Trial Review

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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
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
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
This study evaluates the sleep, stress and attachment outcomes for infants and parents undergoing behavioural interventions using a randomised controlled design.
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
[email protected]
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
[email protected]

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.