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 |
| Protocol serial number | NHMRC 237120; ACTRN12607000036415 |
| Sponsor | Murdoch Children's Research Institute (Australia) |
| Funders | National Health and Medical Research Council (NHMRC) (Australia) (ref: 237120), KIDS:, Foundation for Children (Australia) - Project Grant 2009, University of Melbourne (Australia) - Melbourne Research Scholarship |
- 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
Contact information
Dr Harriet Hiscock
Scientific
Scientific
Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia
| Phone | +61 (0)3 9345 6150 |
|---|---|
| harriet.hiscock@rch.org.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial with long term follow up |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | ISS - Infant Sleep Study / KIDS - Kids Sleep Study |
| Study objectives | 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(s) | Ethics in Human Research Committee, Royal Childrens Hospital (ref: EHRC 23067B, for KIDS follow up ref: EHRC 28137F) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Maternal report of an infant sleep problem at ages 10 and 12 months |
| Key secondary outcome measure(s) |
Maternal psychological and physical wellbeing, maternal sleep quantity and quality at ages 10 and 12 months |
| Completion date | 31/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 328 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 10/10/2003 |
| Date of final enrolment | 31/08/2004 |
Locations
Countries of recruitment
- Australia
Study participating centre
Centre for Community Child Health
Melbourne
3052
Australia
3052
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
