Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PRISM
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Cluster-randomised trial with local government authorities as the unit of randomisation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Postnatal depression and maternal physical health in the year after birth
Intervention
1. Training programme for Maternal and Child Health Nurses
2. Training programme for GPs
3. Mothers' Information Kits
4. Non-professional befriending network (various models)
5. Community Development Officer in each LGA for 2 years
6. Local PRISM steering committee (all participating LGAs agreed prior to randomisation not to implement the specific program elements if randomised to comparison status)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1999
Overall trial end date
31/12/2003
Reason abandoned
Eligibility
Participant inclusion criteria
All women giving birth to a surviving child in 16 participating communities from 6th February 2000 to 6th August 2001 (inclusive)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
11480
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1999
Recruitment end date
31/12/2003
Locations
Countries of recruitment
Australia
Trial participating centre
Director
Carlton
VIC 3053
Australia
Sponsor information
Organisation
La Trobe University (Australia)
Sponsor details
Faculty of Health Sciences
Melbourne
VIC 3086
Australia
+61 (0)3 9479 3583
lhs@latrobe.edu.au
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
La Trobe University Collaborative Industry Grant 1997
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Health and Medical Research Council (Australia), project grants 1997-99, 1999-2001 [# 974083, 990978]
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Department of Human Services (Victoria) 1998-2000
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Victorian Health Promotion Foundation, 1998-2000
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Felton Bequest 1998
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sidney Myer Foundation 1999
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Contributions in kind from participating municipalities
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2003 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/14629776
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16483383
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24586327
Publication citations
-
Protocol
Lumley J, Small R, Brown S, Watson L, Gunn J, Mitchell C, Dawson W, PRISM (Program of Resources, Information and Support for Mothers) Protocol for a community-randomised trial [ISRCTN03464021]., BMC Public Health, 2003, 3, 36, doi: 10.1186/1471-2458-3-36.
-
Results
Lumley J, Watson L, Small R, Brown S, Mitchell C, Gunn J, PRISM (Program of Resources, Information and Support for Mothers): a community-randomised trial to reduce depression and improve women's physical health six months after birth [ISRCTN03464021]., BMC Public Health, 2006, 6, 37, doi: 10.1186/1471-2458-6-37.
-
Results
Small R, Watson L, Gunn J, Mitchell C, Brown S, Improving population-level maternal health: a hard nut to crack? Long term findings and reflections on a 16-community randomised trial in Australia to improve maternal emotional and physical health after birth [ISRCTN03464021]., PLoS ONE, 2014, 9, 2, e88457, doi: 10.1371/journal.pone.0088457.