'Nurture and Play' - a Pilot Study

Protocol

Title 'Nurture and Play' - a randomized controlled pilot study of a perinatal intervention to strengthen parenting among women with psychosocial vulnerabilities and their partners.

The aim of this randomised controlled pilot study is to evaluate the feasibility of the Nurture and Play (NnP) offered to a Danish population of psychosocial vulnerable pregnant women and their partners.

More specifically the objectives of the study are to:

* Test the feasibility of the NnP including both parents * Evaluate the recruitment procedure, the adherence as well as the participant's and professional´s experience of the intervention * Evaluate the collaboration between the hospitals and the municipalities.

The investigators hypothesize that the intervention can strengthen the quality of parent-infant interactions, enhance parental reflective functioning, and improve parental mental well-being. Further, the investigators expect that providing the intervention will strengthen the collaboration between hospitals and municipalities and build an early foundation for a fruitful and secure partnership between future parents and the health and social care system.

Conducting a pilot study provides the opportunity to test the trial in a smaller scale before initiating the full-scale and thereby strengthen the trial.

Background The foundation of children´s physical, mental, and cognitive development is established before birth and is affected by social and psychological risk factors connected to the parents. Meta-analyses have documented that the well-being of the mother during pregnancy both directly and indirectly affects the fetus and the child´s later development. As such, prenatal psychological stress and depression in pregnant women increase the risk of premature birth and low birth weight. Additionally, untreated stress and depression during pregnancy is indirectly related to later developmental problems in the child such as altered stress response, attention deficit hyperactive disorder, depression, and anxiety, e.g. by affecting the mother's parenting skills. Finally, studies have shown that maternal well-being during pregnancy affects the pregnant woman´s emotional involvement with her unborn infant - a prerequisite for later parenting skills. Around 10-15% have symptoms of depression during pregnancy, 15% of anxiety, and the prevalence of antenatal mental health problems is increasing.

A recent systematic review and meta-analysis found that perinatal interventions for women with antenatal depression can decrease the offspring's risk of psychopathology. Core components of effective perinatal interventions for infants of mothers psychosocial vulnerabilities are: Facilitation of positive mother-infant interactions, helping mothers to understand the infant´s perspective, and where applicable the use of video-feedback on parent-infant interactions. Existing perinatal care for pregnant women with psychosocial vulnerabilities in Denmark consists of an interdisciplinary and intersectoral collaboration between midwives, obstetricians, psychiatrists, primary sector health nurses, and general practitioners as well as social workers and family therapists. However, despite the international evidence regarding the effect of perinatal interventions to support parenting, such interventions are not part of the existing Danish perinatal program for women with psychosocial vulnerabilities. In line with this, qualitative interviews conducted by this research group with families with psychosocial vulnerabilities focusing on their need for care and support as a preparation for this project, highlighted the need for 1) more integration of the care provided by midwives and the municipalities, 2) more support for their mental well-being and 3) support to the partners.

The NnP group Intervention (in Danish: 'Omsorg og leg' - for dig og din baby) is a group-based, manualized parenting intervention initiated during pregnancy and continued into the postnatal period until infant age seven months. The program is designed to enhance parenting abilities focusing on three domains: Emotional availability, parental reflective functioning, and the ability to regulate own emotions. Emotional availability refers to the parent´s ability to read and respond appropriate to infant's emotional signals, similar to the attachment concept of parental sensitivity. During NnP, the parents are supported in enhancing their emotional availability through caring and playing activities. These include prenatal activities like singing and playing musical instruments for the future child and postnatal activities such as baby massage and interactive playing, like peekaboo. These activities are designed to enhance an emotional loving contact with the future child through physical contact and reciprocity and after birth shared attention with the child. In addition, each session also contains discussions about a particular theme chosen to activate parents´ reflective functioning, such as thoughts and feelings related to pregnancy and parenthood, memories of their childhood, expectations about their child, prior experiences with pregnancy and parenthood and hopes for own and their child future. Finally, each session contains a psycho-educative component focusing on strategies for regulating own emotions. The intervention has been developed in Finland by Dr. Saara Salo and colleagues and tested in a randomized controlled trial among pregnant women with depression and it is now being implemented in Finland. The results from the study showed that mothers in the intervention group showed more emotional availability and higher levels of reflective functioning and experienced fewer depressive symptoms compared to mothers in the control group. The Nurture and Play program have not been evaluated in a Danish context, which is relevant due to potential differences in the characteristics of the study population and the antenatal care program.

1. Heckman JJ. Skill formation and the economics of investing in disadvantaged children. Science. 2006;312(5782):1900-2. 2. Grote NK, Bridge JA, Gavin AR, Melville JL, Iyengar S, Katon WJ. A Meta-analysis of Depression During Pregnancy and the Risk of Preterm Birth, Low Birth Weight, and Intrauterine Growth Restriction. Archives of General Psychiatry. 2010;67(10):1012-24. 3. Grigoriadis S, VonderPorten EH, Mamisashvili L, Tomlinson G, Dennis C-L, Koren G, et al. The impact of maternal depression during pregnancy on perinatal outcomes: a systematic review and meta-analysis. The Journal of clinical psychiatry. 2013;74(4):0-. 4. Szegda K, Markenson G, Bertone-Johnson ER, Chasan-Taber L. Depression during pregnancy: a risk factor for adverse neonatal outcomes? A critical review of the literature. The Journal of Maternal-Fetal \& Neonatal Medicine. 2014;27(9):960-7. 5. Graignic-Philippe R, Dayan J, Chokron S, Jacquet A, Tordjman S. Effects of prenatal stress on fetal and child development: a critical literature review. Neuroscience \& biobehavioral reviews. 2014;43:137-62. 6. Waters CS, Hay DF, Simmonds JR, van Goozen SH. Antenatal depression and children's developmental outcomes: potential mechanisms and treatment options. European child \& adolescent psychiatry. 2014;23(10):957-71. 7. Stein A, Pearson RM, Goodman SH, Rapa E, Rahman A, McCallum M, et al. Effects of perinatal mental disorders on the fetus and child. Lancet. 2014;384(9956):1800-19. 8. Pearson RM, Evans J, Kounali D, Lewis G, Heron J, Ramchandani PG, et al. Maternal depression during pregnancy and the postnatal period: risks and possible mechanisms for offspring depression at age 18 years. JAMA psychiatry. 2013;70(12):1312-9. 9. Foley S, Hughes C. Great expectations? Do mothers' and fathers' prenatal thoughts and feelings about the infant predict parent-infant interaction quality? A meta-analytic review. Developmental Review. 2018;48:40-54. 10. Antenatal and postnatal mental health: The NICE guideline on clinical management and service guidance. NICE guideline CG45. London: The Royal College of Psychiatrists; 2007. 11. Goodman SH, Cullum KA, Dimidjian S, River LM, Kim CY. Opening windows of opportunities: Evidence for interventions to prevent or treat depression in pregnant women being associated with changes in offspring's developmental trajectories of psychopathology risk. Development and Psychopathology. 2018;30(3):1179-96. 12. Newton K, Taylor Buck E, Weich S, Uttley L. A review and analysis of the components of potentially effective perinatal mental health interventions for infant development and mother-infant relationship outcomes. Development and Psychopathology. 2020:1-18. 13. Salo SJ, Lampi H. Nurture and Play Intervention for Groups. . 2019. 14. Biringen Z. Emotional availability: Conceptualization and research findings. American Journal of Orthopsychiatry. 2000;70(1):104-14. 15. Ainsworth MDS, Blehar MC, Waters E, Wall S. Patterns of Attachment. A psychological study of the strange situation. Hillsdale: Lawrence-Erlbaum; 1978. 16. Salo SJ, Flykt M, Mäkelä J, Biringen Z, Kalland M, Pajulo M, et al. The effectiveness of Nurture and Play: a mentalisation-based parenting group intervention for prenatally depressed mothers. Primary health care research \& development. 2019;20.

Method Design

The study consists of:

1. A randomized controlled pilot study (n=20 women/couples) carried out according to the Standard Protocol Items: Recommendations for Interventional Trials SPIRIT statement for clinical trials. The parents who agree to participate in the study will be randomly assigned in a 1:1 ratio to either the intervention or the control group, using random permuted block randomization. The participants will be informed about which group they enter at their first midwife consultation. 2. A qualitative descriptive interview study aiming to evaluate the participants' and professionals´ experience of the intervention.

Data

Data will be collected through:

* Online Questionnaires. At baseline and follow-up after the intervention, the questionnaires will be distributed to all participants through the REDcap program, regardless of whether they are in the intervention or control group. Since this is a pilot study, the study is not powered to assess effectiveness. The questionnaire data are exploratory outcomes, with a focus on identifying any potential trends. Descriptive analysis will be performed on this data. Having a control group to complete the same questionnaires as the intervention group, it is possible to compare data between the two groups, and thus identify potential trends. * Interviews. All participants in the intervention group will be invited to an initial Parent Development Interview (PDI) to assess reflective functioning (RF). RF is an operationalization of the concept of mentalization, allowing for the evaluation of a parent´s explicit level of mentalization. The interview, coding, and analysis will be conducted by a psychologist who is trained and experienced in administering PDI interviews. * Interviews. Some (n=15) of the participants in the intervention group will be invited to an interview about their experience of the intervention. All healthcare professionals will be invited to an interview about their experience with the intervention, including the collaboration between the hospitals and the municipality. The interviews will be performed online, by phone, in the participants' homes or at the hospital - according to the participant's preferences. Data will be analyzed using Reflexive thematic analysis by Braun and Clark, 2019. * Videotaped settings. Emotional availability (EA): Prenatal and infancy versions observations of emotional availability (will be the primary outcome if a larger RCT will be conducted) will be conducted on semi-structured videotaped setting designed by Ann Jernberg and her colleagues called the Marschak Interaction Method (MIM). Using the MIMs, the mother (parents) is asked to perform playf