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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT01698073

First received: September 25, 2012

Last updated: January 7, 2016

Last verified: January 2016

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: mCOL 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:

Ever had sexual intercourse [ Time Frame: Baseline, 3 months, 1 year ] [ Designated as safety issue: No ]
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.


Enrollment:	167
Study Start Date:	September 2012
Study Completion Date:	March 2015
Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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 (Child)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Kaufman CE, Litchfield A, Schupman E, Mitchell CM. Circle of Life HIV/AIDS-prevention intervention for American Indian and Alaska Native youth. Am Indian Alsk Native Ment Health Res. 2012;19(1):140-53. doi: 10.5820/aian.1901.2012.140.

Kaufman CE, Whitesell NR, Keane EM, Desserich JA, Giago C, Sam A, Mitchell CM. Effectiveness of Circle of Life, an HIV-preventive intervention for American Indian middle school youths: a group randomized trial in a Northern Plains tribe. Am J Public Health. 2014 Jun;104(6):e106-12. doi: 10.2105/AJPH.2013.301822. Epub 2014 Apr 22.


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:	January 7, 2016
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 September 30, 2016

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