Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 55 of 1172 for:    Sexually Transmitted Diseases | ( Map: United States ) | NIH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01170260
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
University of New Mexico

Tracking Information
First Submitted Date  ICMJE July 23, 2010
First Posted Date  ICMJE July 27, 2010
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE August 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
  • Time-Line Follow-Back [ Time Frame: used at Baseline ]
    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.
  • Time-Line Follow-Back [ Time Frame: used at 3 months post-intervention ]
    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.
  • Time-Line Follow-Back [ Time Frame: used at 6 months post-intervention ]
    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.
  • Time-Line Follow-Back [ Time Frame: used at 9 months post-intervention ]
    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.
  • Time-Line Follow-Back [ Time Frame: used at 12 months post-intervention ]
    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01170260 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
  • 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
  • Computer questionnaire [ Time Frame: used at 3 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents
Official Title  ICMJE Alcohol, Marijuana, and Risky Sex: Group Interventions With Detained Adolescents
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Risk Reduction Behavior
  • Health Behavior
  • Sexual Behavior
  • Adolescent Behavior
  • Cannabis
Intervention  ICMJE
  • Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)
    Intervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion
    Other Name: INFO-ONLY
  • Behavioral: SEXUAL 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
    Other Name: (SRRI+ETOH)
  • Behavioral: SEXUAL + 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
    Other Name: (SRRI+ETOH+THC)
Study Arms  ICMJE
  • Active Comparator: Info-only sexual risk reduction
    Corresponding intervention gives information only on STDs/HIV
    Intervention: 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
    Intervention: 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
    Intervention: Behavioral: SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2019)
460
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2010)
520
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01170260
Other Study ID Numbers  ICMJE NIAAA RO1 AA013844-05
R01AA013844-05 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Angela Bryan, University of New Mexico
Study Sponsor  ICMJE University of New Mexico
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE Not Provided
PRS Account University of New Mexico
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP