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

This study is currently recruiting participants.
Verified December 2012 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01698073
First received: September 25, 2012
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Teen Pregnancy Prevention
 Behavioral: COL
Other: AS+

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Teen Pregnancy Prevention Among Native Youth of the Northern Plains

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • onset of sexual activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Onset of sexual activity 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. In conjunction with age data and date of survey administration (also collected in the surveys), these questions provide us the timing (age) of onset of sexual activity. This question is repeated at each data collection point with youth who reported not ever having had sex at the prior survey. Over time, then, we can assess onset of sexual activity prospectively.


Estimated Enrollment: 600
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COL
Circle 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: COL
Other Name: Circle 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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be 10-12 years old at baseline (with parental consent)
  • Must be a member of participating Native Boys and Girls Club

Exclusion Criteria:

  • Not 10-12 years old at baseline (without parental consent)
  • Not a member of participating Native Boys and Girls Club
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698073

Locations
United States, Colorado
University of Colorado - Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Carol Kaufman, PhD     303-724-1464     carol.kaufman@ucdenver.edu    
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

Publications:

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01698073     History of Changes
Other Study ID Numbers: 12-0241
Study First Received: September 25, 2012
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013