ANZCTR - Registration

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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]

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

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

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Public Health

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]

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]

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]

Six months postpartum

Secondary outcome [1]

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]

Six months postpartum

Secondary outcome [2]

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]

Six months postpartum

Secondary outcome [3]

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]

Six months postpartum

Secondary outcome [4]

4. Mother-Infant relationship.
This will be assessed by the Parent-Infant Attachment Scale (Condon & Corkindale, 1998)

Timepoint [4]

Six months postpartum

Secondary outcome [5]

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]

Six months postpartum

Secondary outcome [6]

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]

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

Sex

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

10/05/2013

Actual

10/05/2013

Date of last participant enrolment

Anticipated

31/12/2013

Actual

10/04/2014

Date of last data collection

Anticipated

Actual

13/08/2014

Sample size

Target

400

Accrual to date

Final

400

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3150

Recruitment postcode(s) [2]

3168

Recruitment postcode(s) [3]

3166

Recruitment postcode(s) [4]

3148

Recruitment postcode(s) [5]

3149

Recruitment postcode(s) [6]

3170

Recruitment postcode(s) [7]

3057

Recruitment postcode(s) [8]

3055

Recruitment postcode(s) [9]

3056

Recruitment postcode(s) [10]

3058

Recruitment postcode(s) [11]

3043

Recruitment postcode(s) [12]

3044

Recruitment postcode(s) [13]

3018

Recruitment postcode(s) [14]

3028

Recruitment postcode(s) [15]

3025

Recruitment postcode(s) [16]

3015

Recruitment postcode(s) [17]

3016

Recruitment postcode(s) [18]

3926

Recruitment postcode(s) [19]

3919

Recruitment postcode(s) [20]

3915

Recruitment postcode(s) [21]

3912

Recruitment postcode(s) [22]

3930

Recruitment postcode(s) [23]

3931

Recruitment postcode(s) [24]

3934

Recruitment postcode(s) [25]

3936

Recruitment postcode(s) [26]

3939

Recruitment postcode(s) [27]

3941

Recruitment postcode(s) [28]

3201

Recruitment postcode(s) [29]

3199

Recruitment postcode(s) [30]

3200

Recruitment postcode(s) [31]

3910

Recruitment postcode(s) [32]

3198

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council
APP1026550 2012-2014

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Victoria 3800

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Victorian Government Department of Education and Early Childhood Development

Address [1]

GPO Box 4367
MELBOURNE, Victoria 3001

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee

Ethics committee address [1]

Building 3E, Room 111
Clayton Campus
Wellington Road
Clayton Vic 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/04/2012

Ethics approval number [1]

CF12/1002-2012000474

Ethics committee name [2]

Southern Health Human Research Ethics Committee

Ethics committee address [2]

Monash Medical Centre
246 Clayton Road
Clayton, Victoria, 3168

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

23/04/2012

Ethics approval number [2]

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

Attachments [1]

/AnzctrAttachments/347752-Fisher Rowe et al SPARCS BMJ Open, 2016.pdf (Publication)

Attachments [2]

/AnzctrAttachments/347752-Rowe SPARCS protocol BMJ Open, 2014.pdf (Protocol)

Attachments [3]

/AnzctrAttachments/347752-Ride et al SPARCS economic evalution protocol BMJ Open, 2014.pdf (Protocol)

Attachments [4]

/AnzctrAttachments/347752-Ride et al Economic analysis SPARCS, 2016.pdf (Publication)

Contacts

Principal investigator

Name

Prof Jane Fisher

Address

Jean Hailes Research
School of Public Health and Preventive Medicine
6th Floor Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Australia

Country

Australia

Phone

+61 3 99030290

Fax

jane.fisher@monash.edu

Contact person for public queries

Name

Jane Fisher

Address

Jean Hailes Research Unit
School of Public Health and Preventive Medicine
6th Floor Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Australia

Country

Australia

Phone

+61399030290

Fax

jane.fisher@monash.edu

Contact person for scientific queries

Name

Heather Rowe

Address

Jean Hailes Research Unit
School of Public Health and Preventive Medicine
6th Floor Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Australia

Country

Australia

Phone

+61399030296

Fax

heather.rowe@monash.edu

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Gender-informed, psychoeducational programme for couples to prevent postnatal common mental disorders among primiparous women: Cluster randomised controlled trial.	2016	https://dx.doi.org/10.1136/bmjopen-2015-009396
Embase	Preventing postnatal maternal mental health problems using a psychoeducational intervention: The cost-effectiveness of What Were We Thinking.	2016	https://dx.doi.org/10.1136/bmjopen-2016-012086

N.B. These documents automatically identified may not have been verified by the study sponsor.

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