None listed
Conditions
Brief summary
The study will test the effectiveness of a universal version of a piloted intervention to support parents to bond with and care for their baby during pregnancy and in the early postnatal period. The universal intervention combines an attachment-focused mid-trimester ultrasound with parent support delivered online using “virtual home visits”, and is designed for delivery to all parents as a part of standard care at the Women's and Children's Hospital. The intervention aims to provide support to improve: (i) parents’ emotional bond with their unborn baby and their capacity to consider their unborn baby’s experiences (mentalisation); (ii) sensitive, responsive caregiving in the antenatal and postnatal period; (iii) understanding of normal patterns of infant distress in the new-born 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. By improving parents’ emotional attachment to their baby during pregnancy, and providing support to manage the challenges of the postnatal period, we seek to improve the health of the relationship between parents and their babies. This in turn may provide a healthier transition to parenthood and better mental health for infants. The study will also recruit consumer advocates and clinician representatives to (i) inform the development of the above parenting program; and (ii) form a qualitative study within the project to better understand perinatal experiences across multiple perspectives.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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.