An interventional study of We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth in Reproductive Behavior and Sexual Behavior, sponsored by Montana State University. Completed at 2 sites in United States. Open to participants aged 14 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Montana State University · Not applicable, Interventional, and Prevention
N/E is a community-based participatory research (CBPR) multi-level, multi-component sexual and reproductive health (SRH) intervention, constructed on Ecological Systems Theory. N/E is based on Fort Peck tribal members' desire to implement a holistic SRH intervention for American Indian youth. N/E includes: 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 American Indian youth with adults and elders to discuss traditional American Indian 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 American Indian youth. The overarching aim of this proposal is to refine, tailor, and finalize the components of N/E and evaluate its efficacy. We will use a cluster-randomized stepped-wedge design (SWD), in which 5 schools that American Indian youth from Fort Peck attend are the clusters to be randomized into the intervention 1 at a time, with all schools eventually being randomized to the intervention. The 5 schools are located in separate communities, mitigating the potential for cross-contamination. N/E is a 5-year study involving 456 14- to 18-year-old American Indian youth.
N/E is a community-based participatory research (CBPR) multi-level, multi-component sexual and reproductive health (SRH) intervention, constructed on Ecological Systems Theory. N/E is based on Fort Peck tribal members' desire to implement a holistic SRH intervention for American Indian youth. N/E includes: 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 American Indian youth with adults and elders to discuss traditional American Indian 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 American Indian youth. The overarching aim of this proposal is to refine, tailor, and finalize the components of N/E and evaluate its efficacy. We will use a cluster-randomized stepped-wedge design (SWD), in which 5 schools that American Indian youth from Fort Peck attend are the clusters to be randomized into the intervention 1 at a time, with all schools eventually being randomized to the intervention. The 5 schools are located in separate communities, mitigating the potential for cross-contamination. N/E is a 5-year study involving 456 14- to 18-year-old American Indian youth.
Our specific aims are:
AIM 1: Refine, tailor, and finalize the components of N/E. Our community advisory board and the Fort Peck-based and MSU-based research team will design culturally appropriate adaptations for N/E's 4 levels during the first year of the study, based on the analysis of our recently completed qualitative and quantitative research (focus groups, interviews, and surveys), as well as discussions with elders and community stakeholders.
AIM 2: Test the efficacy of N/E for 14- to 18-year-old American Indian youth. Our hypotheses are:
H1: American Indian youth who participate in N/E will demonstrate increased condom use at 3, 9, and 12 months. (12 months will be used in the Primary Outcome analysis; 3 and 9 months will be used in the Secondary Outcomes analysis.) H2: American Indian youth who participate in N/E will demonstrate increased use of other birth control at 3, 9, and 12 months. They also will demonstrate a decrease in sexual risk behaviors as measured by reduced number of sex partners, delayed onset of sexual intercourse, and decreased substance use during sex, at 3, 9, and 12 months. (Secondary Outcomes) H3: N/E parents/legal guardians and youth will demonstrate significantly increased communication about topics related to SRH at 3, 9, and 12 months. American Indian youth who participate in the cultural mentoring program will demonstrate significantly increased understanding of cultural values related to traditional American Indian beliefs regarding SRH at 3, 9, and 12 months. And American Indian youth who participate in N/E will report significantly increased use of SRH services at 3, 9, and 12 months as a result of improved coordination among education, health care, and social service agencies on the Fort Peck Reservation. (Tertiary Outcomes) AIM 3: Evaluate the fidelity and acceptability of N/E. N/E's fidelity and acceptability will be evaluated using qualitative methods, including focus groups, activity logs, and staff field notes and meetings.
224 studies on the registry are indexed under Sexual Behavior; 30 are open to participants now.
This study's enrollment of 453 is above the median of 264 across 179 interventional studies indexed under Sexual Behavior.
Browse Sexual Behavior studies →Montana State University is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Compared within Sexual Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Reproductive Behavior. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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.
Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth
Cluster 2 includes 1 school 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.
Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth
Cluster 3 includes 1 school 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.
Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth
Cluster 4 includes 1 school on the Fort Peck reservation that will be randomized into the intervention in 2020-2021. Cluster 4 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.
Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth
Cluster 5 includes 1 school on the Fort Peck reservation that will be randomized into the intervention in 2020-2021. Cluster 4 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.
Behavioral: We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth
N/E will be implemented simultaneously over the 9-month school year. Components include: 1) Individual Level- Native Stand 2) Family Level - Native Voices; 3) Community Level - Cultural mentoring program; and 4) Systems Level. The fourth level of N/E mobilizes the existing Epidemiology Team to enhance the coordination and implementation of SRH services at Fort Peck.
Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days.
Number of protected acts of sex using a condom during vaginal and/or anal sex in the past 30 days is measured as proportion of condom use during vaginal/anal sex using 2 items (number of times condom used relative to number of times had vaginal/anal sex).
Time frame: Outcome measure time frame was 30 days from survey completion at 3 months post intervention.
Change in Number of Participants Reporting "Yes" to Having Engaged in Sexual Intercourse
Participants reported whether they ever had sex by responding to the question, "Have you ever had sexual intercourse?", with response options of "Yes" or "No". Answers of "Yes" were coded to "1" and answers of "No" were coded to "0".
Time frame: From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment)
Change in Mean Number of Lifetime Sex Partners.
The mean number of lifetime sex partners (i.e., the total number of people with whom a participant had sex in their lifetime) was assessed by asking participants, "During your life, with how many people have you had sexual intercourse?" with responses of "1 person", "2 people", "3 people", "4 people", "5 people", and "6 or more people". Responses were treated as integer values from 1-6, where the change in mean number of lifetime sex partners was assessed at 3-months post-intervention (12-months post-baseline) compared to baseline.
Time frame: From enrollment (baseline) to 3 months post-intervention (i.e., 12 months after enrollment)
Change in Mean Number of Vaginal and/or Anal Sex Acts in the Past 30 Days.
Participants reported the number of times they had vaginal and/or anal sex in the past 30 days as an integer value (i.e., 0, 1, 2, 3, etc. times), where answers could be at a minimum of 0 times with no maximum limit. The change in mean number of sex acts was calculated from baseline to 3-months post-intervention.
Time frame: From baseline to 3-months post-intervention (i.e., 12 months post-baseline)
Change in Mean Number of Times Non-condom Birth Control Was Used During Sex in the Past 30 Days.
The number of times non-condom birth control was used during sex in the past 30 days was assessed by asking participants, "Of the times you had sex over the past month, how many TIMES did you use birth control other than a condom, like birth control pills or having a deprova shot?". Responses ranged from 0 (minimum) to any positive integer value, where the maximum was limited by the number of times they had sex in the past month.
Time frame: From baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Change in Mean Number of Pregnancies
Number of times participants reported that they had been pregnant or gotten someone pregnant
Time frame: Baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Change in Number of Participants Reporting "Yes" to Having Used Substances During Sex
Participants reported "Yes" or "No" to the question, "Did you drink alcohol or use drugs before you had sexual intercourse the last time?"
Time frame: Baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Change in Mean Score of Parent/Legal Guardian-child Communication About Sexual and Reproductive Health Topics
Parent/legal-child communication about sexual and reproductive health topics was measured using a 24-item communication scale. Each item asked participants if they had discussed a certain topic with their parents, with possible responses of "Yes" and "No". Answers of "Yes" were coded to 1 and "No" coded to 0. All 24 answers were summed to create a communication score with a minimum of 0 and a maximum of 24.
Time frame: Baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Change in Number of Participants Reporting "Yes" to Having Used Sexual and Reproductive Health Services From Indian Health Service (IHS)
Use of sexual and reproductive health services from IHS was measured with one question that asked participants, "Have you ever been to Indian Health Services or Fort Peck Tribal Health for things like condoms, birth control, a pregnancy test, or STD test?", where responses were either "Yes" or "No". Responses of "Yes" were coded to 1 and "No" to 0.
Time frame: From baseline to 3 months post-intervention (i.e., 12 months post-baseline)
Recruitment took place from January 2019 to May 2019. Recruitment included meetings with tribal and school leadership and letters to caregivers who had a child 14- to 18 years old and was attending school.
| Milestone | Cluster 1: Baseline, Then 12 Months NE Intervention | Cluster 2: 12 Months Baseline, Then 12 Months NE Intervention | Cluster 3: 24 Months Baseline, Then 12 Months NE Intervention | Cluster 4: 24 Months Baseline, Then 12 Months NE Intervention | Cluster 5: 36 Months Baseline, Then 12 Months NE Intervention |
|---|---|---|---|---|---|
| Started | 210 | 41 | 23 | 29 | 150 |
| Completed | 95 | 18 | 11 | 17 | 137 |
| Not completed | 115 | 23 | 12 | 12 | 13 |
| Withdrew: Lost to follow-up | 115 | 23 | 12 | 12 | 13 |
Number of protected acts of sex using a condom during vaginal and/or anal sex in the past 30 days is measured as proportion of condom use during vaginal/anal sex using 2 items (number of times condom used relative to number of times had vaginal/anal sex).
| proportion | NE Intervention |
|---|---|
| Change in Number of Protected Acts Using a Condom During Vaginal and/or Anal Sex in the Past 30 Days. | 0.31 (0.15 to 0.47) |
Participants reported whether they ever had sex by responding to the question, "Have you ever had sexual intercourse?", with response options of "Yes" or "No". Answers of "Yes" were coded to "1" and answers of "No" were coded to "0".
| Participants | NE Intervention |
|---|---|
| Change in Number of Participants Reporting "Yes" to Having Engaged in Sexual Intercourse | 179 |
The mean number of lifetime sex partners (i.e., the total number of people with whom a participant had sex in their lifetime) was assessed by asking participants, "During your life, with how many people have you had sexual intercourse?" with responses of "1 person", "2 people", "3 people", "4 people", "5 people", and "6 or more people". Responses were treated as integer values from 1-6, where the change in mean number of lifetime sex partners was assessed at 3-months post-intervention (12-months post-baseline) compared to baseline.
| number of sex partners | NE Intervention |
|---|---|
| Change in Mean Number of Lifetime Sex Partners. | 2.66 ± 1.72 |
Participants reported the number of times they had vaginal and/or anal sex in the past 30 days as an integer value (i.e., 0, 1, 2, 3, etc. times), where answers could be at a minimum of 0 times with no maximum limit. The change in mean number of sex acts was calculated from baseline to 3-months post-intervention.
| Number of anal/vaginal sex acts | NE Intervention |
|---|---|
| Change in Mean Number of Vaginal and/or Anal Sex Acts in the Past 30 Days. | 2.07 ± 3.44 |
The number of times non-condom birth control was used during sex in the past 30 days was assessed by asking participants, "Of the times you had sex over the past month, how many TIMES did you use birth control other than a condom, like birth control pills or having a deprova shot?". Responses ranged from 0 (minimum) to any positive integer value, where the maximum was limited by the number of times they had sex in the past month.
| number of times birth control used | NE Intervention |
|---|---|
| Change in Mean Number of Times Non-condom Birth Control Was Used During Sex in the Past 30 Days. | 0.99 ± 2.27 |
Parent/legal-child communication about sexual and reproductive health topics was measured using a 24-item communication scale. Each item asked participants if they had discussed a certain topic with their parents, with possible responses of "Yes" and "No". Answers of "Yes" were coded to 1 and "No" coded to 0. All 24 answers were summed to create a communication score with a minimum of 0 and a maximum of 24.
| units on a scale | NE Intervention |
|---|---|
| Change in Mean Score of Parent/Legal Guardian-child Communication About Sexual and Reproductive Health Topics | 9.42 ± 6.47 |
Use of sexual and reproductive health services from IHS was measured with one question that asked participants, "Have you ever been to Indian Health Services or Fort Peck Tribal Health for things like condoms, birth control, a pregnancy test, or STD test?", where responses were either "Yes" or "No". Responses of "Yes" were coded to 1 and "No" to 0.
| Participants | NE Intervention |
|---|---|
| Change in Number of Participants Reporting "Yes" to Having Used Sexual and Reproductive Health Services From Indian Health Service (IHS) | 115 (1.69 to 37.15) |
Number of times participants reported that they had been pregnant or gotten someone pregnant
| pregnancies | NE Intervention |
|---|---|
| Change in Mean Number of Pregnancies | 0.09 ± 0.34 |
Participants reported "Yes" or "No" to the question, "Did you drink alcohol or use drugs before you had sexual intercourse the last time?"
| Participants | NE Intervention |
|---|---|
| Change in Number of Participants Reporting "Yes" to Having Used Substances During Sex | 9 |
Collected over Adverse events were assessed at baseline, 3 months, 9 months, and 12 months for participants in NE. Cluster 1 adverse events were assessed September 2019-September 2020; Cluster 2 adverse events were assessed September 2020-September 2021; Cluster 3 & Cluster 4 adverse events were assessed September 2021-September 2022; Cluster 5 adverse events were assessed September 2022-September 2023. No adverse events were reported during NE.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cluster 1 | 0/210 (0%) | 0/210 (0%) | 0/210 (0%) |
| Cluster 2 | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Cluster 3 | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Cluster 4 | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Cluster 5 | 0/150 (0%) | 0/150 (0%) | 0/150 (0%) |
Participants contributed behavioral data on variables related to sexual risk taking.
| Age, Continuous(years) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Cluster 5 | Total |
|---|---|---|---|---|---|---|
| Mean | 15.7 ± 1.5 | 15.9 ± 1.8 | 15.5 ± 1.4 | 15.0 ± 1.5 | 15.6 ± 1.4 | 15.6 ± 1.5 |
| Age, Continuous(years) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Cluster 5 | Total |
|---|---|---|---|---|---|---|
| Mean | 15.7 ± 1.5 | 15.9 ± 1.8 | 15.5 ± 1.4 | 15.0 ± 1.5 | 15.6 ± 1.4 | 15.6 ± 1.5 |
| Age, Customized(years) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Cluster 5 | Total |
|---|---|---|---|---|---|---|
| Age of participants | 15.7 ± 1.5 | 15.9 ± 1.8 | 15.5 ± 1.4 | 15.0 ± 1.5 | 15.6 ± 1.4 | 15.5 ± 1.5 |
| Sex/Gender, Customized(participants) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Cluster 5 | Total |
|---|---|---|---|---|---|---|
| Student gender (number that are male) by cluster. | 107 | 14 | 9 | 13 | 82 | 225 |
| Sex: Female, Male(Participants) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Cluster 5 | Total |
|---|---|---|---|---|---|---|
| Female | 103 | 28 | 14 | 16 | 68 | 229 |
| Male | 107 | 13 | 9 | 13 | 82 | 224 |
| Ethnicity (NIH/OMB)(Participants) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Cluster 5 | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 210 | 41 | 23 | 29 | 150 | 453 |
| Race (NIH/OMB)(Participants) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Cluster 5 | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 210 | 41 | 23 | 29 | 150 | 453 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cluster 1 | Cluster 2 | Cluster 3 | Cluster 4 | Cluster 5 | Total |
|---|---|---|---|---|---|---|
| United States | 210 | 41 | 23 | 29 | 150 | 453 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is no plan to have an IPD sharing plan at this point in time.
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Montana State University