ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

U1111-1273-6711

Trial acronym

Linked study record

Health condition

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

Pregnancy

Postpartum problems

Depression

Child bonding and attachment

Parenting Problems

Infant Development

Condition category

Condition code

Mental Health

Other mental health disorders

Public Health

Health service research

Reproductive Health and Childbirth

Childbirth and postnatal care

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

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]

36-38 weeks gestation

Primary outcome [2]

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]

36-38 weeks gestation

Primary outcome [3]

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]

2 and 6 months postnatal

Secondary outcome [1]

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]

2 and 6 months postnatal

Secondary outcome [2]

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]

2 and 6 months postnatal

Secondary outcome [3]

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]

36-38 weeks gestation

Secondary outcome [4]

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]

2 and 6 months postnatal

Secondary outcome [5]

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]

End of the recruitment period.

Secondary outcome [6]

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]

End of the recruitment period.

Secondary outcome [7]

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]

End of the recruitment period.

Secondary outcome [8]

Secondary outcome 6: Questionnaire return rates. Obtained from audit of response rates to online questionnaires.

Timepoint [8]

Trial entry; 36-38 weeks gestation; 2 months postnatal; 6 months postnatal.

Secondary outcome [9]

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]

26, 28 and 34 weeks gestation 2 weeks postnatal; 6 weeks postnatal.

Secondary outcome [10]

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]

36-38 weeks gestation; 2 months postnatal; and 6 months postnatal.

Secondary outcome [11]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment postcode(s) [1]

5006 - North Adelaide

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Channel 7 Children's Research Foundation

Address [1]

PO Box 2438
Regency Park SA 5942

Country [1]

Australia

Primary sponsor type

University

Name

The University of Adelaide

Address

North Terrace
Adelaide SA 5006

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Women's and Children's Hospital

Address [1]

72 King William Road
North Adelaide SA 5006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network Human Research Ethics Committee

Ethics committee address [1]

72 King William Road
North Adelaide SA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/08/2021

Approval date [1]

05/10/2021

Ethics approval number [1]

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

Dr Alyssa Sawyer

Address

The University of Adelaide
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61883133740

Fax

alyssa.sawyer@adelaide.edu.au

Contact person for public queries

Name

Bronni Simpson

Address

Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006

Country

Australia

Phone

+61402423103

Fax

bronni.simpson@sa.gov.au

Contact person for scientific queries

Name

Bronni Simpson

Address

Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006

Country

Australia

Phone

+61402423103

Fax

bronni.simpson@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email
14778	Study protocol	bronni.simpson@sa.gov.au
14779	Informed consent form	bronni.simpson@sa.gov.au
14780	Ethical approval	bronni.simpson@sa.gov.au

Results publications and other study-related documents

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No additional documents have been identified.

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