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Trial registered on ANZCTR
Registration number
ACTRN12618001925235
Ethics application status
Approved
Date submitted
23/11/2018
Date registered
27/11/2018
Date last updated
28/07/2023
Date data sharing statement initially provided
27/11/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Preventing Adverse Child Development Following Maternal Depression in Pregnancy
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Scientific title
Prevention of Adverse Child Behavioural Development Following Treatment of Maternal Depression in Pregnancy with the Beating the Blues Before Birth Program
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Secondary ID [1]
296421
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GNT1143448 (NHMRC Project Grant ID).
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Antenatal depression
310175
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Child behavioural problems
310176
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Condition category
Condition code
Mental Health
308925
308925
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0
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Depression
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Reproductive Health and Childbirth
308926
308926
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0
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Antenatal care
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Mental Health
308927
308927
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Women assigned to the intervention condition will receive an 8-week cognitive-behavioural therapy program for antenatal depression ('Beating the Blues Before Birth'). These 8 weekly 1-hour sessions cover behavioural and cognitive strategies to recover from depression. Of these sessions, number 6 is a couple session and number 8 is dedicated for relapse prevention. Session content includes understanding antenatal depression & anxiety, pleasant activities, self-care & relaxation in pregnancy, assertiveness & self-esteem, expectations and transition to parenthood and developing a more helpful thinking style, challenging my internal critic. The couple session provides information and support to partners and includes strategies for effective communication. Women without a partner may choose to invite anyone who is involved in supporting them, e.g. friend, mother, etc. Treatments will be delivered by psychologists or provisional psychologists following a detailed manual designed specifically for pregnant women and previously evaluated in a pilot study (Milgrom et al. 2015). Following each CBT session, therapists will check off the items covered (or re-visited) from the manual and will not progress women to new sessions until all content is covered. Audio-recordings from a 10% subsample of intervention group women (with permission) will allow treatment fidelity checks.
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Intervention code [1]
312749
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Treatment: Other
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Intervention code [2]
312750
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Behaviour
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Intervention code [3]
312751
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Lifestyle
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Comparator / control treatment
Women assigned to the control condition ('Treatment as Usual') will be managed by their midwife or general practitioner (GP) who will be free to treat or to refer to other services/agencies as they judge appropriate, as would normally happen where specialised programs are not available.
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Control group
Active
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Outcomes
Primary outcome [1]
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Child behaviour assessed using the Internalising scale of the Child Behaviour Checklist (CBCL)
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Assessment method [1]
307891
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Timepoint [1]
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24-month post-birth
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Secondary outcome [1]
353247
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Cognitive and motor development assessed using the Bayley Scales of Infant Development (BSID-III) or the ASQ-3 scales.
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Assessment method [1]
353247
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Timepoint [1]
353247
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24-month post-birth
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Secondary outcome [2]
353248
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Child behaviour assessed using the Externalising scale of the CBCL
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Assessment method [2]
353248
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Timepoint [2]
353248
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24-month post-birth
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Secondary outcome [3]
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Observer-rated child behaviour assessed using sub-scales of the Parent-Child Early Relational Assessment (PCERA)
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Assessment method [3]
353249
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Timepoint [3]
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3-month and 24-month post-birth
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Secondary outcome [4]
353250
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Infant behaviour assessed using the Revised Infant Behaviour Questionnaire (IBQ-R)
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Assessment method [4]
353250
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Timepoint [4]
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3-month and 12-month post-birth
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Secondary outcome [5]
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Infant developmental milestones assessed using the Ages & Stages Questionnaires (ASQ-3, ASQ-SE)
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Assessment method [5]
353251
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Timepoint [5]
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3-month and 12-month post-birth
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Secondary outcome [6]
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Maternal depression diagnosis assessed using Structured Clinical Interview for DSM-V – Clinician Version (SCID-5-CV).
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Assessment method [6]
353265
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Timepoint [6]
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Baseline, 3-month and 24-month post-birth
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Secondary outcome [7]
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Maternal depression severity assessed using Beck Depression Inventory Revised (BDI-II)
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Assessment method [7]
353266
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Timepoint [7]
353266
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Baseline, 10 weeks post-randomisation, and 3-month, 12-month and 24-month post-birth
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Secondary outcome [8]
353267
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Maternal anxiety severity assessed using Beck Anxiety Inventory (BAI)
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Assessment method [8]
353267
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Timepoint [8]
353267
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Baseline, 10 weeks post-randomisation, and 3-month, 12-month and 24-month post-birth
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Secondary outcome [9]
353268
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Parenting Stress Index (PSI)
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Assessment method [9]
353268
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Timepoint [9]
353268
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3-month, 12-month and 24-month post-birth
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Secondary outcome [10]
353269
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Perceived Stress Scale (PSS)
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Assessment method [10]
353269
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Timepoint [10]
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Baseline, 10 weeks post-randomisation and 3-month, 12-month and 24-month post-birth
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Secondary outcome [11]
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Parenting Sense of Competence Scale (PSOC)
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Assessment method [11]
353270
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Timepoint [11]
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3-month, 12-month and 24-month post-birth
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Secondary outcome [12]
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COVID-19 related questions were added to each timepoint in order to test the impact of COVID-19 situation on the primary and the secondary outcomes of our study. These questions ask about antenatal care accessed during the pandemic, the effect of the COVID-19 situation on the mother's and baby's mental health, the additional stress the COVID-19 situation put the mother under, changes in living and working environemt and whether the mother or someone close to her were tested or diagnosed with COVID-19.
This outcome will be assessed by study-specific questionnaire.
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Assessment method [12]
411425
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Timepoint [12]
411425
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Baseline, 10 weeks post-randomisation, and 3-month, 12-month and 24-month post-birth
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Eligibility
Key inclusion criteria
1. DSM-V diagnosis of major depressive disorder or 'depressive disorder with insufficient symptoms'
2. 30 weeks pregnant or below
3. Women 18 years of age or older
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Psychotic disorders, bipolar disorder, substance abuse
2. Risk requiring crisis or inpatient management
3. Current treatment for depression (medication or psychotherapy)
4. Significant difficulty with English
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised administration of coded, pre-generated allocation schedule by an independent person blind to coding (provided by NHMRC clinical trials center – randomisation service). Allocation is concealed from researchers, clinicians and participants until the point of allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A variable-length, permuted-blocks, computer-generated random sequence.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Consistent with CONSORT standards, the primary analysis will be by intention-to-treat. Primary analyses will be executed twice: once using observed data, and once using multiple imputation, provided the assumptions for imputation are met . The primary outcome (CBCL Internalising scale) will be analysed first using a 2-sample t-test comparing the intervention and control groups, extended to analysis of covariance (ANCOVA) to control for variation in baseline values. Potentially informative covariates, such as maternal antenatal anxiety, and potential mediators, such as maternal postnatal depression, will also be explored using a general linear model. The impact of the intervention on secondary outcomes, including the Externalising scale of the CBCL, and cognitive and motor development will also be explored using t-tests and ANCOVA. This analytical approach provides a direct and statistically sensitive test of the primary aim. In addition to inferential testing, effect sizes and their associated confidence intervals will be calculated. Finally, univariate logistic regression will be executed to determine any prognostic baseline variables that predict the return or non-return of follow-up data.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
28/11/2018
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Actual
7/12/2018
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Date of last participant enrolment
Anticipated
31/12/2023
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
230
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Accrual to date
105
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
12438
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Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
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Recruitment hospital [2]
22664
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The Royal Women's Hospital - Parkville
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Recruitment hospital [3]
22665
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Mercy Hospital for Women - Heidelberg
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Recruitment hospital [4]
25290
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment postcode(s) [1]
24713
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3081 - Heidelberg West
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Recruitment postcode(s) [2]
37941
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3052 - Parkville
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Recruitment postcode(s) [3]
37942
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3084 - Heidelberg
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Recruitment postcode(s) [4]
40962
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3168 - Clayton
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Funding & Sponsors
Funding source category [1]
301025
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Government body
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Name [1]
301025
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National Health and Medical Research Council
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Address [1]
301025
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414 La Trobe St, Melbourne VIC 3000
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Country [1]
301025
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Australia
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Primary sponsor type
Individual
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Name
Professor Jeannette Milgrom
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Address
Parent-Infant Research Institute (PIRI)
Austin Health
level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital campus
300 Waterdale Rd
Heidelberg Heights VIC 3081
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Country
Australia
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Secondary sponsor category [1]
300616
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None
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Name [1]
300616
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Address [1]
300616
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Country [1]
300616
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301780
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
301780
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Austin Hospital
145 Studley Rd
Heidelberg VIC 3084
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Ethics committee country [1]
301780
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Australia
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Date submitted for ethics approval [1]
301780
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27/02/2018
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Approval date [1]
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24/07/2018
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Ethics approval number [1]
301780
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HREC/18/Austin/58
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Summary
Brief summary
Children of women depressed in pregnancy are likely to have an increased risk of behavioural problems such as anxiety, depression and attention deficit/hyperactivity, with effects on mental health lasting at least to adolescence. This study is a fully powered RCT (n=230 women and their infants) which will evaluate medium-term change in child outcomes following cognitive-behavioural therapy (CBT) for depression in pregnancy. We hypothesise that children in the intervention group will have fewer Internalising behavioural problems at the age of 24 months than children in the control group. Pregnant women (30 weeks or below) diagnosed with depression will be allocated to CBT intervention or to treatment as usual. During eight weekly CBT sessions, women will be provided with behavioural and cognitive strategies to help them recover from depression. Other child behavioural, motor and cognitive outcomes will also be assessed.
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Trial website
http://www.piri.org.au/current-treatment-trials-now-open-for-recruitment/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Jeannette Milgrom
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Address
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Parent-Infant Research Institute (PIRI)
Austin Health
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital campus
330 Waterdale Rd
Heidelberg Heights VIC 3081
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Country
88082
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Australia
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Phone
88082
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+61 3 9496 4496
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Fax
88082
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+61 3 9496 4148
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Email
88082
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jeannette.milgrom@austin.org.au
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Contact person for public queries
Name
88083
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Dr Alan Gemmill
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Address
88083
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Parent-Infant Research Institute (PIRI)
Austin Health
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital campus
330 Waterdale Rd
Heidelberg Heights VIC 3081
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Country
88083
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Australia
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Phone
88083
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+61 3 9496 4496
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Fax
88083
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+61 3 9496 4148
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Email
88083
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Alan.Gemmill@austin.org.au
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Contact person for scientific queries
Name
88084
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Dr Alan Gemmill
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Address
88084
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Parent-Infant Research Institute (PIRI)
Austin Health
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital campus
330 Waterdale Rd
Heidelberg Heights VIC 3081
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Country
88084
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Australia
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Phone
88084
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+61 3 9496 4496
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Fax
88084
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+61 3 9496 4148
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Email
88084
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Alan.Gemmill@austin.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Our ethics approval specifies that results of this research project will be published and/or presented in a variety of forums. Information will always be presented in such a way that an individual research participants cannot be identified. Only collated group data will be presented.
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What supporting documents are/will be available?
No other documents available
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Summary results
No Results
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