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The Effect of an Infant Sleep Behavioural Intervention to Treat Infant Sleep Problems on Infant Sleep and Maternal Mental and Physical Health: A Clustered Controlled Trial

Impact of an infant sleep behavioural intervention at age 8 months on infant sleep problems at ages 10 and 12 months and maternal psychological and physical wellbeing: A cluster controlled trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000036415
Acronym
ISS - Infant Sleep Study
Enrollment
270
Registered
2007-01-11
Start date
2003-08-01
Completion date
Unknown
Last updated
2026-02-04

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

Conditions

None listed

Brief summary

The study aims to determine whether a brief, primary-care behavioural intervention, designed to manage infant sleep problems, can improve both infant sleep and symptoms of maternal depression. Up to 45% of parents report a problem with their infant’s sleep in the second six months of life whilst up to 15% of Australian mothers are affected by postnatal depression. There is a strong link between infant sleep problems and postnatal depression. This intervention has the potential to reduce the twin burdens of both sleep problems and postnatal depression and therefore significantly improve the wellbeing of mothers, their children and their families.

Interventions

Arm A: Behavioural interventions to manage frequent night waking and/or difficulty settling to sleep including controlled crying, camping out, and advice on how to manage overnight feeding and dummies (pacifiers). Strategies were delivered by Maternal and Child health (MCH) Nurses over 1 to 3 visits. The initial visit was 30-60 minutes and took place during the routine individual MCH 8-month visit. Subsequent follow-up visits were 10-15 minutes in fortnightly intervals.

Sponsors

DR Harriet Hiscock
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Age
0 to 3 Years
Healthy volunteers
No

Inclusion criteria

Families recruited were attending community well-child clinics across 6 Melbourne local government areas when infants were 4 months postpartum in October/November 2003. Families were recruited from a broad sociodemographic sample. Infants whose parents reported a problem with their sleep at 7-8 months were then eligible to take part in the intervention trial.

Exclusion criteria

Infants born before 32 weeks gestation, mothers with insufficient English to complete brief written questionnaires, and mothers who did not report an infant sleep problem at 7-8 months.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026