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Cluster 1 for Reproductive Behavior (NE Trial)

N/A
Waitlist Available
Research Sponsored by Montana State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 9 months and 12 months
Awards & highlights

NE Trial Summary

This trial is testing a community-based participatory research (CBPR) multi-level, multi-component sexual and reproductive health (SRH) intervention, based on Fort Peck tribal members' desire to implement a holistic SRH intervention for AI youth.

Eligible Conditions
  • Reproductive Behavior
  • Sexual Activity

NE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 9 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 9 months and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in condom use during sexual intercourse at 3 months, 9 months and 12 months
Secondary outcome measures
Change in decreased alcohol/drug use concurrently sexual intercourse at 3 months, 9 months and 12 months
Change in decreased number of sex partners at 3 months, 9 months and 12 months
Change in delayed onset of sexual intercourse at 3 months, 9 months and 12 months
+3 more
Other outcome measures
Change in increased parent/legal guardian-child communication about sexual and reproductive health topics at 3 months, 9 months and 12 months
Change in increased usage of sexual and reproductive health services at 3 months, 9 months and 12 months

NE Trial Design

3Treatment groups
Experimental Treatment
Group I: Cluster 3Experimental Treatment1 Intervention
Cluster 3 are the remaining 2 schools on the Fort Peck reservation that will be randomized into the intervention in 2020-2021. Cluster 3 will receive all four levels of the intervention including: 1) A school-based SRH curriculum called Native Stand, designed to address individual-level factors that lead to sexual risk behaviors; 2) a family-level curriculum called Native Voices, tailored to increase communication between adult family members and youth about SRH topics; 3) a cultural mentoring component at the community level that pairs AI youth with adults and elders to discuss traditional AI beliefs and practices about SRH; and 4) a mobilizing strategy to activate a multi-sectoral network of youth-servicing organizations at the systems level in Fort Peck to coordinate SRH services for AI youth.
Group II: Cluster 2Experimental Treatment1 Intervention
Cluster 2 includes 2 schools on the Fort Peck Reservation that will be randomized in the intervention in 2019-2020. Cluster 2 will receive all four levels of the intervention including: 1) A school-based SRH curriculum called Native Stand, designed to address individual-level factors that lead to sexual risk behaviors; 2) a family-level curriculum called Native Voices, tailored to increase communication between adult family members and youth about SRH topics; 3) a cultural mentoring component at the community level that pairs AI youth with adults and elders to discuss traditional AI beliefs and practices about SRH; and 4) a mobilizing strategy to activate a multi-sectoral network of youth-servicing organizations at the systems level in Fort Peck to coordinate SRH services for AI youth.
Group III: Cluster 1Experimental Treatment1 Intervention
Cluster 1 is 1 school on the Fort Peck Reservation that will be randomized into the intervention in 2019. Cluster 1 will receive all four levels of the intervention including: 1) A school-based SRH curriculum called Native Stand, designed to address individual-level factors that lead to sexual risk behaviors; 2) a family-level curriculum called Native Voices, tailored to increase communication between adult family members and youth about SRH topics; 3) a cultural mentoring component at the community level that pairs AI youth with adults and elders to discuss traditional AI beliefs and practices about SRH; and 4) a mobilizing strategy to activate a multi-sectoral network of youth-servicing organizations at the systems level in Fort Peck to coordinate SRH services for AI youth.

Find a Location

Who is running the clinical trial?

Montana State UniversityLead Sponsor
44 Previous Clinical Trials
1,042,836 Total Patients Enrolled
Florida International UniversityOTHER
99 Previous Clinical Trials
16,297 Total Patients Enrolled
Northern Arizona UniversityOTHER
31 Previous Clinical Trials
5,609 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Preventing Chronic DiseaseJournal
Using Community-based Participatory Research to Design, Conduct, and Evaluate Randomized Controlled Trials with American Indian Communities
Rink, Elizabeth, Kelly Knight, Colter Ellis, Alma McCormick, Paula FireMoon, Suzanne Held, Eliza Webber, and Alexandra Adams. 2020. “Using Community-based Participatory Research to Design, Conduct, and Evaluate Randomized Controlled Trials with American Indian Communities”. Preventing Chronic Disease. Centers for Disease Control and Prevention (CDC). doi:10.5888/pcd17.200099.
Frontiers in Public HealthJournal
Rationale, Design, and Methods for Nen Unkumbi/edahiyedo (“we Are Here Now
Rink, Elizabeth, Paula Firemoon, Michael Anastario, Olivia Johnson, Ramey GrowingThunder, Adriann Ricker, Malory Peterson, and Julie Baldwin. 2022. “Rationale, Design, and Methods for Nen Unkumbi/edahiyedo (“we Are Here Now”): A Multi-level Randomized Controlled Trial to Improve Sexual and Reproductive Health Outcomes in a Northern Plains American Indian Reservation Community”. Frontiers in Public Health. Frontiers Media SA. doi:10.3389/fpubh.2022.823228.
clinicaltrials.govStudy
We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth
Elizabeth Rink 2019. "We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03694418.
~170 spots leftby Apr 2025
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