Condition category
Signs and Symptoms
Date applied
17/05/2010
Date assigned
14/07/2010
Last edited
30/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Harriet Hiscock

ORCID ID

Contact details

Royal Children's Hospital
Centre for Community Child Health
Flemington Road
Parkville
3052
Australia
+61 (0)3 9345 6910
harriet.hiscock@rch.org.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

28130B

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

15/02/2010

Overall trial end date

15/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Families of newborn infants in the local government areas of Yarra, Brimbank and Wyndham (all based around Melbourne, Australia).

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

750

Participant 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

Recruitment start date

15/02/2010

Recruitment end date

15/06/2011

Locations

Countries of recruitment

Australia

Trial participating centre

Royal Children's Hospital
Parkville
3052
Australia

Sponsor information

Organisation

Murdoch Childrens Research Institute (MCRI) (Australia)

Sponsor details

Flemington Road
Parkville
3052
Australia
+61 (0)3 8341 6200
mcri@mcri.edu.au

Sponsor type

Research organisation

Website

http://www.mcri.edu.au

Funders

Funder type

Government

Funder name

Department of Education and Early Childhood Development (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Scobie and Claire MacKinnon Trust (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22309617

Publication citations

  1. Protocol

    Cook F, Bayer J, Le HN, Mensah F, Cann W, Hiscock H, Baby Business: a randomised controlled trial of a universal parenting program that aims to prevent early infant sleep and cry problems and associated parental depression., BMC Pediatr, 2012, 12, 13, doi: 10.1186/1471-2431-12-13.

Additional files

Editorial Notes