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Trial registered on ANZCTR


Registration number
ACTRN12613000204741
Ethics application status
Approved
Date submitted
15/02/2013
Date registered
20/02/2013
Date last updated
12/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
New Technology for New Mums: A Pragmatic Trial of Web-Based Support for Mothers of Young Children
Scientific title
For new mothers, does a combined clinic-nurse plus internet intervention achieve equivalent parenting self-efficacy to current standard nursing practice?
Secondary ID [1] 281967 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenting self-efficacy 288391 0
Condition category
Condition code
Public Health 288738 288738 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a single clinic-based appointment with a nurse during the weeks following the birth of their child. They will also be provided with access to an internet-based program for a 6 month period (when their child is aged 4 weeks to 7 months). They will be able to access the internet website using a range of different devices including computers and smart phones. The website is built around the concept of providing support to mothers through asynchronous online mothers’ groups (i.e., mothers do not all have to be online at the same time) which are moderated by a nurse. The website provides access to substantial information about a range of issues relevant to the care and management of young children. It also utilises a timeline showing normal child development through which nurses provide mothers with reminders about key issues that need to be addressed as their child develops. Mothers are asked to access the website at least two times each week and to respond to comments by other mothers and to "conversation starters" and "quizzes" that are used by nurses to facilitate interaction between mothers and to provide advice about the care and management of young children.
Intervention code [1] 286532 0
Behaviour
Comparator / control treatment
Standard care: “Standard care” provided to mothers in South Australia is comprised of a single home-based appointment with a nurse during the weeks following a child’s birth. Following this, mothers can access the normal range of services available in South Australia. However, there is no specific service offered other than the single home visit. Approximately 10% of mothers in South Australia enrole in face-to face groups moderated by nurses to obtain support and advice. The remainder either receive no support or utilise a range of community and medical services according to their needs at any given time.
Control group
Active

Outcomes
Primary outcome [1] 288879 0
Mean Parenting Stress Index (PSI) competence scale score
Timepoint [1] 288879 0
Baseline, and 6, 12 and 18 months after the commencement of the intervention.
Primary outcome [2] 288880 0
Mean Karitane Self-Efficacy Score
Timepoint [2] 288880 0
Baseline, and 6, 12 and 18 months after the commencement of the intervention.
Secondary outcome [1] 301226 0
Mean PSI (isolation, attachment, spouse & role) scores
Timepoint [1] 301226 0
Baseline, and 6, 12 and 18 months after the commencement of the intervention.
Secondary outcome [2] 301227 0
Mean Maternal Postnatal Attachment Scale Scores
Timepoint [2] 301227 0
Baseline, and 6, 12 and 18 months after the commencement of the intervention.
Secondary outcome [3] 301228 0
Mean Interpersonal Support Evaluation List - Short Form scores
Timepoint [3] 301228 0
Baseline, and 6, 12 and 18 months after the commencement of the intervention.
Secondary outcome [4] 301229 0
Mean Maternal Support Scale scores
Timepoint [4] 301229 0
Baseline, and 6, 12 and 18 months after the commencement of the intervention.
Secondary outcome [5] 301230 0
Mean Everyday Feeling Questionnaire scores
Timepoint [5] 301230 0
Baseline, and 6, 12 and 18 months after the commencement of the intervention.
Secondary outcome [6] 301231 0
Mean Ages and Stages Questionnaire - Social and Emotional scores
Timepoint [6] 301231 0
6, 12 and 18 months after the commencement of the intervention.
Secondary outcome [7] 301232 0
Mean MacArthur Communicative Development Inventory scores
Timepoint [7] 301232 0
18 months after the commencement of the intervention.

Eligibility
Key inclusion criteria
New mothers who are eligible for a Universal Contact Visit from the State-funded Child and Family Health Sevice (CaFHS)
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i) clinician exclusion, ii) insufficient english language skills, iii) do not have access to the internet, iv) did not want or receive a Universal Contact Visit.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Completed
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)
SA

Funding & Sponsors
Funding source category [1] 286743 0
Government body
Name [1] 286743 0
National Health and Medical Research Council
Address [1] 286743 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 286743 0
Australia
Funding source category [2] 286744 0
Government body
Name [2] 286744 0
SA Health
Address [2] 286744 0
Citi Centre Building
11 Hindmarsh Square
Adelaide South Australia 5000

Country [2] 286744 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
The University of Adelaide
SA 5005
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 285526 0
None
Name [1] 285526 0
Address [1] 285526 0
Country [1] 285526 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288816 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 288816 0
Level 2 Samuel Way Building
72 King William Road
NORTH ADELAIDE SA 5006
Ethics committee country [1] 288816 0
Australia
Date submitted for ethics approval [1] 288816 0
10/10/2012
Approval date [1] 288816 0
13/11/2012
Ethics approval number [1] 288816 0
REC2368/4/2017

Summary
Brief summary
The broad aim of the project is to test the effectiveness of a new service program to be made available to mothers of young children. The unique feature of the program is that it will combine the skills of community nurses and web-based technology to enhance support for mothers of infants.
Following the development of the new program, it's effectiveness will be tested in trial involving approximately 800 mothers and infants. Half of the mothers and infants will receive the combined program while the other half will receive routine care provided for by CaFHS.
We will test whether the combined program achieves equivalent outcomes to that achieved by routine care. The outcomes this project will assess include levels of parenting self-efficacy, perceived support, maternal mental health, infant development and the quality of mother-infant attachment.
Trial website
Trial related presentations / publications
Sawyer M, Reece C, Bowering K, Jeffs D, Sawyer ACP, Mpundu-Kaambwa C, Clark JJ, McDonald D, Mittinty M, Peters JD, Lynch J. Usage, adherence and attrition: how new mothers engage with a nurse-moderated web-based intervention to support maternal and infant health. A 9-month observational study. BMJ Open. 2016; 6:e009967 (doi: 10:1136/bmjopen-2015-009967)

Sawyer M, Reece C, Bowering K, Jeffs D, Sawyer A, Mittinty M, Lynch J. Nurse-moderated internet-based support for mothers: A non-inferiority, randomised controlled trial. (submitted for publication – Pediatrics)
Public notes

Contacts
Principal investigator
Name 37906 0
Prof Michael Sawyer
Address 37906 0
Research & Evaluation Unit, WCHN, Dept Paediatrics University of Adelaide,
72 King William Rd
North Adelaide, SA 5006.
Country 37906 0
Australia
Phone 37906 0
+61 8 8161 7207
Fax 37906 0
Email 37906 0
michael.sawyer@adelaide.edu.au
Contact person for public queries
Name 37907 0
Prof Michael Sawyer
Address 37907 0
Research & Evaluation Unit, WCHN, Dept Paediatrics University of Adelaide,
72 King William Rd
North Adelaide, SA 5006.
Country 37907 0
Australia
Phone 37907 0
+61 8 8161 7207
Fax 37907 0
Email 37907 0
michael.sawyer@adelaide.edu.au
Contact person for scientific queries
Name 37908 0
Prof Michael Sawyer
Address 37908 0
Research & Evaluation Unit, WCHN, Dept Paediatrics University of Adelaide,
72 King William Rd
North Adelaide, SA 5006.
Country 37908 0
Australia
Phone 37908 0
+61 8 8161 7207
Fax 37908 0
Email 37908 0
michael.sawyer@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary