The effect of early stimulation on maternal depression: a cluster randomised controlled trial

Aim: To determine the effect of early childhood stimulation with undernourished children and their mothers on maternal depression. Methods: Mothers of 139 undernourished children (weight for age ⩽–1.5 z-scores) aged 9–30 months were recruited from 18 government health centres in the parishes of Kingston, St Andrew, and St Catherine, Jamaica. They received weekly home visits by community health aides for one year. Mothers were shown play activities to do with their child using home made materials, and parenting issues were discussed. Frequency of maternal depressive symptoms was assessed by questionnaire. Child development was also measured. Results: Mothers in the intervention group reported a significant reduction in the frequency of depressive symptoms (b = –0.98; 95% CI –1.53 to –0.41). The change was equivalent to 0.43 SD. The number of home visits achieved ranged from 5 to 48. Mothers receiving ⩾40 visits and mothers receiving 25–39 visits benefited significantly from the intervention (b = –1.84, 95% CI –2.97 to –0.72, and b = –1.06, 95% CI –2.02 to –0.11, respectively) while mothers receiving <25 visits did not benefit. At follow up, maternal depression was significantly negatively correlated with children''s developmental quotient for boys only. Conclusions: A home visiting intervention with mothers of undernourished children, with a primary aim of improving child development, had significant benefits for maternal depression. Higher levels of maternal depression were associated with poorer developmental levels for boys only.     

Improving infant sleep and maternal mental health: a cluster randomised trial.

OBJECTIVES: To determine whether a community-delivered intervention targeting infant sleep problems improves infant sleep and maternal well-being and to report the costs of this approach to the healthcare system. DESIGN: Cluster randomised trial. SETTING: 49 Maternal and Child Health (MCH) centres (clusters) in Melbourne, Australia. PARTICIPANTS: 328 mothers reporting an infant sleep problem at 7 months recruited during October-November 2003. INTERVENTION: Behavioural strategies delivered over individual structured MCH consultations versus usual care. MAIN OUTCOME MEASURES: Maternal report of infant sleep problem, depression symptoms (Edinburgh Postnatal Depression Scale (EPDS)), and SF-12 mental and physical health scores when infants were 10 and 12 months old. Costs included MCH sleep consultations, other healthcare services and intervention costs. RESULTS: Prevalence of infant sleep problems was lower in the intervention than control group at 10 months (56% vs 68%; adjusted OR 0.58 (95% CI: 0.36 to 0.94)) and 12 months (39% vs 55%; adjusted OR 0.50 (0.31 to 0.80)). EPDS scores indicated less depression at 10 months (adjusted mean difference -1.4 (-2.3 to -0.4) and 12 months (-1.7 (-2.6 to -0.7)). SF-12 mental health scores indicated better health at 10 months (adjusted mean difference 3.7 (1.5 to 5.8)) and 12 months (3.9 (1.8 to 6.1)). Total mean costs including intervention design, delivery and use of non-MCH nurse services were 96.93 pounds sterling and 116.79 pounds sterling per intervention and control family, respectively. CONCLUSIONS: Implementing this sleep intervention may lead to health gains for infants and mothers and resource savings for the healthcare system. TRIAL REGISTRATION: Current Controlled Trial Registry, number ISRCTN48752250 [controlled-trials.com] (registered November 2004).     

Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial

ABSTRACT: BACKGROUND: Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 179838 is effective in reducing crying in infants less than 3 months old (<13.0 weeks) with infant colic when compared to placebo. METHODS: Design: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. Participants: 160 breast and formula fed infants less than 3 months old who present either to clinical or community services and meet Wessel's criteria of crying and/or fussing. Intervention: Oral once-daily Lactobacillus reuteri (1x108 cfu) versus placebo for 1 month. Primary outcome: Infant crying/fussing time per 24 hours at 1 month. Secondary outcomes: i) number of episodes of infant crying/fussing per 24 hours and ii) infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months); iii) maternal mental health scores, iv) family functioning scores, v) parent quality adjusted life years scores, and vi) intervention cost-effectiveness (at 1 and 6 months); and vi) infant faecal microbiota diversity, vii) infant faecal calprotectin levels and viii) Eschericia coli load (at 1 month only). Analysis: Primary and secondary outcomes for the intervention vs. control groups will be compared with t tests and non-parametric tests for continuous, normally distributed data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied. DISCUSSION: An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If cost-effective, the intervention's simplicity is such that it could be widely taken up as a new standard of care in the primary and secondary care sectors.Trial RegistrationCurrent Controlled Trials ISRCTN95287767.     

Paraprofessional home visitation program to prevent childhood unintentional injuries in low-income communities: a cluster randomized controlled trial

OBJECTIVE: To investigate the effectiveness of a paraprofessional home visitation program (HVP) to improve home safety and prevent injuries among children living in low-income settings. METHODS: The HVP was implemented in two low-income communities in South Africa. In each community, approximately 200 households were randomly selected for the trial. Eligible households were those with children aged < or = 10 years. Intervention households received four visits, one every two weeks, by trained paraprofessionals that focused on a specific injury topic and consisted of: information dissemination about specific injury prevention practices; home inspection accompanied by information about home hazards; and the supply of safety devices. The key outcomes to measure the presence of home hazards were scores for burns (safety practices, paraffin, and electrical), poisoning, and falls. RESULTS: Significant reductions were found for injury risks related to burn safety practices. For injury risks related to electrical burns, paraffin burns, and poisoning, a decline was also noted although this was not statistically significant. No decline was noted for fall-related risks. CONCLUSIONS: Subject to further replication and evaluation, home visits by paraprofessionals providing safety education, home inspection, and safety devices be considered for integration into a comprehensive child injury prevention strategy in low-income communities.     

The relative efficacy of two brief treatments for sleep problems in young learning disabled (mentally retarded) children: a randomised controlled trial.

BACKGROUND: Settling and night waking problems are particularly prevalent, persistent, and generally considered difficult to treat in children with a learning disability, although intervention trials are few. Scarce resources, however, limit access to proven behavioural treatments. AIMS: To investigate the efficacy of a media based brief behavioural treatment of sleep problems in such children by comparing (1) face-to-face delivered treatment versus control and (2) booklet delivered treatment versus controls. METHODS: The parents of 66 severely learning disabled children aged 2-8 years with settling and/or night waking problems took part in a randomised controlled trial with a wait-list control group. Behavioural treatments were presented either conventionally face-to-face or by means of a 14 page easy to read illustrated booklet. A composite sleep disturbance score was derived from sleep diaries kept by parents. RESULTS: Both forms of treatment were almost equally effective compared with controls. Two thirds of children who were taking over 30 minutes to settle five or more times per week and waking at night for over 30 minutes four or more times per week improved on average to having such settling or night waking problems for only a few minutes or only once or twice per week (H = 34.174, df = 2, p<0.001). These improvements were maintained after six months. CONCLUSIONS: Booklet delivered behavioural treatments for sleep problems were as effective as face-to-face treatment for most children in this population.     

Routine examination of the newborn and maternal satisfaction: a randomised controlled trial

OBJECTIVE: To determine whether the routine examination of the newborn by a midwife compared with a junior paediatrician (SHO) affects maternal satisfaction with this examination. METHODS: Randomised controlled trial: 826 mother and baby pairs in a district general hospital in south east England were randomised to a paediatric SHO or a midwife for the routine newborn examination. Maternal satisfaction with the examination was analysed in relation to intervention group, process, and background variables. RESULTS: Some 81% of mothers reported that they were satisfied or very satisfied with the newborn examination. Mothers assigned to a midwife were more satisfied with the newborn examination (crude odds ratio (OR) 0.54 (95% confidence interval (CI) 0.39 to 0.75), p < 0.001). However, after provision of health education during the examination, continuity of care provided, and history of miscarriage had been controlled for, status of examiner was no longer related to maternal satisfaction (adjusted OR 0.82 (95% CI 0.57-1.20), NS). The discussion of healthcare issues by the examiner (adjusted OR 0.49 (95% CI 0.34 to 0.70), p < 0.001) and continuity of care (adjusted OR 0.43 (95% CI 0.23 to 0.81), p < 0.01) were both related to enhanced satisfaction, and history of miscarriage (adjusted OR 1.61 (1.08 to 2.40), p < 0.05) was associated with lower maternal satisfaction with the newborn examination. Midwives (61%) were more likely than SHOs (33%) to discuss healthcare issues, such as feeding, sleeping, and skin care. CONCLUSIONS: Mothers were more likely to be satisfied with the newborn examination by a midwife than an SHO because midwives were more likely to discuss healthcare issues during the examination and were able to provide continuity of care. However, midwife examinations according to exclusion criteria agreed with trial midwives excluded half of all newborns, and criteria may have to be reconsidered for practice implementation.     

Randomised controlled trial of a parenting intervention in the voluntary sector for reducing child conduct problems: outcomes and mechanisms of change

BACKGROUND: To test effectiveness of a parenting intervention, delivered in a community-based voluntary-sector organisation, for reducing conduct problems in clinically-referred children. METHODS: Randomised controlled trial, follow-up at 6, 18 months, assessors blind to treatment status. Participants--76 children referred for conduct problems, aged 2-9, primarily low-income families, randomised to treatment vs. 6-month wait-list group. Retention was 93% at 6 months, 90% at 18 months. Interventions--Webster-Stratton Incredible Years video-based 14-week group programme, teaches cognitive-behavioural principles for managing behaviour, using a collaborative, practical, problem-solving approach. Primary outcomes--child problem behaviour by parent-report (Eyberg) and home-based direct observation; secondary outcomes--observed positive and negative parenting; parent-reported parenting skill, confidence and depression. RESULTS: Post-treatment improvements were found in child problem behaviour, by parent-report (effect size (ES) .48, p = .05) and direct observation (ES .78, p = .02); child independent play (ES .77, p = .003); observed negative (ES .74, p = .003) and positive (ES .38, p = .04) parenting; parent-reported confidence (ES .40, p = .03) and skill (ES .65, p =.01), using ANCOVA to control for baseline scores. Maternal depression did not change. Consumer satisfaction was high. At 18-month follow-up, although no randomised comparison was possible, changes appeared to maintain, with no significant change toward baseline level on any measure. Change in observed positive parenting appeared to mediate change in child problem behaviour (p < .025). CONCLUSIONS: Findings suggest that a group-based cognitive-behavioural parenting programme, delivered by well-trained and supervised staff, can be effective in a community voluntary-sector setting, for reducing conduct problems and enhancing parenting skills. Change in parenting skill appears to be a key mechanism for change in child behaviour. Findings have implications for feasibility of translating evidence-based programmes, even for clinically-referred conduct problems, into less specialised community settings, likely to have lower costs and be more accessible for families.     

Effects of maternal vitamin B12 supplementation on early infant neurocognitive outcomes: a randomized controlled clinical trial

Maternal nutritional status during pregnancy impacts fetal brain development. Vitamin B12 plays a vital role in neuronal development. However, findings from studies on the association between maternal B12 status and child cognitive functions have been inconsistent. We performed a randomized, placebo‐controlled clinical trial of oral B12 supplementation (50 µg) beginning at <14 weeks of gestation through a 6‐week post‐partum. In the present study, we report the effects of maternal B12 supplementation on cognitive development in infants at 9 months of age on Bayley Scales of Infant Development‐III (BSID‐III). One hundred eighty‐three pregnant women received vitamin B12, and 183 received placebo. Nine‐month BSID‐III development score was available in 178 infants. There were no significant differences in maternal sociodemographic characteristics and baseline biochemical measures between infants who underwent BSID‐III evaluation and infants who were not evaluated. There were no significant differences in any of the subscales of BSID‐III between infants born to mothers who received B12 supplementation (n = 78) vs. placebo (n = 100). On multiple regression analysis, elevated maternal total homocysteine (tHcy) levels adjusted for treatment group, birthweight, parity, income and home environment at second trimester of pregnancy were significantly negatively associated with expressive language (β = 3.13 points, P < 0.001), and in third trimester of pregnancy with expressive language (β = ?2.29 points, P < 0.001) and fine motor (β = ?1.41 points, P = 0.005) domains of BSID‐III. While no significant effects of maternal B12 supplementation were seen on cognitive development in infants at 9 months of age, elevated maternal tHcy levels were associated with poorer cognitive performance in some of the subdomains of BSID‐III. In pregnant women with elevated tHcy levels and or B12 deficiencies, it may be worthwhile to study the impact of longer term maternal supplementation on infant cognitive outcomes.