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 https://doi.org/10.1186/ISRCTN48752250
Secondary identifying numbers NHMRC 237120; ACTRN12607000036415
Submission date
07/09/2004
Registration date
04/11/2004
Last edited
28/01/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Harriet Hiscock
Scientific

Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia

Phone +61 (0)3 9345 6150
Email harriet.hiscock@rch.org.au

Study information

Study designRandomised controlled trial with long term follow up
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleImpact 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
Study acronymISS - Infant Sleep Study / KIDS - Kids Sleep Study
Study objectivesSleep 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(s)Ethics in Human Research Committee, Royal Children’s Hospital (ref: EHRC 23067B, for KIDS follow up ref: EHRC 28137F)
Health condition(s) or problem(s) studiedISS: Paediatric sleep problems
KIDS: Long-term effects of a behavioural sleep intervention
InterventionCluster 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 typeOther
Primary outcome measureMaternal report of an infant sleep problem at ages 10 and 12 months

KIDS: Child emotional and behaviour problems
Secondary outcome measuresMaternal 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 study start date10/10/2003
Completion date31/08/2004

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participantsTarget sample size 270. Recruitment status achieved N = 328 (KIDS: Target sample size 200. Recruitment status achieved N = 225 of eligible 326)
Key inclusion criteriaFamilies 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)
Key exclusion criteriaMothers with insufficient English to complete brief written questionnaires

KIDS: Children diagnosed with intellectual disability or autism since turning 2 years old (n=2)
Date of first enrolment10/10/2003
Date of final enrolment31/08/2004

Locations

Countries of recruitment

  • Australia

Study participating centre

Centre for Community Child Health
Melbourne
3052
Australia

Sponsor information

Murdoch Children's Research Institute (Australia)
Research organisation

Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia

Phone +61 (0)3 8341 6211
Email julia.malone@mcri.edu.au
ROR logo "ROR" https://ror.org/048fyec77

Funders

Funder type

Research council

National Health and Medical Research Council (NHMRC) (Australia) (ref: 237120)
Government organisation / National government
Alternative name(s)
NHMRC
Location
Australia
KIDS:

No information available

Foundation for Children (Australia) - Project Grant 2009

No information available

University of Melbourne (Australia) - Melbourne Research Scholarship

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2007 Yes No
Results article results 01/09/2008 Yes No
Results article results 01/06/2011 Yes No
Results article results 01/09/2012 Yes No
Results article results 01/10/2012 Yes No