Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000270516
Ethics application status
Approved
Date submitted
4/03/2015
Date registered
23/03/2015
Date last updated
7/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating a new parenting kit developed by the Royal Women’s Hospital: a mixed methods study
Scientific title
To explore whether first time mothers who receive the Parenting Kit, in comparison to those who receive standard care, will have better maternal health and well-being outcome, scoring lower on the Experience of Motherhood Questionnaire (EMQ) at two and six months after birth.
Secondary ID [1] 286313 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
PKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parent and infant wellbeing 294412 0
Condition category
Condition code
Public Health 294721 294721 0 0
Health promotion/education
Reproductive Health and Childbirth 294763 294763 0 0
Antenatal care
Reproductive Health and Childbirth 294764 294764 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
First time mothers booking for pregnancy care at the Women’s who are randomly allocated to the intervention group, will receive the Parenting Kit titled "Growing Together" which consists of:
A book of A4 size that covers the journey from conception to one year of age. The book includes information for women regarding pregnancy care options, physical changes in pregnancy, cultural considerations, where to access support, labour and birth information, postnatal information regarding infant feeding, sleep, interaction with baby, and information about caring for a baby throughout the first year incorporating sleep, settling, nutrition, self care. The book has a strong focus on mental health issues which is addressed throughout.

An ‘App’ that has been specifically designed for the project. It will have individual modules - Pregnancy, Parenting, Your Journey and Stories and videos. The Pregnancy module contains information on early pregnancy; healthy pregnancy; labour and birth; pregnancy and birth care and your pregnancy -week by week. The Parenting module includes information on newborn feeding; self care and support; being at home with your baby; feeding your older baby and down the track. Your Journey provides gestation specific advice to women around pregnancy care. There is also a section with a wide range of stories and videos which women can read or view. The ‘App’ is very interactive, and has push notifications, links to various appropriate sites and many other features. It will be available only via a unique code, and each woman will be given only two codes – one for herself and the other for her partner or support person.

A children’s book written by Mem Fox titled ‘Ten little fingers and ten little toes’ – which is aimed at encouraging parents to read to their children, as well as having what are considered to be important messages for the parents.

The duration of the intervention is from recruitment until the final survey at 12 months of age. The intervention is intended to be used as women see fit which would occur in the "real world". As such, there is no expectation that they will use the intervention for a set amount of time each week, or any strategies to monitor adherence to the use if the kit, other than discussion using the kit with the midwife in clinic.
Intervention code [1] 291357 0
Lifestyle
Intervention code [2] 291358 0
Behaviour
Comparator / control treatment
Women in control group will have access to the current resources at the Women’s, such as ‘Having a Baby at the Women’s’ booklet (containing pregnancy, labour and postnatal information) and a smaller booklet on breastfeeding
Control group
Active

Outcomes
Primary outcome [1] 294480 0
The proportion of women with a score <40 on the Experience of Motherhood Questionnaire (EMQ)

Astbury, J., 1994. Making motherhood visible: The experience of motherhood questionnaire. Journal of Reproductive and Infant Psychology 12, 79-88.
Timepoint [1] 294480 0
2,6 and 12 months postpartum
Primary outcome [2] 294482 0
Developmental, emotional and physical health of babies (including infant feeding and temperament - sleeping, crying and settling). (Composite primary outcome)

NEILS (the National Early Intervention Longitudinal Study) Scales (SRI International, 2003) will be used to measure developmental, emotional and physical health of babies as well as infant temperament.
Infant sleeping and settling will be measured using questions adapted from Baby Business RCT:
Cook, F., Bayer, J., Le, H.N.D., Mensah, F., Cann, W. & Hiscock, H. (2012). Baby Business: a randomised controlled trial of a universal parenting program that aims to prevent early infant sleep and cry problems and associated parental depression. BMC Pediatrics, 12 (13).
Timepoint [2] 294482 0
2, 6 & 12 months postpartum
Secondary outcome [1] 313428 0
Maternal-infant and paternal-infant attachment
Four aspects of parent –child interactions will be assessed using short parent-report measures employed by a national Australian study of early child development

Zubrick, S.R., Lucas, N., Westrupp, E. M., & Nicholson, J. M. (2014). Parenting measures in the Longitudinal Study of Australian Children: Construct validity and measurement quality, Waves 1 to 4. (LSAC Technical Paper No. 12). Department of Social Services, Canberra, ACT

Maternal Attachment Inventory: Muller M.E. (1994) A questionnaire to measure mother-to-infant attachment. Journal of Nursing Measurement 2(2), 129–141.
Timepoint [1] 313428 0
2, 6 & 12 months postpartum
Secondary outcome [2] 313429 0
Knowledge and confidence of expectant and new parents from pregnancy to 12 months postpartum

Four items modified from the Early Childhood Longitudinal Study—Birth Cohort (National Center for Education Statistics, 2004)
Timepoint [2] 313429 0
2, 6 & 12 months postpartum
Secondary outcome [3] 313431 0
Parenting fatigue will be assessed using a single item in which women will be asked to rate whether they had experienced extreme tiredness or exhaustion on a four-point scale ranging from 1—Never to 4—Often.

Ref: Giallo R, Gartland D, Woolhouse H, Brown S. "I didn't know it was possible to feel that tired": exploring the complex bidirectional associations between maternal depressive symptoms and fatigue in a prospective pregnancy cohort study. Arch Womens Ment Health. 2015 Jan 11. [Epub ahead of print]
Timepoint [3] 313431 0
2, 6 & 12 months postpartum
Secondary outcome [4] 313432 0
Parental feelings during pregnancy and the first year of parenting. (composite outcome)

Cox, JL (01/01/1987). "Edinburgh Postnatal Depression Scale (EPDS).". Edinburgh Postnatal Depression Scale (EPDS).

Timepoint [4] 313432 0
2, 6 & 12 months postpartum
Secondary outcome [5] 313577 0
Emotional and physical wellbeing of expectant and new parents

Ref: Brown, S. Lumley, J., 2000. Physical health problems after childbirth and maternal depression at six to seven months postpartum. British Journal of Obstetrics and Gynaecology 107, 1194-1201.

Cox, JL (01/01/1987). "Edinburgh Postnatal Depression Scale (EPDS).". Edinburgh Postnatal Depression Scale (EPDS).
Timepoint [5] 313577 0
2, 6 & 12 months postpartum

Eligibility
Key inclusion criteria
First time mothers; with adequate English-speaking ability (i.e. do not require an interpreter for hospital care)at first booking visit from pregnancy diagnosis until 30 weeks gestation
Minimum age
16 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Multiparous women
Women with inadequate English speaking ability
>30 weeks gestation at booking visit

Study design
Purpose of the study
Educational / counselling / training
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; in order to reduce the risk of contamination, clinic days will be randomly allocated rather than individual women. All eligible women on an intervention day will receive the Parenting Kit. A parenting kit will be attached to the woman’s history at her booking in visit, and given to the woman by the midwife conducting the visit. An identifying sticker will be placed in the woman’s medical record so she is easily identified as being in the intervention arm at subsequent visits.
Individual consent will not be gained. However, when the first survey (at 36 weeks gestation) is sent, all women (in both control and intervention groups) will be informed of the evaluation and their choice of opt out from receiving further survey or telephone interview.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each study day (i.e. 4 days x 24 weeks = 96 days total) was randomised to either the control or intervention arm. The randomisation was stratified by clinic day (i.e. Mon, Tu, Wed, Thu) to ensure that the treatment allocation was balanced within each clinic day. Blocked randomisation was used with variable block sizes. The randomisation list was produced in Stata version 13.1 using the “ralloc” command.
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
Given the importance of maternal health and coping on the infant’s health, to determine the sample size for this component we have used the experience of motherhood questionnaire (EMQ), a 20-item self-report measure. The EMQ has been described as a coherent and valid measure of overall coping which is significantly related to and indicative of maternal depression, toddler temperament, social support and life events. It therefore seems reasonable to theorise that the kit may impact on these factors. The EMQ scale goes from 0 to 80, with lower scores indicating better maternal health and wellbeing, and the proportion over and under 40 (often the median) has been used here. To detect a difference of 50% compared to 60% scoring 40 or less between new mothers who have received the kit and those who have not would require 408 per group (that is 816) with 95% confidence and 80% power. Allowing for loss to follow up we aim to recruit 1000 mothers to the RCT component of the trial. This will be an adequate sample size to find meaningful differences (if they exist) in all the other outcomes being measured. We have not allowed for any potential effect of clustering given our randomisation method will ensure that relatively equal numbers of women from the four geographically-based teams (i.e. the main factor which may introduce differenced) will be allocated to both trial arms.
Data will be analysed by intention to treat. Randomising the various clinics over the 22 weeks of 'recruitment' and having such large numbers is likely to result in groups that are evenly distributed - however we will adjust for confounders. The first stage of the analysis will describe the demographics in the two groups using numbers and percentages, and this data will enable us to understand what factors we need to take into account in the analysis of outcomes. Proportions of women scoring above 40 on the EMQ will be compared using an odds ratio, and logistic regression used to adjust for confounders, with an adjusted odds ratio (and 95% confidence interval) presented. Comparison of means will be undertaken for continuous variables using t-tests where data were normally distributed or medians compared otherwise using Mann-Whitney U tests. STATA will be used for data analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/03/2015
Actual
16/03/2015
Date of last participant enrolment
Anticipated
27/08/2015
Actual
10/08/2015
Date of last data collection
Anticipated
6/04/2017
Actual
29/09/2017
Sample size
Target
1000
Accrual to date
Final
1034
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3540 0
The Royal Women's Hospital - Parkville

Funding & Sponsors
Funding source category [1] 290885 0
Hospital
Name [1] 290885 0
The Royal Women's Hospital
Country [1] 290885 0
Australia
Primary sponsor type
University
Name
Judith Lumley Centre, La Trobe University
Address
La Trobe University
215 Franklin Street
Melbourne
Victoria 3000
Country
Australia
Secondary sponsor category [1] 289567 0
Hospital
Name [1] 289567 0
The Royal Women's Hospital
Address [1] 289567 0
Corner Grattan St and Flemington Road
Parkville
Victoria 3052
Country [1] 289567 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292486 0
The Royal Women's Hospital HREC
Ethics committee address [1] 292486 0
Ethics committee country [1] 292486 0
Australia
Date submitted for ethics approval [1] 292486 0
Approval date [1] 292486 0
14/01/2015
Ethics approval number [1] 292486 0
14/44
Ethics committee name [2] 292487 0
University Human Ethics Committee
Ethics committee address [2] 292487 0
Ethics committee country [2] 292487 0
Australia
Date submitted for ethics approval [2] 292487 0
Approval date [2] 292487 0
30/01/2015
Ethics approval number [2] 292487 0
14/44

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

Contacts
Principal investigator
Name 55546 0
Prof Della Forster
Address 55546 0
Judith Lumley Centre La Trobe University, Bundoora, 3086, Victoria, Australia
Country 55546 0
Australia
Phone 55546 0
+61 3 9479 8783
Fax 55546 0
Email 55546 0
[email protected]
Contact person for public queries
Name 55547 0
Sarah Hay
Address 55547 0
Judith Lumley Centre La Trobe University, Bundoora, 3086, Victoria, Australia
Country 55547 0
Australia
Phone 55547 0
+61 3 9479 6681
Fax 55547 0
Email 55547 0
[email protected]
Contact person for scientific queries
Name 55548 0
Sarah Hay
Address 55548 0
Judith Lumley Centre La Trobe University, Bundoora, 3086, Victoria, Australia
Country 55548 0
Australia
Phone 55548 0
+61 3 94796681
Fax 55548 0
Email 55548 0
[email protected]

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.