|
ISRCTN
|
ISRCTN63834603
|
|
DOI
|
10.1186/ISRCTN63834603
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
Baby Business: the first few months of life
|
|
Scientific title
|
The impact of a brief universal parenting program to prevent early infant sleep and cry problems and associated parental depression: a randomised controlled trial
|
|
Acronym
|
N/A
|
|
Serial number at source
|
28130B
|
|
Study hypothesis
|
It is hypothesised that in comparison to the control group, the Baby Business intervention will result in fewer infant crying and sleeping problems, and secondarily, will result in reduced post-natal depression.
It is also predicted that this in turn, will reduce health service costs related to management of infant crying and sleep problems.
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
1. Royal Children's Hospital Human Research Ethics Committee approved on the 5th January 2009 (ref: 28130B)
2. Department of Education and Early Childhood Development Early Childhood Research Committee approved on the 10th December 2009
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Australia
|
|
Disease/condition/study domain
|
Early infant sleep and cry problems
|
|
Participants - inclusion criteria
|
Families of newborn infants in the local government areas of Yarra, Brimbank and Wyndham (all based around Melbourne, Australia).
|
|
Participants - exclusion criteria
|
1. Parents of infants who were born at less than 32 weeks gestation
2. Parents of infants with a severe health problem
3. Parents who cannot read, write or speak English well enough to complete questionnaires, a telephone call and a group session
|
|
Anticipated start date
|
15/02/2010
|
|
Anticipated end date
|
15/06/2011
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
750
|
|
Interventions
|
Maternal child health nurses will approach all parents at the first postnatal home visit (which usually takes place at infant age 1 - 2 weeks) and invite them to participate. All participating primary care-givers will complete a baseline questionnaire including socio-demographic data, infant details (birth weight, birth order, gender, date of birth), feeding method (breast, formula, combination of breast/formula) and whether the infant’s sleep or crying is a problem. Both parents will be encouraged to take part in the study.
Baby Business Intervention:
Parents in the intervention group will be offered a brief parenting intervention in addition to their usual post-natal care. The intervention will consist of:
1. A parenting booklet and DVD
2. A telephone consultation when the infant is 3 - 7 weeks old, followed by
3. A group parenting session at a local maternal child health centre for all parents when their infant is 8 - 12 weeks old
The intervention will focus on normal infant sleep and crying and ways to encourage infants to self-soothe. It will aim to address all concerns raised by parents. Appropriate referrals to other services will be organised if necessary. The intervention will be performed by a member of the research team who is a health professional with expertise in managing maternal and infant health issues in the first few months of life.
Control Group:
Parents in the control group will receive usual post-natal health care.
All parents will complete follow up questionnaires addressing infant sleep and cry problems and parental wellbeing when their infants turn 4 and 6 months of age.
|
|
Primary outcome measure(s)
|
Infant sleep and crying problems as reported by the parents and as recorded in a 72 hour baby diary.
|
|
Secondary outcome measure(s)
|
1. Postnatal depression (Edinburgh Postnatal Depression Scale [EPDS])
2. Costs associated with seeking external help for infant sleep and cry problems and parental depression
Both will be measured when the babies reach 4 and then 6 months of age.
|
|
Sources of funding
|
1. Department of Education and Early Childhood Development (Australia)
2. The Scobie and Claire MacKinnon Trust (Australia)
|
|
Trial website
|
|
|
Publications
|
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22309617
|
|
Contact name
|
Dr
Harriet
Hiscock
|
|
Address
|
Royal Children's Hospital
Centre for Community Child Health
Flemington Road
|
|
City/town
|
Parkville
|
|
Zip/Postcode
|
3052
|
|
Country
|
Australia
|
|
Tel
|
+61 (0)3 9345 6910
|
|
Fax
|
+61 (0)3 9345 5900
|
|
Email
|
harriet.hiscock@rch.org.au
|
|
Sponsor
|
Murdoch Childrens Research Institute (MCRI) (Australia)
|
|
Address
|
Flemington Road
|
|
City/town
|
Parkville
|
|
Zip/Postcode
|
3052
|
|
Country
|
Australia
|
|
Tel
|
+61 (0)3 8341 6200
|
|
Fax
|
+61 (0)3 9348 1391
|
|
Email
|
mcri@mcri.edu.au
|
|
Sponsor website:
|
http://www.mcri.edu.au
|
|
Date applied
|
17/05/2010
|
|
Last edited
|
30/07/2012
|
|
Date ISRCTN assigned
|
14/07/2010
|
