Honoring our teachings: children's storybooks as indigenous public health practice.

Introduction: American Indian and Alaska Native (AIAN) communities continue to flourish and innovate in the face of the COVID-19 pandemic. Storytelling is an important tradition for AIAN communities that can function as an intervention modality. To support the needs of AIAN children and caregivers, we (a collaborative workgroup of Indigenous health researchers) developed a culturally grounded storybook that provides pandemic-related public health guidance and mental health coping strategies woven with Inter-Tribal values and teachings. Methods: A collaborative workgroup, representing diverse tribal affiliations, met via four virtual meetings in early 2021 to discuss evolving COVID-19 pandemic public health guidance, community experiences and responses to emerging challenges, and how to ground the story in shared AIAN cultural strengths. We developed and distributed a brief survey for caregivers to evaluate the resulting book. Results: The workgroup iteratively reviewed versions of the storyline until reaching a consensus on the final text. An AI artist from the workgroup created illustrations to accompany the text. The resulting book, titled Our Smallest Warriors, Our Strongest Medicine: Honoring Our Teachings during COVID-19 contains 46 pages of text and full-color illustrations. An online toolkit including coloring pages, traditional language activities, and caregiver resources accompanies the book. We printed and distributed 50,024 physical copies of the book and a free online version remains available. An online survey completed by N = 34 caregivers who read the book with their child(ren) showed strong satisfaction with the book and interest in future books. Discussion: The development of this storybook provides insights for creative dissemination of future public health initiatives, especially those geared toward AIAN communities. The positive reception and widespread interest in the storybook illustrate how braiding AIAN cultural teachings with public health guidance can be an effective way to disseminate health information. This storybook highlights the importance of storytelling as an immersive learning experience through which caregivers and children connect to family, community, culture, and public health guidance. Culturally grounded public health interventions can be effective and powerful in uplifting AIAN cultural values and promoting health and well-being for present and future generations.

Summarizing Implementation Support for School-Based COVID-19 Testing Programs in Southwest American Indian Communities.

CONTEXT: American Indian communities have been disproportionately affected by the COVID-19 pandemic, with school closures exacerbating health and education disparities. PROGRAM: Project SafeSchools' COVID-19 school-based testing program utilized federal and state funding to provide weekly pooled testing with follow-up rapid antigen testing to students and staff from the White Mountain Apache Tribe and Navajo Nation. IMPLEMENTATION: The project provided partner schools with training and continual logistical and technical support to aid in school-based testing and adherence to state and local reporting requirements. EVALUATION: Using the EPIS (Exploration, Preparation, Implementation, and Sustainment) framework, we identified facilitators and barriers to successful program function. While community support and buy-in were essential for successfully implementing school-based testing in these communities, communication, school staff turnover, and funding are among the most significant challenges. DISCUSSION: Community partnerships in American Indian communities involving schools and local health authorities can successfully implement testing protocols by remaining flexible and working together to maintain strong lines of communication.

Expert-generated standard practice elements for evidence-based home visiting programs using a Delphi process.

BACKGROUND: States, territories, non-profits, and tribes are eligible to obtain federal funding to implement federally endorsed evidence-based home visiting programs. This represents a massive success in translational science, with $400 million a year allocated to these implementation efforts. This legislation also requires that 3% of this annual funding be allocated to tribal entities implementing home visiting in their communities. However, implementing stakeholders face challenges with selecting which program is best for their desired outcomes and context. Moreover, recent reviews have indicated that when implemented in practice and delivered at scale, many evidence-based home visiting programs fail to replicate the retention rates and effects achieved during clinical trials. To inform program implementers and better identify the active ingredients in home visiting programs that drive significant impacts, we aimed to develop an expert derived consensus taxonomy on the elements used in home visiting practice that are essential to priority outcome domains. METHODS: We convened a panel of 16 experts representing researchers, model representatives, and program implementers using a Delphi approach. We first elicited standard practice elements (SPEs) using open-ended inquiry, then compared these elements to behavior change techniques (BCTs) given their general importance in the field of home visiting; and finally rated their importance to 10 outcome domains. RESULTS: Our process identified 48 SPEs derived from the panel, with 83 additional BCTs added based on the literature. Six SPEs, mostly related to home visitor characteristics and skills, were rated essential across all outcome domains. Fifty-three of the 83 BCTs were rated unnecessary across all outcome domains. CONCLUSIONS: This work represents the first step in a consensus-grounded taxonomy of techniques and strategies necessary for home visiting programs and provides a framework for future hypothesis testing and replication studies.

Towards precision home visiting: results at six months postpartum from a randomized pilot implementation trial to assess the feasibility of a precision approach to Family Spirit.

BACKGROUND: Shared implementation challenges at scale in early childhood home visiting have led researchers to explore precision home visiting as a promising service delivery mechanism to better address families' unique needs and build greater program efficiencies. This randomized controlled pilot study aimed to assess the acceptability of a precision approach to one home visiting model, Family Spirit® and explore potential differences between Precision Family Spirit (PFS) and Standard Family Spirit (Standard FS) on participant-home visitor relationship and maternal outcomes. METHODS: Participants (N = 60) were at least 14 years old, pregnant or within 2 months postpartum, and enrolled in Family Spirit. Four sites in Michigan were randomized 1:1 to deliver PFS (up to 17 core lessons plus up to 13 additional lessons as needed) or Standard FS (home visiting services as usual). Primary (program acceptability, participant satisfaction, home visitor-participant relationship quality, retention, adherence) and secondary (knowledge, quality of life, difficulty with parenting problems, substance use, depression, stress) outcomes at 6 months postpartum are presented. PFS participants also self-reported on quality of life, difficulty with parenting problems, stress, substance use, and concerns with sexual and reproductive health and self and child's nutrition status at each home visit. This informed which lessons they should receive. RESULTS: Mothers in both groups reported positive program acceptability, satisfaction, and home visitor-participant relationships at 6 months postpartum. However, open-ended feedback from Standard FS participants indicates that some lesson content may not be applicable to all participants. At 6 months, retention was 82.3% for PFS and 66.7% for Standard FS, and adherence was 30.1% for PFS and 20.6% for Standard FS. CONCLUSIONS: Preliminary findings indicate that precision home visiting may be acceptable and feasible. A definitive trial is needed to build on this pilot data, assess outcomes for mothers and children participating in a precision approach to home visiting as compared to standard home visiting, and ready this approach for scale. TRIAL REGISTRATION: ClinicalTrials.gov NCT03975530 (first posted on 05/06/2019).

Home visitor perspectives on implementing a precision approach to home visiting in communities serving Native American families.

Family Spirit (FS) is a federally endorsed evidence-based home visiting programs serving as a key prevention strategy for expectant families and families with young children. Like other home-visiting programs, it shares client challenges in retention and engagement during implementation. We assessed (1) the feasibility and acceptability of implementing a precision approach to FS; and (2) differences in approaches to FS delivery. Home visitors, serving primarily Native American families, that delivered a standard (N = 6) or a precision approach (N = 6) to FS across four study sites each participated in up to four virtual focus group discussions (FGDs) (N = 16). Facilitators and barriers to implementation were identified across the curriculum approach, relational and contextual levels. Facilitators: Relevant and culturally sensitive lessons, lesson structure, client-home visitor relationship, client buy-in, home visitor autonomy, leadership support, flexible funding, and training. Barriers: Irrelevant lessons, substance use content, missing topics, families experiencing crises, client and home visitor availability, client feedback, nonsupportive leadership, inadequate funding, and organizational policies and practices. The precision approach offers (1) tailoring of lessons that supports relevance of content to clients; and (2) a target timeframe that supports flexibility in lesson delivery. This model structure may improve client participation and retention.

Espíritu de Familia (FS) es un programa de visitas a casa con base en la evidencia y respaldado federalmente, el cual sirve como una estrategia clave de prevención para familias con niños pequeños que esperan otro niño. Tal como otros programas de visitas a casa, éste comparte los retos de los participantes en cuanto a retención y participación activa durante la implementación. Evaluamos 1) la factibilidad y accesibilidad de implementar un acercamiento de precisión a FS; y 2) las diferencias en cuanto al acercamiento del ofrecimiento de FS. Los visitadores a casa, quienes primariamente les sirven a familia nativo-americanas, y que ofrecieron un acercamiento estándar (N = 6) o uno de precisión (N = 6) a FS a través de 4 lugares de estudio, cada uno participó en un máximo de 4 discusiones virtuales de grupos de enfoque (N = 16). Los aspectos que facilitaron y las barreras a la implementación se identificaron a lo largo de los niveles de acercamiento, relacionales y contextuales del currículo. Aspectos que facilitaron: lecciones relevantes y culturalmente sensibles, estructura de lecciones, la relación entre el participante-casa y el visitador, la aceptación por parte del participante, la autonomía del visitador a casa, el apoyo de liderazgo, la flexibilidad de los fondos, así como el entrenamiento. Barreras: lecciones irrelevantes, contenido sobre uso de sustancias, temas que no se incluyeron, las familias que experimentaban una crisis, la disponibilidad del participante y del visitador, información aportada por el participante, falta de apoyo del liderazgo, fondos inadecuados, así como las políticas y prácticas organizacionales. El acercamiento de precisión ofrece 1) moldear las lecciones que apoyan la relevancia del contenido a los participantes; y 2) un definido marco de tiempo que apoya la flexibilidad del ofrecimiento de las lecciones. Esta estructura de modelo pudiera mejorar la participación y retención de participantes.

Le programme Family Spirit (FS, soit Esprit de Famille) est une programme américain, basé sur des données probantes, avalisé par le gouvernement américain, de visite à domicile, servant de stratégie de prévention clé pour les familles attendant un enfant ou les familles avec de jeunes enfants. Comme d'autres programmes de visite à domicile, ce programme partage des difficultés dans la rétention et l'engagement des clients durant la mise en oeuvre. Nous avons évalué 1) la fiabilité et l'acceptabilité de la mise en œuvre d'une approche de précision du FS; et 2) des différences dans les approches de l'application du FS. Les visiteurs à domicile, servant principalement des familles amérindiennes américaines, qui ont présenté une approche standard (N = 6) ou une approche de précision (N = 6) du FS et au travers de 4 sites d'étude chacun ont participé à jusqu'à 4 discussions de groupe d'étude virtuels (n = 16). Les aspects facilitateurs et les barrières à la mise en place ont été identifiés au travers de l'approche du curriculum, des niveaux relationnels et contextuels. Aspects de facilitation: leçons pertinentes et culturellement sensibles, structure de la leçon, relation client-visiteur à domicile, adhésion du client, autonomie du visiteur à domicile, soutient des dirigeants, budget flexible, formation. Barrières: leçons n'étant pas pertinentes, contenu d'usage de substance, sujets qui manquent, familles faisant l'expérience de crises, disponibilité du client et du visiteur à domicile, retour du client, dirigeants qui n'offrent aucun soutien, budget inadéquat, et politiques et pratiques organisationnelles. L'approche de précision offre 1) une adaptation sur mesure des leçons qui soutient la pertinence du contenu pour les clients; et 2) un délai ciblé qui soutient la flexibilité de l'enseignement. Cette structure de modèle peut améliorer la participation et la rétention.

Measuring the effects of the COVID-19 pandemic on Diné and White Mountain Apache school personnel, families, and students: protocol for a prospective longitudinal cohort study.

BACKGROUND: This paper describes the protocol for a longitudinal cohort study, "Project SafeSchools" (PSS), which focuses on measuring the effects of COVID-19 and the return to in-person learning on Diné (Navajo) and White Mountain Apache (Apache) youth, parents, and educators. The early surges of the COVID-19 pandemic led to the closure of most reservation and border town schools serving Diné and Apache communities. This study aims to: (1) understand the barriers and facilitators to school re-opening and in-person school attendance from the perspective of multiple stakeholders in Diné and Apache communities; and (2) evaluate the educational, social, emotional, physical, and mental health impacts of returning to in-person learning for caregivers and youth ages 4-16 who reside or work on the Diné Nation and the White Mountain Apache Tribal lands. METHODS: We aim to recruit up to N = 200 primary caregivers of Diné and Apache youth ages 4-16 and up to N = 120 school personnel. In addition, up to n = 120 of these primary caregivers and their children, ages 11-16, will be selected to participate in qualitative interviews to learn more about the effects of the pandemic on their health and wellbeing. Data from caregiver and school personnel participants will be collected in three waves via self-report surveys that measure COVID-19 related behaviors and attitudes, mental health, educational attitudes, and cultural practices and beliefs for both themselves and their child (caregiver participants only). We hypothesize that an individual's engagement with a variety of cultural activities during school closures and as school re-opened will have a protective effect on adult and youth mental health as they return to in-person learning. DISCUSSION: The results of this study will inform the development or implementation of preventative interventions that may help Diné and Apache youth and their families recover from the negative impact of the COVID-19 pandemic, and positively impact their health and wellness.

Changing the home visiting research paradigm: models' perspectives on behavioral pathways and intervention techniques to promote good birth outcomes.

BACKGROUND: The US is scaling up evidence-based home visiting to promote health equity in expectant families and families with young children. Persistently small average effects for full models argue for a new research paradigm to understand what interventions within models work best, for which families, in which contexts, why, and how. Historically, the complexity and proprietary nature of most evidence-based models have been barriers to such research. To address this, stakeholders are building the Precision Paradigm, a common framework and language to define and test interventions and their mediators and moderators. This observational study used portions of an early version of the Precision Paradigm to describe models' intended behavioral pathways to good birth outcomes and their stance on home visitors' use of specific intervention technique categories to promote families' progress along intended pathways. METHODS: Five evidence-based home visiting models participated. Model representatives independently completed three structured surveys focused on 41 potential behavioral pathways to good birth outcomes, and 23 behavior change technique categories. Survey data were used to describe and compare models' intended behavioral pathways, explicit endorsement of behavior change technique categories, expectations for home visitors' relative emphasis in using endorsed technique categories, and consistency in endorsing technique categories across intended pathways. RESULTS: Models differed substantially in nearly all respects: their intended pathways to good birth outcomes (range 16-41); the number of technique categories they endorsed in any intended pathway (range 12-23); the mean number of technique categories they endorsed per intended pathway (range 1.5-20.0); and their consistency in endorsing technique categories across intended pathways (22%-100% consistency). Models were similar in rating nearly all behavior change technique categories as at least compatible with their model, even if not explicitly endorsed. CONCLUSIONS: Models successfully used components of the Precision Paradigm to define and differentiate their intended behavioral pathways and their expectations for home visitors' use of specific technique categories to promote family progress on intended pathways. Use of the Precision Paradigm can accelerate innovative cross-model research to describe current models and to learn which interventions within home visiting work best for which families, in which contexts, why and how.

Development and Dissemination of a Strengths-Based Indigenous Children's Storybook: "Our Smallest Warriors, Our Strongest Medicine: Overcoming COVID-19".

The traditions, strengths, and resilience of communities have carried Indigenous peoples for generations. However, collective traumatic memories of past infectious diseases and the current impact of the coronavirus disease 2019 (COVID-19) pandemic in many Indigenous communities point to the need for Indigenous strengths-based public health resources. Further, recent data suggest that COVID-19 is escalating mental health and psychosocial health inequities for Indigenous communities. To align with the intergenerational strengths of Indigenous communities in the face of the pandemic, we developed a strengths- and culturally-based public health education and mental health coping resource for Indigenous children and families. Using a community-engaged process, the Johns Hopkins Center for American Indian Health collaborated with 14 Indigenous and allied child development, mental health, health communications experts and public health professionals, as well as a Native American youth artist. Indigenous collaborators and Indigenous Johns Hopkins project team members collectively represented 12 tribes, and reservation-based, off-reservation, and urban geographies. This group shared responsibility for culturally adapting the children's book "My Hero is You: How Kids Can Fight COVID-19!" developed by the Inter-Agency Standing Committee Reference Group on Mental Health and Psychosocial Support in Emergency Settings and developing ancillary materials. Through an iterative process, we produced the storybook titled "Our Smallest Warriors, Our Strongest Medicine: Overcoming COVID-19" with content and illustrations representing Indigenous values, experiences with COVID-19, and strengths to persevere. In addition, parent resource materials, children's activities, and corresponding coloring pages were created. The book has been disseminated online for free, and 42,364 printed copies were distributed to early childhood home visiting and tribal head start programs, Indian Health Service units, tribal health departments, intertribal, and urban Indigenous health organizations, Johns Hopkins Center for American Indian Health project sites in partnering communities, schools, and libraries. The demand for and response to "Our Smallest Warriors, Our Strongest Medicine: Overcoming COVID-19" demonstrates the desire for Indigenous storytelling and the elevation of cultural strengths to maintain physical, mental, emotional, and spiritual health during the COVID-19 pandemic.

Precision Family Spirit: a pilot randomized implementation trial of a precision home visiting approach with families in Michigan-trial rationale and study protocol.

BACKGROUND: Home visiting is a well-supported strategy for addressing maternal and child health disparities. However, evidence-based models generally share implementation challenges at scale, including engagement and retention of families. Precision home visiting may address this issue. This paper describes the first known pilot randomized implementation trial of a precision home visiting approach vs. standard implementation. Primary aims are to: 1) explore the acceptability and feasibility of a precision approach to home visiting and 2) examine the difference between Standard Family Spirit and Precision Family Spirit on participants' program satisfaction, client-home visitor relationship, goal alliance, and the impact of these factors on participant engagement and retention. Secondary aims are to explore potential differences on maternal behavioral and mental health outcomes and child development outcomes to inform sample size estimations for a fully powered study. METHODS: This is a pilot Hybrid Type 3 implementation trial. Four Michigan communities primarily serving the Native American families and already using Family Spirit were randomized by site to receive Standard Family Spirit or Precision Family Spirit. Participants include N = 60 mothers at least 14 years of age (pregnant or with a newborn < 2 months of age) currently enrolled in Family Spirit. Precision Family Spirit participants receive core lessons plus additional lessons based on needs identified at baseline and that emerge during the trial. Control mothers receive the standard sequence of Family Spirit lessons. Data is collected at baseline (< 2 months postpartum), and 2, 6, and 12 months postpartum. All Precision Family Spirit participants are invited to complete qualitative interviews at study midpoint and endpoint. All home visitors are invited to participate in focus groups between study midpoint and endpoint. Exploratory data analysis will assess feasibility, acceptability, client-home visitor relationship, retention, adherence, and potential differences in intervention outcomes. DISCUSSION: This trial will provide new information about the acceptability and feasibility of precision home visiting and pilot data on program satisfaction, client-home visitor relationship, goal alliance, retention, and targeted maternal-child intervention outcomes. Findings will inform the design of a fully powered randomized implementation trial of precision vs. standard home visiting. TRIAL REGISTRATION: ClinicalTrials.gov # NCT03975530 ; Registered on June 5, 2019.

Effect of a Home-Visiting Intervention to Reduce Early Childhood Obesity Among Native American Children: A Randomized Clinical Trial.

Importance: Early childhood obesity disproportionately affects Native American communities. Home visiting is a promising strategy for promoting optimal infant growth in this population. Objective: To assess the impact of a brief home-visiting approach, Family Spirit Nurture (FSN), on sugar-sweetened beverage (SSB) consumption, responsive parenting and infant feeding practices, and optimal growth through 12 months post partum. Design, Setting, and Participants: This study was a 1:1 randomized clinical trial comparing FSN with an injury prevention education control condition in a reservation-based community. Participants were Navajo mothers 13 years or older with infants younger than 14 weeks recruited between March 22, 2017, and May 18, 2018, and followed up through 12 months post partum. Intent-to-treat analyses were conducted. Interventions: The 6-lesson FSN curriculum, delivered 3 to 6 months post partum by Navajo paraprofessionals, targeted optimal responsive and complementary feeding practices and avoidance of SSBs. The control group received 3 injury prevention lessons. Main Outcomes and Measures: Primary outcomes established a priori were infant SSB consumption and responsive parenting and complementary feeding practices (responsive feeding scale, age at complementary food introduction, and percentage of mothers who introduced complementary food to infants at 6 months of age or older). The secondary outcome was the effect of the intervention on infant body mass index z scores (zBMIs). Results: A total of 134 Navajo mothers of infants younger than 14 weeks were enrolled in the randomized clinical trial, including 68 (mean [SD] maternal age at enrollment, 27.4 [6.4] years) in the intervention group and 66 (mean [SD] maternal age at enrollment, 27.5 [6.1] years) in the control group. Intervention participants reported statistically significantly lower infant SSB consumption through 12 months post partum (mean [SE], 0.56 [0.12] cups per week in the intervention group and 1.78 [0.18] cups per week in the control group; incidence rate ratio, 0.31; 95% CI, 0.19-0.50). Improvements in responsive feeding practices were observed through 9 months post partum (mean [SE], 3.48 [0.07] in the intervention group and 3.22 [0.08] in the control group) (difference, 0.26; 95% CI, 0.06-0.47); statistical significance was lost at 12 months post partum. Age at which the infant was given first food was younger in the intervention group (mean [SE] age, 4.61 [0.21] months in the intervention group and 5.28 [0.23] months in the control group) (difference, -0.67; 95% CI, -0.04 to -1.29). Infants in the intervention group had lower zBMI at 6 and 9 months compared with those in the control group (mean [SE] at 9 months, 0.27 [0.14] in the intervention group and 0.81 [0.14] in the control group; difference, -0.54; 95% CI, -0.94 to -0.14). The 12-month between-group difference was meaningful but not statistically significant (mean [SE], 0.61 [0.16] in the intervention group and 1.07 [0.20] in the control group; difference, -0.46; 95% CI, -0.92 to 0.01). Conclusions and Relevance: Infants of Native American mothers who participated in a home-visiting intervention had substantially lower SSB consumption and improvements in responsive feeding practices and infant zBMI scores, suggesting the intervention is effective for promoting healthy infant feeding and growth. Trial Registration: ClinicalTrials.gov Identifier: NCT03101943.

Entrepreneurial, Economic, and Social Well-Being Outcomes from an RCT of a Youth Entrepreneurship Education Intervention among Native American Adolescents.

Background: Entrepreneurship education has demonstrated positive impacts in low-resource contexts. However, there is limited evidence of such programs evaluated among Native American (NA) youth in a rural reservation. Methods: A 2:1 randomized controlled trial evaluated the impact of the Arrowhead Business Group (ABG) entrepreneurship education program on entrepreneurship knowledge, economic empowerment, and social well-being among 394 NA youth. An intent to treat analysis using mixed effects regression models examined within and between study group differences from baseline to 24 months. An interaction term measured change in the intervention relative to change in the control. ABG participants were purposively sampled to conduct focus groups and in-depth interviews. Results: Significant intervention vs. control group improvements were sustained at 12 months for entrepreneurship knowledge and economic confidence/security. Significant within-group improvements were sustained for ABG participants at 24 months for connectedness to parents, school, and awareness of connectedness. Qualitative data endorses positive impacts on social well-being among ABG participants. Conclusion: Observed effects on entrepreneurship knowledge, economic empowerment, and connectedness, supplemented by the experiences and changes as described by the youth themselves, demonstrates how a strength-based youth entrepreneurship intervention focused on developing assets and resources may be an innovative approach to dually address health and economic disparities endured in Native American communities.

Utilizing broad-based partnerships to design a precision approach to implementing evidence-based home visiting.

The aim of this paper is to describe a participatory process for adapting an implementation strategy, using a precision approach, for an evidence-based home visiting program, Family Spirit. Family Spirit serves Native American and low-income communities nationwide. To redesign Family Spirit's implementation strategy, we used workshops (n = 5) with key stakeholders and conducted an online survey with implementers (n = 81) to identify hypothesized active ingredients and "pivot points" to guide when to tailor the program and for whom. Active ingredients identified included the relationship between the home visitor and clients, lessons ensuring child safety and healthy development, parent-child communication, and goal setting. Pivot points included whether the client is a first-time mother who has substance abuse history, has a baby at risk for childhood obesity, and/or has sexual or reproductive health concerns. These results are informing the adaptation of Family Spirit' implementation strategy making it more responsive to diverse families while balancing fidelity to the previously proven standard model.

Evaluation of an Entrepreneurship Education Intervention for American Indian Adolescents: Trial Design and Baseline Sample Characteristics.

Entrepreneurship education is a strength-based approach and holds promise for promoting health equity for American Indian youth. Arrowhead Business Group (ABG) was developed by a tribal-academic research partnership and is being rigorously evaluated for impacts on psychosocial, behavioral, educational, and economic outcomes. This article describes: 1) the trial design and conceptual model under-girding the ABG program; 2) the sociodemographic, sociocultural, and family/household characteristics of participants at baseline; and 3) the baseline differences in key outcome indicators between study groups. Results demonstrate participants have baseline characteristics appropriate for study aims and are compared and contrasted with other youth from the participating tribal community and state in which the tribe resides. Findings inform future analyses to explore how baseline characteristics are associated with primary and secondary outcomes of the evaluation.

Family Spirit Nurture (FSN) - a randomized controlled trial to prevent early childhood obesity in American Indian populations: trial rationale and study protocol.

BACKGROUND: Childhood overweight and obesity is a persistent public health issue in the US. Risk for obesity and obesity-related morbidity throughout the life course begins in utero. Native Americans suffer the greatest disparities in the US in childhood overweight and obesity status of any racial or ethnic group. Existing early childhood home-visiting interventions provide an opportunity for addressing obesity during the first 1000 days. However, to date, no evidence-based model has been specifically designed to comprehensively target early childhood obesity prevention. METHODS: This study is a randomized controlled trial to test the efficacy of home-visiting intervention, called Family Spirit Nurture, on reducing early childhood obesity in Native American children. Participants are expectant Native American mothers ages 14-24 and their child, enrolled from pregnancy to 24 months postpartum and randomized 1:1 to receive the Family Spirit Nurture intervention or a control condition. The intervention includes 36 lessons delivered one-on-one by locally-hired Native American Family Health Coaches to participating mothers from pregnancy until 18 months postpartum. A mixed methods assessment includes maternal self-reports, maternal and child observations, and physical and biological data collected at 11 time points from 32 weeks gestation to 2 years postpartum to measure the intervention's primary impact on maternal feeding behaviors; children's healthy diet and physical activity; children's weight status. Secondary measures include maternal psychosocial factors; household food and water security; infant sleep and temperament; and maternal and child metabolic status. DISCUSSION: None of the 20 current federally-endorsed home-visiting models have demonstrated impacts on preventing early childhood obesity. The original Family Spirit program, upon which Family Spirit Nurture is based, demonstrated effect on maternal and child behavioral health, not including obesity related risk factors. This trial has potential to inform the effectiveness of home-visiting intervention to reduce obesity risk for tribal communities and other vulnerable populations and expand public health solutions for the world's obesity crisis. TRIAL REGISTRATION: Clinicaltrials.gov (Identifier: NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months; Retrospectively registered on 07 November 2017).

Entrepreneurship education: A strength-based approach to substance use and suicide prevention for American Indian adolescents.

American Indian (AI) adolescents suffer the largest disparities in substance use and suicide. Predominating prevention models focus primarily on risk and utilize deficit-based approaches. The fields of substance use and suicide prevention research urge for positive youth development frameworks that are strength based and target change at individual and community levels. Entrepreneurship education is an innovative approach that reflects the gap in available programs. This paper describes the development and evaluation of a youth entrepreneurship education program in partnership with one AI community. We detail the curriculum, process evaluation results, and the randomized controlled trial evaluating its efficacy for increasing protective factors. Lessons learned may be applicable to other AI communities.