Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Harriet Hiscock
ORCID ID
Contact details
Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 9345 6150
harriet.hiscock@rch.org.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NHMRC 237120; ACTRN12607000036415
Study information
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
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 childrens 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
Ethics approval
Ethics in Human Research Committee, Royal Childrens Hospital (ref: EHRC 23067B, for KIDS follow up ref: EHRC 28137F)
Study design
Randomised controlled trial with long term follow up
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
ISS: Paediatric sleep problems
KIDS: Long-term effects of a behavioural sleep intervention
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Maternal report of an infant sleep problem at ages 10 and 12 months
KIDS: Child emotional and behaviour problems
Secondary outcome measures
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
Overall trial start date
10/10/2003
Overall trial end date
31/08/2004
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Child
Gender
Both
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)
Participant 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)
Recruitment start date
10/10/2003
Recruitment end date
31/08/2004
Locations
Countries of recruitment
Australia
Trial participating centre
Centre for Community Child Health
Melbourne
3052
Australia
Sponsor information
Organisation
Murdoch Children's Research Institute (Australia)
Sponsor details
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
+61 (0)3 8341 6211
julia.malone@mcri.edu.au
Sponsor type
Research organisation
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council (NHMRC) (Australia) (ref: 237120)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
Funder name
KIDS:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foundation for Children (Australia) - Project Grant 2009
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Melbourne (Australia) - Melbourne Research Scholarship
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Results
Hiscock H, Bayer JK, Hampton A, Ukoumunne OC, Wake M, Long-term mother and child mental health effects of a population-based infant sleep intervention: cluster-randomized, controlled trial., Pediatrics, 2008, 122, 3, e621-7, doi: 10.1542/peds.2007-3783.
-
Results
Wake M, Price A, Clifford S, Ukoumunne OC, Hiscock H, Does an intervention that improves infant sleep also improve overweight at age 6? Follow-up of a randomised trial., Arch. Dis. Child., 2011, 96, 6, 526-532, doi: 10.1136/adc.2010.196832.
-
Results
Price AM, Wake M, Ukoumunne OC, Hiscock H, Five-year follow-up of harms and benefits of behavioral infant sleep intervention: randomized trial., Pediatrics, 2012, 130, 4, 643-651, doi: 10.1542/peds.2011-3467.
-
Results
Price AM, Wake M, Ukoumunne OC, Hiscock H, Outcomes at six years of age for children with infant sleep problems: longitudinal community-based study., Sleep Med., 2012, 13, 8, 991-998, doi: 10.1016/j.sleep.2012.04.014.
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Hiscock H, Bayer J, Gold L, Hampton A, Ukoumunne OC, Wake M, Improving infant sleep and maternal mental health: a cluster randomised trial., Arch. Dis. Child., 2007, 92, 11, 952-958, doi: 10.1136/adc.2006.099812.