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Trial registered on ANZCTR


Registration number
ACTRN12622000287730
Ethics application status
Approved
Date submitted
27/01/2022
Date registered
15/02/2022
Date last updated
23/01/2023
Date data sharing statement initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
New technology for new parents: Using technology to help parents bond with and care for their new baby
Scientific title
A preliminary evaluation of a new approach to improve parental mentalization and emotional attachment during pregnancy and the postnatal period in families experiencing psychosocial adversity
Secondary ID [1] 306260 0
Nil known
Universal Trial Number (UTN)
U1111-1273-6711
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 325006 0
Postpartum problems 325007 0
Depression 325008 0
Child bonding and attachment 325023 0
Parenting Problems 325024 0
Infant Development 325046 0
Condition category
Condition code
Mental Health 322444 322444 0 0
Other mental health disorders
Public Health 322481 322481 0 0
Health service research
Reproductive Health and Childbirth 322482 322482 0 0
Childbirth and postnatal care
Mental Health 322536 322536 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A hospital-based clinical psychologist or social worker with additional training will deliver three individualised 1 hour virtual home visits (via telehealth) to women and their partners (if applicable).

During the first virtual home visit (when mothers are approximately 26 weeks pregnant) parents will complete ‘Baby CHAT’, a manualised psychoeducational intervention designed to improve parental mentalization and emotional attachment during pregnancy (Cox et al 2021). The parent's will receive the Baby CHAT booklet prior to the virtual-home-visit and during the visit be guided through fetal development and postnatal social development of the baby. Parents will be guided to develop reflective functioning and bond with the baby. The booklet may be utilised throughout the pregnancy and provides parents with an overview of baby’s development from conception onwards and what they might say if they could talk in the first few weeks and months after birth. The booklet provides workspaces to enable parents’ to document aspects of mentalization, attachment and bonding. The booklet also provides resources for singing, playing music and talking/reading/telling stories to the unborn baby. Importantly, mindfulness techniques for the parent are also discussed as well as how to incorporate ‘Baby CHAT’ into everyday life. Time commitment to Baby Chat documentation will vary according to parental engagement with the Baby Chat intervention.

Women and their partners (if applicable) will also attend two 30-minute 4-D ultrasound sessions at the Women's and Children's Hospital (at 28 and 34 weeks gestation) where a sonographer will conduct the ultrasound while a psychologist or social worker will work with parents-to-be to get to know their unborn baby via mentalization approaches. Parents will be given images and a short video of their baby on USB to take home.

The second and third virtual-home-visits will be provided at approximately 2 and 6 weeks after the birth of the baby. The 2-week visit will focus on parent understanding of infant development and parental stresses associated with persistent infant crying. The visit will help parents develop strategies to cope with persistent infant crying and to develop a safety checklist when they are getting too frustrated to provide safe care. Other focus areas include bonding and baby cues. The 6 week visit will review how parent's are coping, review what is working well and further problem solve. Other focus areas include getting to know their baby and infant social development.

Parent's will receive booklets outlining settling and coping strategies, a safety planning checklist and South Australian parent support networks. These resources were specifically designed by psychologists and social workers within Child Protection Services at the study institution for use within the study.

Cox H, James A, Day C, Reissland N, 2021. Feasibility of a psychoeducational group intervention to improve parental reflective functioning and bonding in pregnancy: a randomised trial. Journal of Reproductive and Infant Psychology 39(5), 499-515.
Intervention code [1] 322677 0
Treatment: Other
Intervention code [2] 322678 0
Behaviour
Comparator / control treatment
Participants in the control group will receive ‘Standard Care’ which as per the South Australian Perinatal Practice Guidelines for Antenatal Care which states standard (minimum) antenatal visits at (after the period of trial randomisation) 28, 32, 36, 38 and 40 weeks gestation; in-hospital and at home postnatal care will be guided by the South Australia Perinatal Practice Guidelines for Postnatal Care, where the total number of home visits will be guided by the woman’s individual circumstances and hospital specific criteria which determines number of visits allocated. 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] 330344 0
Antenatal attachment measured by the maternal antenatal attachment scale (MAAS).

The online outcomes questionnaire described above will be sent to all randomised women approximately 36-38 weeks gestation, with the exception of women with severe adverse outcomes (e.g. fetal death).
Timepoint [1] 330344 0
36-38 weeks gestation
Primary outcome [2] 330345 0
Antenatal reflective functioning measured by the prenatal parenting reflective functioning questionnaire (P-PRFQ).

The online outcomes questionnaire described above will be sent to all randomised women approximately 36-38 weeks gestation, with the exception of women with severe adverse outcomes (e.g. fetal death)..
Timepoint [2] 330345 0
36-38 weeks gestation
Primary outcome [3] 330346 0
Parenting competence and attachment measured by parenting stress index (PSI-IV) parent domain subscales.

The online outcomes questionnaire described above will be sent to all randomised women approximately 2 months postnatal, with the exception of women with severe adverse outcomes (e.g. fetal or neonatal death).
Timepoint [3] 330346 0
2 and 6 months postnatal
Secondary outcome [1] 405887 0
Primary outcome 4: Postnatal reflective functioning measured by the Parental Reflective Functioning Questionnaire (PRFQ).

The online outcomes questionnaire described above will be sent to all randomised women approximately 2 months postnatal, with the exception of women with severe adverse outcomes (e.g. fetal or neonatal death).
Timepoint [1] 405887 0
2 and 6 months postnatal
Secondary outcome [2] 405888 0
Primary outcome 5: Infant crying questionnaire assessing knowledge of infant crying and assessing number of times of frustration with infant crying (Period of Purple Cry).

The online outcomes questionnaire described above will be sent to all randomised women approximately 2 months postnatal, with the exception of women with severe adverse outcomes (e.g. fetal or neonatal death).
Timepoint [2] 405888 0
2 and 6 months postnatal
Secondary outcome [3] 405889 0
Secondary outcome 1: Antenatal health behaviours measured by the prenatal health behaviours scale (PHBS).

The online outcomes questionnaire described above will be sent to all randomised women approximately 36-38 weeks gestation, with the exception of women with severe adverse outcomes (e.g. fetal death)..
Timepoint [3] 405889 0
36-38 weeks gestation
Secondary outcome [4] 405890 0
Secondary outcome 2: Maternal depressive symptoms measured using scores on the Edinburgh Postnatal Depression Scale (EPDS).

The online outcomes questionnaire described above will be sent to all randomised women approximately 2 months postnatal, with the exception of women with severe adverse outcomes (e.g. fetal or neonatal death).
Timepoint [4] 405890 0
2 and 6 months postnatal
Secondary outcome [5] 405891 0
Secondary outcome 3: Eligibility rates of the number participants deemed eligible against inclusion/exclusion criteria by 25 weeks pregnant within the pre-screened population. Obtained from audit of online pre-screening and consent to contact records.
Timepoint [5] 405891 0
End of the recruitment period.
Secondary outcome [6] 405892 0
Secondary outcome 4: Consent rates, assessing the number consenting to participate by 25 weeks pregnant within the eligible population. Obtained from audit of online pre-screening records and online consent to participate records.
Timepoint [6] 405892 0
End of the recruitment period.
Secondary outcome [7] 405893 0
Secondary outcome 5: Randomisation rates, assessing the number randomised from the number consenting to participate by 25 weeks pregnant. Obtained from audit of online pre-screening records and online consent to participate records.
Timepoint [7] 405893 0
End of the recruitment period.
Secondary outcome [8] 405894 0
Secondary outcome 6: Questionnaire return rates. Obtained from audit of response rates to online questionnaires.
Timepoint [8] 405894 0
Trial entry; 36-38 weeks gestation; 2 months postnatal; 6 months postnatal.
Secondary outcome [9] 405895 0
Secondary outcome 7: Attendance at the intervention and reasons for non-attendance. The outcome will be obtained by audit of attendance and follow-up of non-attendance reasons via phone call to participants for virtual home visits and 4-D ultrasounds.
Timepoint [9] 405895 0
26, 28 and 34 weeks gestation 2 weeks postnatal; 6 weeks postnatal.
Secondary outcome [10] 405896 0
Secondary outcome 8 Intervention quality will be assessed using 9 item questionnaire (antenatal) and 8 item questionnaire (postnatal) which we have developed for this purpose. Items ask about the length/timing of the interventions, what was enjoyed, what could be improved and what was most useful about the interventions.
Timepoint [10] 405896 0
36-38 weeks gestation; 2 months postnatal; and 6 months postnatal.
Secondary outcome [11] 405897 0
Impact evaluation of the views of the health professionals delivering the intervention, reported experience and satisfaction with delivering the intervention in terms of time taken and the response of parents using a free-response questionnaire developed for this purpose.
Timepoint [11] 405897 0
At completion of study.

Eligibility
Key inclusion criteria
< 24 weeks pregnant
Singleton pregnancy
Identified at the antenatal booking appointment as being at moderate psychosocial risk.
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Fetal abnormality identified at morphology (approx. 18 - 20 week) ultrasound
Reporting current domestic violence
Illicit drug use
Severe mental health issues
Requiring interpreter/lack of sufficient English skills to complete questionnaires
No internet access on a mobile phone, tablet, or computer
Clinician exclusion

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
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
Primary analyses will be by intention-to-treat and will focus on intervention effects on the primary outcomes at 6 months postnatal using general linear modelling techniques when outcomes are continuous scores and log-binomial regression for dichotomous outcomes (e.g., the percentage of mothers scoring above recommended cut-offs). Data collected at baseline will be used to control for any imbalance between trial arms. In addition we will be undertaking descriptive analyses focused on participant recruitment rates and retention. An important element of the pilot study is to determine whether a larger scale study is feasible in the Women’s and Children’s Hospital setting.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
20/09/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
60
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21545 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 36453 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 310554 0
Charities/Societies/Foundations
Name [1] 310554 0
Channel 7 Children's Research Foundation
Country [1] 310554 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace
Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 311815 0
Hospital
Name [1] 311815 0
Women's and Children's Hospital
Address [1] 311815 0
72 King William Road
North Adelaide SA 5006
Country [1] 311815 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310164 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 310164 0
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 310164 0
Australia
Date submitted for ethics approval [1] 310164 0
11/08/2021
Approval date [1] 310164 0
05/10/2021
Ethics approval number [1] 310164 0
2021/HRE00263

Summary
Brief summary
The study is testing the effectiveness of a new web-based intervention for mothers and their partners. The intervention is designed to provide parents with accurate and up-to-date information about their unborn child’s development during pregnancy and how to help manage problems with infant sleeping or crying, and how to best cope when parents are feeling stressed by the demands of caring for young infants.

Parents who are allocated to the intervention group will meet online with our research psychologist at approximately 25 weeks of pregnancy to learn how their baby is growing and how to better get to know their baby during pregnancy. They will also have 4D ultrasounds at 28 and 34 weeks of pregnancy when they can view their baby in real time, and together with our psychologist observe what their baby is doing. After their baby is born, they will meet online with our psychologist when their baby is 2 weeks and 6 weeks old for support about how to care for themselves and their baby during stressful times, like when babies are having difficulty sleeping or settling.

We hypothesise that parents undertaking the intervention will form a stronger attachment to their child, be able to better undertake health-promoting behaviors during pregnancy, and will be better equipped to manage personal distress, infant crying and sleep problems,

Trial website
Trial related presentations / publications
Public notes
New Technology for New Parents is a pilot randomised controlled trial to test the feasibility of implementing and evaluating a novel intervention combining mentalization-based support utilising 4D ultrasounds and parent support delivered using “virtual home visits”. The latter will include: (i) education about normal patterns of infant distress in the newborn period; (ii) how to best manage infant distress; and (iii) training in use of safety planning to manage parental frustration during periods of infant distress.

The intervention goals are to promote parents’: (i) emotional connectedness with their unborn baby and capacity to consider their unborn baby’s experiences; (ii) sensitive, responsive caregiving in the antenatal and postnatal period; (iii) understanding of normal patterns of infant distress in the newborn period, including how to effectively manage infant distress, and; (iv) ability to use safety planning to manage parental frustration during periods of persistent infant distress.

Specific objectives are:

1. To obtain preliminary evidence of antenatal and postnatal outcomes (e.g., self-reported attachment, parenting competence, and parental mentalizing capacity). These outcomes will be used to derive power estimates for a full-scale efficacy trial that will be the subject of subsequent grant applications.
2. To obtain information about eligibility rates; consent/recruitment rates; questionnaire return rates; reasons for consenting to the trial or declining; uptake of and adherence to the intervention; reasons for attending and not attending the intervention visits.
3. To evaluate parents’ experiences of the intervention including levels of satisfaction, and to obtain feedback on both positive and negative aspects of the intervention.
4. To conduct an impact evaluation of the views of the health professionals delivering the intervention, reported experience and satisfaction with delivering the intervention in terms of time taken and the response of parents.


Specifically we hypothesize that, as compared to parents experiencing adversity who receive usual care, parents who also receive the study intervention will have:

1. A better mentalizing capacity with their child during the antenatal and postnatal periods;

2. A stronger attachment to their child during the antenatal and postnatal periods;

3. A better capacity to undertake health-promoting behaviours relevant to pregnancy;

4. A higher level of parenting competence including better knowledge about how to manage personal distress, and infant crying and sleep problems.

To the best of our knowledge, no previous study has evaluated the combined effectiveness of two novel technologies (4D ultrasound and virtual home visits) used to support parents across the antenatal and postnatal periods.

Contacts
Principal investigator
Name 116714 0
Dr Alyssa Sawyer
Address 116714 0
The University of Adelaide
North Terrace
Adelaide SA 5000
Country 116714 0
Australia
Phone 116714 0
+61883133740
Fax 116714 0
Email 116714 0
alyssa.sawyer@adelaide.edu.au
Contact person for public queries
Name 116715 0
Dr Bronni Simpson
Address 116715 0
Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Country 116715 0
Australia
Phone 116715 0
+61402423103
Fax 116715 0
Email 116715 0
bronni.simpson@sa.gov.au
Contact person for scientific queries
Name 116716 0
Dr Bronni Simpson
Address 116716 0
Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Country 116716 0
Australia
Phone 116716 0
+61402423103
Fax 116716 0
Email 116716 0
bronni.simpson@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Pilot study from which data will be utilised to obtain future funding and inform future research by the institutions.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14778Study protocol  bronni.simpson@sa.gov.au
14779Informed consent form  bronni.simpson@sa.gov.au
14780Ethical approval  bronni.simpson@sa.gov.au



Results publications and other study-related documents

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