Risk Factors for Chronic Abdominal Pain After RYGB: Are Patients Adequately Selected Beforehand?

PURPOSE: Chronic abdominal pain after RYGB is a known issue. Identifying the potential patient-related and modifiable risk factors might contribute to diminish the risk for this undesirable outcome. METHODS: A single-center retrospective cohort study with prospective data collection was conducted with inclusion of all patients who underwent RYGB surgery between 2015 and 2021. Data from the NBSR and medical records were used. Patients with chronic abdominal pain were defined when pain lasting or recurring for more than 3 to 6 months. RESULTS: Six hundred sixty-four patients who underwent RYGB surgery were included with a median follow-up of 60.5 months. Forty-nine patients (7.3%) presented with chronic abdominal pain. Postoperative complications (OR 13.376, p = 0.020) and diagnosis of depression (OR 1.971, p = 0.037) were associated with developing abdominal pain. On the other hand, ex-smokers (OR 0.222, p = 0.040) and older age (0.959, p = 0.004) presented as protective factors. CONCLUSION: Postoperative complications and diagnosis of depression are risk factors for chronic pain after RYGB. The role of the bariatric MDT remains crucial to select these patients adequately beforehand.

Unique Profiles of Postpartum Family Needs and Evidence of Racial and Ethnic Disparities: Insights from Community Implementation of Family Connects.

OBJECTIVES: To delineate specific family needs during the postpartum period using data from Family Connects (FC), a universal home-visiting initiative, and to scrutinize potential racial and ethnic disparities in these needs. METHOD: FC implementation data spanned from July 1, 2009, to August 31, 2021, in seven counties across the USA. Data encompassed nurse-led in-home assessments for 34,119 families. Nurses evaluated needs across four domains (healthcare, parenting/childcare, safe home, and parent support) comprising 12 risk factors. FINDINGS: Overall, families reported high levels of need, and community connections were facilitated for 57% of visited families. Significant differences in need profiles between whites and minority groups were revealed, reflecting both disparity and uniqueness. Employing the Oaxaca decomposition approach, we found that racial/ethnic disparities in socioeconomic attributes were associated with racial/ethnic gaps in the need profiles. CONCLUSIONS: The event of giving birth is both high risk and high opportunity for preventive intervention. Home-visiting programs, as an evidence-based approach, must address the diverse spectrum of familial needs comprehensively.

Time to unshackle the medical treatment of obesity in the NHS.

Obesity affects one in four people in the United Kingdom and costs the National Health Service (NHS) ∼£6.5 billion annually. The glucagon-like peptide-1 (GLP-1) receptor analogues, such as once-daily subcutaneous Liraglutide 3.0 mg (Saxenda®) and once-weekly subcutaneous Semaglutide 2.4 mg (Wegovy®), were approved by the National Institute of Health and Care Excellence (NICE) as a treatment for obesity and funded by the NHS for 2 years. Our local data shows that Saxenda is effective at reducing body weight and glycaemia in people with obesity and diabetes; however, the supply issues of GLP-1 receptor analogues have contributed to the unavailability of Saxenda and Wegovy in our service. Our patients are devastated that they cannot access NICE-approved GLP-1 receptor analogues for obesity. The 2-year GLP-1 receptor analogue treatment limit for obesity alongside a lack of funded NHS services and supply issues represent barriers to treatment for people living with obesity who have clear medical indications.

The Day-in-the-Life method for assessing infant caregiving in rural Pakistan.

Objective: This manuscript describes the Day-in-the-Life (DIL) method for assessing child caregiving activities, its implementation, and findings regarding family members' roles and associations with maternal depression symptoms. Background: Infant caregiving activities are most commonly performed by the mother, although there is increasing acknowledgement of others' contribution. Few methods exist to measure the diverse caregiving activities that mothers and others perform. Method: Method development occurred within the Bachpan Cohort Study in rural Pakistan (N = 1,154 maternal-child dyads) when the child was 3 months old. The DIL was designed as a semi-structured interview in which the mother describes her child's day from their perspective. Regression analyses were then used to explore the correlation between the DIL and depression symptoms, using the Patient Health Questionnaire-9 (PHQ-9) measure. Results: The DIL method was easy to administer and displayed excellent interrater agreement. The findings indicated that instrumental caregiving was mostly provided by the mother alone, others in the household tended to contribute more to infant social interactions, and there was more support from others when the mother was less able to provide care (e.g., when ill). Depression symptoms were higher among women who experienced less contribution from family members when the mother was less able to provide care. Conclusions: The DIL can be deployed to measure infant caregiving activities and associations with maternal mental health. Implications: This method is promising for researchers interested in disentangling the contribution of multiple family members toward child caregiving and its impacts on maternal and child health.

The effects of a universal short-term home visiting program: Two-year impact on parenting behavior and parent mental health.

BACKGROUND: At the time of childbirth, families face heightened levels of unmet need. These needs, if left unmet, can lead parents to engage in less positive parenting practices, which in turn, increase the risk of child maltreatment. Family Connects (FC) is a universal postnatal nurse home-visiting program designed to prevent child maltreatment by supporting all families in a community through one to three visits to improve parent mental health and parenting behaviors. A randomized controlled trial of FC demonstrated improving positive parenting and reducing postpartum depression through age 6 months. OBJECTIVE: To determine sustained (2-year) impact of random assignment to FC on parenting behavior and parent mental health and identify heterogeneity of effects. PARTICIPANTS AND SETTING: A representative subsample of 496 families that had been randomized to FC (255 treatment; 241 control) of infants born between July 1, 2009, and December 31, 2010, in Durham County, North Carolina. METHODS: Demographic characteristics were collected through hospital discharge data. Treatment-blinded interviewers collected maternal reports of parenting behavior and mental health at infant age two years. Moderation and subgroup analyses were conducted to estimate heterogeneity in impact of FC. RESULTS: Mothers assigned to FC engaged in more self-reported positive parenting relative to control mothers (B = 0.21; p < 0.05). Hispanic mothers assigned to FC reported greater sense of parenting competence (B = 1.28; p < 0.05). No significant main effect differences were identified for negative parenting, maternal depression, or father involvement. CONCLUSIONS: Assignment to FC was associated with improvements in population-level self-reported scores of positive parenting 2 years post-intervention.

A group-based mental health intervention for Tanzanian youth living with HIV: Secondary analysis of a pilot trial.

BACKGROUND: Youth living with human immunodeficiency virus (YLWH) are vulnerable to incomplete adherence to antiretroviral therapy in the context of stigma, decreased hope for future, and mental health challenges. Despite these challenges, few mental health interventions have been developed to support YLWH. Previous randomized results from the Sauti ya Vijana (SYV; "The Voice of Youth") mental health intervention were indicative of the intervention's benefits in promoting virologic suppression. METHODS: SYV is a group-based mental health and life skills intervention (pilot, individually randomized group treatment trial) developed alongside YLWH. SYV was comprised of 10, 90-minute sessions based on evidence-based treatment models designed to improve coping, social support, and hope for future as a pathway to improved adherence and virologic suppression. At baseline, YLWH 12 to 24 years of age were randomized to SYV or standard of care. Participants included in this secondary analysis were enrolled in SYV's crossover waves due to either being randomized to standard of care or inability to attend an earlier group, and therefore delayed intervention exposure. Measured outcomes included self-reported mental health measures, self-reported human immunodeficiency virus measures (stigma and adherence), and human immunodeficiency virus ribonucleic acid. Data was collected at baseline, preintervention, and postintervention timepoints. Participants were included if they attended a crossover wave and had data at all 3 timepoints. RESULTS: Twenty-one crossover participants met inclusion criteria. Mean scores of self-reported mental health questionnaires were in an asymptomatic range both pre- and postintervention. Viral suppression was N = 15 (71%) preintervention compared to N = 17 (81%) postintervention. The participants who became virologically suppressed had no change in antiretroviral therapy. CONCLUSIONS: Despite the small sample size, findings from this study demonstrate that mental wellbeing may be an important pathway to improved HIV outcomes for YLWH. The same trend toward virologic suppression pre- to postintervention was demonstrated in the randomized pilot trial and suggests that SYV holds promise to improve HIV outcomes. Data from this analysis support the fully powered trial that is now underway.

Sauti ya Vijana (SYV; The Voice of Youth): Longitudinal Outcomes of an Individually Randomized Group Treatment Pilot Trial for Young People Living with HIV in Tanzania.

Sauti ya Vijana is a mental health and life skills intervention delivered by young adult group leaders for the improvement of HIV outcomes in young people living with HIV in Tanzania. This pilot randomized controlled trial estimated exploratory intervention effectiveness compared to standard of care. YPLWH (N = 105) were randomized to receive intervention or SOC. The mean age of participants was 18.1 years and 53% were female. Mean scores on mental health measures (Patient Health Questionnaire [PHQ-9], Strengths and Difficulties Questionnaire [SDQ], UCLA Trauma) were asymptomatic to mild in both study arms through 30-month follow-up with a non-significant fluctuation of 1-2 points. The mean self-reported adherence was higher in the intervention arm across all time points (but the confidence interval contained the null at all time points except 6 months). Risk ratio of virologic suppression (HIV RNA < 400 copies/mL) in the intervention arm compared to SOC was 1.15 [95% CI = 0.95, 1.39]) at 6-months, 1.17 [95% CI: 0.92, 1.48] at 12-months, and 0.99 [95% CI 0.76, 1.31] at 18-months. Though these findings were not powered for statistical significance, the trends in HIV outcomes suggest that SYV holds promise for improving antiretroviral therapy (ART) adherence and virologic suppression in YPLWH.

Evaluation of a Family Connects Dissemination to Four High-Poverty Rural Counties.

OBJECTIVES: Home visiting is a popular approach to improving the health and well-being of families with infants and young children in the United States; but, to date, no home visiting program has achieved population impact for families in rural communities. The current report includes evaluation results from the dissemination of a brief, universal postpartum home visiting program to four high-poverty rural counties. METHODS: The study utilized a quasi-experimental design. From Sept. 1, 2014-Dec. 31, 2015, families of all 994 resident births in four rural eastern North Carolina counties were assigned to receive Family Connects (FC; intervention group). A representative subsample of families participated in impact evaluation when the infants were 6 months old: 392 intervention group families and 126 families with infants born between Feb. 1, 2014-July 31, 2014 (natural comparison group). Data were analyzed preliminarily for reporting to funders in 2016 and, more comprehensively, using propensity score matching in 2020. RESULTS: Of FC-eligible families, 78% initiated participation; 83% of participating families completed the program (net completion = 65%). At age 6 months, intervention parents reported more community connections, more frequent use of community services, greater social support, and greater success with infants sleeping on their backs. Intervention infants had fewer total emergency department and urgent care visits. Intervention parents had more total emergency department and urgent care visits and (marginally) fewer overnights in the hospital. CONCLUSIONS FOR PRACTICE: FC can be implemented successfully in high-poverty rural communities with broad reach and positive benefits for infants and families.

Maximizing the return on investment in Early Childhood Home Visiting through enhanced eligibility screening.

BACKGROUND: The MIECHV (Maternal, Infant, and Early Childhood Home Visiting) program invests substantial federal resources to prevent child maltreatment and emergency medical costs. Eligibility is based on screening of demographic or clinical risk factors, but because screening accuracy in predicting poor outcomes is unknown, assignment to home-visiting might miss high-risk families or waste resources on low-risk families. OBJECTIVES: To guide eligibility decisions, this study tested accuracy of demographic and clinical screening in predicting child maltreatment and emergency medical care. PARTICIPANTS AND SETTING: A population-representative sample of 201 birthing mothers (39.8% Black, 33.8% Latina) in Durham, NC, was enrolled between July 2009, and December 2010, and followed through December 2015. METHODS: Participants were screened demographically (i.e., Medicaid, first-born, teenage, no high school diploma) and clinically (i.e., health/health care, parenting readiness, home safety, and parent mental health) at birth and followed through age 60 months, when Child Protective Services and hospital records were reviewed. Cox hazard models tested accuracy of prediction from screening variables. RESULTS: Demographic factors did not significantly predict outcomes, except having Medicaid/uninsured predicted more emergency medical care and being first-born was a (surprising) protective factor against a child maltreatment investigation. In contrast, clinical factors strongly predicted both maltreatment investigations (Hazard Ratio = 4.01 [95% CI = 1.97, 8.15], sensitivity = 0.70, specificity = 0.64, accuracy = 0.65) and emergency medical care (Hazard Ratio = 2.14 [95% CI = 1.03, 2.14], sensitivity = 0.50, specificity = 0.69, accuracy = 0.58). CONCLUSIONS: Even with added costs for clinical screening, selecting families for home visiting based on assessed clinical risk will improve accuracy and may yield a higher return on investment. The authors recommend a universal system of screening and care to support birthing families.

Effect of a Universal Postpartum Nurse Home Visiting Program on Child Maltreatment and Emergency Medical Care at 5 Years of Age: A Randomized Clinical Trial.

Importance: The Family Connects (FC) program, a community-wide nurse home visiting program for newborns, has been shown to provide benefits for children and families through the first 2 years of life. Potential longer-term outcomes for child well-being remain unknown. Objective: To determine the effect of randomization to FC on child maltreatment investigations and emergency medical care through 5 years of age. Design, Setting, and Participants: In this randomized clinical trial, families of all 4777 resident births in Durham County, North Carolina, from July 1, 2009, to December 31, 2010, were randomly assigned to receive the FC program or treatment as usual. Impact evaluation was on an intent-to-treat basis and focused on a subsample of 549 families randomly selected from the full population and included review of hospital and Child Protective Services (CPS) administrative records. Statistical analysis was conducted from November 6, 2020, to April 25, 2021. Interventions: The FC programs includes 1 to 3 nurse home visits beginning at the infant age of 3 weeks designed to identify family-specific needs, deliver education and intervention, and connect families with community resources matched to their needs. Ongoing program engagement with service professionals and an electronic resource directory facilitate effective family connections to the community. Main Outcomes and Measures: Two primary trial outcomes were CPS-recorded child maltreatment investigations and emergency medical care use based on hospital records. Results: Of the 4777 randomized families, 2327 were allocated to the intervention, and 2440 were allocated to services as usual. Among the children in the full study population, 2380 (49.8%) were female, 2397 (50.2%) were male, and 3359 (70.3%) were from racial/ethnic minority groups; of the 531 children included in the impact evaluation follow-up, 284 (53.5%) were female, 247 (46.5%) were male, and 390 (73.4%) were from racial/ethnic minority groups. Negative binomial models indicated that families assigned to FC had 39% fewer CPS investigations for suspected child maltreatment through 5 years of age (95% CI, -0.80 to 0.06; 90% CI, -0.73 to -0.01; control = 44 total investigations per 100 children and intervention = 27 total investigations per 100 children); intervention effects did not differ across subgroups. Families assigned to FC also had 33% less total child emergency medical care use (95% CI, -0.59 to -0.14; 90% CI, -0.55 to -0.18; control = 338 visits and overnight hospital stays per 100 children and intervention = 227 visits and overnight hospital stays per 100 children). Positive effects held across birth risk, child health insurance, child sex, single-parent status, and racial/ethnic groups. Effects were larger for nonminority families compared with minority families. Conclusions and Relevance: The findings of this randomized clinical trial suggest that, when implemented with high quality and broad reach, a brief postpartum nurse home visiting program can reduce population rates of child maltreatment and emergency medical care use in early childhood. Trial Registration: ClinicalTrials.gov Identifier: NCT01406184.

A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial.

BACKGROUND: Increasing numbers of young people living with HIV (YPLWH) have unaddressed mental health challenges. Such challenges are associated with poor antiretroviral therapy (ART) adherence and high mortality. Few evidence-based mental health interventions exist to improve HIV outcomes among YPLWH. METHODS: This pilot group treatment trial individually randomized YPLWH from two clinical sites in Tanzania, evaluated acceptability, feasibility, and preliminary effectiveness of a mental health intervention, Sauti ya Vijana (SYV; The Voice of Youth), was compared to the local standard-of-care (SOC) for improving ART adherence and virologic suppression. Enrolled YPLWH were 12-24 years of age and responded to mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA at baseline and 6-months (post-intervention). Feasibility and acceptability were evaluated, and potential effectiveness was assessed by comparing outcomes between arms using mixed effects modeling. RESULTS: Between June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis. Mean age was 18.1 years; 51% were female; and 84% were HIV-infected perinatally. Attendance to intervention sessions was 86%; 6-month follow-up was 88%, and fidelity to the protocol approached 100%. Exploratory analyses of effectiveness demonstrated self-reported adherence improved by 7.3 percentage points (95% CI: 2.2, 12.3); and the pooled standard deviation for all ART concentration values increased by 0.17 units (95% CI: - 0.52, 0.85) in the SYV arm compared to SOC. Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36). CONCLUSIONS: YPLWH often have poor HIV outcomes, making interventions to improve outcomes in this population critical. This pilot trial of the Tanzania-based SYV intervention demonstrated trends towards improvement in ART adherence and virologic outcomes among YPLWH, supporting efforts to scale the intervention into a fully-powered effectiveness trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02888288 . Registered August 9, 2016. Retrospectively registered as first participant enrolled June 16, 2016.

Effectiveness of a peer-delivered, psychosocial intervention on maternal depression and child development at 3 years postnatal: a cluster randomised trial in Pakistan.

BACKGROUND: Maternal depression has a recurring course that can influence offspring outcomes. Evidence on how to treat maternal depression to improve longer-term maternal outcomes and reduce intergenerational transmission of psychopathology is scarce, particularly for task-shifted, low-intensity, and scalable psychosocial interventions. We evaluated the effects of a peer-delivered, psychosocial intervention on maternal depression and child development at 3 years postnatal. METHODS: 40 village clusters in Pakistan were randomly allocated using a computerised randomisation sequence to receive a group-based, psychosocial intervention and enhanced usual care for 36 months, or enhanced usual care alone. Pregnant women (≥18 years) were screened for moderate or severe symptoms of depression (patient health questionnaire-9 [PHQ-9] score ≥10) and were recruited into the trial (570 participants), and a cohort without depression (PHQ-9 score <10) was also enrolled (584 participants). Including the non-depressed dyads enabled us to determine how much of the excess risk due to maternal depression exposure the intervention could mitigate. Research teams responsible for identifying, obtaining consent, and recruiting trial participants were blind to the allocation status throughout the duration of the study, and principal investigators, site coordinators, statisticians, and members of the trial steering committee were also blinded to the allocation status until the analysis of 6-month data for the intervention. Primary outcomes were maternal depression symptoms and remission (PHQ-9 score <10) and child socioemotional skills (strengths and difficulties questionnaire [SDQ-TD]) at 36-months postnatal. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02658994. FINDINGS: From Oct 15, 2014 to Feb 25, 2016 46 village clusters were assessed for eligibility, of which 40 (including 1910 mothers were enrolled. After exclusions, 288 women were randomly assigned to the enhanced usual care group and 284 to the intervention group, and 1159 women were included in a group without prenatal depression. At 36-months postnatal, complete data were available from 889 mother-child dyads: 206 (72·5%) in the intervention group, 216 (75·3%) in the enhanced usual care group, and 467 (80·0%) women who did not have prenatal-depression. We did not observe significant outcome differences between the intervention group and the enhanced usual care group for the primary outcomes. The standardised mean difference of PHQ-9 total score was -0·13 (95% CI -0·33 to 0·07), relative risk of patient health questionnaire-9 remission was 1·00 (95% CI 0·88 to 1·14), and the SDQ-TD treatment estimate was -0·10 (95% CI -1·39 to 1·19). INTERPRETATION: Reduced symptom severity and high remission rates were seen across both the intervention and enhanced usual care groups, possibly masking any effects of the intervention. A multi-year, psychosocial intervention can be task-shifted via peers but might be susceptible to reductions in fidelity and dosage over time (which were not among the outcomes of this trial). Early intervention efforts might need to rely on multiple models (eg, collaborative care), be of greater intensity, and potentially targeted at mothers who are at high risk for depression to reduce the intergenerational transmission of psychopathology from mothers to children. FUNDING: National Institutes of Health.

The contribution of grandmother involvement to child growth and development: an observational study in rural Pakistan.

INTRODUCTION: Early childhood interventions primarily focus on the mother-child relationship, but grandmothers are often critical in childcare in low-resource settings. Prior research is mixed on how grandmother involvement influences child outcomes and there is a paucity of research on grandmother caregiving in low-income and middle-income countries. We examined the role of grandmother involvement on child growth and development in the first 2 years of life cross sectionally and longitudinally in rural Pakistan. METHODS: We used data from the Bachpan Cohort, a longitudinal birth cohort in rural Pakistan. Maternally reported grandmother involvement in daily instrumental and non-instrumental caregiving was collected at 3 and 12 months. A summed score was created and categorised into non-involved, low and high. Outcomes included 12-month and 24-month child growth, 12-month Bayley Scales of Infant and Toddler Development and 24-month Ages and Stages Questionnaire-Socioemotional. We used multivariable generalised linear models to estimate mean differences (MD) at 12 months (n=727) and 24 months (n=712). Inverse probability weighting was used to account for missingness and sampling. RESULTS: In our sample, 68% of children lived with a grandmother, and most grandmothers were involved in caregiving. Greater 3-month grandmother involvement was positively associated with 12-month weight z-scores; however, greater involvement was associated with lower 24-month weight z-scores. High 12-month grandmother involvement was associated with improved 12-month cognitive (MD=0.38, 95% CI -0.01 to 0.76), fine motor skills (MD=0.45, 95% CI 0.08 to 0.83) and 24-month socioemotional development (MD=-17.83, 95% CI -31.47 to -4.19). No meaningful associations were found for length z-scores or language development. CONCLUSION: In rural Pakistan, grandmothers provide caregiving that influences early child development. Our findings highlight the complex relationship between grandmother involvement and child weight, and suggest that grandmothers may positively promote early child cognitive, fine motor and socioemotional development. Understanding how grandmother involvement affects child outcomes in early life is necessary to inform caregiving interventions.

Effectiveness of Task-Shifted Trauma-Focused Cognitive Behavioral Therapy for Children Who Experienced Parental Death and Posttraumatic Stress in Kenya and Tanzania: A Randomized Clinical Trial.

Importance: Approximately 140 million children worldwide have experienced the death of one or both parents. These children, mostly in low- and middle-income countries, have higher rates of mental health problems than those who have not experienced parental death. Cognitive behavioral therapy (CBT) may improve the well-being of these children, but to our knowledge there have been no randomized clinical trials specifically focused on this population. Objectives: To test the effectiveness of trauma-focused CBT (TF-CBT) for improving posttraumatic stress (PTS) in children in Kenya and Tanzania who have experienced parental death, to test the effects of TF-CBT on other mental health symptoms, and to examine the feasibility of task-shifting with greater reliance on experienced, local lay counselors as trainers and supervisors. Design, Setting, and Participants: A randomized clinical trial conducted in urban and rural areas of Tanzania and Kenya compared TF-CBT and usual care (UC) for 640 children aged 7 to 13 years who were recruited from February 13, 2013, to July 24, 2015. All children had experienced the death of one or both parents and had elevated PTS and/or prolonged grief. Interviewers were masked to study condition. Participants were followed up for 12 months after the randomized clinical trial. Statistical analysis was performed from February 3, 2017, to August 26, 2019. All analyses were on an intent-to-treat basis. Interventions: In the intervention condition, 320 children received 12 weeks of group TF-CBT delivered by lay counselors who were supervised weekly. In the UC condition, 320 children received community services typically offered to this population. Main Outcomes and Measures: The primary outcome was PTS, evaluated using a continuous, standardized measure. Other mental health symptoms and child-guardian relationship were also measured. Results: A total of 640 children (320 girls and 320 boys; mean [SD] age, 10.6 [1.6] years) were included in the study. Trauma-focused CBT was more effective than UC for PTS in 3 of 4 sites after treatment (end of 3-month randomized clinical trial): rural Kenya (Cohen d = 1.04 [95% CI, 0.72-1.36]), urban Kenya (Cohen d = 0.56 [95% CI, 0.29-0.83]), and urban Tanzania (Cohen d = 0.45 [95% CI, 0.10-0.80]). At 12-month follow-up, TF-CBT remained more effective than UC in both rural (Cohen d = 0.86 [95% CI, 0.64-1.07]) and urban (Cohen d = 0.99 [95% CI, 0.75-1.23]) Kenya. At 12-month follow-up in Tanzania, children who received TF-CBT and UC had comparable rates of improvement (rural Tanzania, Cohen d = 0.09 [95% CI, -0.08 to 0.26]; urban Tanzania, Cohen d = 0.11 [95% CI, -0.09 to 0.31]). A similar pattern was seen for secondary outcomes, with stronger effects observed in Kenya, where children experienced greater stress and adversity (eg, more food scarcity, poorer guardian health, and greater exposure to traumatic events). Conclusions and Relevance: This study found that TF-CBT was more effective than UC in reducing PTS among children who experienced parental death in 3 of 4 sites in Kenya and Tanzania. At 12-month follow-up, TF-CBT was more effective in reducing PTS only among children in rural and urban Kenya. Trial Registration: ClinicalTrials.gov identifier: NCT01822366.

Effect of a Community Agency-Administered Nurse Home Visitation Program on Program Use and Maternal and Infant Health Outcomes: A Randomized Clinical Trial.

Importance: Postnatal home visitation to support parenting and infant healthy development is becoming increasingly common based on university efficacy studies, but effectiveness when disseminated by communities is not clear. Objective: To test implementation and impact of the Family Connects (FC) program when administered by a community agency. Design, Setting, and Participants: In this randomized clinical trial, births were randomly assigned to receive FC or treatment as usual. Independent evaluation was conducted through parent interviews and review of health and child protective services records. Interviewers were blind to the experimental condition of participants, and participants were blind about the purpose of the interview as an intervention evaluation. A total of 936 consecutive residential births at Duke University Hospital from January 1, 2014, through June 30, 2014, were included. Data were analyzed preliminarily for reporting to funders in early 2015 before all birth-record covariates were scored and were analyzed more comprehensively in mid-2019 after administrative birth and child protective service records became available. Interventions: The goals of the FC brief universal program were to assess family-specific needs, complete brief interventions, and connect families with community resources. Community agencies and families were aligned through an electronic data system. Main Outcomes and Measures: Case records documented program penetration and quality. The primary outcome was child protective services investigations for maltreatment. Secondary outcomes were the number of sustained community connections, maternal mental health, parenting behavior, infant well-child care visits and maternal postpartum care compliance, and emergency health care utilization. Results: Of 936 births, 451 infants (48.2%) were female and 433 (46.3%) were from racial/ethnic minority groups. In all, 456 births (46.5%) were randomized to the intervention and 480 (53.5%) were randomized to the control. All analyses were based on intention to treat. The impact analysis included 158 intervention families and 158 control families. Intervention penetration was 76%, adherence to the protocol was 90%, and independent agreement in scoring (κ) was 0.75. Nurses identified and addressed minor problems for 52% of families and connected an additional 42% to community resources. Analysis of the primary outcome of child abuse investigations revealed a mean (SD) of 0.10 (0.30) investigations for the intervention group vs 0.18 (0.56) investigations for the control group (b = -0.09; 90% CI, -0.01 to -0.12; 95% CI, -0.18 to 0.01; P = .07). The intervention group's rate of possible maternal anxiety or depression was 18.2% vs 25.9% for the control group (b = -7.70; 90% CI, -15.2 to -0.1; 95% CI, -16.6 to 1.3; P = .09). Conclusions and Relevance: This study indicates that a nurse home visitation program for families of newborns can be implemented by a community agency with high penetration and quality. Other communities could benefit from wider dissemination of the program provided that quality remains strong and evaluation continues. Trial Registration: ClinicalTrials.gov identifier: NCT01843036.

Randomized controlled trial of Family Connects: Effects on child emergency medical care from birth to 24 months.

One of Tom Dishion's most significant contributions to prevention science was the development of affordable, ecologically valid interventions, such as the Family Check-Up, that screen for child and family risk factors broadly, but concentrate family-specific interventions on those with greatest potential for population impact. In the spirit of this approach, investigators examined effects of a brief, universal postnatal home visiting program on child emergency medical care and billing costs from birth to age 24 months. Family Connects is a community-wide public health intervention that combines identification and alignment of community services and resources with brief, postpartum nurse home visits designed to assess risk, provide supportive guidance, and connect families with identified risk to community resources. Over 18 months, families of all 4,777 resident Durham County, North Carolina, births were randomly assigned based on even or odd birth date to receive a postnatal nurse home visiting intervention or services as usual (control). Independently, 549 of these families were randomly selected and participated in an impact evaluation study. Families, blind to study goals, provided written consent to access hospital administrative records. Results indicate that children randomly assigned to Family Connects had significantly less total emergency medical care (by 37%) through age 24 months, with results observed across almost all subgroups. Examination of billing records indicate a $3.17 decrease in total billing costs for each $1 in program costs. Overall, results suggest that community-wide postpartum support program can significantly reduce population rates of child emergency medical care through age 24 months while being cost-beneficial to communities.

Father involvement in the first year of life: Associations with maternal mental health and child development outcomes in rural Pakistan.

The contribution of fathers to child development and maternal mental health is increasingly acknowledged, although research on this topic outside of high income countries is limited. Using longitudinal data, we characterized father involvement in a rural setting in Pakistan and investigated the link between father involvement in the first year of life and child development and maternal depression. Data come from the Bachpan study, a birth cohort established in the context of a perinatal depression intervention. Father involvement was mother reported at 3 and 12 months postpartum and covered domains such as playing with or soothing the infant. Child outcomes included growth at 3, 6 and 12 months postpartum, socioemotional development at 6 months (Ages and Stages Questionnaire-socioemotional), and developmental milestones at 12 months (Bayley Scales of Infant and Toddler Development, BSID)). Maternal depression was assessed at 3, 6, and 12 months postpartum. Roughly 20% of the fathers were temporarily non-resident. Among the rest, most mothers reported that fathers were involved: for example, approximately 40% reported that the father plays with the baby on a typical day. We observed no clear pattern of association between 3-month father involvement and child growth at any time point; however, 12-month father involvement was cross-sectionally inversely associated with child growth. We observed a protective pattern of association between 3-month father involvement and 6-month child socioemotional development. For the BSID domains, while almost all effect estimates suggested a protective association with higher levels of father involvement/father being temporarily non-resident, the magnitude of the estimates was smaller and most 95% confidence intervals crossed the null. Finally, there was a trend toward greater father involvement/being temporary non-resident predicting lower levels of maternal depression. Using longitudinal data, these results provide new evidence about the association between father involvement, and both child development and maternal mental health.

Cohort Profile: Perinatal depression and child socioemotional development ; the Bachpan cohort study from rural Pakistan.

PURPOSE: This is a prospective pregnancy-birth cohort designed to investigate the effects of depression on socioemotional development of children. Perinatal depression is a risk factor for poor child development and for many it has a recurring chronic course. Thus, the exposure to depression can continue through the early years of the child with detrimental developmental outcomes. PARTICIPANTS: Between October 2014 and February 2016, we recruited 1154 pregnant women from a rural subdistrict of Pakistan. Data include longitudinal and repeated measures of maternal psychosocial measures and child growth, cognitive and socioemotional measures. Follow-up include mother-child dyad assessments at 3rd, 6th, 12th, 24th and 36th months of child age. All these follow-ups are community based at the household level. We have competed baseline assessment. FINDINGS TO DATE: Of the eligible dyads, we followed 885 (76.6%), 929 (91%) and 940 (93.3%) at 3, 6 and 12 months post-childbirth. We include a subsample mother-child dyad DNA and inflammatory biomarkers, 73 and 104, respectively. FUTURE PLANS: While we continue to do 24-month and 36-month follow-up assessments, we plan to follow these mother-child dyads up to the age of 7-8 years with some children being exposed to at least 1 year of school environment. Investigators interested in learning more about the study can contact (jmaselko@unc.edu) and (siham.sikander@hdrfoundation.org).

Moving Beyond Program to Population Impact: Toward a Universal Early Childhood System of Care.

Families have clearly benefited from increased availability of evidence-based intervention, including home-visiting models and increased federal funding for programs benefiting parents and children. The goal of population-level impact on the health and well-being of infants and young children across entire communities, however, remains elusive. New approaches are needed to move beyond scaling of individual programs toward an integrated system of care in early childhood. To advance this goal, the current article provides a framework for developing an early childhood system of care that pairs a top-down goal for the alignment of services with a bottom-up goal of identifying and addressing needs of all families throughout early childhood. Further, we describe how universal newborn home visiting can be utilized to both support alignment of and family entry into an early childhood system of care with broad reach, high quality, and evidence of population impact for families and children.

The relationship between responsive caregiving and child outcomes: evidence from direct observations of mother-child dyads in Pakistan.

BACKGROUND: Responsive caregiving, or interactions in which caregivers give appropriate responses to a child's signals, is linked to improved psychosocial, cognitive and physical outcomes in children. However, much remains unknown about how responsive caregiving affects child development across cultural and socioeconomic contexts. The purpose of this study is to examine predictors of maternal responsive caregiving and investigate how these interactions are associated with children's development. METHODS: Data for the current analyses came from a longitudinal study designed to follow mothers from the third trimester through the first three years of the child's life. To assess responsive caregiving, the Observation of Mother-Child Interaction (OMCI) measure was used to examine maternal and child behaviors during a 5-min picture book activity at 24 months. Outcomes included child height-for-age z-score and child socioemotional development, using the Ages and Stages Questionnaire-Socioemotional (ASQ-SE) in which lower scores demonstrated better development. Using mean comparisons, the effects of baseline sociodemographic factors and maternal depression on responsive caregiving were tested. Analyses utilized hierarchical linear regressions to examine cross-sectional associations between responsive caregiving and child development outcomes at 24 months. Additional analyses controlled for the Home Observation for Measurement of the Environment (HOME), a common measure in low-income contexts of caregiving, to assess whether OMCI was uniquely predictive of child outcomes. RESULTS: Higher maternal education attainment, lower number of children, greater socioeconomic assets, and lack of maternal depression were associated with higher levels of observed responsive caregiving behaviors. Higher total OMCI scores were associated with positive child socioemotional outcomes in adjusted models (ß: -0.84, 95% CI [- 1.40, - 0.29]). The finding was statistically significant, even after controlling for HOME score (ß: -0.83, 95% CI [- 1.38, - 0.27]). There was no association between OMCI scores and child linear growth. CONCLUSIONS: Responsive caregiving is linked to positive child socioemotional development in rural Pakistan. Our findings suggest that incorporating responsive caregiving into child health interventions in LMIC may have valuable impacts on child socioemotional development. The OMCI may be useful in identifying important pathways for change to responsive caregiving behaviors and may be of service for future interventions that optimize child development through responsive caregiving. TRIAL REGISTRATION: NCT02111915 (09/18/2015); NCT02658994 (01/22/2016). Trials were prospectively registered.