Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000036415
Ethics application status
Approved
Date submitted
25/05/2006
Date registered
11/01/2007
Date last updated
11/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of an Infant Sleep Behavioural Intervention to Treat Infant Sleep Problems on Infant Sleep and Maternal Mental and Physical Health: A Clustered Controlled Trial
Scientific title
Impact of an infant sleep behavioural intervention at age 8 months on infant sleep problems at ages 10 and 12 months and maternal psychological and physical wellbeing: A cluster controlled trial.
Secondary ID [1] 328 0
International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN48752250
Universal Trial Number (UTN)
Trial acronym
ISS - Infant Sleep Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep problems (e.g. frequent night waking) in babies aged 6 to 12 months. 1531 0
Concurrent maternal psychological (depression symptoms) and physical wellbeing which may or may not be related to the infant's sleeping patterns. 1532 0
Condition category
Condition code
Other 1627 1627 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Mental Health 1628 1628 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 (MCH) Nurses over 1 to 3 visits. The initial visit was 30-60 minutes and took place during the routine individual MCH 8-month visit. Subsequent follow-up visits were 10-15 minutes in fortnightly intervals.
Intervention code [1] 1072 0
Behaviour
Comparator / control treatment
Arm B: Usual care from MCH Nurses who provide a universal and free health service to Melbourne families in the first 5 years of life (active control).
Control group
Active

Outcomes
Primary outcome [1] 2246 0
Maternal report of an infant sleep problem when infants turned 10 and 12 months old
Timepoint [1] 2246 0
When infants are 10 and 12 months old (ie approximately 2 and 4 months post randomisation).
Secondary outcome [1] 3920 0
Maternal psychological and physical wellbeing, maternal sleep quantity and quality.
Timepoint [1] 3920 0
When infants turned 10 and 12 months old
Secondary outcome [2] 3921 0
Economic evaluation (cost consequences).
Timepoint [2] 3921 0
When infants turned 10 and 12 months old

Eligibility
Key inclusion criteria
Families recruited were attending community well-child clinics across 6 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 the intervention trial.
Minimum age
0 Years
Maximum age
3 Years
Sex
Can healthy volunteers participate?
No
Key exclusion criteria
Infants born before 32 weeks gestation, mothers with insufficient English to complete brief written questionnaires, and mothers who did not report an infant sleep problem at 7-8 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This was a cluster randomised controlled trial. Families were appraoched by their Maternal and Child Health nurse to take part in the study. Interested families were then cotacted by the research team to obtain informed consent. After all recruitment was complete, Maternal and Child Health centres (and their families) were randomly allocated to the intervention or control arm using a computer generated random number sequences for each Local Geovernment Area. An independent statisticain performed the randomisation and as all families and the researchers were unaware of intervention status at the time of recruitment and consent, allocation concealment was acheived.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerized sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1775 0
Government body
Name [1] 1775 0
National Health & Medical Research Council, Australia. NHMRC grant no. 237120
Country [1] 1775 0
Australia
Primary sponsor type
Individual
Name
DR Harriet Hiscock
Address
Country
Secondary sponsor category [1] 1580 0
None
Name [1] 1580 0
Nil
Address [1] 1580 0
Country [1] 1580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3329 0
Ethics in Human Research Committee, Royal Children’s Hospital
Ethics committee address [1] 3329 0
Ethics committee country [1] 3329 0
Australia
Date submitted for ethics approval [1] 3329 0
Approval date [1] 3329 0
Ethics approval number [1] 3329 0
EHRC 23067B

Summary
Brief summary
The study aims to determine whether a brief, primary-care behavioural intervention, designed to manage infant sleep problems, can improve both infant sleep and symptoms of maternal depression. Up to 45% of parents report a problem with their infant’s sleep in the second six months of life whilst up to 15% of Australian mothers are affected by postnatal depression. There is a strong link between infant sleep problems and postnatal depression. This intervention has the potential to reduce the twin burdens of both sleep problems and postnatal depression and therefore significantly improve the wellbeing of mothers, their children and their families.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35730 0
Address 35730 0
Country 35730 0
Phone 35730 0
Fax 35730 0
Email 35730 0
Contact person for public queries
Name 10261 0
Dr Harriet Hiscock
Address 10261 0
Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville Melbourne VIC 3052
Country 10261 0
Australia
Phone 10261 0
+61 3 93456910
Fax 10261 0
+61 3 93455900
Email 10261 0
[email protected]
Contact person for scientific queries
Name 1189 0
Dr Jordana Bayer
Address 1189 0
Centre for Community Child Health
Royal Children's Hospital
Flemington Road
Parkville Melbourne VIC 3052
Country 1189 0
Australia
Phone 1189 0
+61 3 93457952
Fax 1189 0
+61 3 93455900
Email 1189 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.