Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000222842
Ethics application status
Approved
Date submitted
7/02/2012
Date registered
22/02/2012
Date last updated
10/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
An Antenatal Resilience and Optimism Workshop on Postnatal Depressive Symptoms
Scientific title
Pregnant women in Indonesia, attending an Antenatal Resilience and Optimism Workshop, to reduce postnatal depression symptoms?
Secondary ID [1] 279906 0
Nil
Universal Trial Number (UTN)
U1111-1126-5428
Trial acronym
Resilience & Optimism Workshop (ROW)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal Depression 285907 0
Condition category
Condition code
Reproductive Health and Childbirth 285977 285977 0 0
Childbirth and postnatal care
Mental Health 285978 285978 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Resilience and Optimism Workshop (ROW).

This intervention is a 2-day consecutive workshop, each day starts at 8.30am - 4pm with 1 hour lunch break and two 15 minute coffee breaks in the morning and afternoon.

The workshop will be facilitated by a clinical psychologist who is the author of the ROW intervention (Josephine Ratna). Josephine is an experienced clinical psychologist who speaks English and Bahasa Indonesia. The intervention will include group disscussion, activities, role play and brain storming activities for pregnant women who are at least in their second trimester of pregnancy. Topics cover empowerment, resilience, and optimistic thinking will be developed in consultation with a clinical psychologst, Obstetrician/ Gynaecologist, a nurse and a psychiatrist, taking into account suggestions from previous studies and relevant programs, as well as specific cultural issues and myths.

The workshop will use examples and hypothetical situations that are common but specifically challenging for pregnant women e.g. what if they deliver a child who has a developmental delay; what if their husband or close family member can not attend the birth; what to do if the child is struggling when do you intervene to get help rather than watch and wait a child that is struggling, what actions can be taken to gather extra support while the family is trying to meet the needs of a difficult child. ROW will be specifically designed for the purpose of preventing postnatal depressive symptoms, emphasising efforts to increase individual resilience in the mother and the family, and optimism based activities based on previous research studies and activity outcomes.

Participants will receive a booklet which describes key themes (pregnancy, changes, depression, protective and risk factors, attributions - optimism vs pessimism, resilience, support systems and cultural aspects of childbirth and caring and caring for a new baby). There will be sections for critical reflection, individual and group learning activities (including possible implementations in a personal context) to complete and inspirational quotations.
Intervention code [1] 284199 0
Prevention
Intervention code [2] 284218 0
Lifestyle
Intervention code [3] 284219 0
Behaviour
Comparator / control treatment
Standard Control Group. The control participants will receive the active ROW intervention 6 weeks after the intervention group has completed their intervention. At this time the control group will be appoximately 4.5 - 7 months pregnant.
Control group
Active

Outcomes
Primary outcome [1] 286439 0
Score on Attributional Style Questionnaire
Timepoint [1] 286439 0
At baseline, post-intervention, 6-weeks after intervention, 6 months after intervention
Primary outcome [2] 286440 0
Score on Depression, Anxiety and Stress Scale
Timepoint [2] 286440 0
At baseline, post-intervention, at 6 weeks and 6 months after intervention completion.
Primary outcome [3] 286441 0
Score on Edinburg Postnatal Depression Scale
Timepoint [3] 286441 0
6 months after intervention
Secondary outcome [1] 295895 0
Score on Connor-Davidson Resilience Scale
Timepoint [1] 295895 0
At baseline, post-intervention, 6-weeks after intervention, 6 months after intervention
Secondary outcome [2] 295897 0
Score on Self-Report Questionnaire
Timepoint [2] 295897 0
At baseline, post-intervention, 6-weeks after intervention, 6 months after intervention
Secondary outcome [3] 295898 0
Score on Quality of Life Enjoyment and Satisfaction Questionnaire
Timepoint [3] 295898 0
At baseline, post-intervention, 6-weeks after intervention, 6 months after intervention

Eligibility
Key inclusion criteria
Women at least in their second trimester of pregnancy who agree to participate fully in antenatal and postnatal activities, complete the consent form, are not in high risk pregnancy condition (evaluation made by the Obstetrician/ Gynecologist), do not indicate clinical psychopathologies (anxiety, depression and psychosis) and deliver life born babies.
Minimum age
15 Years
Maximum age
59 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pre-eclampsia, potential miscarriage due to frequent bleeding, or recurrent pregnancy loss and clinical depression/anxiety and psychosis as per latest antenatal check-up

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pregnant women attending antenatal care at 8 primary health care clinics in Surabaya (East Java) - will be recruited. After completing the pre-tests, clinics will be randomly allocated to one of two groups. The random allocation will be performed by our statistician who will be blind to the identity (intervention or control) of the two groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After completing the pre-tests, clinics (rather than participants) will be randomly allocated to either an intervention or a wait-list control group with the proviso that there are four clinics from each city in each group. The online randomizer at http://www.randomizer.org/form.htm will be used to accomplish this.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 4105 0
Indonesia
State/province [1] 4105 0
N/A
Country [2] 4106 0
Indonesia
State/province [2] 4106 0
East Java

Funding & Sponsors
Funding source category [1] 284646 0
University
Name [1] 284646 0
Curtin University
Country [1] 284646 0
Australia
Funding source category [2] 284648 0
Government body
Name [2] 284648 0
AusAID - using the Australian Leaderhip Awards (ALA) Study Enrichment Allowance
Country [2] 284648 0
Australia
Funding source category [3] 284665 0
Self funded/Unfunded
Name [3] 284665 0
Josephine Ratna
Country [3] 284665 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Psychology and Speech Pathology
GPO Box U1987
Perth, Western Australia 6845
Country
Australia
Secondary sponsor category [1] 283555 0
Government body
Name [1] 283555 0
AusAID using the Australian Leadership Award (ALA) Study Enrichment Allowance
Address [1] 283555 0
Curtin University
International Sponsored Student Unit
Curtin international, building 103
GPO Box U1987
Perth Western Australia 6845
Country [1] 283555 0
Australia
Other collaborator category [1] 260517 0
Individual
Name [1] 260517 0
Josephine M J Ratna
Address [1] 260517 0
27 North Lake Road, Alfred Cove, Western Australia 6154
Country [1] 260517 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286641 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 286641 0
/- Office of Research and Development, Curtin University, GPO Box U1987, Perth, WA 6845
Ethics committee country [1] 286641 0
Australia
Date submitted for ethics approval [1] 286641 0
Approval date [1] 286641 0
13/01/2012
Ethics approval number [1] 286641 0
HR164/2011
Ethics committee name [2] 286670 0
Ethics Committee - Ministry of Health Indonesia
Ethics committee address [2] 286670 0
Komisi Etik
Badan Penelitian dan Pengembangan Kesehatan
Jl. Percetakan Negara 29
Jakarta 10560
Ethics committee country [2] 286670 0
Indonesia
Date submitted for ethics approval [2] 286670 0
09/11/2011
Approval date [2] 286670 0
01/03/2012
Ethics approval number [2] 286670 0
KE.01.02/EC/057/2012

Summary
Brief summary
This study will investigate the efficacy of a Resilience and Optimism Workshop (ROW) given to pregnant women as part of their antenatal care. It will involve Primary Health Care in East Java (Surabaya) Indonesia. Eight Primary Health Care (PHC) clinics will be randomly assigned to either an intervention or a wait-list (WL) control group conditions. Eight to twelve pregnant women from each clinic will participate, in total 64 - 96 participants. Pregnant women from clinics receiving the intervention will attend a two day workshop. For the intervention and control groups, measures of depression, anxiety, stress, attributional style, resilience and quality of life will be taken at pre-test, post-test, 6-week follow-up, and 6-month follow-up. The control group will be assessed with the same measures, but will not get the intervention until after the 6-week follow-up. It is hypothesized that, the intervention group will show significant therapeutic changes in outcomes from pre-test to post-test and these changes will be maintained at the 6-week and 6-month follow-ups. If ROW is effective it will be recommended as a regular antenatal care program in Indonesia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33735 0
Address 33735 0
Country 33735 0
Phone 33735 0
Fax 33735 0
Email 33735 0
Contact person for public queries
Name 16982 0
Josephine M J Ratna
Address 16982 0
27 North Lake Road, Alfred Cove, WA 6154
Country 16982 0
Australia
Phone 16982 0
+61451997812
Fax 16982 0
Email 16982 0
ratna.josephine@gmail.com
Contact person for scientific queries
Name 7910 0
Associate Professor Clare Roberts
Address 7910 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987, Perth, WA 6845
Country 7910 0
Australia
Phone 7910 0
+61892667992
Fax 7910 0
Email 7910 0
c.roberts@curtin.edu.au

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

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