Teen Pregnancy PreventionCOL/AS+NCT01698073
Effect of a Culturally-based Intervention on Sexual Risky Behavior Among Young American Indian Adolescents
A study testing mCOL and AS+ in people with Teen Pregnancy Prevention, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- mCOL and AS+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- None Noted
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- Teen Pregnancy Prevention
- Being tested
- mCOL, AS+
- Keywords
- Teen pregnancy prevention, American Indian, Group-randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCOLBehavioural
Also called mCircle of Life
AS+Other
Also called After-School Science Plus
| Study group | Role | What they receive |
|---|---|---|
| mCOL | Experimental | 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. Receives: Behavioral: mCOL |
| AS+ | Active comparator | 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. Receives: Other: AS+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Teen Pregnancy PreventionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carol E Kaufman, PhD, Principal investigator, University of Colorado Anschutz Medical Campus, Centers for American Indian and Alaska Native Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698073
- Sponsor's protocol ID
- 12-0241
- Acronym
- COL/AS+
- Status last verified
- Jan 2016
- First submitted
- 25 Sep 2012
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22569729Kaufman 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.
PubMed 24754555Black KJ, Morse B, Tuitt N, Big Crow C, Shangreau C, Kaufman CE. Beyond Content: Cultural Perspectives on Using the Internet to Deliver a Sexual Health Intervention to American Indian Youth. J Prim Prev. 2018 Feb;39(1):59-70. doi: 10.1007/s10935-017-0497-0.
PubMed 29344773
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teen Pregnancy Prevention Among Native Youth of the Northern Plains
- ClinicalTrials.gov ID
- NCT01698073
- Acronym / sponsor ID
- COL/AS+ / 12-0241
- Conditions
- Teen Pregnancy Prevention
- Keywords
- Teen pregnancy prevention, American Indian, Group-randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mCOL | Experimental | Behavioral: mCOLmCircle 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. |
| AS+ | Active comparator | Other: 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. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None Noted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mCOLAlso: mCircle of Life | Behavioural | mCOL |
| AS+Also: After-School Science Plus | Other | AS+ |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Background: PubMed 22569729Kaufman 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.
- Background: PubMed 24754555Kaufman 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.
- Derived from this study: PubMed 29344773Black KJ, Morse B, Tuitt N, Big Crow C, Shangreau C, Kaufman CE. Beyond Content: Cultural Perspectives on Using the Internet to Deliver a Sexual Health Intervention to American Indian Youth. J Prim Prev. 2018 Feb;39(1):59-70. doi: 10.1007/s10935-017-0497-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol E Kaufman, PhD principal investigator
University of Colorado Anschutz Medical Campus, Centers for American Indian and Alaska Native Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mCOL and AS+ in people with Teen Pregnancy Prevention, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ever had sexual intercourse (time frame: Baseline, 3 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01698073, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.