Effect of a Culturally-based Intervention on Sexual Risky Behavior Among Young American Indian Adolescents

Teen Pregnancy Prevention Clinical Trial

— COL/AS+  

Official title:

Teen Pregnancy Prevention Among Native Youth of the Northern Plains

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698073
• Other study ID #: 12-0241
• Status: Completed
• Phase: N/A
• First received: September 25, 2012
• Last updated: January 7, 2016
• Start date: September 2012
• Est. completion date: March 2015

Study information

• Verified date: January 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Teen Pregnancy Prevention

Intervention

Behavioral:
• mCOL

Other:
• AS+

Locations

Country	Name	City	State
United States	University of Colorado - Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ever had sexual intercourse	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	No