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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
DOI 10.1186/ISRCTN48752250
ClinicalTrials.gov identifier
EudraCT number
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
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22966034
5. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22748447
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
  Email 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
  Email julia.malone@mcri.edu.au
Date applied 07/09/2004
Last edited 28/01/2013
Date ISRCTN assigned 04/11/2004
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