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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
13/12/2018
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
Scientific title
Prevention of Adverse Child Behavioural Development Following Treatment of Maternal Depression in Pregnancy with the Beating the Blues Before Birth Program
Secondary ID [1] 296421 0
GNT1143448 (NHMRC Project Grant ID).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antenatal depression 310175 0
Child behavioural problems 310176 0
Condition category
Condition code
Mental Health 308925 308925 0 0
Depression
Reproductive Health and Childbirth 308926 308926 0 0
Antenatal care
Mental Health 308927 308927 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 312749 0
Treatment: Other
Intervention code [2] 312750 0
Behaviour
Intervention code [3] 312751 0
Lifestyle
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.
Control group
Active

Outcomes
Primary outcome [1] 307891 0
Child behaviour assessed using the Internalising scale of the Child Behaviour Checklist (CBCL)
Timepoint [1] 307891 0
24-month post-birth
Secondary outcome [1] 353247 0
Cognitive and motor development assessed using the Bayley Scales of Infant Development (BSID-III)
Timepoint [1] 353247 0
24-month post-birth
Secondary outcome [2] 353248 0
Child behaviour assessed using the Externalising scale of the CBCL
Timepoint [2] 353248 0
24-month post-birth
Secondary outcome [3] 353249 0
Observer-rated child behaviour assessed using sub-scales of the Parent-Child Early Relational Assessment (PCERA)
Timepoint [3] 353249 0
3-month and 24-month post-birth
Secondary outcome [4] 353250 0
Infant behaviour assessed using the Revised Infant Behaviour Questionnaire (IBQ-R)
Timepoint [4] 353250 0
3-month and 12-month post-birth
Secondary outcome [5] 353251 0
Infant developmental milestones assessed using the Ages & Stages Questionnaires (ASQ-3, ASQ-SE)
Timepoint [5] 353251 0
3-month and 12-month post-birth
Secondary outcome [6] 353265 0
Maternal depression diagnosis assessed using Structured Clinical Interview for DSM-V – Clinician Version (SCID-5-CV).
Timepoint [6] 353265 0
Baseline, 3-month and 24-month post-birth
Secondary outcome [7] 353266 0
Maternal depression severity assessed using Beck Depression Inventory Revised (BDI-II)
Timepoint [7] 353266 0
Baseline, 10 weeks post-randomisation, and 3-month, 12-month and 24-month post-birth
Secondary outcome [8] 353267 0
Maternal anxiety severity assessed using Beck Anxiety Inventory (BAI)
Timepoint [8] 353267 0
Baseline, 10 weeks post-randomisation, and 3-month, 12-month and 24-month post-birth
Secondary outcome [9] 353268 0
Parenting Stress Index (PSI)
Timepoint [9] 353268 0
3-month, 12-month and 24-month post-birth
Secondary outcome [10] 353269 0
Perceived Stress Scale (PSS)
Timepoint [10] 353269 0
Baseline, 10 weeks post-randomisation and 3-month, 12-month and 24-month post-birth
Secondary outcome [11] 353270 0
Parenting Sense of Competence Scale (PSOC)
Timepoint [11] 353270 0
3-month, 12-month and 24-month post-birth

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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A variable-length, permuted-blocks, computer-generated random sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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. The primary outcome (CBCL Internalising scale) will be analysed first using a 2-sample t-test comparing the intervention and control groups. Potentially informative covariates, such as maternal antenatal anxiety, and potential mediators, such as maternal postnatal depression, will 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.

Recruitment
Recruitment status
Recruiting
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 hospital [1] 12438 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 24713 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 301025 0
Government body
Name [1] 301025 0
National Health and Medical Research Council
Address [1] 301025 0
414 La Trobe St, Melbourne VIC 3000
Country [1] 301025 0
Australia
Primary sponsor type
Individual
Name
Professor Jeannette Milgrom
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
Country
Australia
Secondary sponsor category [1] 300616 0
None
Name [1] 300616 0
Address [1] 300616 0
Country [1] 300616 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301780 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 301780 0
Austin Hospital
145 Studley Rd
Heidelberg VIC 3084
Ethics committee country [1] 301780 0
Australia
Date submitted for ethics approval [1] 301780 0
27/02/2018
Approval date [1] 301780 0
24/07/2018
Ethics approval number [1] 301780 0
HREC/18/Austin/58

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.
Trial website
http://www.piri.org.au/current-treatment-trials-now-open-for-recruitment/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88082 0
Prof Jeannette Milgrom
Address 88082 0
Parent-Infant Research Institute (PIRI)
Austin Health
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital campus
330 Waterdale Rd
Heidelberg Heights VIC 3081
Country 88082 0
Australia
Phone 88082 0
+61 3 9496 4496
Fax 88082 0
+61 3 9496 4148
Email 88082 0
jeannette.milgrom@austin.org.au
Contact person for public queries
Name 88083 0
Dr Alan Gemmill
Address 88083 0
Parent-Infant Research Institute (PIRI)
Austin Health
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital campus
330 Waterdale Rd
Heidelberg Heights VIC 3081
Country 88083 0
Australia
Phone 88083 0
+61 3 9496 4496
Fax 88083 0
+61 3 9496 4148
Email 88083 0
Alan.Gemmill@austin.org.au
Contact person for scientific queries
Name 88084 0
Dr Alan Gemmill
Address 88084 0
Parent-Infant Research Institute (PIRI)
Austin Health
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital campus
330 Waterdale Rd
Heidelberg Heights VIC 3081
Country 88084 0
Australia
Phone 88084 0
+61 3 9496 4496
Fax 88084 0
+61 3 9496 4148
Email 88084 0
Alan.Gemmill@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable