Condition category
Pregnancy and Childbirth
Date applied
14/01/2003
Date assigned
14/01/2003
Last edited
13/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Judith Lumley

ORCID ID

Contact details

Director
Centre for the Study of Mothers' and Children's Health
La Trobe University
251 Faraday Street
Carlton
VIC 3053
Australia

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

http://www.latrobe.edu.au/health/healthsci_schoolcent.html

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes