TRUE Dads, a federally funded Responsible Fatherhood intervention, aims to strengthen three of men's key roles in the family: (1) as fathers, building and maintaining positive engagement with their ...child; (2) as partners, maintaining a positive relationship with their co‐parent; and (3) as providers, through fostering employment and economic self‐sufficiency. A feature of the program is that low‐income fathers and their co‐parenting partners participate together in 6 3‐hour group workshops, followed by optional participation in an additional 6 3‐hour workshops. Fathers in the intervention condition were offered a chance to participate in a 2‐week employment program. 1,042 co‐parenting teams were recruited and randomly assigned to TRUE Dads’ group intervention (60%) or a no‐treatment control group (40%). In analyses of single measures, one year after study entry, compared with no‐treatment controls, TRUE Dads program participants reported fewer depressive symptoms, less destructive couple communication and domestic violence, and increased employment for fathers. Using expanded latent variable measures of core constructs, Structural Equation Modeling revealed indirect effects of the intervention, in which reductions in both parents’ negative symptoms and destructive couple communication were associated with (a) reductions in negative parenting qualities and children's behavior problems and (b) increases in fathers’ economic self‐sufficiency. Reducing parents’ personal distress and improving relationship quality between co‐parents appears to be important to enhancing fathers’ positive family engagement. From a family policy perspective, the results suggest that integration rather than separation of healthy marriage, responsible fatherhood, and employment programs could provide synergistic power to programs designed to strengthen low‐income families.
Resumen
TRUE Dads, una intervención en la paternidad responsable financiada con fondos federales, tiene como finalidad fortalecer tres de los papeles fundamentales de los hombres en la familia: 1) como padres, construir y mantener un compromiso positivo con su hijo; 2) como compañeros de cocrianza, mantener una relación positiva con el otro padre; y 3) como proveedores, fomentar el empleo y la autonomía económica. Una característica del programa es que los padres de bajos recursos y sus compañeros de cocrianza participan juntos en 6 talleres grupales de 3 horas, y luego pueden participar de manera opcional en otros 6 talleres de 3 horas. A los padres del grupo de intervención se les ofreció una oportunidad de participar en un programa de empleo de dos semanas. Se convocó a 1042 equipos de cocrianza, los cuales fueron asignados aleatoriamente a una intervención grupal de TRUE Dads (60%) o a un grupo de referencia sin tratamiento (40%). En los análisis de medidas simples, un año después del ingreso en el estudio, en comparación con los integrantes del grupo de referencia sin tratamiento, los participantes del programa TRUE Dads informaron menos síntomas depresivos, menos comunicación destructiva de pareja y violencia doméstica, y un aumento del empleo para los padres. Usando medidas variables latentes ampliadas de constructos centrales, el modelo de ecuación estructural reveló efectos indirectos de la intervención, en los cuales las reducciones en los síntomas negativos y la comunicación destructiva de la pareja en ambos padres estuvieron asociadas con (a) disminuciones de las cualidades negativas de crianza y de los problemas de conducta de los niños, y (b) aumentos de la autonomía económica de los padres. La reducción del distrés personal de los padres y la mejora de la calidad de la relación entre los copadres parece ser importante para mejorar el compromiso familiar positivo de los padres. Desde una perspectiva de política familiar, los resultados indican que la integración, en lugar de la separación de un matrimonio saludable, la paternidad responsable y los programas de empleo podrían aportar poder sinérgico a los programas diseñados para fortalecer a las familias de bajos recursos.
摘要
TRUE Dads“真正的父亲”是由联邦政府资助的一个“负责任的父亲”干预项目, 旨在加强男性在家庭中的三个关键角色:1)作为父亲, 建立并保持与孩子的积极互动; 2)作为伴侣, 与共同抚养孩子的伴侣保持积极的关系; 3)作为经济来源提供者, 通过促进就业和经济自给自足。该计划的一个特点是, 低收入的父亲和他们的共同养育孩子的伴侣一起参加6个3小时的小组研讨会, 然后自主选择参加另外6个3小时的研讨会。处于干预状态的父亲有机会参加为期两周的就业计划。本研究招募了1042个共同养育小孩的家庭组合, 并随机分配到TRUE Dads干预组(60%)和无干预组对照组(40%)。在研究开始一年后对单一措施的分析中, 与不接受干预的对照组相比, TRUE Dads项目参与者报告的抑郁症状较少, 破坏性的伴侣沟通和家庭暴力较少, 父亲的就业率也有所提高。通过核心结构的扩大后的潜在变量的测量, 结构方程模型揭示了干预项目可以产生间接的影响, 其中父母双方消极症状和破坏性的夫妻沟通的减少与以下两点相关 (a) 消极父母素质和孩子行为问题的减少, (b) 父亲在经济上自给自足能力的提高。减少父母的个人消极情绪和改善共同抚养监护孩子的伴侣之间的关系质量似乎对提高父亲对家庭的积极参与有很重要的意义。从家庭政策的角度来看, 研究表明“负责任的父亲”和就业计划能把婚姻变得紧密融合而不是分离健康的婚姻、可以为旨在加强低收入家庭的计划提供协同力量。
Clinical OCT angiography (OCTA) of the retinal microvasculature offers a quantitative correlate to systemic disease burden and treatment efficacy in sickle cell disease (SCD). The purpose of this ...study was to use the higher resolution of adaptive optics scanning light ophthalmoscopy (AOSLO) to elucidate OCTA features of parafoveal microvascular compromise identified in SCD patients.
Case series of 11 SCD patients and 1 unaffected control.
A total of 11 eyes of 11 SCD patients (mean age, 33 years; range, 23-44; 8 female, 3 male) and 1 eye of a 34-year-old unaffected control.
Ten sequential 3 × 3 mm parafoveal OCTA full vascular slab scans were obtained per eye using a commercial spectral domain OCT system (Avanti RTVue-XR; Optovue). These were used to identify areas of compromised perfusion near the foveal avascular zone (FAZ), designated as regions of interest (ROIs). Immediately thereafter, AOSLO imaging was performed on these ROIs to examine the cellular details of abnormal perfusion. Each participant was imaged at a single cross-sectional time point. Additionally, 2 of the SCD patients were imaged prospectively 2 months after initial imaging to study compromised capillary segments across time and with treatment.
Detection and characterization of parafoveal perfusion abnormalities identified using OCTA and resolved using AOSLO imaging.
We found evidence of abnormal blood flow on OCTA and AOSLO imaging among all 11 SCD patients with diverse systemic and ocular histories. Adaptive optics scanning light ophthalmoscopy imaging revealed a spectrum of phenomena, including capillaries with intermittent blood flow, blood cell stasis, and sites of thrombus formation. Adaptive optics scanning light ophthalmoscopy imaging was able to resolve single sickled red blood cells, rouleaux formations, and blood cell-vessel wall interactions. OCT angiography and AOSLO imaging were sensitive enough to document improved retinal perfusion in an SCD patient 2 months after initiation of oral hydroxyurea therapy.
Adaptive optics scanning light ophthalmoscopy imaging was able to reveal the cellular details of perfusion abnormalities detected using clinical OCTA. The synergy between these clinical and laboratory imaging modalities presents a promising avenue in the management of SCD through the development of noninvasive ocular biomarkers to prognosticate progression and measure the response to systemic treatment.
Objective: To ascertain adult outcomes in 10 domains reflecting symptomatology (internalizing, externalizing, self-injury, substance use), attainment (education, employment), and impairment (health, ...social, driving, overall) as a function of both childhood diagnosis of attention-deficit/hyperactivity disorder (ADHD) and persistence of ADHD symptoms across time. Method: We prospectively followed 140 grade-school-aged girls with rigorously diagnosed childhood ADHD and 88 age- and ethnicity-matched comparison girls for 16 years. Outcome measures were obtained via self- and parent-report questionnaires, interviews, and objective tests. Results: Childhood ADHD, whether it remitted or persisted, was a pernicious risk factor for a limited number of poor outcomes, including low educational attainment, unplanned pregnancy, body mass index (BMI), and clinician-rated impairment. Childhood ADHD that persisted over time, whether completely or partially, was associated with a number of additional detrimental outcomes in the externalizing, internalizing, self-injury, occupational, social, and overall impairment domains. Finally, in this all-female sample, ADHD was not associated with objective measures of employment, substance use, or driving outcomes. Conclusions: We discuss the considerable impairments accruing from both childhood-limited and adult-persisting ADHD, with major implications for the health and well-being of females with this neurodevelopmental disorder.
What is the public health significance of this article?
Although a minority of girls no longer meet symptom criteria for ADHD in adulthood, they still show substantial educational underachievement over time, as well as increased body mass index and much greater likelihood of at least 1 unplanned pregnancy. Among girls, childhood ADHD that persists into adulthood is associated with these educational and health problems (increased body mass index and unplanned pregnancy) as well as substantially increased risk for internalizing problems (e.g., anxiety and depression), externalizing problems (e.g., aggression and defiance), self-injury, and occupational impairment. On average, however, girls with childhood ADHD are not at increased risk for later substance use problems, at least in the present sample.
Clinical OCT angiography (OCTA) of the retinal microvasculature offers a quantitative correlate to systemic disease burden and treatment efficacy in sickle cell disease (SCD). The purpose of this ...study was to use the higher resolution of adaptive optics scanning light ophthalmoscopy (AOSLO) to elucidate OCTA features of parafoveal microvascular compromise identified in SCD patients.
Case series of 11 SCD patients and 1 unaffected control.
A total of 11 eyes of 11 SCD patients (mean age, 33 years; range, 23–44; 8 female, 3 male) and 1 eye of a 34-year-old unaffected control.
Ten sequential 3 × 3 mm parafoveal OCTA full vascular slab scans were obtained per eye using a commercial spectral domain OCT system (Avanti RTVue-XR; Optovue). These were used to identify areas of compromised perfusion near the foveal avascular zone (FAZ), designated as regions of interest (ROIs). Immediately thereafter, AOSLO imaging was performed on these ROIs to examine the cellular details of abnormal perfusion. Each participant was imaged at a single cross-sectional time point. Additionally, 2 of the SCD patients were imaged prospectively 2 months after initial imaging to study compromised capillary segments across time and with treatment.
Detection and characterization of parafoveal perfusion abnormalities identified using OCTA and resolved using AOSLO imaging.
We found evidence of abnormal blood flow on OCTA and AOSLO imaging among all 11 SCD patients with diverse systemic and ocular histories. Adaptive optics scanning light ophthalmoscopy imaging revealed a spectrum of phenomena, including capillaries with intermittent blood flow, blood cell stasis, and sites of thrombus formation. Adaptive optics scanning light ophthalmoscopy imaging was able to resolve single sickled red blood cells, rouleaux formations, and blood cell–vessel wall interactions. OCT angiography and AOSLO imaging were sensitive enough to document improved retinal perfusion in an SCD patient 2 months after initiation of oral hydroxyurea therapy.
Adaptive optics scanning light ophthalmoscopy imaging was able to reveal the cellular details of perfusion abnormalities detected using clinical OCTA. The synergy between these clinical and laboratory imaging modalities presents a promising avenue in the management of SCD through the development of noninvasive ocular biomarkers to prognosticate progression and measure the response to systemic treatment.
Objective
To expand the evidence base of the Supporting Father Involvement (SFI) intervention to include child welfare families.
Background
Taking a preventive father‐inclusive approach, SFI aims to ...strengthen coparenting, parent–child relationships, and child outcomes. This study replicates 4 prior iterations of the program using the same 32‐hour curriculum facilitated by clinically trained staff, case managers, and onsite child care and family meals.
Method
Participants (N = 239) included low‐income (median = $24,000) coparenting pairs, typically mothers and fathers/father figures, half of whom were Mexican American, with toddlers (median age < 3 years). Questionnaires assessing multiple family domains were administered verbally over an 18‐month period. Intervention effectiveness was tested through a randomized control trial with immediate treatment or waitlist–control groups using a moderated mediator structural equation model.
Results
The model explained 49% to 56% of the variance in children's problem behaviors (intervention and autoregressive effects). The intervention reduced couple conflict, which reduced anxious and harsh parenting, leading to better child outcomes. The intervention was equally effective for community and child welfare–referred families and family dynamics pathways were similar across conditions.
Conclusion
With its intentional outreach and inclusion of fathers, SFI offers an effective intervention for lower risk child welfare–involved families.
Implications
Results argue for the utility of treating community and child welfare parents in mixed‐gender prevention groups that focus on strengthening multiple levels of family relationships.
Following an earlier randomized clinical trial, now with broadened sample criteria, 236 low-income White, Mexican American, and African American couples participated in 16-week Supporting Father ...Involvement couples groups, with assessments at baseline, 2-, and 13-months postintervention. Because couples in the earlier control condition experienced no benefits and some declines in adaptation, a control condition was not offered. Data from the original couples groups (n = 96) and controls (n = 98) served as benchmarks for evaluating the current results. Of 11 measures in this study, 10 revealed positive baseline-post 2 changes. Father involvement increased for current couples group participants, though not as much as for benchmark couples group participants: they showed statistically similar positive changes on six measures (decline in parenting stress, stability in couple relationship satisfaction, children's hyperactivity, social withdrawal, psychological symptoms, increased income), and greater positive change on two of three measures (reductions in parents' violent problem solving, children's aggression).
Sickle cell disease (SCD) is a disorder characterized by repetitive vaso-occlusive crises causing microvascular obstruction, tissue ischemia and pain that may lead to chronic multi-organ ischemic ...sequelae. Nailfold videocapillaroscopy (NFC) is a non-invasive imaging technique used in clinical rheumatology to directly visualize capillaries located near the fingertip. To characterize NFC abnormalities in the setting of SCD, we performed NFC on 71 SCD patients and 70 age matched controls using a video capillaroscope on 8 digits. As compared to controls, mean capillary number was lower and the final capillary score (measure of capillary dropout inversely related to capillary density) was higher in the SCD group. The SCD group had a lower percentage of stereotype hairpin shapes and a higher percentage of crossing type capillaries. On multivariate linear analyses, both mean capillary number and final capillary score were independently associated with SCD after adjusting for age, body mass index, and gender. SCD was associated with more dilated capillaries but similar numbers of hemorrhages. In conclusion, SCD is associated with lower capillary density and more dilated capillaries on NFC. These changes appear unrelated to markers of disease severity including frequency of sickle crises, number of transfusions, and HbS levels. The relation between NFC and target organ involvement merits further study.
•Sickle cell disease is associated with abnormal nailfold capillaroscopy findings.•There is lower capillary density and capillary dilation.•Nailfold capillary abnormalities are unrelated to biomarkers of disease severity.
Pathophysiology of sickle cell disease (SCD) features intermittent vaso-occlusion of microcirculatory networks that facilitate ischemic damage. Past research has, however, relied on static images to ...characterize this active disease state. This study develops imaging metrics to more fully capture dynamic vascular changes, quantifying intermittent retinal capillary perfusion in unaffected controls and SCD patients using sequential optical coherence tomography angiography (OCT-A) scans. The results reveal significant dynamic variation of capillary perfusion in SCD patients compared to controls. This measurement of vaso-occlusive burden in patients would provide utility in monitoring of the disease state and in evaluating treatment efficacy.
Background: Sickle cell disease (SCD) is the most common inherited blood disorder in the United States, caused by polymerization of a mutated form of hemoglobin (HbS). HbS can form long polymers ...inside red blood cells (RBCs) that affect RBC shape and adhesion, resulting in RBC destruction, acute and chronic pain, inflammation and cumulative organ damage. SCD-101 is a botanical drug with in vitro and in vivo anti-sickling activity. The mechanism by which SCD-101 inhibits sickling is unknown; however, it does not bind directly to Hb or change the affinity of Hb for oxygen. We recently completed a dose-escalation clinical study of SCD-101 in adults with sickle cell disease in steady state, and other clinical studies are on-going.
Methods: The initial prospective, open-label, Phase 1B dose-escalation study enrolled homozygous (SS) sickle cell patients and S/beta0 thalassemia patients ages 18-55 with baseline Hb levels 6.0-9.0 g/dL and hemoglobin F ≤10%. Admission within 30 days, transfusion within 90 days, and hydroxyurea within 6 months were exclusions. SCD-101 was dosed orally for 28-days with a 14-day follow-up visit. Doses administered during the dose escalation study were 550 mg, 1100 mg, 2200 mg and 4400 mg BID. The primary endpoint was safety, and the secondary endpoints were mean change in Hb, Hct, percent reticulocytes, LDH, indirect bilirubin, CRP, PROMIS fatigue questionnaire score, and percent circulating partially oxygenated sickle cells (POSCs) in venous whole blood fixed in 2% glutaraldehyde without exposure to air. A repeat cohort study is ongoing with dose adjusted to 2750 mg TID, a 6-minute walk test added as a functional endpoint and measurement of inflammatory cytokines by ELISA to explore the effect of SCD-101 on inflammation.
Results: As of August 4, 2016, 26 patients with sickle cell disease have been enrolled, 20 patients have completed the 28-day dose-escalation study and 3 were discontinued before receiving their first dose of SCD-101. Three patients are enrolled in the 28-day repeat cohort study. There have been no dose reductions or interruptions due to drug-related effects. SCD-101 was generally well-tolerated with mild-moderate bloating and flatulence at the highest dose on a BID schedule in the dose-escalation study, which were not observed with a TID schedule in the repeat cohort study. There were no significant changes in safety laboratory tests and no significant changes in hemoglobin, hematocrit, LDH, unconjugated bilirubin, or reticulocytes. No significant changes were observed in renal, hepatic or other safety chemistries or electrocardiograms. SCD-101 participants treated at higher doses reported a decrease in chronic pain and fatigue after 7-14 days, which returned post-treatment when measured on the 14-day follow-up visit. Participants at the two highest doses reported an increase in exercise capacity and an improvement in sleep. Two participants with ankle ulcers, enrolled at the two highest doses, showed improved healing. Analysis of peripheral blood smears revealed an improvement in the shape of circulating RBCs. There was no change in inflammatory cytokines in the first 7 days in the repeat cohort study, though the Day 28 data may show a different result.
Conclusions: SCD-101 is a promising new drug for the treatment of sickle cell disease, based on the results from the studies reported here. SCD-101 was well tolerated over an 8-fold dose range, and dose-dependent anti-sickling effects on RBC were observed, though without significant changes in hemolysis. Clinical benefits included reduced chronic pain and fatigue, improved sleep and improved ulcer healing. While the identity of the active substance(s) in SCD-101 and the mechanism(s) of action are unknown, SCD-101 has a direct anti-sickling effect on RBCs, compatible with an intracellular or membrane effect on RBCs. We hypothesize that the observed effects could be explained by increased vascular flow or increased oxygen delivery or a reduction in inflammation. A placebo-controlled crossover study will be completed in 2016 including a 6-minute walk test as a primary clinical endpoint, and a multi-site Phase 2 study is planned for 2017. As a botanical drug, SCD-101 may be a useful treatment for sickle cell disease worldwide.
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Swift:Global Blood Therapeutics: Equity Ownership; Mast Therapeutics: Equity Ownership; SCD Development: Employment, Equity Ownership.
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