Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001256662
Ethics application status
Approved
Date submitted
21/11/2014
Date registered
2/12/2014
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Date results information initially provided
14/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Baby Steps: An online program promoting the wellbeing of new mothers and fathers
Scientific title
An evaluation of new mothers and fathers using an online program promoting perinatal mental health versus an online program providing tips on early childcare on perinatal well being
Secondary ID [1] 285515 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal psychological distress 293313 0
perinatal quality of life 293314 0
self-efficacy in child rearing 293315 0
satisfaction with parenting role and skills 293316 0
relationship satisfaction 293317 0
Condition category
Condition code
Mental Health 293588 293588 0 0
Other mental health disorders
Public Health 293589 293589 0 0
Health promotion/education
Reproductive Health and Childbirth 293590 293590 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be assigned to one of two Baby Steps interactive web-based interventions:
Arm 1) Babycare – modules that provide access to information and tips on early childcare in the areas of feeding, soothing, sleep and getting prepared. Links to additional relevant information on childcare are provided throughout. Automated text messages at 2, 4, 7 and 10 weeks post registration remind participants to visit and continue use of the site.
Arm 2) Wellbeing - includes all content from Babycare plus additional modules specifically targeting parent wellbeing. The additional Wellbeing modules focus on self-care through promoting pleasurable physical and social activity, parents’ strengths, sleep tips, and stress reduction. Additionally, Wellbeing focuses on couples’ relationships, interacting with baby and changing roles. Planning tools assist parents to develop action plans based on tips from the program. Wellbeing also includes a Scrapbook section where parents are encouraged to upload photos that remind them of positive aspects of parenting and of achievements. The Wellbeing program is also supported by SMSs at 2, 4, 7 and 10 weeks to encourage continued program use.

The two online interventions are designed to be used at times and places that are convenient to the participant. Participants are able to use the program in sessions as brief or long as he or she desires and then can return to the modules whenever they want. The modules are not time-based and progression through the website is not linear. Rather, participants are able to pick and choose relevant topics to read and then develop plans based on these. Program completion time will depend on the number of topics that participants choose to work through. Participants can spend as much or as little time as they like using the website and there is no minimum or maximum program completion time.

Program adherence to each intervention is automatically monitored through the Baby Steps program. The website collects program use data encompassing number of logins, pages viewed, Babycare pages viewed, Wellbeing pages viewed, plans made and photos uploaded as well as total time spent on program pages.

There is no end date to either online intervention. Participants can continue to access the website for the life of the website (i.e. indefinitely). Their participation in the research and hence the monitoring of their use of the website will end after the six month follow-up point.
Intervention code [1] 290457 0
Prevention
Intervention code [2] 290715 0
Behaviour
Comparator / control treatment
The comparator treatment is the active control website providing information and tips on early childcare, Babycare (described previously). Babycare supports new parents with childcare in the areas of feeding, soothing, sleep and getting prepared. The Babycare program is supported by SMSs at 2, 4, 7 and 10 weeks to encourage continued use of the program.

Babycare differs to ‘standard treatment’ that is typically provided by health care professionals in a face-to-face context.
Control group
Active

Outcomes
Primary outcome [1] 293402 0
Perinatal psychological distress as measured by the mean score on the Edinburgh Postnatal Depression Scale. The Edinburgh Postnatal Depression Scale is a 10-item screening instrument that assesses generalised depression and anxiety symptoms over the past week.
Timepoint [1] 293402 0
baseline, 3 months (13 weeks) and 6 months (26 weeks) after randomisation.
Primary outcome [2] 293403 0
Quality of life as measured by the mean score on the Assessment of Quality of Life 8D Instrument (AQoL-8D). The AQoL-8D is a 35-item scale assessing 8 dimensions of quality of life over the past week (independent living, relationships, mental health, coping, pain, senses, life satisfaction and self-worth).
Timepoint [2] 293403 0
baseline, 3 months (13 weeks) and 6 months (26 weeks) after randomisation.
Secondary outcome [1] 310943 0
Self-efficacy in child rearing as measured by the mean score on three self-efficacy items. Three items that were created specifically for this study measure self-efficacy in a number of child rearing domains. Participants will be asked “Thinking about the next 13 weeks, how confident are you with: 1. Feeding your baby, 2. Putting your baby to sleep, and 3. Settling your baby." Response options range from 0 (not at all confident) to 100 (extremely).
Timepoint [1] 310943 0
baseline, 3 months (13 weeks) and 6 months (26 weeks) after randomisation.
Secondary outcome [2] 310944 0
Satisfaction (with parenting role and skills, relationship, and social support) will be measured by the mean score on each of seven satisfaction items. Seven items created for this study ask "How satisfied are you with: 1. Your parenting role, 2. Your parenting skills, 3. Your relationship with your partner, 4. The support you receive from your partner, 5. The practical support you receive from others, 6. The emotional support you receive from others, and 7. The support you have been providing to your partner." Response options range from 0 (not at all) to 100 (extremely) satisfied.
Timepoint [2] 310944 0
baseline, 3 months (13 weeks) and 6 months (26 weeks) after randomisation.
Secondary outcome [3] 310945 0
Relationship satisfaction will be assessed using the mean score on the Couples Satisfaction Index (CSI-16). The CSI-16 is a 16-item instrument examining overall quality of and satisfaction with romantic relationships.
Timepoint [3] 310945 0
baseline, 3 months (13 weeks) and 6 months (26 weeks) after randomisation.
Secondary outcome [4] 310946 0
Social support as indicated by the mean score on the four-item Social Support Survey. This scale asks respondents the availability of different types of social support.
Timepoint [4] 310946 0
baseline, 3 months (13 weeks) and 6 months (26 weeks) after randomisation.
Secondary outcome [5] 311000 0
Program usage is quantified by mean number of logins, pages viewed, Babycare pages viewed, Wellbeing pages viewed, plans made and photos uploaded as well as total time spent on program pages, Babycare pages and Wellbeing pages.
Timepoint [5] 311000 0
3 months (13 weeks) and 6 months (26 weeks) after randomisation.
Secondary outcome [6] 311001 0
Program satisfaction will be examined using a mean score on each of four created items. The four items assess satisfaction with program relevance, usefulness, and ease of navigation on a scale from 0 (not at all) to 100 (extremely).
Timepoint [6] 311001 0
3 months (13 weeks) after randomisation.
Secondary outcome [7] 311002 0
Cost-effectiveness of the intervention. Past 13-week number of days of unpaid absenteeism due to: 1. reasons related to the baby, 2. the parent's own illness, and/or 3. other reasons will be assessed. Overall performance on the days parents worked in the past 13 weeks is assessed on a scale ranging from 0 (worst performance) to 10 (top performance).
Timepoint [7] 311002 0
Parent absenteeism and work performance: baseline, 3 months (13 weeks) and 6 months (26 weeks) after randomisation.

Eligibility
Key inclusion criteria
Inclusion criteria are:
1) Co-parenting male-female couple
2) First child for both parents
3) Gestation between 26 and 38 weeks
4) Pregnancy is singleton with no complications
5) Literacy in English
6) Internet and mobile phone access
7) Aged 18 years or over


The project aims to enhance wellbeing in the transition to parenthood. It therefore focuses on first-time parents.
Participants are recruited antenatally at a gestation of 26 to 38 weeks. This represents a range of strong fetal viability if premature labour were to occur and also allows time to engage with the program before the arrival of the baby.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The current study specifically excludes:
Children and young people under the age of 18: Participants under 18 are excluded as young adolescent pregnancies require greater monitoring and support than this study can provide. Participants under 18 may still access the Babycare program (as per other participants who do not meet the inclusion criteria), but will be referred to other appropriate sources of support outside of the study.

Pregnancies that are multiple or have complications have greater support needs than this study can offer.

Individuals that do not have a high level of English literacy, and participants with an intellectual or cognitive impairment will also be excluded as they will be unable to give informed consent. Additionally, they will not be able to complete the assessments or understand the intervention, all of which is presented in written format. They may still access the Babycare program if they desire to as per other individuals who do not meet the inclusion criteria.
Same-sex couples are excluded as this research is specifically studying the wellbeing of male-female couples in the transition to parenthood. Same-sex couples may still access the Babycare program if they desire to as per other individuals who do not meet the inclusion criteria.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are screened through an online survey after both parents have registered at the website. If eligible, participants are directed to the online baseline assessment survey. This must be completed by both parents before participants are randomly assigned to one of the two intervention groups.
Allocations are generated by the Goji program, a research trials management software developed at QUT by the same programmers who developed the Baby Steps program. Goji automatically allocates participants to a research group once their baseline is completed, recording the allocation in the research database. Couples are randomised as a unit to ensure they are allocated to the same intervention. The program then automatically emails participants with login details to access the program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Baby Steps program generates allocations in permuted blocks. Randomisations are stratified by depression at intake as measured using the Edinburgh Postnatal Depression Scale (neither parent elevated on the EPDS vs either parent elevated according to cut-offs of >5 for fathers and >7 for mothers).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined based on time and budget. The data will be analysed as group data to compare the effectiveness of the two interventions, Babycare and Wellbeing. This project is applying intention-to-treat analysis, meaning all couples randomised to a condition will be included in the analyses, regardless of their completion of the study.
Data analysis will utilise repeated measures MANCOVAs controlling for couple psychiatric history (history of treatment).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2015
Actual
28/02/2015
Date of last participant enrolment
Anticipated
9/10/2015
Actual
2/10/2015
Date of last data collection
Anticipated
Actual
11/05/2016
Sample size
Target
480
Accrual to date
Final
496
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 3054 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 8826 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 290110 0
Charities/Societies/Foundations
Name [1] 290110 0
Beyond Blue Limited (beyondblue National Priority Driven Research 2011 Grant Round)
Country [1] 290110 0
Australia
Primary sponsor type
Individual
Name
Prof David Kavanagh
Address
Centre for Children's Health Research
Queensland University of Technology
62 Graham Street
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 288818 0
None
Name [1] 288818 0
Address [1] 288818 0
Country [1] 288818 0
Other collaborator category [1] 278206 0
Individual
Name [1] 278206 0
Dr Kyra Hamilton
Address [1] 278206 0
School of Applied Psychology
Psychology Building (M24)
Griffith University
Messines Ridge Road
Mt Gravatt QLD 4122
Country [1] 278206 0
Australia
Other collaborator category [2] 278207 0
Individual
Name [2] 278207 0
Prof Jeannette Milgrom
Address [2] 278207 0
Department of Clinical and Health Psychology
Austin Health
Heidelberg Repatriation Hospital
Centaur Building
300 Waterdale Road
Heidelberg Heights VIC 3081
Country [2] 278207 0
Australia
Other collaborator category [3] 278208 0
Individual
Name [3] 278208 0
Dr Heather Rowe
Address [3] 278208 0
Jean Hailes Research Unit
Monash University
PO Box 1108
Clayton South VIC 3169
Country [3] 278208 0
Australia
Other collaborator category [4] 278209 0
Individual
Name [4] 278209 0
Prof Jane Fisher
Address [4] 278209 0
School of Public Health & Preventive Medicine
Monash University
Locked Bag 29
Clayton VIC 3168
Country [4] 278209 0
Australia
Other collaborator category [5] 278210 0
Individual
Name [5] 278210 0
Dr Anja Wittkowski
Address [5] 278210 0
School of Psychological Science
University of Manchester
2nd Floor Zochonis Building
Brunswick Street
Manchester M13 9PL
Country [5] 278210 0
United Kingdom
Other collaborator category [6] 278211 0
Individual
Name [6] 278211 0
Prof Paul Scuffham
Address [6] 278211 0
School of Medicine
Griffith University
Logan Campus
University Dr,
Meadowbrook QLD 4131
Country [6] 278211 0
Australia
Other collaborator category [7] 278212 0
Individual
Name [7] 278212 0
Dr Leigh Davis
Address [7] 278212 0
School of Nursing
Queensland University of Technology
GPO Box 2434
Brisbane QLD 4001
Country [7] 278212 0
Australia
Other collaborator category [8] 278213 0
Individual
Name [8] 278213 0
Dr Anne Walsh
Address [8] 278213 0
School of Nursing
Queensland University of Technology
GPO Box 2434
Brisbane QLD 4001
Country [8] 278213 0
Australia
Other collaborator category [9] 278214 0
Individual
Name [9] 278214 0
Prof Katherine White
Address [9] 278214 0
School of Psychology & Counselling
Queensland University of Technology
GPO Box 2434
Brisbane QLD 4001
Country [9] 278214 0
Australia
Other collaborator category [10] 278215 0
Individual
Name [10] 278215 0
A/Prof Leanne Hides
Address [10] 278215 0
Centre for Children's Health Research
Queensland University of Technology
62 Graham Street
South Brisbane QLD 4101
Country [10] 278215 0
Australia
Other collaborator category [11] 278216 0
Individual
Name [11] 278216 0
Prof Kim Halford
Address [11] 278216 0
School of Psychology
The University of Queensland
St Lucia QLD 4072
Country [11] 278216 0
Australia
Other collaborator category [12] 278217 0
Individual
Name [12] 278217 0
A/Prof Dian Tjondronegoro
Address [12] 278217 0
Science and Engineering Faculty
Queensland University of Technology
GPO Box 2434
Brisbane QLD 4001
Country [12] 278217 0
Australia
Other collaborator category [13] 278218 0
Individual
Name [13] 278218 0
Ms Michelle Kelly
Address [13] 278218 0
Mater Mother's Hospital
Parent education and support service
Raymond Terrace
South Brisbane QLD 4101
Country [13] 278218 0
Australia
Other collaborator category [14] 278219 0
Individual
Name [14] 278219 0
Dr Elizabeth Hurrion
Address [14] 278219 0
Mater Mother's Hospital
Neonatal Critical Care Unit
Raymond Terrace
South Brisbane QLD 4101
Country [14] 278219 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291820 0
Mater Health Services Human Research Ethics Committee (EC00332)
Ethics committee address [1] 291820 0
Room 294, Level 2, Aubigny Place
Raymond Terrace
South Brisbane Qld 4101
Ethics committee country [1] 291820 0
Australia
Date submitted for ethics approval [1] 291820 0
Approval date [1] 291820 0
17/11/2014
Ethics approval number [1] 291820 0
Ethics committee name [2] 291821 0
Queensland University of Technology University Human Research Ethics Committee (EC00171)
Ethics committee address [2] 291821 0
Research Ethics Officer
Queensland University of Technology
Office of Research
GPO Box 2434
BRISBANE QLD 4001
Ethics committee country [2] 291821 0
Australia
Date submitted for ethics approval [2] 291821 0
Approval date [2] 291821 0
Ethics approval number [2] 291821 0

Summary
Brief summary
The objective of this project is to conduct the first randomised controlled trial of a combined Internet and SMS intervention for perinatal wellbeing in both mothers and fathers. Two hundred primiparous mother-father couples will be recruited.
The study aims to:
1.Compare the effectiveness on indices of wellbeing of two online programs for first-time parents:
a) Babycare - access to information and tips on early childcare in the areas of feeding, soothing, sleep and getting prepared. The Babycare program is supported by SMSs at 2, 4, 7 and 10 weeks to encourage continued use of the program;
b) Wellbeing - includes all content from Babycare plus additional modules specifically targeting wellbeing in the areas of self-care, relationships, interacting with baby and changing roles. Wellbeing also includes a Scrapbook section where parents are encouraged to upload photos that remind them of positive aspects of parenting and of achievements. The Wellbeing program is also supported by SMSs at 2, 4, 7 and 10 weeks.
2. Assess the cost-effectiveness of each intervention.

It is hypothesised that:
1. Participants receiving the Wellbeing program will show greater program use and improved confidence in childcare at 3 and 6 months than those in Babycare.
2. Levels of distress, quality of life, relationship satisfaction and cost-effectiveness will be greater for Wellbeing than Babycare.
Trial website
www.babysteps.org.au
Trial related presentations / publications
Hamilton, K., Kavanagh, D., Connolly, J., Davis, L., Fisher, J., Halford, K., Hides, L., Milgrom, J., Rowe, H., Sanders, D., Scuffham, P. A., Tjondronegoro, D., Walsh, A., White, K. M., Wittkowski, A. (2016). Baby Steps - An online program promoting the well-being of new mothers and fathers: A study protocol. JMIR Research Protocols, 5(3), e140.

Kavanagh, D., & Sanders D. (2016). Does an Online Wellbeing Program (Baby Steps) Prevent Perinatal Distress in First-Time Fathers and Mothers? Oral presentation at Marce 2016.

Baby Steps – can an online wellbeing program offered during the perinatal period prevent distress in new mothers and fathers? Oral presentation at WCBCT 2016.
Public notes

Contacts
Principal investigator
Name 52166 0
Prof David Kavanagh
Address 52166 0
Centre for Children's Health Research
Queensland University of Technology
62 Graham Street
South Brisbane QLD 4101
Country 52166 0
Australia
Phone 52166 0
+61 7 3069 7327
Fax 52166 0
Email 52166 0
david.kavanagh@qut.edu.au
Contact person for public queries
Name 52167 0
Prof David Kavanagh
Address 52167 0
Centre for Children's Health Research
Queensland University of Technology
62 Graham Street
South Brisbane QLD 4101
Country 52167 0
Australia
Phone 52167 0
+61 7 3069 7327
Fax 52167 0
Email 52167 0
david.kavanagh@qut.edu.au
Contact person for scientific queries
Name 52168 0
Prof David Kavanagh
Address 52168 0
Centre for Children's Health Research
Queensland University of Technology
62 Graham Street
South Brisbane QLD 4101
Country 52168 0
Australia
Phone 52168 0
+61 7 3069 7327
Fax 52168 0
Email 52168 0
david.kavanagh@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
The results have not yet been published so data sharing arrangements are undecided at this time.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
118Study protocol    https://www.researchprotocols.org/2016/3/e140/



Results publications and other study-related documents

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