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Baby Business: the first few months of life

The impact of a brief universal parenting program to prevent early infant sleep and cry problems and associated parental depression: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN63834603
Enrollment
750
Registered
2010-07-14
Start date
2010-02-15
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early infant sleep and cry problems Signs and Symptoms Early infant sleep and cry problems

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

Sponsors

Murdoch Childrens Research Institute (MCRI) (Australia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Infant sleep and crying problems as reported by the parents and as recorded in a 72 hour baby diary.

Secondary

MeasureTime frame
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.

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026