Baby Business: the first few months of life

ISRCTN	ISRCTN63834603
DOI	https://doi.org/10.1186/ISRCTN63834603
Secondary identifying numbers	28130B

Submission date: 17/05/2010
Registration date: 14/07/2010
Last edited: 26/02/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

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

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

Phone	+61 (0)3 9345 6910
Email	harriet.hiscock@rch.org.au

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	Early infant sleep and cry problems
Intervention	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 infants 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.
Intervention type	Other
Primary outcome measure	Infant sleep and crying problems as reported by the parents and as recorded in a 72 hour baby diary.
Secondary outcome measures	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.
Overall study start date	15/02/2010
Completion date	15/06/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	750
Total final enrolment	781
Key inclusion criteria	Families of newborn infants in the local government areas of Yarra, Brimbank and Wyndham (all based around Melbourne, Australia).
Key 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
Date of first enrolment	15/02/2010
Date of final enrolment	15/06/2011

Locations

Countries of recruitment

Australia

Study participating centre

Royal Children's Hospital

Parkville
3052
Australia

Sponsor information

Murdoch Childrens Research Institute (MCRI) (Australia)
Research organisation

Flemington Road
Parkville
3052
Australia

Phone	+61 (0)3 8341 6200
Email	mcri@mcri.edu.au
Website	http://www.mcri.edu.au
"ROR"	https://ror.org/048fyec77

Funders

Funder type

Government

Department of Education and Early Childhood Development (Australia)

No information available

The Scobie and Claire MacKinnon Trust (Australia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	06/02/2012		Yes	No
Results article	results	01/02/2014	26/02/2021	Yes	No

Editorial Notes

26/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.