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Trial registered on ANZCTR


Registration number
ACTRN12613000506796
Ethics application status
Approved
Date submitted
26/04/2013
Date registered
7/05/2013
Date last updated
31/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A brief couple-focussed psychoeducational intervention to prevent postnatal mental health problems in women: a cluster randomised controlled trial
Scientific title
Participation by mothers of first babies in a psycho-educational intervention compared with standard care to prevent postpartum mental health problems
Secondary ID [1] 273448 0
Nil
Universal Trial Number (UTN)
U1111-1125-8208
Trial acronym
SPARCS
(Sleep, Parenting And Relationships in Community Settings)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Episode 279239 0
Generalised Anxiety Disorder






279240 0
Adjustment Disorder with Anxiety or with Depressed mood or with Mixed Anxiety and Depressed mood 279241 0
Agoraphobia with or without Panic 289007 0
Panic Disorder with or without Agoraphobia 289008 0
Social Phobia 289009 0
Adult Separation Anxiety 289010 0
Condition category
Condition code
Mental Health 279441 279441 0 0
Depression
Mental Health 279442 279442 0 0
Anxiety
Public Health 279507 279507 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"What Were We Thinking" (WWWT) is a single day, 6 hour, psycho-educational program for mothers, fathers and their first newborn infants offered in primary care maternal and child health services prior to 8 weeks postpartum. Programs are delivered to groups of 5 - 7 couples and their infant. WWWT addresses two known risk factors for postpartum mental health problems: infant sleep and settling and intimate partner relationship. Content is presented in a variety of formats, including didactic presentations, discussion, completion of worksheets individually or as a couple, practical demonstration and individual practice.
Intervention code [1] 283831 0
Prevention
Comparator / control treatment
Standard Maternal and Child Health care.
All Victorian Maternal and Child Health (MCH) centres offer care to parents and infants according to the Key Ages and Stages Framework. A detailed description of the platform of care is available at http://www.education.vic.gov.au/childhood/parents/mch/Pages/visits.aspx.
Most MCH centres also offer parents of a first infant the opportunity to participate in a First Time Parent group, which consists of one session per week for 6 - 8 weeks. These groups are facilitated by MCH nurses and include topics related to feeding, teething, child safety, settling and toys, but do not address the two key modifyable risk factors addressed by What Were We Thinking.
Control group
Active

Outcomes
Primary outcome [1] 286073 0
30 day prevalence of DSM-IV diagnosis of any of the following conditions: Major Depressive Episode, Generalised Anxiety Disorder, Adjustment Disorder with Anxiety or with Depressed mood or with Mixed Anxiety and Depressed mood, Agoraphobia with or without Panic, Panic Disorder with or without Agoraphobia, Social Phobia, Adult Separation Anxiety
Timepoint [1] 286073 0
Six months postpartum
Secondary outcome [1] 295073 0
1. General and emotional health. This will be assessed by
Demoralisation Scale (Kissane et al., 2004)
Patient Health Questionnaire Depression (Spitzer et al., 1999), Generalised Anxiety Disorder (Spitzer et al., 2007) and Panic Disorder (Spitzer et al., 1999; Spitzer et al., 2000) modules
Fatigue Assessment Scale (FAS; Michielsen et al., 2004, modified by Giallo et al., 2011)
Self rated health question: "In general, would you say your health is: Excellent / Very good / Good / Fair / Poor"

Timepoint [1] 295073 0
Six months postpartum
Secondary outcome [2] 295074 0
2. Unsettled infant behaviours. This will be assessed in two ways:
1. A single validated question about problematic infant sleep (Hiscock, 2001)
2. The number of minutes of infant fussing and crying between 07h00 and 19h00, and between 19h00 and 07h00, during the previous 24 hour period.
Timepoint [2] 295074 0
Six months postpartum
Secondary outcome [3] 297188 0
3. Breastfeeding.
This will be assessed by endorsement of "breast milk" in response to a single fixed-choice question: "What are you feeding your baby at present (in the last 24 hours)? Select all that apply."
Timepoint [3] 297188 0
Six months postpartum
Secondary outcome [4] 297189 0
4. Mother-Infant relationship.
This will be assessed by the Parent-Infant Attachment Scale (Condon & Corkindale, 1998)
Timepoint [4] 297189 0
Six months postpartum
Secondary outcome [5] 297190 0
5. Satisfaction with intimate partner relationship.
Study-specific questions about perception of quality of intimate partner relationship, and overall satisfaction with the relationship.
Timepoint [5] 297190 0
Six months postpartum
Secondary outcome [6] 297191 0
6. Healthcare costs and outcomes.
Healthcare costs will be assessed by resource use and out-of-pocket costs associated with postnatal health care for the six month period (GP visits, emergency department attendances etc ).
Outcomes will be measured in Disability Adjusted Life Years (DALYs), calculated using the EQ-5D: EuroQol Group (1990).
Timepoint [6] 297191 0
6 months post partum

Eligibility
Key inclusion criteria
Primiparous women with adequate English fluency residing in participating local government areas who have given birth in the previous two weeks and are receiving care in a trial maternal and child health centre. Both the mother and father will be invited and encouraged to attend, however in situations where the father is unable or unwilling to attend, mothers will be encouraged to attend with a nominated support person, for example, their mother, friend or grandmother, but if this is not possible, women will be welcome to attend alone. Parents in same sex relationships are invited and welcome to attend.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Insufficient English to complete structured interviews, and/or mother-reported infant health or developmental anomalies

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)
This is a cluster randomised controlled trial, using the maternal and child health centre as the unit of randomisation.
Women who have recently given birth in Victoria are assigned to a MCH centre based on their residential address. Women allocated to care in an intervention MCH centre will receive the intervention as part of their care and those allocated to care in a control centre will receive usual best practice care.
All women meeting inclusion criteria and receiving care in a participating maternal and child health (MCH) centre will be invited to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 31 local government areas (LGAs) in the greater metropolitan area of Melbourne, Victoria will be ranked by the Socio-Economic Indexes for Areas (SEIFA) (ABS) and divided into high, middle and low tertiles. LGAs from each tertile will be invited to participate until 6 (2 from each tertile) have signed agreements.
48 MCH centres, which provide care for at least 16 primiparous women per annum, will be selected from participating LGAs and randomly allocated by an independent statistician, using the Stata v12 random allocation program, to intervention or control group, stratifying by local government area (LGA).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
This is a cluster randomised controlled trial. Individuals will not be randomly allocated to groups. Group allocation of participants will depend on participants' residential location, which defines their MCH centre allocation and therefore their trial arm allocation.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Baseline demographic and clinical characteristics will be compared between the intervention and control groups to establish the validity of the randomization process. Binary outcomes (Primary, Secondary 3 and Secondary 5 outcomes) will be analyzed using logistic regression models to compare the proportions at 6 months between the intervention and control groups. Continuously valued outcomes (Secondary 1, Secondary 2, Secondary 4 and Secondary 6 outcomes) will be analysed using linear regression. All regression analyses will be adjusted for clustering, baseline differences and relevant covariates. All analyses will be by intention to treat and conducted using Stata. Secondary outcome 6 will estimate the total costs and QALYs; average costs and QALYs will be compared between the two study arms. Regression analysis will estimate the ICER, that is the cost per QALY gained. Sensitivity analysis will use non-parametric bootstrapping, and uncertainty will be presented in cost effectiveness acceptability curves.
Power and sample size
Based on our controlled before-and-after study we will power the trial to detect a reduction of 12.5% (25% in the control arm, 12.5% in the intervention arm) in the primary outcome. A randomised trial of individuals would require 168 participants in each arm, with a type 1 error of 5% and 80% power. Adjusting for clustering (intra-class correlation = 0.01), the required sample is n=184, a total sample of n=368. Allowing for attrition of 10% after enrolment, we will continue recruiting until 400 (200 in each arm) participants have entered the trial. A conservatively estimated 50% recruitment of eligible participants will require 48 MCHCs (clusters) each meeting the criterion of caring for an average of 16 primiparous women per annum.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 5846 0
3150
Recruitment postcode(s) [2] 5847 0
3168
Recruitment postcode(s) [3] 5848 0
3166
Recruitment postcode(s) [4] 5849 0
3148
Recruitment postcode(s) [5] 5850 0
3149
Recruitment postcode(s) [6] 5851 0
3170
Recruitment postcode(s) [7] 5852 0
3057
Recruitment postcode(s) [8] 5853 0
3055
Recruitment postcode(s) [9] 5854 0
3056
Recruitment postcode(s) [10] 5855 0
3058
Recruitment postcode(s) [11] 5856 0
3043
Recruitment postcode(s) [12] 5857 0
3044
Recruitment postcode(s) [13] 5858 0
3018
Recruitment postcode(s) [14] 5859 0
3028
Recruitment postcode(s) [15] 5860 0
3025
Recruitment postcode(s) [16] 5861 0
3015
Recruitment postcode(s) [17] 5862 0
3016
Recruitment postcode(s) [18] 5863 0
3926
Recruitment postcode(s) [19] 5864 0
3919
Recruitment postcode(s) [20] 5865 0
3915
Recruitment postcode(s) [21] 5866 0
3912
Recruitment postcode(s) [22] 5867 0
3930
Recruitment postcode(s) [23] 5868 0
3931
Recruitment postcode(s) [24] 5869 0
3934
Recruitment postcode(s) [25] 5870 0
3936
Recruitment postcode(s) [26] 5871 0
3939
Recruitment postcode(s) [27] 5872 0
3941
Recruitment postcode(s) [28] 5873 0
3201
Recruitment postcode(s) [29] 5874 0
3199
Recruitment postcode(s) [30] 5875 0
3200
Recruitment postcode(s) [31] 5876 0
3910
Recruitment postcode(s) [32] 5877 0
3198

Funding & Sponsors
Funding source category [1] 284310 0
Government body
Name [1] 284310 0
National Health and Medical Research Council
APP1026550 2012-2014
Address [1] 284310 0
GPO Box 1421
Canberra ACT 2601
Country [1] 284310 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Victoria 3800
Country
Australia
Secondary sponsor category [1] 283254 0
Other
Name [1] 283254 0
Victorian Government Department of Education and Early Childhood Development
Address [1] 283254 0
GPO Box 4367
MELBOURNE, Victoria 3001
Country [1] 283254 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288228 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 288228 0
Building 3E, Room 111
Clayton Campus
Wellington Road
Clayton Vic 3800
Ethics committee country [1] 288228 0
Australia
Date submitted for ethics approval [1] 288228 0
Approval date [1] 288228 0
23/04/2012
Ethics approval number [1] 288228 0
CF12/1002-2012000474
Ethics committee name [2] 288468 0
Southern Health Human Research Ethics Committee
Ethics committee address [2] 288468 0
Monash Medical Centre
246 Clayton Road
Clayton, Victoria, 3168
Ethics committee country [2] 288468 0
Australia
Date submitted for ethics approval [2] 288468 0
Approval date [2] 288468 0
23/04/2012
Ethics approval number [2] 288468 0
11388B

Summary
Brief summary
Postnatal depression and anxiety in women are associated with disability and diminished caregiving capacity and are of national concern. The 2009 National Perinatal Depression Initiative addresses identification of and treatment for currently symptomatic women. However, a comprehensive health service response also requires strategies to promote mental health and prevent mental disorders. To date, interventions to prevent postnatal mental health problems have had limited success, perhaps because they focused only on women and did not include fathers or the baby; addressed needs for support by providing increased professional care rather than attempting to enhance a woman’s intimate relationships, and did not take history of mental disorders into account. The common agenda of the Victorian Department of Education and Early Childhood Development; the Mental Health Division of the Victorian Department of Health, the Parenting Research Centre and the Jean Hailes Research Unit, Monash University is to optimize maternal mental health and wellbeing through evidence-based universal approaches. This inclusive Partnership is essential to the implementation and testing of a novel intervention to meet these needs. What Were We Thinking (WWWT) is a well-theorized, salient, structured, gender-informed, couples-based early postpartum psycho-educational intervention provided in maternal and child health services. It addresses the intimate partner relationship, infant behaviour management, and the mediating effects of occupational fatigue. We have promising early evidence from a controlled before and after study that WWWT prevents postpartum mental health problems in women. This cluster randomized controlled trial will establish whether WWWT is effective in reducing the 30 day prevalence of depression, anxiety and adjustment disorders in primiparous women and improving infant behaviour, mother-infant relationship and partner relationship at six months postpartum.
Trial website
Trial related presentations / publications
1. Fisher J, Rowe H, Wynter K, Tran T, Lorgelly P, Amir L, Proimos J, Ranasinha S, Hiscock H, Bayer J, Cann W. A gender-informed, psychoeducational program for couples to prevent postnatal common mental disorders among primiparous women: cluster randomised controlled trial. BMJ Open 2016; 6:e009396. doi: 10.1136/bmjopen-2015-009396
2. Rowe H, Wynter K, Burns J, Fisher J. A complex postnatal mental health intervention: Australian translational formative evaluation. Health Promotion International; 2017; 32:610–623. DOI: https://doi.org/10.1093/heapro/dav110.
3. Rowe H, Wynter K, Lorgelly P, Amir LH, Ranasinha S, Proimos J, Cann W, Hiscock H, Bayer J, Burns J, Ride J, Bobevski I, Fisher J. A cluster randomised controlled trial of a brief couple-focussed psycho-educational intervention to prevent common postnatal mental disorders among women: study protocol. BMJ Open 2014; 4(9): e006436. doi: 10.1136/bmjopen-2014-006436.
4. Ride J, Lorgelly P, Tran T, Wynter K, Rowe H, Fisher J. Preventing postnatal maternal mental health problems using a psychoeducational intervention: the cost-effectiveness of What Were We Thinking. BMJ Open 2016; 6:e012086 http://dx.doi.org/10.1136/bmjopen-2016-012086
5. Ride J, ROWE H, Wynter K, Fisher J, Lorgelly P. Protocol for economic evaluation alongside a cluster-randomised controlled trial of a psychoeducational intervention for the primary prevention of postnatal mental health problems in first-time mothers. BMJ Open 2014; 4: e006226. doi:10.1136/bmjopen-2014-006226.
6. Wynter K, Tran TD, Rowe H, Fisher J. Development and properties of a brief scale to assess intimate partner relationship in the postnatal period. Journal of Affective Disorders 2017; 215: 56–61 http://dx.doi.org/10.1016/j.jad.2017.03.001
7. Fisher J, Thach T, Karen K, Hiscock H, Bayer J, Rowe H. Gender-informed psycho-educational programme to promote respectful relationships and reduce postpartum common mental disorders among primiparous women: long-term follow-up of participants in a community-based cluster randomised controlled trial. Global Mental Health in press June 2018.
Public notes

Contacts
Principal investigator
Name 33430 0
Prof Jane Fisher
Address 33430 0
Jean Hailes Research
School of Public Health and Preventive Medicine
6th Floor Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Australia
Country 33430 0
Australia
Phone 33430 0
+61 3 99030290
Fax 33430 0
Email 33430 0
jane.fisher@monash.edu
Contact person for public queries
Name 16677 0
Prof Jane Fisher
Address 16677 0
Jean Hailes Research Unit
School of Public Health and Preventive Medicine
6th Floor Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Australia
Country 16677 0
Australia
Phone 16677 0
+61399030290
Fax 16677 0
Email 16677 0
jane.fisher@monash.edu
Contact person for scientific queries
Name 7605 0
Dr Heather Rowe
Address 7605 0
Jean Hailes Research Unit
School of Public Health and Preventive Medicine
6th Floor Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Australia
Country 7605 0
Australia
Phone 7605 0
+61399030296
Fax 7605 0
Email 7605 0
heather.rowe@monash.edu

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary