Condition category
Mental and Behavioural Disorders
Date applied
07/09/2004
Date assigned
04/11/2004
Last edited
28/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.rch.org.au/ccch/research.cfm?doc_id=10629

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 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

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

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes