Editorial: Open science and methods review for Child and Adolescent Mental Health.

This editorial introduces the journal's new open data policy for original articles using quantitative data. It discusses key opportunities from data and code sharing. It further briefly sets out the new methods review that articles which use quantitative analysis will automatically undergo. With both changes we hope to strengthen our review process and contribute to a better evidence base in the field.

Adolescence and the risk of ART non-adherence during a geographically focused public health intervention: an analysis of clinic records from Nigeria.

The risk of poor antiretroviral therapy (ART) adherence among adolescents is a challenge to controlling HIV. This study aims to provide guidance for geographically focussed public health interventions to improve adherence. Through clinic records, it investigates adolescents' non-adherence risk and clinic-level differences in regions of Nigeria which were part of PEPFAR's geographical pivot. Records (n = 26,365) were selected using systematic random sampling from all PEPFAR-supported facilities (n = 175) in targeted Local Government Areas across three regions in Nigeria. Adolescents' risk of non-adherence was estimated using region-specific random-effects models accounting for clinic-level variation. These were adjusted for sex, whether a patient had to travel to a different region, clinic location (urban/rural), clinic type (primary, secondary, tertiary). Despite regional variations, adolescents were at higher risk of non-adherence compared to adults. A similar, but weaker, association was found for children. Patients attending tertiary facilities for ART in the South-South region exhibited very high risk of non-adherence. Adolescents and children are at an increased risk of poor ART adherence in rural regions of Nigeria. Regional differences and facility type are critical factors. Future public health programmes focused on the risk of poor adherence targeting "high-prevalence areas" should be sensitive to contextual differences and age-appropriate care.

Video feedback for parental sensitivity and attachment security in children under five years.

BACKGROUND: Children who are securely attached to at least one parent are able to be comforted by that parent when they are distressed and explore the world confidently by using that parent as a 'secure base'. Research suggests that a secure attachment enables children to function better across all aspects of their development. Promoting secure attachment, therefore, is a goal of many early interventions. Attachment is mediated through parental sensitivity to signals of distress from the child. One means of improving parental sensitivity is through video feedback, which involves showing a parent brief moments of their interaction with their child, to strengthen their sensitivity and responsiveness to their child's signals. OBJECTIVES: To assess the effects of video feedback on parental sensitivity and attachment security in children aged under five years who are at risk for poor attachment outcomes. SEARCH METHODS: In November 2018 we searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, nine other databases and two trials registers. We also handsearched the reference lists of included studies, relevant systematic reviews, and several relevant websites SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs that assessed the effects of video feedback versus no treatment, inactive alternative intervention, or treatment as usual for parental sensitivity, parental reflective functioning, attachment security and adverse effects in children aged from birth to four years 11 months. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: This review includes 22 studies from seven countries in Europe and two countries in North America, with a total of 1889 randomised parent-child dyads or family units. Interventions targeted parents of children aged under five years, experiencing a wide range of difficulties (such as deafness or prematurity), or facing challenges that put them at risk of attachment issues (for example, parental depression). Nearly all studies reported some form of external funding, from a charitable organisation (n = 7) or public body, or both (n = 18). We considered most studies as being at low or unclear risk of bias across the majority of domains, with the exception of blinding of participants and personnel, where we assessed all studies as being at high risk of performance bias. For outcomes where self-report measures were used, such as parental stress and anxiety, we rated all studies at high risk of bias for blinding of outcome assessors. Parental sensitivity. A meta-analysis of 20 studies (1757 parent-child dyads) reported evidence of that video feedback improved parental sensitivity compared with a control or no intervention from postintervention to six months' follow-up (standardised mean difference (SMD) 0.34, 95% confidence interval (CI) 0.20 to 0.49, moderate-certainty evidence). The size of the observed impact compares favourably to other, similar interventions. Parental reflective functioning. No studies reported this outcome. Attachment security. A meta-analysis of two studies (166 parent-child dyads) indicated that video feedback increased the odds of being securely attached, measured using the Strange Situation Procedure, at postintervention (odds ratio 3.04, 95% CI 1.39 to 6.67, very low-certainty evidence). A second meta-analysis of two studies (131 parent-child dyads) that assessed attachment security using a different measure (Attachment Q-sort) found no effect of video feedback compared with the comparator groups (SMD 0.02, 95% CI -0.33 to 0.38, very low-certainty evidence). Adverse events. Eight studies (537 parent-child dyads) contributed data at postintervention or short-term follow-up to a meta-analysis of parental stress, and two studies (311 parent-child dyads) contributed short-term follow-up data to a meta-analysis of parental anxiety. There was no difference between intervention and comparator groups for either outcome. For parental stress the SMD between video feedback and control was -0.09 (95% CI -0.26 to 0.09, low-certainty evidence), while for parental anxiety the SMD was -0.28 (95% CI -0.87 to 0.31, very low-certainty evidence). Child behaviour. A meta-analysis of two studies (119 parent-child dyads) at long-term follow-up found no evidence of the effectiveness of video feedback on child behaviour (SMD 0.04, 95% CI -0.33 to 0.42, very low-certainty evidence). A moderator analysis found no evidence of an effect for the three prespecified variables (intervention type, number of feedback sessions and participating carer) when jointly tested. However, parent gender (both parents versus only mothers or only fathers) potentially has a statistically significant negative moderation effect, though only at α (alpha) = 0.1 AUTHORS' CONCLUSIONS: There is moderate-certainty evidence that video feedback may improve sensitivity in parents of children who are at risk for poor attachment outcomes due to a range of difficulties. There is currently only little, very low-certainty evidence regarding the impact of video feedback on attachment security, compared with control: results differed based on the type of measure used, and follow-up was limited in duration. There is no evidence that video feedback has an impact on parental stress or anxiety (low- and very low-certainty evidence, respectively). Further evidence is needed regarding the longer-term impact of video feedback on attachment and more distal outcomes such as children's behaviour (very low-certainty evidence). Further research is needed on the impact of video-feedback on paternal sensitivity and parental reflective functioning, as no study measured these outcomes. This review is limited by the fact that the majority of included parents were mothers.

Intimate Partner Violence and HIV Sexual Risk Behaviour Among Women Who Inject Drugs in Indonesia: A Respondent-Driven Sampling Study.

Women who inject drugs are disproportionately affected by HIV and intimate partner violence (IPV); however, the link between IPV and HIV remains under-researched among substance-using women in low- and middle-income countries. This study examined associations and additive effects of different forms of IPV victimization (psychological, physical and/or injurious, and sexual) on HIV sexual risk behavior among women who inject drugs in Indonesia. Respondent-driven sampling (RDS) was used to recruit 731 women from Greater Jakarta and Bandung, West Java. RDS-II weighted prevalence of any past-year IPV was 68.9% (95% CI 65.0, 72.6) in Jakarta and 55.9% (95% CI 48.0, 63.5) in Bandung. In separate logistic regressions controlling for socio-demographic covariates, all three forms of IPV showed statistically significant associations with sexual risk behavior. After adjusting for all IPV types, psychological (OR 1.87; 95% CI 1.17, 2.99; p = 0.009) and sexual (OR 1.98; 95% CI 1.22, 3.21; p = 0.006) IPV independently predicted women's sexual risk behavior. Marginal effects models suggested that co-occurrence of multiple forms of IPV had greater adverse consequences: sexual risk behavior was reported by 64.1% of women who did not experience any IPV, but increased to 89.9% among women exposed to all three types. Comprehensive harm reduction services that integrate IPV monitoring and prevention are urgently needed to reduce both HIV and IPV.

Editorial: Changes in the field: banning p-values (or not), transparency, and the opportunities of a renewed discussion on rigorous (quantitative) research.

Research transparency is becoming increasingly important across the social and medical sciences and thereby to the field of child and adolescent mental health. As the incoming associate editor for quantitative methods to CAMH, my contribution to the journal over the course of my editorship will be to encourage a discussion on research transparency and potential new types of submissions. Some editorials concerned with quantitative methods have recently taken rather stringent methodological stances, such as the one on "banning p-values" in the Journal of Basic and Applied Social Psychology and Political Analysis (Gill, Political Analysis, 2018, 26, 1; Trafimow & Marks, Basic and Applied Social Psychology, 2015, 37, 1). These editorials are part of a wider discussion in psychology, social sciences, public health, and the sciences more generally on the use of quantitative methods, and set the terms of the debate about the conditions for scientific research.

Fatty acids and sleep in UK children: subjective and pilot objective sleep results from the DOLAB study--a randomized controlled trial.

Sleep problems in children are associated with poor health, behavioural and cognitive problems, as are deficiencies of long-chain omega-3 fatty acids such as docosahexaenoic acid. Theory and some evidence support a role for these fatty acids in sleep regulation, but this issue has received little formal investigation. We examined associations between blood fatty acid concentrations (from fingerstick blood samples) and subjective sleep (using an age-standardized parent questionnaire) in a large epidemiological sample of healthy children aged 7-9 years (n = 395) from mainstream UK schools. In a randomized controlled trial, we then explored whether 16-week supplementation (600 mg day(-1) ) with algal docosahexaenoic acid versus placebo might improve sleep in a subset of those children (n = 362) who were underperforming in reading. In a randomly selected subsample (n = 43), sleep was also assessed objectively via actigraphy. In 40% of the epidemiological sample, Child Sleep Habits Questionnaire scores indicated clinical-level sleep problems. Furthermore, poorer total sleep disturbance scores were associated weakly but significantly with lower blood docosahexaenoic acid (std coeff. -0.105*) and a lower docosahexaenoic acid : arachidonic acid ratio (std coeff. -0.119**). The treatment trial showed no significant effects on subjective sleep measures. However, in the small actigraphy subsample, docosahexaenoic acid supplementation led on average to seven fewer wake episodes and 58 min more sleep per night. Cautiously, we conclude that higher blood levels of docosahexaenoic acid may relate to better child sleep, as rated by parents. Exploratory pilot objective evidence from actigraphy suggests that docosahexaenoic acid supplementation may improve children's sleep, but further investigations are needed.

Can synthetic controls improve causal inference in interrupted time series evaluations of public health interventions?

Interrupted time series designs are a valuable quasi-experimental approach for evaluating public health interventions. Interrupted time series extends a single group pre-post comparison by using multiple time points to control for underlying trends. But history bias-confounding by unexpected events occurring at the same time of the intervention-threatens the validity of this design and limits causal inference. Synthetic control methodology, a popular data-driven technique for deriving a control series from a pool of unexposed populations, is increasingly recommended. In this paper, we evaluate if and when synthetic controls can strengthen an interrupted time series design. First, we summarize the main observational study designs used in evaluative research, highlighting their respective uses, strengths, biases and design extensions for addressing these biases. Second, we outline when the use of synthetic controls can strengthen interrupted time series studies and when their combined use may be problematic. Third, we provide recommendations for using synthetic controls in interrupted time series and, using a real-world example, we illustrate the potential pitfalls of using a data-driven approach to identify a suitable control series. Finally, we emphasize the importance of theoretical approaches for informing study design and argue that synthetic control methods are not always well suited for generating a counterfactual that minimizes critical threats to interrupted time series studies. Advances in synthetic control methods bring new opportunities to conduct rigorous research in evaluating public health interventions. However, incorporating synthetic controls in interrupted time series studies may not always nullify important threats to validity nor improve causal inference.

Combining parenting and economic strengthening programmes to reduce violence against children: a cluster randomised controlled trial with predominantly male caregivers in rural Tanzania.

INTRODUCTION: Parenting programmes may reduce the risk of violence against children and improve child well-being. However, additional economic support may be necessary in highly deprived rural communities in sub-Saharan Africa. Furthermore, delivering programmes within farmer groups may increase male caregiver recruitment and engagement. METHODS: A parallel cluster randomised controlled trial examined the combined and separate effects of parenting and economic strengthening programmes on reducing violence against children aged 0-18 years in farming communities in Tanzania (n=248 families; 63% male caregivers). Eight villages were randomly assigned to four conditions (2:2:2:2): (1) 12-session parenting programme (n=60); (2) agribusiness training (n=56); (3) parenting and agribusiness combined (n=72); (4) control (n=60). Parent-report, child-report and early childhood observation assessments were conducted at baseline, mid-treatment and post-treatment. Primary outcomes were child maltreatment and parenting behaviour. Secondary outcomes included corporal punishment endorsement, parenting stress, parent/child depression, child behaviour, economic well-being and child development. RESULTS: At post-treatment, parents and children receiving the combined interventions reported less maltreatment (parents: incidence rate ratio (IRR=0.40, 95% CI 0.24 to 0.65; children: IRR=0.40, 95% CI 0.17 to 0.92). Parents reported reduced endorsement of corporal punishment (Dw =-0.43, 95% CI -0.79 to 0.07) and fewer child behaviour problems (Dw =-0.41, 95% CI -0.77 to 0.05). Parents in parenting-only villages reported less abuse (IRR=0.36, 95% CI 0.21 to 0.63) and fewer child behaviour problems (Dw =-0.47, 95% CI -0.84 to 0.11). Parents in agribusiness-only villages reported fewer child behaviour problems (Dw =-0.43, 95% CI -0.77 to 0.08) and greater household wealth (Dw =0.57, 95% CI 0.08 to 1.06). However, children in agribusiness-only villages reported increased physical abuse (IRR=2.26, 95% CI 1.00 to 5.12) and less positive parenting (Dw =-0.50, 95% CI -0.91 to 0.10). There were no other adverse effects. CONCLUSION: Parent training may be the active ingredient in reducing maltreatment in farmer groups with majority male caregivers, while agribusiness training programmes may have unintended negative consequences on children when delivered alone. Locating parenting support in existing farmer groups can engage much higher proportions of fathers than stand-alone programmes.ClinicalTrials.gov: NCT02633319.

Intimate partner violence and receptive syringe sharing among women who inject drugs in Indonesia: A respondent-driven sampling study.

BACKGROUND: Intimate partner violence (IPV) and HIV are overlapping public health problems that disproportionately affect women who inject drugs. Little is known about the relationship between IPV and HIV-related unsafe injecting practices among women in low- and middle-income settings. This study investigated whether IPV victimisation was associated with receptive syringe sharing among women who inject drugs in Indonesia. METHODS: Respondent-driven sampling (RDS) was used to recruit 731 women aged 18+ years, injecting drugs in the preceding 12 months, and residing in Greater Jakarta or Bandung, West Java. Population estimates were derived using the RDS-II estimator. Multivariate logistic regressions assessed relationships between different forms of past-year IPV (i.e. psychological abuse, physical and/or injurious assault, forced sex) and receptive syringe sharing, controlling for city differences and sociodemographic cofactors. RESULTS: Overall, 21.1% of participants reported engaging in past-month receptive syringe sharing. In multivariate analyses controlling for all forms of IPV, receptive syringe sharing was significantly positively associated with experiencing psychological abuse (OR = 1.86; 95% CI = 1.06,3.24; p = 0.030), physical and/or injurious assault (OR = 1.73; 95% CI = 1.04,2.89; p = 0.034), and several covariates: injecting pharmaceuticals only (versus heroin only) (OR = 3.58; 95% CI = 1.66,7.69; p = 0.001), experiencing unstable housing and/or homelessness (OR = 2.89; 95% CI = 1.41,5.95; p = 0.004), and residing in Bandung, West Java (versus Greater Jakarta) (OR = 2.33; 95% CI = 1.40,3.90; p = 0.001). CONCLUSION: IPV is a significant risk factor for HIV-related injecting risk among women who inject drugs in Indonesia. These findings indicate the urgent need to scale up harm reduction interventions and align existing programs with IPV prevention and support services, with specific efforts targeting the needs of female injectors.

Interventions to reduce gender-based violence among young people living with or affected by HIV/AIDS in low-income and middle-income countries.

OBJECTIVE(S): This study explored the effectiveness of gender-based violence (GBV) interventions on young people living with or affected by HIV in low- and middle-income countries (LMICs). DESIGN: Systematic review and meta-analysis. METHODS: We pre-registered a protocol, then searched 13 databases and grey literature. We screened randomized and quasi-experimental studies (n = 2199) of young people (aged 10-24) living with or affected by HIV in LMICs. Outcomes were GBV and/or GBV-related attitudes. We appraised the data for risk of bias and quality of evidence. Narrative syntheses and multilevel random effects meta-analyses were conducted. RESULTS: We included 18 studies evaluating 21 interventions. Intervention arms were categorized as: sexual health and social empowerment (SHSE; n = 7); SHSE combined with economic strengthening (n = 4); self-defence (n = 3); safer schools (n = 2); economic strengthening only (n = 2); GBV sensitization (n = 2) and safer schools and parenting (n = 1). Risk of bias was moderate/high and quality of evidence low. Narrative syntheses indicated promising effects on GBV exposure, but no or mixed effects on GBV perpetration and attitudes for self-defence and GBV sensitization interventions. Safer school interventions showed no effects. For SHSE interventions and SHSE combined with economic strengthening, meta-analyses showed a small reduction in GBV exposure but not perpetration. Economic-only interventions had no overall effect. CONCLUSION: SHSE, SHSE plus and self-defence and gender sensitization interventions may be effective for GBV exposure and GBV-related attitudes but not for GBV perpetration. However, the quality of evidence is poor. Future intervention research must include both boys and girls, adolescents living with HIV and key populations.

Docosahexaenoic acid for reading, working memory and behavior in UK children aged 7-9: A randomized controlled trial for replication (the DOLAB II study).

BACKGROUND: Omega-3 fatty acids are central to brain-development of children. Evidence from clinical trials and systematic reviews demonstrates the potential of long-chain Omega-3 supplementation for learning and behavior. However, findings are inconclusive and in need of robust replication studies since such work is lacking. OBJECTIVES: Replication of the 2012 DOLAB 1 study findings that a dietary supplementation with the long-chain omega-3 docosahexaenoic acid (DHA) had beneficial effects on the reading, working memory, and behavior of healthy schoolchildren. DESIGN: Parallel group, fixed-dose, randomized (minimization, 30% random element), double-blind, placebo-controlled trial (RCT). SETTING: Mainstream primary schools (n = 84) from five counties in the UK in 2012-2015. PARTICIPANTS: Healthy children aged 7-9 underperforming in reading (<20th centile). 1230 invited, 376 met study criteria. INTERVENTION: 600 mg/day DHA (from algal oil), placebo: taste/color matched corn/soybean oil; for 16 weeks. MAIN OUTCOME MEASURES: Age-standardized measures of reading, working memory, and behavior, parent-rated and as secondary outcome teacher-rated. RESULTS: 376 children were randomized. Reading, working memory, and behavior change scores showed no consistent differences between intervention and placebo group. Some behavioral subscales showed minor group differences. CONCLUSIONS: This RCT did not replicate results of the earlier DOLAB 1 study on the effectiveness of nutritional supplementation with DHA for learning and behavior. Possible reasons are discussed, particularly regarding the replication of complex interventions. TRIAL REGISTRATION AND PROTOCOL: www.controlled-trials.com (ISRCTN48803273) and protocols.io (https://dx.doi.org/10.17504/protocols.io.k8kczuw).

Emotional abuse of girls in Swaziland: prevalence, perpetrators, risk and protective factors and health outcomes.

BACKGROUND: Research on emotional child abuse in sub-Saharan Africa is scarce. Few studies thus far have examined prevalence, risk and protective factors for emotional child abuse or the associations between emotional abuse and girls' health. METHODS: A nationally representative two-stage, cluster-sampled, household survey of females aged 13-24 years (n = 1244) on childhood abuse victimisation was conducted. Participants completed interviewer-assisted questionnaires. Associations between emotional abuse and putative risk, and protective factors and health outcomes were analyzed using separate logistic regression models accounting for sampling design. Marginal effects of cumulative risk factors for emotional abuse victimisation were examined. RESULTS: Lifetime prevalence of emotional abuse was 28.5% with 58.3% of these girls reporting many abusive incidents. The most common perpetrators were female (27.8%) and male (16.7%) relatives and, more rarely, biological parents. Risk factors associated with emotional abuse were frequent caregiver changes (odds ratio (OR) 1.42, 95% confidence interval (CI) 1.03-1.970, poverty (OR 1.51, 95% CI 1.12-2.03), and physical abuse (OR 1.98, 95% CI 1.45-2.71) and sexual abuse (OR 2.22, 95% CI 1.57-3.10) victimisation. Being close to one's mother was a protective factor (OR 0.88, 95% CI 0.80-0.97). Risk for emotional abuse increased from 13% with no risk factors present to 58.4% -with all four risk factors present. Health outcomes associated with emotional child abuse were suicidal ideation (OR 1.85, 95% CI 1.30-2.63) and feeling depressed (OR 1.89, 95% CI 1.31-2.71). CONCLUSIONS: Girls in Swaziland experience high levels of emotional abuse victimisation. Emotional abuse is associated with economic disadvantage, family factors, other types of abuse victimisation and poor mental health. Therefore, a holistic approach to prevention is needed, incorporating poverty reduction and programmes to improve parent-child relationships, reduce the use of harsh criticism, and change parenting social norms.

Low blood long chain omega-3 fatty acids in UK children are associated with poor cognitive performance and behavior: a cross-sectional analysis from the DOLAB study.

BACKGROUND: Omega-3 long-chain polyunsaturated fatty acids (LC-PUFA), especially DHA (docosahexaenonic acid) are essential for brain development and physical health. Low blood Omega-3 LC-PUFA have been reported in children with ADHD and related behavior/learning difficulties, as have benefits from dietary supplementation. Little is known, however, about blood fatty acid status in the general child population. We therefore investigated this in relation to age-standardized measures of behavior and cognition in a representative sample of children from mainstream schools. PARTICIPANTS: 493 schoolchildren aged 7-9 years from mainstream Oxfordshire schools, selected for below average reading performance in national assessments at age seven. METHOD: Whole blood fatty acids were obtained via fingerstick samples. Reading and working memory were assessed using the British Ability Scales (II). Behaviour (ADHD-type symptoms) was rated using the revised Conners' rating scales (long parent and teacher versions). Associations were examined and adjusted for relevant demographic variables. RESULTS: DHA and eicosapentaenoic acid (EPA), accounted for only 1.9% and 0.55% respectively of total blood fatty acids, with DHA showing more individual variation. Controlling for sex and socio-economic status, lower DHA concentrations were associated with poorer reading ability (std. OLS coeff. = 0.09, p = <.042) and working memory performance (0.14, p = <.001). Lower DHA was also associated with higher levels of parent rated oppositional behavior and emotional lability (-0.175, p = <.0001 and -0.178, p = <.0001). CONCLUSIONS: In these healthy UK children with below average reading ability, concentrations of DHA and other Omega-3 LC-PUFA were low relative to adult cardiovascular health recommendations, and directly related to measures of cognition and behavior. These findings require confirmation, but suggest that the benefits from dietary supplementation with Omega-3 LC-PUFA found for ADHD, Dyspraxia, Dyslexia, and related conditions might extend to the general school population.

Docosahexaenoic acid for reading, cognition and behavior in children aged 7-9 years: a randomized, controlled trial (the DOLAB Study).

BACKGROUND: Omega-3 fatty acids are dietary essentials, and the current low intakes in most modern developed countries are believed to contribute to a wide variety of physical and mental health problems. Evidence from clinical trials indicates that dietary supplementation with long-chain omega-3 may improve child behavior and learning, although most previous trials have involved children with neurodevelopmental disorders such as attention-deficit/hyperactivity disorder (ADHD) or developmental coordination disorder (DCD). Here we investigated whether such benefits might extend to the general child population. OBJECTIVES: To determine the effects of dietary supplementation with the long-chain omega-3 docosahexaenoic acid (DHA) on the reading, working memory, and behavior of healthy schoolchildren. DESIGN: Parallel group, fixed-dose, randomized, double-blind, placebo-controlled trial (RCT). SETTING: Mainstream primary schools in Oxfordshire, UK (n = 74). PARTICIPANTS: Healthy children aged 7-9 years initially underperforming in reading (≤ 33(rd) centile). 1376 invited, 362 met study criteria. INTERVENTION: 600 mg/day DHA (from algal oil), or taste/color matched corn/soybean oil placebo. MAIN OUTCOME MEASURES: Age-standardized measures of reading, working memory, and parent- and teacher-rated behavior. RESULTS: ITT analyses showed no effect of DHA on reading in the full sample, but significant effects in the pre-planned subgroup of 224 children whose initial reading performance was ≤ 20(th) centile (the target population in our original study design). Parent-rated behavior problems (ADHD-type symptoms) were significantly reduced by active treatment, but little or no effects were seen for either teacher-rated behaviour or working memory. CONCLUSIONS: DHA supplementation appears to offer a safe and effective way to improve reading and behavior in healthy but underperforming children from mainstream schools. Replication studies are clearly warranted, as such children are known to be at risk of low educational and occupational outcomes in later life. TRIAL REGISTRATION: ClinicalTrials.gov NCT01066182 and Controlled-Trials.com ISRCTN99771026.