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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

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Teen Pregnancy Prevention Behavioral: mCOL Other: AS+ Not Applicable

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Teen Pregnancy Prevention Among Native Youth of the Northern Plains
Study Start Date : September 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015
Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: mCOL
Other Name: mCircle of Life
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.
 Other: AS+
Other Name: After-School Science Plus


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698073


Locations
United States, Colorado
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Carol E Kaufman, PhD University of Colorado Anschutz Medical Campus, Centers for American Indian and Alaska Native Health
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01698073     History of Changes
Other Study ID Numbers: 12-0241
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016

Keywords provided by University of Colorado, Denver:
Teen pregnancy prevention
American Indian
Group-randomized trial