Paediatrics (RCH) - Theses

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End date: 2015 × Subject: child × Subject: cluster randomized controlled trial ×

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    The ‘Kids Sleep Study': effects of an infant sleep intervention at 6 years of age: follow-up of a randomised controlled trial
    Price, Anna Myfanwy Horadam ( 2011)
    BACKGROUND: Behavioural sleep problems in infancy are highly prevalent. They increase the risk of maternal depression symptoms and predict later child sleep problems, which in turn are associated with adverse mental and general health outcomes for children and parents. Controlled trials demonstrate that behavioural sleep techniques effectively reduce infant sleep problems and associated maternal depression symptoms in the short- to medium-term. However, theoretical concerns remain that these techniques harm child-parent attachment and lead to later child emotional and behaviour problems. Although they are yet to be empirically tested, these concerns are potentially causing harm, as are some practitioners who hold these concerns, by discouraging the use of effective behavioural management strategies. The capacity for behavioural techniques to have long-lasting benefits on child, child-parent and maternal outcomes to school-entry age is also unknown, because studies are yet to examine whether early child sleep problems predict these later outcomes. AIMS: Part 1 aimed to determine whether an infant behavioural sleep program caused lasting harms or benefits at child age 6 years (school-entry) to: (1) attachment-related, (2) sleep and (3) maternal mental health outcomes. Part 2 aimed to determine whether early child sleep problems (4, 12 and 24 months) predicted (4) child sleep, and (5) secondary child, child-parent, and maternal outcomes at child age 6 years, after accounting for concurrent child sleep problems. METHODS: This study drew on a pre-existing population-based cluster controlled trial of a behavioural sleep intervention (n=328, ISRCTN48752250), which recruited infants with parent-reported sleep problems at 7 months from six socioeconomically diverse Melbourne (Australia) local government areas. The original study compared an intervention comprising behavioural sleep strategies delivered by well-child nurses at 1-3 individual consultations at child age 8-10 months, with usual care. The current study revisited children and their mothers at child age 6 years with a parent questionnaire and direct assessment in the family home. Part 1 analysed data as a randomised controlled trial follow-up. Based on the results of Part 1, Part 2 pooled trial arms to analyse data as an epidemiological cohort. Aims were analysed using unadjusted and adjusted regression modelling (linear for continuous outcomes, logistic for binary outcomes) controlling for known confounders selected a priori, where possible. RESULTS: Families retained at 6 years (n=225, 69%) were more likely to speak English than those lost to follow-up (84% versus 74%, p=0.03). There was no evidence of attrition bias between groups. Part 1: There was no evidence of a difference between groups for any attachment-related, sleep or maternal mental health outcome. Although power was limited to detect effect sizes ≥0.4 standard deviations between groups, 95% confidence intervals tended to centre on equivalence and there was no pattern of effect across the sample estimates toward harms or benefits. Part 2: Early sleep problems at individual time points (4, 12, 24 months) rarely predicted outcomes at 6 years, but, when measured as an ordinal persistent count (1, 2, 3 or 4 sleep problems at these ages, taking a single sleep problem at 7 months as the reference category), demonstrated an increasing dose-response relationship with later child, child-parent and maternal outcomes, with evidence strongest for child outcomes. CONCLUSION: This brief behavioural sleep intervention was effective in the short- to medium-term and safe to use in the long-term, at least to five years post-intervention. Parents and health professionals can feel confident using and offering behavioural strategies to manage infant sleep in the second six months of life. In a sample selected for infant sleep problems at 7 months, recurring or persistent early child sleep problems predisposed children and their mothers to poorer outcomes at 6 years. Health professionals need to offer, and parents need to be able to access, strategies that adapt to the changing nature of child sleep problems as the child develops.