Baby Business: the first few months of life
| ISRCTN | ISRCTN63834603 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63834603 |
| Protocol serial number | 28130B |
| Sponsor | Murdoch Childrens Research Institute (MCRI) (Australia) |
| Funders | Department of Education and Early Childhood Development (Australia), The Scobie and Claire MacKinnon Trust (Australia) |
- 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
Scientific
Royal Children's Hospital
Centre for Community Child Health
Flemington Road
Parkville
3052
Australia
| Phone | +61 (0)3 9345 6910 |
|---|---|
| harriet.hiscock@rch.org.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Infant sleep and crying problems as reported by the parents and as recorded in a 72 hour baby diary. |
| Key secondary outcome measure(s) |
1. Postnatal depression (Edinburgh Postnatal Depression Scale [EPDS]) |
| Completion date | 15/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 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
3052
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2014 | 26/02/2021 | Yes | No |
| Protocol article | protocol | 06/02/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
