Improving the efficiency of evidence-based interventions: The strengths and limitations of randomised controlled trials

Globally, randomised controlled trials (RCTs) are increasingly seen as the gold standard of programme evaluation, representing the best way to determine whether new interventions are effective – but they are not without limitations. In this article, we discuss the phases of scientific discovery and the research standards that are necessary before scaling up interventions. We also outline the core characteristics of RCTs, such as randomisation, efficacy and effectiveness, and discuss the benefits of using the RCT as the standard of intervention evaluation. We discuss how ‘realist’ evaluation contributes to what policymakers need to know in order to make a decision about an evaluation and alternatives to the RCT, such as stepped wedge, regression discontinuity, non-randomised cohort, and time series designs

Relationships between concurrent language ability and mental health outcomes in a South African sample of 13-year-olds

Children and adolescents with delayed or disordered language development are at increased risk of a number of negative outcomes, including social and emotional problems and mental health difficulties. Yet, in low- and middle- income countries, where risk factors for compromised language development are known to be prevalent, there is a lack of research on the association between child and adolescent language ability and mental health outcomes. This study evaluates data from a cross-sectional study in Khayelitsha, a semi-urban impoverished community near Cape Town, South Africa. To measure language ability, behaviour and mental health, adolescents aged 13 (n = 200) were assessed using the Riddles subtest of the Kaufman Assessment Battery for Children Version 2, the parent report Child Behaviour Checklist, and the self-report Moods and Feelings Questionnaire and the Self-Esteem Questionnaire. We conducted univariate and multivariate analyses to determine associations between language skills, self-esteem and mental health in this group of adolescents. Poor language ability was related to a range of concurrent adverse difficulties, such as attention deficits, self-esteem problems, social withdrawal, and depressive symptoms. Increased levels of language ability were related to better psychosocial profiles. In some cases, only individuals with a low level of language (bottom 10% of sample) were at increased risk of maladaptive outcomes. This study replicates the well-established relationship between language ability and poorer mental health found within high income countries in an upper middle-income country setting. Locally accessible support for children with reduced language ability is required, given the longer-term consequences of poorer mental health

Adolescent parenthood and HIV-infection in South Africa—Associations with child cognitive development

HIV, both directly and indirectly, impacts child development outcomes. The most severe impacts are for children infected with HIV, and those exposed but uninfected are also shown to have challenges-though less severe. However, little is known regarding the development of children born to adolescent mothers affected by HIV. This study aims to examine cognitive development for children born to adolescent mothers, comparing those children living with HIV, those HIV exposed and uninfected (HEU) and those HIV unexposed (HU). Analyses utilise cross-sectional data from 920 adolescent mother (10-19 years)-first born child dyads residing in the Eastern Cape Province, South Africa. Participants completed detailed study questionnaires inclusive of validated and study specific measures relating to sociodemographic characteristics, HIV, and maternal and child health. Trained assessors administered standardised child development assessments (using the Mullen Scales of Early Learning) with all children. Chi-square tests and ANOVA tests were used to explore maternal and child characteristics according to child HIV status (HIV, HEU, HU) on cognitive development. Linear regression models were used to explore the cross-sectional associations between child HIV status and child cognitive development. 1.2% of children were living with HIV, 20.5% were classified as being HEU and, 78.3% were classified as HU. Overall, children living with HIV were found to perform lower across developmental domains compared to both HEU and HU groups (composite score of early learning: 73.0 vs 91.2 vs. 94.1, respectively: F = 6.45, p = 0.001). HEU children on average scored lower on all developmental domains compared to HU children, reaching significance on the gross motor domain (p<0.05). Exploratory analyses identified maternal education interruption as a potential risk factor for lower child cognitive development scores and, higher maternal age to be protective of child cognitive development scores. These exploratory findings address a critical evidence gap regarding the cognitive development of children born to adolescent mothers affected by HIV in South Africa. Analyses identify stepwise differences in the average scoring on child cognitive development domains according to child HIV status among children born to adolescent mothers affected by HIV; with children living with HIV performing worse overall. Young mothers and their children may benefit from adapted interventions aimed at bolstering child development outcomes. Targeted programming particularly among younger adolescent mothers and those experiencing education interruption may identify those families, particularly in need. Attention to maternal continuity of education and age of conception may be interventions to consider

Staff experiences of a reablement approach to care for older people in a regional Australian community : a qualitative study

Reablement is described as a person-centred, goal-directed intervention with a view to regain, maintain or improve the independence of older clients. Although evidence to support the use of reablement as a multidisciplinary, home-based intervention for community-dwelling older adults is increasing, there is limited knowledge about what it means for care staff who provide client-based services. This study, which was nested in a larger program evaluation, used a descriptive qualitative approach to explore direct care staff and care coordinator experiences of translating a reablement training program into practice for older people in a regional Australian community. Two months after the training program four focus groups were conducted with 13 care coordinators to assimilate staff experiences with development of care plans, systems, processes and practices of reablement. In addition, four direct care staff took part in individual interviews, which centred on eliciting their experience using the reablement approach with clients. Results from the care coordinator focus groups and the direct care staff interviews highlight the importance of reablement staff training and the involvement of staff in the development and delivery of a reablement approach to client-centred care. A number of organisational and client-centred challenges such as communication, functional partnerships, staff education and resourcing are also uncovered in this research into the development of a reablement-focused care service in a regional setting. Overall there is support for the dominating discourse around healthy ageing and the policy approach of ageing in place to support wellness

Modelling the impact of maternal HIV on uninfected children: correcting current estimates

A mathematical model, populated primarily with data from South Africa, was developed to model the numbers of children affected by maternal HIV, and the number who will experience long-term negative developmental consequences. A micro-simulation model generated two scenarios. The first simulated a cohort of women whose HIV status mimicked that of a target population, and mother–child dyads by way of age- and disease-specific fertility rates. Factors defining risk were used to characterize the simulated environment. The second scenario simulated mother-child dyads without maternal HIV. In the first scenario an estimated 26% of children are orphaned, compared to 10% in the absence of HIV. And a further 19% of children whose mother is alive when they turn 18 are affected by maternal HIV. School drop-out among all children increased by 4 percentage points because of maternal HIV, similarly population level estimates of abuse and negative mental health outcomes are elevated

Adolescent mothers and their children affected by HIV-An exploration of maternal mental health, and child cognitive development.

BACKGROUND: Some children born to adolescent mothers may have developmental challenges, while others do not. Research focusing on which children of adolescent mothers are at the highest risk for cognitive delay is still required. Both maternal HIV status and maternal mental health may affect child development. An examination of maternal mental health, especially in the presence of maternal HIV infection may be timely. This study explores the relationship between the mental health of adolescent mothers (comparing those living with and not living with HIV) and the cognitive development performance scores of their children. Additional possible risk and protective factors for poor child development are explored to identify those children born to adolescent mothers who may be at the greatest risk of poor cognitive development. METHODS: Cross-sectional data utilised within the analyses was drawn from a large cohort of adolescent mothers and their children residing in South Africa. Detailed study questionnaires were completed by adolescent mothers relating to their self and their child and, standardised cognitive assessments were completed by trained researchers for all children using in the Mullen Scales of Early Learning. Chi-square, t-tests (Kruskal Wallis tests, where appropriate), and ANOVA were used to explore sample characteristics and child cognitive development scores by maternal mental health status (operationalised as likely common mental disorder) and combined maternal mental health and HIV status. Multivariable linear regression models were used to explore the relationship between possible risk factors (including poor maternal mental health and HIV) and, child cognitive development scores. RESULTS: The study included 954 adolescent mothers; 24.1% (230/954) were living with HIV, 12.6% (120/954) were classified as experiencing likely common mental disorder. After adjusting for covariates, maternal HIV was found to be associated with reduced child gross motor scores (B = -2.90 [95%CI: -5.35, -0.44], p = 0.02), however, no other associations were identified between maternal likely common mental disorder, or maternal HIV status (including interaction terms), and child cognitive development scores. Sensitivity analyses exploring individual maternal mental health scales identified higher posttraumatic stress symptomology scores as being associated with lower child cognitive development scores. Sensitivity analyses exploring potential risk and protective factors for child cognitive development also identified increased maternal educational attainment as being protective of child development scores, and increased child age as a risk factor for lower development scores. CONCLUSIONS: This study addresses a critical evidence gap relating to the understanding of possible risk factors for the cognitive development of children born to adolescent mothers affected by HIV. This group of mothers experience a complex combination of risk factors, including HIV, likely common mental disorder, and structural challenges such as educational interruption. Targeting interventions to support the cognitive development of children of adolescent mothers most at risk may be of benefit. Clearly a basket of interventions needs to be considered, such as the integration of mental health provision within existing services, identifying multiple syndemics of risk, and addressing educational and structural challenges, all of which may boost positive outcomes for both the mother and the child

Evidence for Better Lives Study: a comparative birth-cohort study on child exposure to violence and other adversities in eight low- and middle-income countries - foundational research (study protocol)

Funder: Consuelo Zobel Alger Foundation, Inc.Funder: British Academy; FundRef: http://dx.doi.org/10.13039/501100000286Funder: Cambridge Humanities Research Grants SchemeFunder: University of Cambridge GCRF Quality ResearchFunder: Jacobs Foundation; FundRef: http://dx.doi.org/10.13039/501100003986Funder: Wolfson discretionary researchIntroduction: Violence against children is a health, human rights and social problem affecting approximately half of the world’s children. Its effects begin at prenatal stages with long-lasting impacts on later health and well-being. The Evidence for Better Lives Study (EBLS) aims to produce high-quality longitudinal data from cities in eight low- and middle-income countries—Ghana, Jamaica, Pakistan, the Philippines, Romania, South Africa, Sri Lanka and Vietnam—to support effective intervention to reduce violence against children. EBLS-Foundational Research (EBLS-FR) tests critical aspects of the planned EBLS, including participant recruitment and retention, data collection and analysis. Alongside epidemiological estimates of levels and predictors of exposure to violence and adversity during pregnancy, we plan to explore mechanisms that may link exposure to violence to mothers’ biological stress markers and subjective well-being. Methods and analyses: EBLS-FR is a short longitudinal study with a sample of 1200 pregnant women. Data are collected during the last trimester of pregnancy and 2 to 6 months after birth. The questionnaire for participating women has been translated into nine languages. Measures obtained from mothers will include, among others, mental and physical health, attitudes to corporal punishment, adverse childhood experiences, prenatal intimate partner violence, substance use and social/community support. Hair and dry blood spot samples are collected from the pregnant women to measure stress markers. To explore research participation among fathers, EBLS-FR is recruiting 300 fathers in the Philippines and Sri Lanka. Ethics and dissemination: The study received ethical approvals at all recruiting sites and universities in the project. Results will be disseminated through journal publications, conferences and seminar presentations involving local communities, health services and other stakeholders. Findings from this work will help to adjust the subsequent stages of the EBLS project

Perceived stress during the prenatal period: assessing measurement invariance of the Perceived Stress Scale (PSS-10) across cultures and birth parity

Maternal prenatal stress places a substantial burden on mother’s mental health. Expectant mothers in low- and middle-income countries (LMICs) have thus far received less attention than mothers in high-income settings. This is particularly problematic, as a range of triggers, such as exposure to traumatic events (e.g. natural disasters, previous pregnancy losses) and adverse life circumstances (e.g. poverty, community violence), put mothers at increased risk of experiencing prenatal stress. The ten-item Perceived Stress Scale (PSS-10) is a widely recognised index of subjective experience of stress that is increasingly used in LMICs. However, evidence for its measurement equivalence across settings is lacking. This study aims to assess measurement invariance of the PSS-10 across eight LMICs and across birth parity. This research was carried out as part of the Evidence for Better Lives Study (EBLS, vrc.crim.cam.ac.uk/vrcresearch/EBLS). The PSS-10 was administered to N = 1,208 expectant mothers from Ghana, Jamaica, Pakistan, the Philippines, Romania, South Africa, Sri Lanka and Vietnam during the third trimester of pregnancy. Confirmatory factor analysis suggested a good model fit of a two-factor model across all sites, with items on experiences of stress loading onto a negative factor and items on perceived coping onto a positive factor. Configural and metric, but not full or partial scalar invariance, were established across all sites. Configural, metric and full scalar invariance could be established across birth parity. On average, first-time mothers reported less stress than mothers who already had children. Our findings indicate that the PSS-10 holds utility in assessing stress across a broad range of culturally diverse settings; however, caution should be taken when comparing mean stress levels across sites

Exploring the cognitive development of children born to adolescent mothers in South Africa

This study explores the cognitive development of children born to adolescent mothers within South Africa compared to existing reference data, and explores development by child age bands to examine relative levels of development. Cross-sectional analyses present data from 954 adolescents (10–19 years) and their first-born children (0–68 months). All adolescents completed questionnaires relating to themselves and their children, and standardized child cognitive assessments (Mullen Scales of Early Learning) were undertaken. Cognitive development scores of the sample were lower than USA reference population scores and relative performance compared to the reference population was found to decline with increasing child age. When compared to children born to adult mothers in the sub-Saharan African region, children born to adolescent mothers (human immunodeficiency virus [HIV] unexposed; n = 724) were found to have lower cognitive development scores. Findings identify critical periods of development where intervention may be required to bolster outcomes for children born to adolescent mothers