Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000567628
Ethics application status
Approved
Date submitted
11/09/2005
Date registered
30/09/2005
Date last updated
19/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
What Were We Thinking! An innovative psycho-educational intervention for first time mothers, fathers and newborns
Scientific title
A non-randomised controlled trial, conducted in sequential consecutive cohorts, to evaluate the effectiveness of a psychoeducational group intervention for first time mothers and fathers of newborn babies, for the prevention of common postpartum mood disorders.
Secondary ID [1] 182 0
Mothers, Fathers and Newborns - Preventing Distress and Promoting Confidence
Universal Trial Number (UTN)
Trial acronym
WWWT!
Linked study record

Health condition
Health condition(s) or problem(s) studied:
common postpartum mental disorders 693 0
Condition category
Condition code
Mental Health 768 768 0 0
Depression
Mental Health 252207 252207 0 0
Anxiety
Mental Health 252208 252208 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psycho-educational intervention is a helf-day seminar conducted by trained facilitator with two components: infant soothing and settling strategies, and language, concepts and skills for re-negotiation of the unpaid workload between couples and adjustment to parenthood
Intervention code [1] 455 0
Prevention
Comparator / control treatment
Control group will recieve current standard postnatal care.
Control group
Active

Outcomes
Primary outcome [1] 977 0
Diagnosis of depression, anxiety or adjustment disorder on Composite International Diagnostic Interview in the first six months postpartum
Timepoint [1] 977 0
At 6 months postpartum
Secondary outcome [1] 1851 0
None
Timepoint [1] 1851 0
N/A

Eligibility
Key inclusion criteria
Participants in this trial will be English-speaking partnered women who have very recently given birth to a first baby. Women low proficiency in speaking and reading English, or who have premature babies or infants admitted to the Special Care Nursery or Neonatal Intensive Care Unit, who have given birth to triplets or higher multiples, or who are not currently partnered will not be recruited to the trial because the nature of the intervention is not appropriate to their needs.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Sequential recruitment of trial arms: 1) recruitment and follow-up of control group, followed immediately by 2) recruitment, intervention and follow-up of intervention group
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
439
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 849 0
Government body
Name [1] 849 0
Australian Government Department of Families, Housing, Community Services and Indigenous Affairs 'Invest to Grow' initiative
Country [1] 849 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Key Centre for Women's Health in Society
Melbourne School of Population Health
University of Melbourne
Victoria 3010
Country
Australia
Secondary sponsor category [1] 717 0
None
Name [1] 717 0
none
Address [1] 717 0
Country [1] 717 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35915 0
Address 35915 0
Country 35915 0
Phone 35915 0
Fax 35915 0
Email 35915 0
Contact person for public queries
Name 9644 0
Dr Heather Rowe
Address 9644 0
Key Centre for Women's Health in Society Melbourne School of Population Health
University of Melbourne VIC 3010
Country 9644 0
Australia
Phone 9644 0
+61 3 8344 0778
Fax 9644 0
Email 9644 0
[email protected]
Contact person for scientific queries
Name 572 0
Heather Rowe
Address 572 0
Key Centre for Women's Health in Society Melbourne School of Population Health
University of Melbourne VIC 3010
Country 572 0
Australia
Phone 572 0
+61 3 8344 0778
Fax 572 0
Email 572 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
SourceTitleYear of PublicationDOI
EmbaseInnovative psycho-educational program to prevent common postpartum mental disorders in primiparous women: a before and after controlled study.2010
N.B. These documents automatically identified may not have been verified by the study sponsor.