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Trial registered on ANZCTR


Registration number
ACTRN12616001732471
Ethics application status
Approved
Date submitted
2/12/2016
Date registered
16/12/2016
Date last updated
6/12/2018
Date data sharing statement initially provided
6/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the effectiveness of a nurse-moderated group-based internet support program for mothers with comorbid mild to moderate depression and parenting problems
Scientific title
A randomised controlled trial evaluating the effectiveness of a nurse-moderated group-based internet support program for mothers with comorbid mild to moderate depression and parenting problems
Secondary ID [1] 289938 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12613000204741

Health condition
Health condition(s) or problem(s) studied:
Postnatal Depression

 299584 0
Parenting Problems 301264 0
Infant Development 301337 0
Condition category
Condition code
Mental Health 299552 299552 0 0
Depression
Public Health 299553 299553 0 0
Health service research
Reproductive Health and Childbirth 299554 299554 0 0
Childbirth and postnatal care

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. During this appointment all mothers will complete a questionnaire comprised of a 4-item parenting problems scale and the Edinburgh Postnatal Depression Scale (EPDS). Mothers who score greater than or equal to 7 on the EPDS and report at least one problem on the 4-item parenting problems questionnaire will be recruited to the study. Mothers in the intervention arm will be assigned to an online group comprised of 20 mothers of similar-aged infants. They will be provided with access to an internet based program for a four month period (when their child is aged 2-6 months). The app is an extension of that used in the New Technology for New Mums trial (ACTRN12613000204741) and encourages mothers to exchange information and mutual support and to seek help from their nurse moderator when necessary. Mothers will be able to access the app at any time. Sections of the app, such as the 'Resources' component, have been enriched and content includes both Parenting resources and self-guided modules to help reduce depressive symptoms. Resources will be posted for discussion twice per week, and mothers can post their messages in "Chat', and complete related 'Activities'. Nurses will also direct mothers to the 'Resources' during group discussions. Mothers will have the option of privately messaging their Nurse, although they are made aware that the Nurse in only online every few days. Intervention adherence and fidelity will be assessed using system measures such as number of logins, posts to 'Chat', and number and type of resources accessed. Mothers will also complete a questionnaire about their experience with the app. Strategies to improve adherence and fidelity include Nurses contacting mothers directly by phone when, in their clinical judgement, they consider it necessary, and also, methods of reporting problems within the app itself. Mothers in the intervention will also have access to standard care services.
Intervention code [1] 295376 0
Prevention
Intervention code [2] 295377 0
Treatment: Other
Intervention code [3] 295378 0
Behaviour
Comparator / control treatment
Participants in the control group will receive 'Standard Care' which involves a standard home-based health check in the weeks following the child's birth. These mothers can then access the normal range of services available in South Australia. The normal services include face-to-face, nurse moderated group support and/or access to a range of community-based resources. Alternatively, mothers can choose to receive no further support.
Control group
Active

Outcomes
Primary outcome [1] 299180 0
Maternal depressive symptoms measured using mean scores on the Edinburgh Postnatal Depression Scale (EPDS).
Timepoint [1] 299180 0
When infants are aged 1-2 months (baseline), and 8 months and 12 months.
Primary outcome [2] 299181 0
Quality of maternal caregiving measured using mean scores on the NCAST Parent-Child Interaction Teaching Total Scale .
Timepoint [2] 299181 0
When infants are aged 1-2 months (baseline), and 8 months and 12 months.
Primary outcome [3] 299182 0
Perceived maternal parenting competence using mean scores on the Parenting Sense of Competence Scale (PSCS).
Timepoint [3] 299182 0
When infants are aged 1-2 months (baseline), and 8 months and 12 months.
Secondary outcome [1] 326436 0
Parent and child characteristics using PSI (competence, isolation, attachment, spouse & role scales) scores.
Timepoint [1] 326436 0
When infants are aged 1-2 months (baseline), and 8 months and 12 months.
Secondary outcome [2] 326437 0
Service utilisation (e.g. number of CaFHS clinic visits).
Timepoint [2] 326437 0
When infants are aged 1-2 months (baseline), and 8 months and 12 months.
Secondary outcome [3] 326438 0
Intervention quality will be assessed using an 18 item questionnaire which we have developed for this purpose. Items ask about the effectiveness of the intervention and the usability of the app.
Timepoint [3] 326438 0
When infants are aged 8 and 12 months.

Eligibility
Key inclusion criteria
New mothers who are eligible for a Universal Contact Visit from the State-funded Child and Family Health Sevice (CaFHS), who score 7 or more on the EPDS and who report at least one parenting problem.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
i) EPDS scores less than 7. ii) Clinician exclusion. iii) Experiencing domestic violence, illicit drug use or other major distress. iv) insufficient English language skills. v) No internet access on a mobile phone or tablet.

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)
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
1/02/2017
Actual
1/03/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
30/06/2017
Date of last data collection
Anticipated
Actual
6/07/2018
Sample size
Target
160
Accrual to date
Final
133
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 294236 0
Charities/Societies/Foundations
Name [1] 294236 0
Channel 7 Children's Research Foundation
Country [1] 294236 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
The University of Adelaide
North Terrace
Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 293065 0
None
Name [1] 293065 0
Address [1] 293065 0
Country [1] 293065 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295657 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 295657 0
Ethics committee country [1] 295657 0
Australia
Date submitted for ethics approval [1] 295657 0
31/03/2016
Approval date [1] 295657 0
19/04/2016
Ethics approval number [1] 295657 0
HREC/16WCHN/14

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

Contacts
Principal investigator
Name 67634 0
Prof Michael Sawyer
Address 67634 0
Research & Evaluation Unit, WCHN,
Dept Paediatrics, University of Adelaide
72 King William Rd
North Adelaide
South Australia 5006
Country 67634 0
Australia
Phone 67634 0
+61 8 8161 7207
Fax 67634 0
Email 67634 0
michael.sawyer@adelaide.edu.au
Contact person for public queries
Name 67635 0
Michael Sawyer
Address 67635 0
Research & Evaluation Unit,
Women's & Children's Health Network
72 King William Rd
North Adelaide
South Australia 5006
Country 67635 0
Australia
Phone 67635 0
+61 8 8161 7207
Fax 67635 0
Email 67635 0
michael.sawyer@adelaide.edu.au
Contact person for scientific queries
Name 67636 0
Michael Sawyer
Address 67636 0
Research & Evaluation Unit,
Women's & Children's Health Network
72 King William Rd
North Adelaide
South Australia 5006
Country 67636 0
Australia
Phone 67636 0
+61 8 8161 7207
Fax 67636 0
Email 67636 0
michael.sawyer@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We did not apply for approval from the Ethics Committee to share individual participant data, therefore we are unable to share this data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
625Study protocol    Study protocol will be available in the manuscript... [More Details]



Results publications and other study-related documents

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

Documents added automatically
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