Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000693325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
2/12/2025
Date registered
Help: Date registered
10/06/2026
Date last updated
Help: Date last updated
10/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/06/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Together from the Start: Strengthening parent-infant relationships and wellbeing through sonography and online parenting support.
Scientific title
Attachment-informed perinatal care – Evaluating a universal program to support infant mental health at the transition to parenthood.
Additional trial identifiers [1] 315519 0
Women’s & Children’s Hospital Foundation BRP101525
Universal Trial Number (UTN)
U1111-1329-6023
Trial acronym
Related trial records
ACTRN12622000287730 - follow-up to this pilot study for parents with moderate psychosocial adversity. The pilot protocol will be developed as a universal program to support parents across the perinatal period.

Health condition
Health condition(s) studied:
Universal Parenting Support 339113 0
Infant Mental Health 339114 0
Parent-Infant Attachment 339115 0
Condition category
Condition code
Public Health 335401 335401 0 0
Health promotion/education
Public Health 335402 335402 0 0
Health service research
Reproductive Health and Childbirth 335403 335403 0 0
Antenatal care
Reproductive Health and Childbirth 335404 335404 0 0
Childbirth and postnatal care
Mental Health 335405 335405 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This project will assess the effectiveness of a new ‘attachment-focused’ intervention designed to support infant mental health by improving new parents’ ability to: (i) bond with their infant, (ii) understand their infant’s experiences, and (iii) support their infant during the antenatal and early postnatal periods. The intervention was evaluated in a pilot trial for parents experiencing moderate psychosocial adversity, implemented at the Women's and Children's Hospital (WCH), Adelaide, South Australia (ACTRN12622000287730) and led by Chief Investigator A Sawyer.

The current project responds to feedback from pilot-participants that support to bond with baby during pregnancy, and knowledge about self-care and care for infants during persistent infant crying, should be available to all parents. For this study we will modify the pilot intervention so that it can be delivered as a universal parenting support program alongside standard care at WCH.

The program will include informational videos, group- and individual-based virtual home visits (VHVs), and an ‘attachment-focused’ 20-week mid-trimester ultrasound scan. Non-birthing partners will be invited to attend the VHVs and ultrasound regardless of whether or not they consent to participate in the research components of the study.

Intervention Components:
1. Informational videos.
Intervention participants will receive two informational videos (approximately 5 minutes in duration each) via the Personify Care app already in use at SA Medical Imaging (SAMI) at around 18 weeks of pregnancy. These videos will include practical details regarding the routine mid-trimester ultrasound process, as well as information on fetal development across pregnancy with a focus on information to support antenatal bonding, such as when senses develop and fetal social development (e.g., when they can recognise parental voices; the development of facial expressions).

2. Mid-trimester ‘attachment-focused’ ultrasound.
SAMI provides routine ultrasound services to women birthing at the WCH. These services are focused on the medical health of the baby and birthing parent, however these ultrasound scans provide an innovative and unique opportunity to support bonding with the fetus during pregnancy, and parental mentalization capacity. Investigators Russo and Sawyer will train a number of sonographers (up to 2 hours face-to-face training) at SAMI in an attachment-focused ultrasound procedure for the 20-week mid-trimester scan. These trained sonographers will then provide 20-week mid-trimester ultrasounds to parents receiving the intervention in a 1 hour ‘attachment enhanced’ scan, which will include 45 minutes of the routine mid-trimester scan, and an integrated 15 minutes dedicated to bonding with the fetus. Sonographer training will be provided in the months prior to participant recruitment and study mid-trimester ultrasound commencement.

3. Virtual Home Visits.
Participants will receive three virtual home visits (VHVs) during the program. Investigator Sawyer will train a number of clinical psychologists/social workers in the delivery of the VHVs (up to 2 hours face to face, plus 3 hours self-directed preparation with provided training materials) in the months prior to participant recruitment and VHV delivery. VHVs are up to 1.5 hours in duration and conducted online via Healthdirect video call (accessible via mobile phone, tablet, or personal computer). The first two VHVs are group-based, with approximately 7 participants per group. Group membership and the psychologist/social worker delivering the program to each group member will be maintained throughout the study where possible.

The first VHV will be a group session conducted at 26 weeks of pregnancy. During this VHV parents will complete ‘BabyCHAT’, a manualised psychoeducational intervention designed to improve parental mentalization and emotional attachment during pregnancy, as well as anticipatory guidance about periods of persistent infant crying. Intervention participants will receive a hard copy of the program booklets ('BabyCHAT', 'Getting to Know your Unborn Baby', and 'Finding Calm in the Chaos') via post prior to this VHV. During the VHV, parental reflections regarding their unborn baby, group discussions around activities parents can do with baby before birth, (e.g., singing; reading; talking etc.); and BabyCHAT booklet completion will be encouraged.

Parents in the intervention will also receive one group postnatal VHV at 2-6 weeks postnatal, followed by an individual VHV approximately 4 weeks after the group postnatal VHV, providing individualized support. Postnatal VHVs will focus on managing postnatal infant and parent distress, as well as support for bonding and knowledge about infants social-emotional development and mental health. The intervention focuses on educating parents about normal infant crying and sleeping patterns, how to manage persistent infant crying and sleeping problems, how to develop and utilise a personal safety plan to manage frustration arising from persisting infant distress, and how to support infant mental health.

Participants in the intervention will also have access to standard care services. Intervention adherence and fidelity will be assessed using participant attendance records for mid-trimester ultrasound and VHVs. Participants in the intervention group will also be asked to complete questionnaires about their experience of the intervention. Intervention group participants and delivery staff will be also asked to participate in a qualitative interview about their study experiences.

We will also form consumer and clinician representative focus groups, which aim to (i) inform the development of the universal parenting program; and (ii) constitute a qualitative study to better understand perinatal experiences. Strategies to facilitate adherence and fidelity will be informed by a consumer advisory committee and a clinician reference group, who will advise on the structure, content, and delivery of the intervention when embedded as a part of standard care at the WCH. Intervention structure and content will be modified based on feedback from the consumer and clinician reference groups prior to participant recruitment. The consumer advocate group (target n=8) will meet online or in-person 9 times between 2026 and 2030. The first 4 meetings will be every 2-3 months from mid-2026 to early 2027, and the remaining 5 meetings will be every 8-12 months thereafter until early 2030. The clinician reference group (target n=6) will meet 6 times between 2026 and 2030. There will be 3 meetings in 2026 approximately 2 months apart, and yearly thereafter excluding 2028. The parenting program protocol for the antenatal period will be prioritized in the early focus group meetings, and the postnatal period in the later meetings to allow for updates to the protocol, and related ethics amendment requests, prior to these elements of the parenting program being implemented for any participants. The focus group meetings to be recorded and transcribed for qualitative analysis and publication.
Intervention code [1] 332142 0
Prevention
Intervention code [2] 332143 0
Behaviour
Intervention code [3] 332144 0
Treatment: Other
Description of the comparator or control
Only participants in the intervention group will have access to the informational videos, attachment-focused component of the mid-trimester ultrasounds, and VHVs. However, parents in both intervention and control groups will have access to standard care arrangements. Commonly, standard care involves a WCH clinic appointment at approximately 12-14 weeks including a screening ultrasound, a 20-22 week mid-trimester ultrasound scan (focused on the medical health of the baby and birth parent), and up to 7 additional routine antenatal visits. Additionally, parents can access a number of online or in-person antenatal classes focused on different aspects of birthing and early parenting (i.e., breastfeeding, caesarean birth, multiple births.)
Control group
Active

Outcomes
Primary outcome [1] 342979 0
Parent-Infant Attachment
Timepoint [1] 342979 0
3 months postnatally (outcomes on this measure at 6 months postnatal will assess the stability of any observed effects).
Primary outcome [2] 342981 0
Infant social-emotional development
Timepoint [2] 342981 0
3 months postnatally (outcomes on this measure at 6 months postnatal will assess the stability of any observed effects).
Secondary outcome [1] 452987 0
Antenatal Parent-Infant Attachment
Timepoint [1] 452987 0
baseline & 32 weeks antenatally
Secondary outcome [2] 452988 0
Parental Reflective Functioning
Timepoint [2] 452988 0
baseline & 32 weeks gestation (prenatal scale); 3 and 6 months postnatally (postnatal scale)
Secondary outcome [3] 452989 0
Parenting stress
Timepoint [3] 452989 0
3 and 6 months postnatally
Secondary outcome [4] 453002 0
Knowledge of Infant Crying
Timepoint [4] 453002 0
3 and 6 months postnatally
Secondary outcome [5] 457886 0
Experience of Infant Crying
Timepoint [5] 457886 0
3 and 6 months postnatally
Secondary outcome [6] 461339 0
Parental depressive symptoms
Timepoint [6] 461339 0
baseline, 32 weeks antenatally, 3 months postnatally, 6 months postnatally
Secondary outcome [7] 461340 0
Intervention Quality: parent ratings of Virtual Home Visits
Timepoint [7] 461340 0
32 weeks antenatally (antenatal Virtual Home Visit), 3 months postnatally (postnatal Virtual Home Visits)
Secondary outcome [8] 461906 0
Intervention Quality: parent ratings of attachment-focused mid-trimester ultrasound
Timepoint [8] 461906 0
32 weeks antenatally
Secondary outcome [9] 461909 0
Participant experience of Intervention: Qualitative
Timepoint [9] 461909 0
Interviews will be conducted after all intervention components are completed, starting from 3 months postnatal up to 8 months postnatal.
Secondary outcome [10] 461917 0
Intervention delivery staff experience of intervention: Qualitative
Timepoint [10] 461917 0
Once all participant mid-trimester ultrasounds have been completed (sonographers) and once the psychologist/social worker has delivered all of postnatal Virtual Home Visits for the study.

Eligibility
Key inclusion criteria
RCT study: Pregnant people less than 15 weeks pregnant at the time of expression of interest who are planning to birth at the Women's and Children's Hospital (WCH), Adelaide, South Australia. Birthing participants can opt to invite their parenting partner to participate if applicable.

Consumer Advisory Committee Focus Group Member: Parent who has had a baby at the WCH in the previous 5 years.

Clinician Reference Group Focus Group Member: Has provided perinatal care at the WCH within the previous 5 years.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
Yes
Key exclusion criteria
RCT participants:
1. Current experience of domestic violence, illicit drug use, or other major distress warranting ‘high-risk’ support such that study enrollment would be inappropriate according to clinical judgement.
2. Major structural anomaly at 12-14 week ultrasound or high probability of anomaly from genetic screening (non-invasive prenatal testing or cell-free fetal DNA).
3. Insufficient access to the internet and an internet enabled device (e.g., mobile phone, tablet, desktop computer) to attend the Virtual Home Visits.
4. Lacking sufficient English skills to complete the self-report questionnaires.

Consumer Advisory Committee Focus Group Member:
1. Has not had a baby at the WCH within the previous 5 years.
2. Insufficient access to the internet and an internet enabled device (e.g., mobile phone, tablet, desktop computer) in case of online meetings.
3. Lacking sufficient English skills to participate in the meetings.

Clinician Reference Group Focus Group Member:
1. Has not provided perinatal care at the WCH within the previous 5 years.
2. Insufficient access to the internet and an internet enabled device (e.g., mobile phone, tablet, desktop computer) in case of online meetings.
3. Lacking sufficient English skills to participate in the meetings.

Note Consumer Advisory Group and Clinician Reference Group members may be male or female.

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)
RCT participants will be randomised in groups of 6-7 participants. Groups will be randomised to the intervention or control arm according to a randomisation sequence generated via the R Studio package RandomizeR. The randomisation sequence for the study will be generated in a concealed manner prior to the first group being randomised. The R-code required to generate the randomisation sequence will not display the sequence, and it will not be revealed to anyone (within or external to the project) when it is generated.

To ensure allocation concealment, once a group of 6-7 RCT participants has been recruited and all group members have completed their baseline survey, a study staff member will run the RandomizeR package to extract that group's randomisation allocation. Only that group's allocation will be revealed, and this process will be completed separately for each group.

Consumer advisory and clinician reference focus group members will inform the development of the universal parenting program (i.e., the treatment) and in the process form a qualitative sub-study exploring perinatal experiences across multiple perspectives. They will not be randomised and will not be participants in the RCT element of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
RandomizeR utilises Maximum Tolerated Imbalance to progressively weight the randomisation sequence to reduce imbalance between groups. We will use an MTI of 3 for the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2026
Actual
Date of last participant enrolment
Anticipated
31/03/2028
Actual
Date of last data collection
Anticipated
30/04/2029
Actual
Sample size
Target
478
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 28617 0
Womens and Childrens Hospital - North Adelaide

Funding & Sponsors
Funding source category [1] 320116 0
Hospital
Name [1] 320116 0
The Women’s & Children’s Hospital Foundation
Country [1] 320116 0
Australia
Funding source category [2] 321169 0
University
Name [2] 321169 0
Adelaide University
Country [2] 321169 0
Australia
Primary sponsor type
University
Name
Adelaide University
Address
Country
Australia
Secondary sponsor category [1] 322675 0
None
Name [1] 322675 0
Address [1] 322675 0
Country [1] 322675 0
Other collaborator category [1] 283704 0
Hospital
Name [1] 283704 0
Women's and Children's Hospital
Address [1] 283704 0
Country [1] 283704 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318665 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 318665 0
Ethics committee country [1] 318665 0
Australia
Date submitted for ethics approval [1] 318665 0
28/10/2025
Approval date [1] 318665 0
06/05/2026
Ethics approval number [1] 318665 0
2025/HRE00350

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

Contacts
Principal investigator
Name 144858 0
Dr Alyssa Sawyer
Address 144858 0
Adelaide University, Adelaide, South Australia, 5005
Country 144858 0
Australia
Phone 144858 0
+61 8 8313 3740
Fax 144858 0
Email 144858 0
[email protected]
Contact person for public queries
Name 144859 0
Dr Alyssa Sawyer
Address 144859 0
Adelaide University, Adelaide, South Australia, 5005
Country 144859 0
Australia
Phone 144859 0
+61 8 8313 3740
Fax 144859 0
Email 144859 0
[email protected]
Contact person for scientific queries
Name 144860 0
Dr Alyssa Sawyer
Address 144860 0
Adelaide University, Adelaide, South Australia, 5005
Country 144860 0
Australia
Phone 144860 0
+61 8 8313 3740
Fax 144860 0
Email 144860 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.