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

January 7, 2016 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado - Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • After-School Science Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimate)

October 2, 2012

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-0241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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