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Trial registered on ANZCTR


Registration number
ACTRN12616001217493
Ethics application status
Approved
Date submitted
12/08/2016
Date registered
2/09/2016
Date last updated
4/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Integrated e-Screening for Postnatal Depression and Anxiety
Scientific title
Integrated e-Screening for Postnatal Depression and Anxiety- feasibility and effectiveness
Secondary ID [1] 289860 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal depression 299801 0
Postnatal anxiety 299802 0
Condition category
Condition code
Mental Health 299729 299729 0 0
Depression
Reproductive Health and Childbirth 299730 299730 0 0
Childbirth and postnatal care
Mental Health 300036 300036 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
e-Screening. Maternal and child health nurses (MCHNs) in this condition will use an e-screening system ("iCOPE") as part of each woman's emotional health assessment during her 4-week Key Ages and Stages (KAS) visit at the maternal and child health centre. iCOPE is a tablet-based electronic screening system for carrying out perinatal depression screening and providing clinical decision support to health professionals. It includes the Whooley questions, Edinburgh Postnatal Depression Scale (EPDS) and psychosocial questions following the beyondblue Clinical Practice Guidelines for Depression and Related Disorders in the Perinatal Period. The woman answers the questions on the tablet herself (approximately 5 minutes). iCOPE automatically scores the EPDS and the other psychosocal information is collated. The MCHN is then provided with reports offering guidance, support and prompts for best-practice management tailored to each individual woman's data. Adherence to the intervention will be monitored using a Logbook specifically developed for this study on which information is recorded about the number of potential participants, number who agree to participate in the study, and number screened using the e-screening system. This data will be compared with completed consent forms, data from the e-screening system and service level data to monitor adherence.
Intervention code [1] 295545 0
Early detection / Screening
Comparator / control treatment
Standard care. Maternal and child health nurses (MCHNs) in this condition will continue to follow their usual practice when completing each woman's emotional health assessment during her 4-week Key Ages and Stages (KAS) visit at the maternal and child health centre.
Control group
Active

Outcomes
Primary outcome [1] 299192 0
Depression screening acceptability measured by a questionnaire developed specifically for this study
Timepoint [1] 299192 0
4-week KAS visit
Primary outcome [2] 299193 0
Uptake: Proportion of participants receiving a depression screening assessment at the 4-week KAS visit
Timepoint [2] 299193 0
4-week KAS visit
Primary outcome [3] 299194 0
Depression symptoms as measured by the Depression, Anxiety and Stress Scales (DASS-21)
Timepoint [3] 299194 0
3-months post-birth
Secondary outcome [1] 326476 0
Depressive Disorder measured by the Structured Clinical Interview for the DSM-5
Timepoint [1] 326476 0
3-months post-birth
Secondary outcome [2] 326477 0
Referral rates and types of services referred to measured by a questionnaire developed for this project
Timepoint [2] 326477 0
4-week KAS visit
Secondary outcome [3] 326478 0
Staff time and costs (composite outcome) measured by a questionnaire developed for this project
Timepoint [3] 326478 0
4-week KAS visit
Secondary outcome [4] 326479 0
Ease of implementation and integration into existing clinical systems measured by a questionnaire developed for this project and thematic analysis of qualitative data from focus group transcripts
Timepoint [4] 326479 0
Post-recruitment
Secondary outcome [5] 327136 0
Anxiety symptoms as measured by the Depression, Anxiety and Stress Scales (DASS-21)
is also a primary outcome.
Timepoint [5] 327136 0
3-months post-birth
Secondary outcome [6] 327137 0
Stress symptoms as measured by the Depression, Anxiety and Stress Scales (DASS-21)
is also a primary outcome.
Timepoint [6] 327137 0
3-months post-birth

Eligibility
Key inclusion criteria
Ability to understand spoken and written language
Baby aged 4-6 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed from researchers and maternal and child health nurses. Sealed opaque envelopes are used to allocate maternal and child health nurses to the two conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permuted blocks, computer generated random sequence. The schedule is stratified by municipality and years of experience as a perinatal nurse.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Frequency data will be assessed by Chi square. Parameter estimates will be given with 95% Confidence Intervals (CIs). Logistic regression models will be fitted to data and regression coefficients expressed in terms of Odds Ratios. For continuous outcome variables, between-group comparisons will be made by fitting generalised estimating equations (GEEs) that account for the clustering of data. In addition, some outcomes are qualitative and descriptive and these will be analysed and presented using standard conventions.
With 80% power at a = 0.05, taking into account a conservative estimate of the intra-cluster correlation (0.1) with a cluster size of 15 women per nurse, the power achieved with n = 600 is sufficient to detect small-to-medium effect sizes in the outcome measures, for example, correlations (e.g., between depression score and an acceptability scale), differences in frequencies of dichotomous variables (e.g. Diagnostic status), and mean between-group differences on continuous outcomes (e.g. symptom severity).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
68
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294240 0
Charities/Societies/Foundations
Name [1] 294240 0
Collier Charitable Fund
Country [1] 294240 0
Australia
Primary sponsor type
Other
Name
Parent-Infant Research Institute
Address
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg Heights VIC 3081
Country
Australia
Secondary sponsor category [1] 293075 0
None
Name [1] 293075 0
Address [1] 293075 0
Country [1] 293075 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295664 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 295664 0
Ethics committee country [1] 295664 0
Australia
Date submitted for ethics approval [1] 295664 0
25/09/2015
Approval date [1] 295664 0
19/04/2016
Ethics approval number [1] 295664 0
HREC/15/Austin/273

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68050 0
Prof Jeannette Milgrom
Address 68050 0
Parent-Infant Research Institute
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg Heights VIC 3081
Country 68050 0
Australia
Phone 68050 0
+61 3 9496 4009
Fax 68050 0
Email 68050 0
jeannette.milgrom@austin.org.au
Contact person for public queries
Name 68051 0
Charlene Holt
Address 68051 0
Parent-Infant Research Institute
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg Heights VIC 3081
Country 68051 0
Australia
Phone 68051 0
+61 3 9496 4496
Fax 68051 0
Email 68051 0
charlene.holt@austin.org.au
Contact person for scientific queries
Name 68052 0
Alan Gemmill
Address 68052 0
Parent-Infant Research Institute
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg Heights VIC 3081
Country 68052 0
Australia
Phone 68052 0
+61 3 9496 4496
Fax 68052 0
Email 68052 0
alan.gemmill@austin.org.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.