Four weeks of trauma-informed yoga intervention and autonomic tone in female veteran and non-veteran college students

Introduction: Female college students (veteran and non-veteran) are exposed to cumulative stressors and trauma that may lead to an imbalanced autonomic nervous system. Yoga has emerged as an efficacious intervention for psychological and physical trauma; however, the therapeutic dose of intervening yoga is unknown. Additionally, the frequency, duration, and type of yoga needed to achieve a therapeutic dose appear to be population specific when applied to trauma victims. The purpose of the study was to examine whether a short-term trauma-informed yoga intervention altered metrics of autonomic tone as assessed by heart rate variability (HRV) in female veteran and non-veteran college students. Methods: Nine female college students (age: 33 years ± 11, veteran, n = 4, non-veteran, n = 5) engaged in trauma-informed yoga once per week for one-hour over a four-week intervention. Repeated measures ANOVA were performed on the HRV variables lnRMSSD, lnHF, lnLF, and LF:HF. Results: Findings indicated no effect of the intervention on HRV as measured by lnRMSSD (p = .116), lnHF (p = .073), lnLF (p = .316), and LF:HF (p = .131). Further, no acute alterations in HRV were observed following a single session of trauma-informed yoga (p > .05). Conclusion: The findings of the study revealed no significant effect of trauma-informed yoga on HRV following a single session or after a four-week yoga intervention

Early childhood educator's implementation readiness and intervention fidelity: Findings from a person-centered study

Research has indicated that early educators’ intervention fidelity is a significant predictor of children's responsiveness to classroom interventions. To improve understanding of predictors of intervention fidelity in early childhood settings, this study adopted a person-centered approach to identify profiles of “implementation readiness” in 1,192 Danish educators, and to examine relations with implementation fidelity. Multilevel latent profile analyses including setting-level characteristics as well as characteristics particular to the individual educator, showed reliable profiles of general and intervention-specific implementation readiness, which were associated with proportion of fulltime educators, employees with a teaching-related pre-service education, and investment in professional development. Higher and more positive implementation readiness predicted implementation dosage and adherence to early childhood interventions

SMS Parent Action Intervention (SPAN): Using text messaging to promote child health on an American Indian Reservation

SMS Parent Action iNtervention (SPAN): Using text messaging to promote child health on an American Indian Reservation Purpose: Childhood obesity and its associated health risks are widely recognized as a major public health crisis in the United States (Johnson & Johnson, 2014; Proctor, 2008; Rogers et al, 2013; Vinci et al, 2016). Prevention efforts include focusing on educating parents with young children on healthy habits. Text messaging is an attractive means of communication because it is portable, cost-effective, accessible, and able to reach across demographic spheres to serve underserved and rural populations (Terry, 2008). The primary purpose of the SMS (Short Messaging System or text messaging) Parent Action iNtervention (SPAN) trial was to assess the feasibility of a texting intervention to improve obesity-related health behaviors in young children living on or near an American Indian reservation. Methods: SPAN trial is a 5-week, one-group, pre- to post- test pilot study. Cluster and snowball sampling was used to recruit parents with children aged 3 to 5 to participate in the study. At the beginning of the intervention, participants completed a survey about their child’s behaviors, they then received three text messages focused on establishing healthy childhood habits each week for 5 weeks. Topics included childhood nutrition, physical activity and sleep requirements, and recommendations for limiting screen time and sugary beverage consumption. Each week participants were prompted to respond to one question about their child’s behavior specific to the weekly topic. At the end of the 5-week intervention, participants completed a survey about the timing, frequency and content of the text messages, as well as their child’s behaviors. Participants were given $50 cash upon completion of the study. Results: Recruitment yielded 17 parents who enrolled in the study (mean age = 34 years, 88% female, 47% Native American). Each participant received 17 intervention text messages over 5 weeks. No participant opted out of receiving intervention messages. For each participant, 5 of the text messages were survey questions that requested a response. For all participants, of the 85 text messages that requested a response, 78 (91%) were returned with a response that answered the survey question. Follow up assessments are on-going, with 12 out of 17 (71%) participants completed. Discussion: Texting is a feasible and acceptable intervention medium for sending and receiving messages related to diet and exercise (Shaw & Bosworth, 2012); however, there has been minimal research conducted on text messaging obesity prevention health topics to parents of young children living on or near American Indian reservations in rural settings. Our study targets this gap in the literature and helps guide future research using text messaging to promote child health and prevent obesity

Early childhood educator's implementation readiness and intervention fidelity: Findings from a person-centered study

Research has indicated that early educators’ intervention fidelity is a significant predictor of children's responsiveness to classroom interventions. To improve understanding of predictors of intervention fidelity in early childhood settings, this study adopted a person-centered approach to identify profiles of “implementation readiness” in 1,192 Danish educators, and to examine relations with implementation fidelity. Multilevel latent profile analyses including setting-level characteristics as well as characteristics particular to the individual educator, showed reliable profiles of general and intervention-specific implementation readiness, which were associated with proportion of fulltime educators, employees with a teaching-related pre-service education, and investment in professional development. Higher and more positive implementation readiness predicted implementation dosage and adherence to early childhood interventions

Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach

To support registration of monoclonal antibodies (mAbs) for chronic indications, 6-month toxicity studies have historically been conducted. Experience with mAb development has shown a relatively benign and well-understood safety profile for this class, with most toxicity findings anticipated based on pharmacology. We evaluated whether a 6-month toxicity study is optimal to assess the long-term safety of mAbs. Data on First-in-Human (FIH)-enabling and chronic toxicity studies were shared for 142 mAbs submitted by 11 companies. Opportunities to further optimize study designs to reduce animal usage were identified. For 71% of mAbs, no toxicities or no new toxicities were noted in chronic studies compared to FIH-enabling study findings. New toxicities of potential concern for human safety or that changed trial design were identified in 13.5% of cases, with 7% being considered critical and 2% leading to program termination. An iterative, weight-of-evidence model which considers factors that influence the overall risk for a mAb to cause toxicity was developed. This model enables an evidence-based justification, suggesting when 3-month toxicity studies are likely sufficient to support late-stage clinical development and registration for some mAbs