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11 February 2012
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| [ Print-friendly version ] |
| Impact of an infant sleep parenting intervention at age 6 months on infant sleep problems at ages 6 to 12 months and maternal psychological and physical wellbeing |
| ISRCTN | ISRCTN48752250 |
| ClinicalTrials.gov identifier | |
| Public title | Impact of an infant sleep parenting intervention at age 6 months on infant sleep problems at ages 6 to 12 months and maternal psychological and physical wellbeing |
| Scientific title | Impact of an infant sleep parenting intervention at age 6 months on infant sleep problems at ages 6 to 12 months and maternal psychological and physical wellbeing: a cluster controlled trial |
| Acronym | ISS - Infant Sleep Study / KIDS - Kids Sleep Study |
| Serial number at source | NHMRC 237120; ACTRN12607000036415 |
| Study hypothesis |
Sleep problems (e.g. frequent night waking) in babies aged 6 to 12 months and impact of treating problems on maternal psychological and physical wellbeing.
1. A brief behavioural intervention delivered by Maternal and Child Health (MCH) nurses will lead to the following outcomes: 1.1. Decreased prevalence of infant sleep problems (3 months after treatment) 1.2. Improved infant sleep patterns (3 months after treatment) 1.3. Improved wellbeing for mothers with initial scores indicative of postnatal depression (3 months after treatment) 1.4. Sustained improvement in maternal wellbeing and infant sleep patterns (5 months after treatment) 2. A structured training and education package emphasising simple behavioural management strategies will lead to a sustained increase in knowledge, competence and confidence of MCH nurses in addressing sleep problems in 8-10 month infants Added 23/06/10: KIDS: Kids Sleep Study: Long-term outcomes and impacts on mental and physical health at age 6 of a randomised controlled trial of a behavioural sleep intervention delivered at 8-months - A follow up study, which ran from 01/04/09 to 31/12/09, was added to this trial called KIDS (all updates pertaining to the follow up study will be headed with the title KIDS) with the following hypotheses: In a cohort of children drawn from the pre-existing Infant Sleep Study RCT, we hypothesise that: 1. At child age 6 there will be no meaningful differences between intervention and control groups in: 1.1. Current child sleep problems 1.2. Child emotional and behaviour problems 1.3. Maternal depression 1.4. Child stress as measured by salivary cortisol and glycosylated haemoglobin and 1.5. Disengaged neglectful parenting style and children’s disinhibited attachment; proxies for child attachment to the primary caregiver 2. Overweight/obesity at age 6 will be predicted by: 2.1. Group membership (i.e. intervention versus control groups), or 2.2. Shorter sleep duration at ages 12 and/or 24 months, regardless of group membership |
| Lay summary | Not provided at time of registration |
| Ethics approval | Ethics in Human Research Committee, Royal Children’s Hospital (ref: EHRC 23067B, for KIDS follow up ref: EHRC 28137F) |
| Study design | Randomised controlled trial with long term follow up |
| Countries of recruitment | Australia |
| Disease/condition/study domain |
ISS: Paediatric sleep problems
KIDS: Long-term effects of a behavioural sleep intervention |
| Participants - inclusion criteria |
Families recruited were attending community well-child clinics across six Melbourne local government areas when infants were 4 months postpartum in October/November 2003. Families were recruited from a broad sociodemographic sample. Infants whose parents reported a problem with their sleep at 7 - 8 months were then eligible to take part in this trial.
KIDS: All families who participated in the original Infant Sleep Study (n=328) |
| Participants - exclusion criteria |
Mothers with insufficient English to complete brief written questionnaires
KIDS: Children diagnosed with intellectual disability or autism since turning 2 years old (n=2) |
| Anticipated start date | 10/10/2003 |
| Anticipated end date | 31/08/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | Target sample size 270. Recruitment status achieved N = 328 (KIDS: Target sample size 200. Recruitment status achieved N = 225 of eligible 326) |
| Interventions |
Cluster randomised controlled trial, cluster at the level of the well-child centre. Masking occurred at randomisation, with group allocation concealed from researchers and participants until allocation was complete.
Arm A: Behavioural interventions to manage frequent night waking and/or difficulty settling to sleep including controlled crying, camping out and advice on how to manage overnight feeding and dummies (pacifiers). Strategies were delivered by maternal and child health nurses over 2 to 3 visits (initial visit 30-60 minutes, subsequent visits 10-15 minutes). Arm B: Usual care from maternal and child health nurses who provide a universal and free surveillance service to Melbourne families in the first 5 years of life (active control). KIDS study contact details: Ms Anna Price Centre for Community Child Health Royal Children's Hospital Flemington Road Parkville Melbourne 3052 Australia +61 (0)3 9345 6355 anna.price@mcri.edu.au |
| Primary outcome measure(s) |
Maternal report of an infant sleep problem at ages 10 and 12 months
KIDS: Child emotional and behaviour problems |
| Secondary outcome measure(s) |
Maternal psychological and physical wellbeing, maternal sleep quantity and quality at ages 10 and 12 months
KIDS: Child stress, child sleep habits and problems, maternal psychological wellbeing and parenting style |
| Sources of funding |
National Health and Medical Research Council (NHMRC) (Australia) (ref: 237120)
KIDS: 1. Foundation for Children (Australia) - Project Grant 2009 2. University of Melbourne (Australia) - Melbourne Research Scholarship |
| Trial website | http://www.rch.org.au/ccch/research.cfm?doc_id=10629 |
| Publications |
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17158146
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18762495 3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21402578 |
| Contact name | Dr Harriet Hiscock |
| Address |
Centre for Community Child Health
Royal Children's Hospital Flemington Road Parkville |
| City/town | Melbourne |
| Zip/Postcode | 3052 |
| Country | Australia |
| Tel | +61 (0)3 9345 6150 |
| Fax | +61 (0)3 9345 5900 |
| harriet.hiscock@rch.org.au | |
| Sponsor | Murdoch Children's Research Institute (Australia) |
| Address |
Royal Children's Hospital
Flemington Road Parkville |
| City/town | Melbourne |
| Zip/Postcode | 3052 |
| Country | Australia |
| Tel | +61 (0)3 8341 6211 |
| Fax | +61 (0)3 9348 1391 |
| julia.malone@mcri.edu.au | |
| Date applied | 07/09/2004 |
| Last edited | 14/07/2011 |
| Date ISRCTN assigned | 04/11/2004 |
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