Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000063516
Ethics application status
Approved
Date submitted
24/01/2006
Date registered
15/02/2006
Date last updated
22/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of an early parenting intervention on maternal mood and infant behavior disorders
Scientific title
A controlled before-and-after study of an early parenting intervention to reduce maternal mood disorder and infant behaviour disturbance
Secondary ID [1] 262673 0
None
Universal Trial Number (UTN)
Trial acronym
REPIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternal mood disturbance 1024 0
Dysregulated infant behaviour 1025 0
Compromised mother-infant relationship 1026 0
Condition category
Condition code
Mental Health 268512 268512 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The intervention will involve attending and completing a 3 - 5 night residential admission to an early parenting centre with a baby between 3 - 5 months old. This is an observational study of an ongoing intervention and will involve follow-up assessments of participants at 6 and 12 months postpartum.
Intervention code [1] 861 0
Treatment: Other
Comparator / control treatment
The control treatment will be existing standard primary care available to all families with infants.
Control group
Active

Outcomes
Primary outcome [1] 1468 0
Participation in the intervention compared to the control will be associated with a reduction from 25% to 10% in prevalence of maternal depression, anxiety and adjustment disorders at 12 months postpartum. This will be assessed using the Composite International Diagnostic Interview (CIDI) administered at 12 months postpartum with prevalence comparisons made between the intervention and the control arms of the study.
Timepoint [1] 1468 0
12 months postpartum
Secondary outcome [1] 2634 0
Improved infant behaviour and mother-infant relationship.
Timepoint [1] 2634 0
One month after the intervention (infant age 5-6 months) sustained when the infants are 12-months-old.

Eligibility
Key inclusion criteria
All mothers attending immusation clinics or contacting early parenting centres with their 2 – 4 month old infant and scoring 10 or more on the EPDS and reporting behaviour disturbance in their infant will be included.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with insufficient English to complete interviews and written questionnaires.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
226
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1204 0
Government body
Name [1] 1204 0
NHMRC
Country [1] 1204 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Melbourne Research
Level 5, Alan Gilbert Blding,
161 Barry St (Cnr Grattan St)
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 1063 0
University
Name [1] 1063 0
University of Melbourne - pending
Address [1] 1063 0
Melbourne Research
Level 5, Alan Gilbert Blding,
161 Barry St (Cnr Grattan St)
Carlton VIC 3053
Country [1] 1063 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35655 0
Address 35655 0
Country 35655 0
Phone 35655 0
Fax 35655 0
Email 35655 0
Contact person for public queries
Name 10050 0
Professor Jane Fisher
Address 10050 0
Jean Hailes Research Unit, School of Public Health and Preventive Medicine, Monash University, Clayton, 3168
Country 10050 0
Australia
Phone 10050 0
+61 3 9594 7503
Fax 10050 0
Email 10050 0
[email protected]
Contact person for scientific queries
Name 978 0
Professor Jane Fisher
Address 978 0
Jean Hailes Research Unit, School of Public Health and Preventive Medicine, Monash University, Clayton, 3168
Country 978 0
Australia
Phone 978 0
+61 3 9594 7503
Fax 978 0
Email 978 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.