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Trial registered on ANZCTR


Registration number
ACTRN12612000813886
Ethics application status
Approved
Date submitted
30/07/2012
Date registered
3/08/2012
Date last updated
3/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of behavioural interventions for infant sleep disturbance.
Scientific title
A randomised controlled trial of behavioural interventions for infants with sleep disturbance: effect on sleep, parental and infant stress and attachment.
Secondary ID [1] 280930 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disorder 287022 0
Condition category
Condition code
Other 287351 287351 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 285364 0
Behaviour
Intervention code [2] 285389 0
Treatment: Other
Comparator / control treatment
Sleep Education (educating parents about infants' average nocturnal sleep time, individual difference in sleep obtained, sleep architecture (eg, sleep stages) and napping). Administered in a single 50-minute session on an individual basis.
Control group
Active

Outcomes
Primary outcome [1] 287619 0
Sleep (including sleep onset latency and wake after sleep onset, both in minutes; and the number of nocturnal awakenings). Outcome assessed with parent-completed 7-day sleep diaries of their infant's sleep, as well as a activity monitor worn on the infant's ankle.
Timepoint [1] 287619 0
Pre-treatment, 1 week after beginning treatment, 1 month after, 3 months after and 12 months after.
Secondary outcome [1] 298538 0
Infant stress (salivary cortisol).
Timepoint [1] 298538 0
pre-treatment, 1 week-, 1 month-, 3 months- and 12 months after treatment.
Secondary outcome [2] 298540 0
Parental (self-reported) stress, as measured by the Stress subscale of the Depression Anxiety Stress Scale (Short Form).
Timepoint [2] 298540 0
pre-treatment, 1 week-, 1 month-, 3 months- and 12 months after treatment.

Eligibility
Key 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.
Minimum age
6 Months
Maximum age
15 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Atypically developing infants (physical and mental); clinical levels of maternal post-natal depression.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised block scheduling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285711 0
Charities/Societies/Foundations
Name [1] 285711 0
Australian Rotary Health Fund
Country [1] 285711 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 284541 0
University
Name [1] 284541 0
University of Adelaide
Address [1] 284541 0
The University of Adelaide
SA 5005
Country [1] 284541 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34500 0
Address 34500 0
Country 34500 0
Phone 34500 0
Fax 34500 0
Email 34500 0
Contact person for public queries
Name 17747 0
Dr Michael Gradisar
Address 17747 0
c/o Flinders University,
School of Psychology,
GPO Box 2100,
Adelaide, SA, 5001
Country 17747 0
Australia
Phone 17747 0
+61 8 8201 2324
Fax 17747 0
Email 17747 0
grad0011@flinders.edu.au
Contact person for scientific queries
Name 8675 0
Dr Michael Gradisar
Address 8675 0
c/o Flinders University,
School of Psychology,
GPO Box 2100,
Adelaide, SA, 5001
Country 8675 0
Australia
Phone 8675 0
+61 8 8201 2324
Fax 8675 0
Email 8675 0
grad0011@flinders.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.