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Effect of a Culturally-based Intervention on Sexual Risky Behavior Among Young American Indian Adolescents (COL/AS+)

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ClinicalTrials.gov Identifier: NCT01698073
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

September 25, 2012
October 2, 2012
January 11, 2016
September 2012
March 2015   (Final data collection date for primary outcome measure)
Ever had sexual intercourse [ Time Frame: Baseline, 3 months, 1 year ]
Ever had sexual intercourse is measured by youth self-reported answers in an online survey to a question on lifetime sexual activity. Specifically, youth are coded "1" if they report having had sex ever before in their lifetimes, "0" otherwise. This question is repeated at each data collection point with youth.
onset of sexual activity [ Time Frame: 2 years ]
Onset of sexual activity is measured by youth self-reported answers to questions on lifetime sexual activity, age at first sex, and sex in past 3 months.
Complete list of historical versions of study NCT01698073 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of a Culturally-based Intervention on Sexual Risky Behavior Among Young American Indian Adolescents
Teen Pregnancy Prevention Among Native Youth of the Northern Plains
Youth who participate in the Circle of Life (COL) program will report less sexual risk taking behavior compared to youth who do not receive the program.
Youth who participate in the Circle of Life (COL) program will report less sexual risk taking behavior and fewer pregnancies compared to youth who do not receive the program.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Teen Pregnancy Prevention
  • Behavioral: mCOL
    Other Name: mCircle of Life
  • Other: AS+
    Other Name: After-School Science Plus
  • Experimental: mCOL
    mCircle of Life is a culturally-based HIV-prevention intervention designed for American Indian and Alaska Native 10-12 year-olds. It includes both online and facilitated material.
    Intervention: Behavioral: mCOL
  • Active Comparator: AS+
    After-School Science Plus is a curriculum designed for youth to teach science and literacy using everyday materials. It helps youth see how science is a part of everyday life and provides role models of scientists who come from different backgrounds and ethnicities.
    Intervention: Other: AS+

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
600
March 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 10-12 years old at baseline
  • A member of participating Native Boys and Girls Club
  • Signed Parental Consent Form
  • Signed Parental Permission Form
  • Signed Child Assent Form

Exclusion Criteria:

  • None Noted
Sexes Eligible for Study: All
10 Years to 12 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01698073
12-0241
No
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Carol E Kaufman, PhD University of Colorado Anschutz Medical Campus, Centers for American Indian and Alaska Native Health
University of Colorado, Denver
January 2016

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