Assessing the Effectiveness of the Respecting the Circle of Life Project on Condom and Contraception Self-efficacy Among American Indian Youth.

Respecting the Circle of Life (RCL) is a teen pregnancy prevention program that was evaluated for effectiveness on sexual health risk behaviors through a two-arm randomized control trial (RCT) with American Indian (AI) youth ages 11-19. The objective of this study is to investigate the effects of RCL compared to a control group on items of condom and contraception self-efficacy. Linear regression analysis was used to compare differences in each item that included condom and contraception self-efficacy scales among the intervention and control participants at baseline, 3 and 9 months post intervention. Youth enrolled in the intervention reported higher levels of condom and contraception self-efficacy across almost all individual items. Exceptions include items related to partner negotiation of condom self-efficacy at 3 months (p = 0.227) and 9 months (p = 0.074) post intervention. Findings indicate RCL is effective at improving overall condom and contraception self-efficacy but did not impact the specific component of partner negotiation for either condom or contraception self-efficacy. This inquiry provides rationale to further explore components of RCL related to partner negotiation.

Implementation Fidelity and Theory-Informed Dose Effects of a Teen Pregnancy Prevention Program for Native American Youth.

In 2019, Native youth had the highest rate of teen pregnancy of all racial/ethnic groups. "Respecting the Circle of Life" (RCL) is one of the first evidence-based teen pregnancy prevention programs for Native teens and there is interest in replicating the program across tribal communities. To inform replication, it is important to consider process data including quality, fidelity, and dosage as these may all moderate impact of the program. Participants were Native youth aged 11-19 and a trusted adult. This study includes participants randomized to the RCL program only (N = 266). Data sources include independent observations, facilitator self-assessments, attendance logs, and self-report assessments completed by enrolled youth at baseline and 3 months post assessment. Data was compiled and summed by cohort. Dosage was number of minutes participating in activities separated by theoretical constructs. Linear regression models were utilized to assess moderation of the effects of the intervention dosage on outcomes of interest. Eighteen facilitators delivered RCL. One hundred eighteen independent observations and 320 facilitator self-assessments were collected and entered. Findings indicate RCL was implemented with high fidelity and quality (4.40 to 4.82 out of a 5-point Likert scale; 96.6% of planned activities completed). Dosage was high with an average completion of 7 out of 9 lessons. There was no association between theoretical construct dosage and outcomes of interest. Overall, this study indicates RCL was delivered with high fidelity, quality, and dosage in this trial. This paper informs future replication of RCL and provides support for hiring paraprofessionals from the local community as facilitators, delivering the RCL to peer groups of the same age and sex, delivering the RCL with short duration and high frequency, and encouraging youth to attend all RCL lessons, but continue to serve youth who have missed one or more lessons.

Predictors of STD Screening From the Indigenist Stress-Coping Model Among Native Adults With Binge Substance Use.

Objective: The American Indian/Alaska Native (AI/AN) population in the U.S. is thriving in spite of settler colonialist efforts of erasure. AI/AN people, however, continue to experience persistent health disparities including a disproportionate burden of substance use and sexually transmitted diseases/infections (STDs/STIs), as well as a disproportionate lack of public health STD screening services and STD prevention interventions grounded in AI/AN social contexts, experiences, and epistemologies. The present study explored how stressors and protective factors based on the Indigenist Stress Coping framework predict STD screening outcomes among Native adults. Methods: We analyzed baseline self-report data from 254 Native adults ages 18-55 years with recent binge substance use who were enrolled in an evaluation of "EMPWR," a two-session STD risk reduction program in a rural, reservation-based community in the U.S. Southwest. Logistic regression models with robust variance were used to estimate odds ratios of lifetime STD testing for the theoretical stressors and cultural buffers. Results: A little over half the sample were males (52.5%, n = 136), with a mean age of 33.6 years (SD = 8.8). The majority (76.7%, n = 195) reported having ever been screened for STD in their life. Discrimination score were significantly associated with lifetime STD testing: The higher discrimination was associated with lower odds of STD testing in the fully adjusted model (aOR = 0.40, 95%CI: 0.18, 0.92). The effects of AI/AN-specific cultural buffer such as participation in traditional practices on STD testing outcomes was in the expected positive direction, even though the association was not statistically significant. Household size was significantly associated with STD screening: The higher the number of people lived together in the house, the higher the odds of STD testing in the fully adjusted model (aOR = 1.19, 95%CI: 1.04, 1.38). Conclusion: Our findings suggest that STD prevention programs should take into consideration AI/AN-specific historical traumatic stressors such as lifetime discrimination encounters and how these interact to drive or discourage sexual health services at local clinics. In addition, larger household size may be a protective factor functioning as a form of social support, and the extended family's role should be taken into consideration. Future research should consider improvement in measurements of AI/AN enculturation constructs.

Improving communication between American Indian youth and caregivers to prevent teenage pregnancy.

American Indian (AI) youth are at increased risk for poor reproductive health outcomes. Parental communication and monitoring are established predictors of sexual risk-taking among adolescents. No program evaluations of sexual risk avoidance programs have focused exclusively on AI youth and parents. This study assesses the impact of the Respecting the Circle of Life (RCL) Teenage Pregnancy Prevention program on parent-youth communication and parental monitoring through a randomized controlled trial with AI youth ages 11-19 and their trusted adults (parents/caregivers) (N = 518). RCL consists of 8-peer group and one parent-youth session. Trusted adult participants completed the Parental Monitoring Scale and the Parent Adolescent Communication Scale at baseline and 3 and 9 months post-intervention via self-report. Intervention impact was evaluated using linear regression models, which included an indicator for study group. At 3 months post, trusted adults in the intervention reported significantly higher levels of sexual health communication (P = 0.042) and spoke to their child more often about how to get condoms (P = 0.001), get birth control (P = 0.014) and protect themselves from human immunodeficiency virus (P = 0.005) compared with trusted adults in the control condition. Program impact varied by age and sex. This study adds to literature and extends findings on RCL impact.

Empowering our people: Predictors of retention in an STI risk reduction program among rural Native Americans with binge substance use.

PURPOSE: Substance use and sexual risk-taking have been shown to co-occur. Programs focused on sexually transmitted infections (STIs) reduction may benefit substance-using, particularly binge substance-using, adults. This is especially true for rural Native American communities who endure sexual and substance use disparities and have few STI risk reduction programs. This study explores factors predicting retention in an STI risk reduction program among rural Native adults engaged in binge substance use. METHODS: We analyzed data from 150 Native adults ages 18-55 participating in an evaluation of "EMPWR," a 2-session STI risk reduction program in a rural, reservation-based community. Multivariate logistic regression models were used to estimate associations between independent variables and program completion across demographics, sexual behaviors, substance use behaviors, mental health, recent health care utilization, and perceived enculturation and discrimination. FINDINGS: The sample was 49.2% (n = 59) female with a mean age of 33.61 years (SD = 8.25). Twenty-six completed only the first EMPWR session, 94 completed both EMPWR sessions, and 30 were randomized but completed 0 sessions. Being married/cohabiting (adjusted odds ratio [AOR] = 6.40, P = .0063) and living with an older generation (AOR = 4.86, P = .0058) were significantly associated with higher odds of completing EMPWR. CONCLUSIONS: Findings provide insight on factors driving retention of Natives with recent binge substance use in STI risk reduction programming. An important contribution to Native health literature is that living with an older generation positively predicted EMPWR program completion, suggesting that STI risk reduction programs should harness the strength of families to ensure program attendance and optimize impacts in rural reservation contexts.

Diet quality scores associated with improved cardiometabolic measures among African American adolescents.

BACKGROUND: The Reversing the Negative cardiovascular Effects on Weight (ReNEW) Clinic is a prospective cohort study in children and adolescents (≤21 years) at the Johns Hopkins Children's Center. METHODS: Cross-sectional analysis between diet quality using the Alternative Healthy Eating Index (AHEI-2010), pro-inflammatory potential using the Children's Dietary Inflammatory Index (C-DII), and cardiometabolic outcomes. AHEI-2010 and C-DII scores were assessed by median intake determined from the sample distribution and associated with cardiometabolic measures using linear regression models. Changes in measures were evaluated in a sub-sample of participants invited to attend follow-up visits due to the presence of hypertensive blood pressure (n = 33). RESULTS: Participants (n = 90) reported an average energy intake of 1790 kcal/day (SD ± 734), AHEI-2010 score of 55.04 (SD ± 9.86) (range: 0 to 110) and C-DII score of -0.12 (±0.86) (range -5 to 5). Participants with higher quality/anti-inflammatory diets trended towards more favorable cardiometabolic measures at baseline. Among the sub-sample (n = 33), there was a significant reduction in total energy (m = -302 kcal/day; p-value= 0.03) but no change in AHEI-2010 (p-value = 0.73) or C-DII score (p-value = 0.85) over follow-up. CONCLUSIONS: Despite stable diet quality scores, outpatient dietary and behavioral counseling may be an effective tool to reduce energy intake in youth with overweight/obesity and elevated blood pressure. IMPACT: Diet quality scores among obese, hypertensive, African American adolescents were low and reflect a pro-inflammatory diet. Reported intake was negligible for fruits, whole grains, nuts, and legumes, and well above the daily limit for sodium and saturated fat. Participants with high quality/anti-inflammatory diet quality scores trended toward improved cardiometabolic measures. Outpatient dietary counseling resulted in reduced total energy intake.

Impacts of the respecting the circle of life teen pregnancy prevention program on risk and protective factors for early substance use among native American youth.

BACKGROUND: Early substance use disproportionately impacts Native American (Native) youth and increases their risk for future abuse and dependence. The literature urges for interventions to move beyond focusing on single risk behaviors (e.g. substance use) and instead have capacity to improve health risk behaviors co-occuring during adolescence, particularly among Native populations for whom few evidence-based interventions (EBI) exist. We evaluated the effectiveness of the Respecting the Circle of Life program (RCL) on risk and protective factors for early substance use. RCL is a culturally tailored EBI shown to improve sexual health outcomes among Native youth. METHODS: We conducted secondary analyses of data collected through a community-based randomized controlled trial of RCL evaluated among Native youth (ages 11-19) residing on a rural reservation between 2015-2020 (N = 534, 47.4 % male). We used linear regression, controlling for baseline age and sex, to test between study group differences in outcomes at 3-, 9-, and 12-month post-intervention. Models were stratified by sex and age (11-12, 13-14, and 15+ years of age) to examine differences within these subgroups. RESULTS: Youth receiving RCL reported lower intention to use substances through 12-months follow-up (p = 0.006). Statistically significant improvements were also observed across peer, parent, and sexual partner risk and protective factors to delay substance use initiation, with notable differences among boys and participants ages 13-14. CONCLUSIONS: RCL is a primary prevention, skills-based program effective in preventing risks for substance use. This evaluation underscores the value in developing programs that influence concurrent adolescent risk behaviors, especially for Native communities who endure multiple health disparities.

Prevention of Sexually Transmitted Diseases and Pregnancy Prevention Among Native American Youths: A Randomized Controlled Trial, 2016-2018.

Objectives. To evaluate the efficacy of the Respecting the Circle of Life program (RCL) among Native American youths 11 to 19 years of age residing in a rural reservation community in the southwestern United States. Methods. Between 2016 and 2018, we conducted a randomized controlled trial of the RCL program with 534 Native youths. Participants completed assessments at baseline and 9 and 12 months after the intervention. We conducted intention-to-treat analyses based on study group randomization. Results. At 9 months, intervention participants had significantly better condom use self-efficacy (P < .001), higher intentions to use condoms (P = .024) and abstain from sex (P = .008), and better contraceptive use self-efficacy (P < .001) than control participants, as well as better condom use (P = .032) and contraceptive use (P = .002) negotiation skills. At 12 months, intervention participants had significantly better sexual and reproductive health knowledge (P = .021), condom use self-efficacy (P < .001), contraceptive use self-efficacy (P < .001), and contraceptive use negotiation skills (P = .004) than control participants. Intervention participants reported significantly more communication with their parents about sexual and reproductive health than control participants at both 9 and 12 months (P = .042 and P = .001, respectively). Conclusions. The RCL program has a significant impact on key factors associated with pregnancy prevention among Native youths and should be used as an adolescent pregnancy prevention strategy. Trial Registration.  Clinical Trials.gov identifier: NCT02904629. (Am J Public Health. 2021;111(10): 1874-1884. https://doi.org/10.2105/AJPH.2021.306447).

Rigorous evaluation of a substance use and teen pregnancy prevention program for American Indian girls and their female caregivers: a study protocol for a randomized controlled trial.

BACKGROUND: Early sexual initiation is associated with higher risk for sexually transmitted infection, teen pregnancy, domestic violence and substance use in later adolescence and early adulthood. Native American adolescents are more likely to have early sexual initiation compared to other racial/ethnic groups. Few programs designed with and for Native adolescents to delay sexual initiation and substance use have been tested through rigorous evaluations. This is the protocol for the randomized controlled trial of the Asdzáán Be'eena' program, a teen pregnancy and substance use prevention program for young Native girls and their female caregivers. METHODS: N = 410 female adolescents ages 10-14 and their female caregivers will be enrolled in the study and randomized to the intervention or control arm. The intervention consists of the 11-session Asdzáán Be'eena' program. The control arm consists of mailed non-monetary incentives. All participants will complete evaluations at baseline and 3 follow-up timepoints (immediate, 6 and 12 months post intervention). Evaluations include measures to assess protective factors associated with delayed sexual initiation and substance use. DISCUSSION: This is one of the first rigorous evaluations of a gender-specific, culturally tailored teen pregnancy and substance use primary prevention program for Native girls and their female caregivers. If proven efficacious, Native communities will have a culturally appropriate program for promoting protective factors associated with delayed substance use and sexual risk taking. TRIAL REGISTRATION: NCT04863729 ; April 27, 2021.

"Empowering Our People": Impact of a Culturally Adapted Evidence-Based Intervention on Sexually Transmitted Infection Risks Among Native Americans With Binge Substance Use.

BACKGROUND: The objective of this study was to evaluate a culturally adapted evidence-based intervention called EMPWR (Educate, Motivate, Protect, Wellness and Respect) for impacts on sexually transmitted infection (STI) screening and sexual health risk behaviors. METHODS: We enrolled Native American adults with recent binge substance use from a rural, reservation community in the Southwest into a 1:1 randomized controlled trial conducted on July 2015 to June 2019. All participants were offered non-clinic-based self-administered STI screening. Data were collected via self-report at baseline, 3 months, and 6 months after the intervention. Baseline and end line data are presented. RESULTS: Three hundred one participants were enrolled and had a mean age of 33.8 years; 46.5% of the sample were female, and 9.1% were employed at baseline. EMPWR participants were more likely to complete STI self-screening than control participants (38.2% vs. 23.8%, P = 0.0275). EMPWR participants reported fewer unprotected sex acts in the past 3 months (9.3 vs. 16.0, P = 0.001) and were more likely to refuse sex if their partner was not tested (23.6% vs. 12.4%, P = 0.049). The between-group difference in STI positivity 1 year after study completion was nearing statistical significance (intervention: 39.5% vs. control: 59.6%, P = 0.0575). CONCLUSIONS: The culturally adapted evidence-based intervention, EMPWR, increased uptake of STI screening and refusal of sex if partner was not STI tested and decreased the frequency of unprotected sex acts among Native American adults with recent binge substance use living on a rural reservation. Future research is needed to examine EMPWR impacts among other Native American subgroups and its potential for advancing sexual health equity in this high-priority population.

Impact of emollient therapy for preterm infants in the neonatal period on child neurodevelopment in Bangladesh: an observational cohort study.

BACKGROUND: Topical treatment with sunflower seed oil (SSO) or Aquaphor® reduced sepsis and neonatal mortality in hospitalized preterm infants <33 weeks' gestational age in Bangladesh. We sought to determine whether the emollient treatments improved neurodevelopmental outcomes during early childhood. METHODS: 497 infants were randomized to receive SSO, Aquaphor®, or neither through the neonatal period or hospital discharge. 159 infant survivors were enrolled in the longitudinal follow-up study using a validated Rapid Neurodevelopmental Assessment tool and the Bayley Scales of Infant Development II (BSID II) administered at three-monthly intervals for the first year and thereafter at six-monthly intervals. Lowess smoothing was used to display neurodevelopmental status across multiple domains by age and treatment group, and Generalized Estimating Equations (GEE) were used to compare treatment groups across age points. RESULTS: 123 children completed at least one follow-up visit. Lowess graphs suggest that lower proportions of children who received massage with either SSO or Aquaphor® had neurodevelopmental delays than control infants in a composite outcome of disabilities. In GEE analysis, infants receiving SSO showed a significant protective effect on the development of fine motor skills [odds ratio (OR) 0.92, 95% confidence interval (CI) 0.86-0.98, p=0.006]. The Psychomotor Development Index (PDI) in the BSID II showed significantly lower disability rates in the Aquaphor group (23.6%) compared to the control (55.2%) (OR 0.21, 95% CI 0.06-0.72, p=0.004). CONCLUSIONS: Emollient massage of very preterm, hospitalized newborn infants improved some child neurodevelopmental outcomes over the first 2 years of follow-up. Findings warrant further confirmatory research. TRIAL REGISTRATION: ClinicalTrials.gov (98-04-21-03-2) under weblink https://clinicaltrials.gov/ct2/show/NCT00162747.

Higher Diet Quality in African-American Adolescents Is Associated with Lower Odds of Metabolic Syndrome: Evidence from the NHANES.

BACKGROUND: Development of clinical risk factors linked to metabolic syndrome (MetS) in adolescence is associated with higher incidence of atherosclerotic cardiovascular events in adulthood. Given the increasing burden of obesity and MetS in African-American (AA) youth, there is a need to establish the relation of MetS with modifiable risk factors such as diet quality, because these data may enhance preventative and treatment approaches. OBJECTIVES: The purpose of this study was to assess diet quality, measured by the Alternative Healthy Eating Index 2010 (AHEI-2010) and the Dietary Approaches to Stop Hypertension (DASH) pattern score, in AA adolescents and youth (aged 12-21 y) from the NHANES, and to investigate the association of diet quality with MetS and its components. METHODS: This study is a cross-sectional analysis of NHANES data from the 2005-2016 cycles (n = 2459). Survey-weighted logistic regression models were used to assess the association of diet quality with the prevalence of MetS and individual cardiometabolic components [overweight/obesity, hypertensive blood pressure (BP), impaired fasting glucose, low HDL cholesterol, hypertriglyceridemia]. RESULTS: The mean ± SD AHEI-2010 score was 38.9 ± 9.7 and DASH pattern score was 21.8 ± 4.4, which is equivalent to 35% adherence to recommendations to achieve an optimal diet quality and 45% adherence to the DASH-style dietary pattern, respectively. Compared with those within the lowest quartile of DASH pattern score, individuals in the fourth quartile group had 0.63 (95% CI: 0.41, 0.97) times the odds of having hypertensive BP. Among individuals with complete clinical measures (n = 1007), individuals within the highest-quartile AHEI-2010 group had 0.25 (95% CI: 0.06, 0.99) times the odds of having MetS compared with those within the lowest quartile. CONCLUSIONS: Diet quality in US AA youth is low. Higher DASH pattern scores were associated with lower odds of hypertensive BP and higher AHEI-2010 scores were associated with lower odds of MetS.

Native Youth Participating in the Together on Diabetes 12-Month Home-Visiting Program Reported Improvements in Alternative Healthy Eating Index-2010 Diet Quality Domains Likely to Be Associated With Blood Pressure and Glycemic Control.

BACKGROUND: The Together on Diabetes (TOD) intervention was a home-visiting diabetes prevention and management program for Native youth. OBJECTIVES: (1) Examine the impact of the TOD program on diet quality using the Alternative Healthy Eating Index (AHEI-2010); (2) determine association between diet quality and cardiometabolic health. DESIGN: The TOD program was conducted from October 2012 to June 2014 and was evaluated using a pretest-posttest study design from baseline to 12 months. Dietary intake was assessed using a food frequency questionnaire. PARTICIPANTS/SETTING: There were 240 participants between 10 and 19 years of age from 4 reservation-based, rural tribal communities in the southwestern United States that had been diagnosed with T2DM or prediabetes or were identified as at risk based on body mass index and a qualifying laboratory test. INTERVENTION: Youth were taught a 12-lesson curriculum on goal setting, nutrition, and life skills education. MAIN OUTCOME MEASURES: Behavioral and physiologic outcomes related to diabetes. STATISTICAL ANALYSIS: Changes in AHEI-2010 score and associations with cardiometabolic measures were tested, over time, using adjusted longitudinal linear mixed-effects models. RESULTS: The study sample reported an average energy intake of 2016 kcal/d (±1260) and AHEI-2010 score of 47.4 (±7.4) (range: 0-110, higher = better diet quality), indicating low diet quality at baseline. At 12 months' follow-up, there was a reduction in kilocalories (mean = -346 kcal/d; P < .001), sugar-sweetened beverages (mean = -2 fluid oz/d; P = .032), red/processed meat (mean = -1.5 oz/d; P = .008), and sodium (mean = -650 mg/d; P < .001) but no change in AHEI-2010 score (P = .600). The change in systolic blood pressure from baseline to 12 months for participants within the highest AHEI-2010 quartile group was significantly larger than the change in participants within the lowest quartile group (mean = -5.90 mm Hg; P = .036). CONCLUSIONS: Despite stable AHEI-2010 scores during follow-up, there were improvements in diet quality domains likely to be associated with cardiometabolic health. Home-visiting programs like TOD are promising interventions for decreasing dietary intake of poor-quality foods.

Empowering Native Adolescents: Responsibility for Their Health Behaviors.

Objectives: In this study, we assess the impact of a home-based diabetes prevention program, Together on Diabetes (TOD), on adolescent responsibility-taking for tasks related to diabetes risk. Methods: Participants were Native American youth ages 10-19 with or at risk of type 2 diabetes who participated in a 12-session, 6-month diabetes prevention program with an adult caretaker. Assessments completed at baseline, 6-month, and 12-month follow-up include demographics and the Diabetes and Obesity Task Sharing (DOTS) Questionnaire. We used latent class analysis (LCA) at baseline to examine heterogeneity in DOTS responses. We identified 3 classes (adolescent, shared, caretaker). We used latent transition analysis to examine stability and change in latent status at baseline, 6- and 12-month follow-up. Results: At baseline, the mean age of participants was 13.6 years and 55.9% were boys. From baseline to 6-month follow-up, the adolescent class was most stable, whereas the shared and caretaker classes were less stable. For participants who transition from the adolescent class, most transition to shared class compared to caretaker class. Conclusions: TOD helps to empower Native American adolescents to take responsibility for their health and engage with their caregivers in these decisions.

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.

Predictors of Responsiveness Among American Indian Adolescents to a Community-Based HIV-Risk Reduction Intervention Over 12 Months.

This analysis explored predictors of responsiveness to the Respecting the Circle of Life (RCL) intervention, a sexual and reproductive health program for American Indian (AI) youth. Data were collected over 12-month follow-up with 267 AI youth aged 13-19. We used mixed effects regression models to examine: (1) whether trajectory patterns of HIV/AIDS knowledge, condom beliefs, condom use self-efficacy, condom use intention and partner negotiation skills differed by baseline levels categorized into low, medium, and high scorers, and (2) the characteristics of youth who made no improvement over the post-intervention period. Results indicate the RCL intervention had greater longitudinal impact among subgroups with low and medium initial scores. High initial scores in knowledge, beliefs, efficacy, intention and skills predicted unresponsiveness to the RCL intervention. Youth differences in age, gender and school truancy (skipping/suspension) did not predict responsiveness to RCL. Results have important prevention science implications: (1) AI youth at greater risk (i.e., those with low initial levels of knowledge, beliefs, self-efficacy, intention and skills) are likely to respond to RCL and should be the target of replication and dissemination efforts. (2) Responsiveness analyses can guide adaptation of RCL and other sexual and reproductive health programs for AI youth to improve efficacy among unresponsive subgroups (i.e., high initial scorers). (3) RCL is equally likely to impact AI youth across different ages, genders and school status, thus validating population-wide implementation strategies.

Self-efficacy and response-efficacy: critical components of sexual and reproductive health interventions targeting condom use intention among American Indian adolescents.

The Respecting the Circle of Life (RCL) intervention is a comprehensive, skills-based sexual/reproductive health program shown to be effective for reducing sexual risk among American Indian (AI) adolescents (13-19 years of age). This paper seeks to identify critical program components of the RCL intervention for replication of impacts on condom use intention (CUI) when scaling to additional communities. RCL was tested among AI adolescents through a cluster randomized controlled trial (N = 267) embedded in an 8-day basketball camp. Data were collected at baseline, immediately post-camp, at 6 and 12 months post-camp. Previously established predictors of CUI that were statistically significantly impacted by RCL at the post-camp time point were tested as mediators of RCL impact on CUI. Condom use self-efficacy and response efficacy fully mediated the effect of RCL on CUI. The indirect path through condom use self-efficacy had the greatest effect on CUI, explaining 79% of the direct effect. When stratified by gender, there was only evidence of mediation among girls. Results indicate condom use self-efficacy and response efficacy are critical components of the RCL intervention for AI girls, and sexual/reproductive health programs should include practical skills training to improve these constructs to maximize intervention impact on CUI.

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.