex Plus Alcohol Risk ReductionSex + Alcohol + Marijuana Risk ReductionTotal
Female707887235
Male737775225
Region of Enrollment
Region of Enrollment(Participants)Info-only Sexual Risk ReductionSex Plus Alcohol Risk ReductionSex + Alcohol + Marijuana Risk ReductionTotal
United States143155162460
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Study locations

1 site
  • Juvenile Detention Center (JDC)
    Albuquerque, New Mexico 87107, United States
09

References and documents

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 33341180 ↗
  • 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. PubMed 29435591 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01170260
Lead sponsor
University of New Mexico
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Sponsor
First posted
Jul 27, 2010
Start date
Aug 2010
Primary completion
Jun 2014
Completion
Jun 2014
Results posted
Apr 23, 2024
Last update
Apr 23, 2024
View the source record on ClinicalTrials.gov ↗

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