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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 000507
ACTR Number: ACTRN12605000567628
Trial Status: Registered
Date Submitted: 11/09/2005
Date Registered: 30/09/2005
Date Last Updated: 19/10/2009
Registration Type: Prospective registered

Page 1

Public title: What Were We Thinking! An innovative psycho-educational intervention for first time mothers, fathers and newborns
ANZCTR registration 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:Mothers, Fathers and Newborns - Preventing Distress and Promoting Confidence 
UTN:
Trial acronym: WWWT!

Page 2

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

Page 3

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:Prevention 
Comparator / control treatment: Control group will recieve current standard postnatal care.
Control group: Active

Page 4

Primary outcome:Diagnosis of depression, anxiety or adjustment disorder on Composite International Diagnostic Interview in the first six months postpartum 
Timepoint:At 6 months postpartum 
Secondary outcome:None 
Timepoint:N/A 

Page 5

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
Gender: Females
Healthy volunteers? No
Key exclusion criteria: No exclusion criteria

Page 6
Study type: Interventional
Purpose of the study: Prevention
Allocation to intervention: Nonrandomised trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded:
Assignment: Other
Other design features (specify): 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
Type of endpoint(s): Efficacy

Page 7
Phase
Anticipated or actual date of first participant enrolement: 6/02/2006
Target sample size: 439
Recruitment status: Completed

Page 8

Funding source:Government funding body e.g. Australian Research Council 
Name:Australian Government Department of Families, Housing, Community Services and Indigenous Affairs 'Invest to Grow' initiative 
Address:Tuggeranong Office Park
Soward Way (cnr Athllon Drive)
Greenway ACT 2900

PO Box 7576
Canberra Business Centre ACT 2610
Canberra, ACT 
Country:Australia 
Primary sponsor: 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:None 
Name:none 
Address: 
Country: 
Other collaborator: 

Page 9

Has the study received approval from at least one ethics committee? Yes
Ethics Committee: 
Countries of recruitment:Australia 
Brief summary:
Trial website:
Presentations / publication list:

Page 10

Contact person for public queries
Name: Dr Heather Rowe
Address: Key Centre for Women's Health in Society Melbourne School of Population Health
University of Melbourne VIC 3010
Country: Australia
Tel: +61 3 8344 0778
Fax:
Email: h.rowe@unimelb.edu.au

Contact person for scientific queries
Name: Heather Rowe
Address: Key Centre for Women's Health in Society Melbourne School of Population Health
University of Melbourne VIC 3010
Country: Australia
Tel: +61 3 8344 0778
Fax:
Email: h.rowe@unimelb.edu.au
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