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A randomised controlled trial of behavioural interventions for infant sleep disturbance.

A randomised controlled trial of behavioural interventions for infants with sleep disturbance: effect on sleep, parental and infant stress and attachment.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000813886
Enrollment
60
Registered
2012-08-03
Start date
2007-05-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This study evaluates the sleep, stress and attachment outcomes for infants and parents undergoing behavioural interventions using a randomised controlled design.

Interventions

Graduated Extinction (gradually extending the time between the infants' cry and the parents' response to the infant: response time night 1, 2-6min; night 2, 3-7min; night 3, 5-15min; night 4, 10-20 min; night 5, 15-25 min; night 6, 20-30min; night 7, 25-35min [duration of treatment =1 week]) vs. Bedtime Fading (bedtime restriction therapy: gradually reducing infants' time in bed to more closely match their total sleep time, 15-min changes to bedtime made once per night until desired bedtime is r

Graduated Extinction (gradually extending the time between the infants' cry and the parents' response to the infant: response time night 1, 2-6min; night 2, 3-7min; night 3, 5-15min; night 4, 10-20 min; night 5, 15-25 min; night 6, 20-30min; night 7, 25-35min [duration of treatment =1 week]) vs. Bedtime Fading (bedtime restriction therapy: gradually reducing infants' time in bed to more closely match their total sleep time, 15-min changes to bedtime made once per night until desired bedtime is reached [duration of treatment=1 week]). Parents supported with 24/7 mobile phone support during treatment, when needed.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
6 Months to 15 Months
Healthy volunteers
Yes

Inclusion criteria

Infants identified by their parents as possessing a sleep problem; sleep onset latency > 30 min; wake after sleep onset > 60 min; number of awakenings > 3.

Exclusion criteria

Atypically developing infants (physical and mental); clinical levels of maternal post-natal depression.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026