Impact of an mHealth intervention on parents’ emotional health and on the neurodevelopment of high-risk infants

Depósito de investigación de la Universidad de Sevilla https://idus.us.es/ This is an Accepted Manuscript of an article published by Sage in Journal of Health Psychology: Bellido-González, M., Padilla Muñoz, E. M., Castelar-Ríos, M. J., Díaz López, M. Á., Lozano, J. M., & Lanzarote Fernández, M. D. (2024). Impact of an mHealth intervention on parents’ emotional health and on the neurodevelopment of high-risk infants. Journal of Health Psychology. https://doi.org/10.1177/13591053241287035 High-Risk Pregnancy and Baby Parenting programme 1 Title page Article Title: Impact of an mHealth intervention on parents’ emotional health and on the neurodevelopment of high-risk infants Short title: High-Risk Pregnancy and Baby Parenting programme Author names and affiliations: 1. Mercedes Bellido-González1,2. Department of Developmental Psychology and Education, University of Granada, Spain1. Researcher at the Biosanitary Research Institute of Granada (ibs.GRANADA), Spain2 [email protected] ORCID: 0000- 0003-1853-859X 2. Eva María Padilla Muñoz3. Department of Personality, Evaluation and Psychological Treatment, University of Sevilla, Spain3. eva[email protected] ORCID: 0000-0001-6322- 2952 3. María José Castelar-Ríos1. PhD student. Department of Developmental Psychology and Education, University of Granada, Spain1. [email protected] ORCID: 0000- 0003-2233-3925 4. Miguel Ángel Díaz López1,2,5. Department of Gynecology and Obstetrics, Faculty of Medicine, University of Granada, Spain1. Gynecology and Obstetrics Service, Virgen de las Nieves Hospital, Granada, Spain5. [email protected] ORCID: 0000-0002-9912- 7399 5. José Maldonado Lozano1,2,5. Department of Pediatrics, Faculty of Medicine, University of Granada, Spain1. Pediatric Service, Virgen de las Nieves Hospital, Granada, Spain4. [email protected] ORCID: 0000-0002-4280-0415 6. María Dolores Lanzarote Fernández3. Department of Personality, Evaluation and Psychological Treatment, University of Sevilla, Spain3. [email protected] ORCID: 0000-0003-4812-1971 Author affiliations: University of Granada, Granada, Spain1 Biosanitary Research Institute (Ibs.Granada), Granada, Spain2 University of Sevilla, Sevilla, Spain3 Pediatric Service, Virgen de las Nieves Hospital, Granada, Spain4 Gynecology and Obstetrics Service, Virgen de las Nieves Hospital, Granada, Spain5 Corresponding author: Mercedes Bellido-González University of Granada, Spain. Department of Developmental Psychology and Education, Campus de Cartuja. 18071 Granada (España) Phone: +34 958 249037 E-mail: [email protected] High-Risk Pregnancy and Baby Parenting programme 2 ORCID iDs Mercedes Bellido-González 0000-0003-1853-859X Eva María Padilla Muñoz 0000-0001-6322-2952 María José Castelar-Ríos 0000-0003-2233-3925 Miguel Ángel Díaz López 0000-0002-9912-7399 José Maldonado Lozano 0000-0002-4280-0415 María Dolores Lanzarote Fernández 0000-0003-4812-1971 Author contributions: Conceptualization MBG, EMPM, MJCR, MADL, JML, MDLF; methodology MBG, EMPM MADL, JML, MDLF; software, MBG, EMPM, MJCR, MADL, JML, MDLF; formal analysis, MBG, MDLF; research, MBG, EMPM, MJCR, MADL, JML, MDLF; writing and supervision, MBG, EMPM, MJCR, MADL, JML, MDLF; project management, MBG, EMPM; fund acquisition, MBG, EMPM. All authors have read and agree with the published version of the manuscript. Acknowledgements. The authors thank the families involved for their participation in the study. We also thank the Pediatrics, Obstetrics and Gynecology Servicies at the Virgen de las Nieves University Hospital, Granada, Spain and the Pediatrics, Obstetrics and Gynecology Servicies at the Virgen del Rocío University Hospital, Sevilla, Spain for allowing us the use of their outpatient clinics during the psychological assessment of the participants. Thank the Biosanitary Research Institute of Granada (ibs.GRANADA), Spain. Declaration of conflicting interest The authors declare that they have no conflicts of interest. Funding This publication is part of a project funded by the Andalusia Ministry of Health (Junta de Andalucia, Spain) Ref. PC-0526-2016-0526. Ethics approval Ethics approval and consent to participate The study was approved by the Ethics Committee Autonomous Community of Andalusia, Spain, date 30/11/2016 (code/29d1f3f9bf2b2ffbfd6b25d7136d7ab7a7558494), and informed consents were obtained from the participants to be included in the study. Consent for publication All authors have approved the manuscript and agree with its submission to Journal of Health Psychology. High-Risk Pregnancy and Baby Parenting programme 3 Pre-registration: https://www.isrctn.com/ISRCTN15627704 Data availability statement: “The data generated during and/or analysed during the current study are not publicly available due to Protection of health and medical data (BOE» no. 294, December 6, 2018) but are available from the corresponding author on reasonable request. Supplemental material: Figure 1, Figure 2, figure 3, Table 2, Table 3, Table 4, Table 5. High-Risk Pregnancy and Baby Parenting programme 4 Title: Impact of an mHealth intervention on parents’ emotional health and on the neurodevelopment of high-risk infants ABSTRACT We assess the prenatal and postnatal effect of the High-Risk Pregnancy and Baby Parenting programme, which is complemented with two mHealth (app-based) resources. The GLM Repeated Measures Model technique was used to explore differences in the emotional health of the participants and in their infants’ neurodevelopment, comparing programme vs. usual care groups, composed of 150 and 195 participants, respectively. The mothers presented lower levels of depression (mean difference 1.74, p = .04, 95% CI .07, 3.40) and higher levels of resilience (mean difference 4.09, p = .004, 95% CI 1.40, 6.78). For the fathers, positive effects on resilience were recorded (p < .001). A positive treatment effect was perceived in the infants’ cognitive (p = .014), language (p < .001) and motor (p = .006) development. These findings suggest application of the programme can benefit maternal emotional health and infant neurodevelopment. M-Health technology could make this programme more accessible. Keywords: Programme; mHealth; Premature infant; Small-for-gestational-age infant; Psychological distress; Resilience. INTRODUCTION A pregnancy with neurological risk can be traumatic for the parents, and intervention to protect their emotional health is often indicated (Glover, 2020). Such an intervention should span the period not only prior to birth but also afterwards, in order to optimise the parents’ abilities to interpret the behaviour and meet the needs of their baby, regardless of health status. Achieving this goal would help develop the baby’s potential and strengthen the bond High-Risk Pregnancy and Baby Parenting programme 5 between the parents (Haeusslein et al., 2021; Mause et al., 2021; Spinelli et al., 2016) and their child (Porreca et al., 2017). Active participation by the family is essential if lasting positive effects on neonatal physical, cognitive and psychosocial development are to be obtained. Many studies have observed that the mental health of the main caregiver and the relationship between the parents can influence the development of children born with neurological risk (Crovetto et al., 2021; Nordheim et al., 2018; O’Donnell et al., 2017; Tuovinen et al., 2021). However, a major problem is that, despite the enormous efforts made and the gradual incorporation of parents into this process, the families of babies born prematurely and treated in Neonatology Units may not receive care themselves during the infant’s hospitalisation, during preparation for discharge or during the next few months of parenting (Polizzi et al., 2021). Family-centred neurodevelopmental care is a philosophy of care based on an alliance between the health team and the families concerned (Quiroga, 2018). However, very few studies have included the fathers in the intervention programmes considered (Padilla‐Muñoz et al., 2024). In the context of neonatology there is a need for systematic interventions to reduce stress, to strengthen the parent-child interaction (Sgandurra et al., 2019; Urech et al., 2019) and to consider protective factors such as family resilience (Caruso and Mikulic, 2010; Escartí et al., 2016). When resilience is supported, the family is more likely to overcome the traumatic experience of a high-risk pregnancy (Tedeschi and Calhoum, 2004). According to Jayawickreme et al. (2021), traditional research in this field has too often consisted of methodologically flawed cross-sectional studies with retrospective assessments of posttraumatic growth, an approach that is open to criticism. Therefore, further prospective studies should be conducted, based on methodologies that are accessible to the parents involved. The need for accessibility is one reason why the demand for virtual healthcare is now increasing. High-Risk Pregnancy and Baby Parenting programme 6 Mobile health, or mHealth, is an app-based virtual healthcare resource, which with changing lifestyles and the almost universal use of smartphones is becoming increasingly popular. This approach represents a new model of supported health intervention that facilitates behavioural change in users, enabling them to improve their health status via a straightforward, convenient resource (Voorheis et al., 2022). This type of approach offers many advantages, for example by enabling the medical office to monitor interventions without requiring the user’s physical presence (Silva-Jose et al., 2022). However, despite the advantages offered by mHealth, for patients and health professionals alike, not all interventions generate statistically significant changes (Junker et al., 2024; Kusyanti et al., 2022). Moreover, with the scientific evidence currently available it is not possible to specify the areas of intervention in which mHealth might be beneficial and those in which an in-person intervention would be more appropriate (Hussain et al., 2020). It has been reported that the parents of premature and/or Small for Gestional Age (SGA) babies are especially suited to make good use of apps designed to reduce the stress and anxiety derived from the traumatic experience of being separated from their baby immediately after birth due to the necessity of neonatal intensive care unit (NICU) hospitalisation. This separation can lead to difficulties in later establishing attachment, heighten uncertainty regarding the infant’s health and/or provoke emotional challenges between the parents (Castelar-Ríos et al., 2022; Sabuncuoglu and Basgul, 2016; Sadeghi et al., 2021; Worrall et al., 2023). Parenthood is in itself a complex situation, and this is accentuated if the baby is born prematurely and/or SGA. Therefore, a purpose-built, scientifically endorsed app could be highly useful, providing these mothers and fathers with much-needed information and coping strategies. High-Risk Pregnancy and Baby Parenting programme 7 To date, most of the mobile apps designed for this population have focused on providing information about the basic care of premature and/or SGA babies (Khoshnood et al., 2023; Rau et al., 2020; Zahedpasha et al., 2019), paying little attention to the prenatal stage. Objectives and hypotheses In view of these considerations, our research team has developed a programme termed High-Risk Pregnancy and Baby Parenting (HRP&BP), supported by two mHealth apps (CAREpregnancy and CAREparenting). The aim is to help parents protect their emotional health during pregnancy and to promote the child’s health and development during the first year of life. To assess the outcomes achieved with this programme, two study groups were compared: those who participated in HRP&BP from the prenatal stage until the infant reached twelve months of life, versus those who received usual care. We hypothesised that the study group would achieve better results, in terms of the emotional health of the parents and the neurodevelopment of the infant during this period. METHODS A prospective longitudinal study with intervention and control groups was conducted to determine the effect of an app-based care programme (HRP&BP) used during pregnancy and the post-natal period by parents of infants at risk (due to premature and/or SGA birth). Participants The study population was recruited from two tertiary referral hospitals, one in SE Spain (Hospital 1) and the other in SW Spain (Hospital 2), within the same Autonomous Community (administrative region). Both samples were recruited according to the same inclusion and exclusion criteria. High-Risk Pregnancy and Baby Parenting programme 8 In every case, the participants were parents of infants identified as SGA and/or at risk of preterm birth (WHO, 2006). Hospital 1 mainly studies SGA infants (birth weight below the 10th percentile according to gestational age), while Hospital 2 focuses more on those at risk of premature birth. Babies who were not high risk at the time of birth (i.e., they did not meet the criteria for SGA or prematurity) and the parents of babies who died were excluded from the study. All participants received support and training in the use of the programme and the associated apps and gave signed informed consent to take part. Hospital 1. The participants were selected from the 78 mothers, together with the same number of fathers and live-born infants, attended from April 2017 to July 2018. The recruitment was sequential. Half of the couples with foetuses diagnosed as SGA were randomly assigned to the HRP&BP psychological care programme and the other half, of similar characteristics, were assigned to the control or non-treatment group, which received usual care. 23 couples (12 from the HRP&BP programme and 11 from the usual care group) dropped out of the study for reasons such as change of address, lack of interest or incompatibility with their work. The resulting sample from Hospital 1 thus consisted, in the HRP&BP programme, of 27 mothers, fathers and infants, and in the usual care group, of 28 mothers, fathers and infants. Hospital 2. The participants were selected from the 94 mothers, together with their partners, who met the inclusion criteria and were treated at this hospital during the period from June 2017 to March 2019. High-Risk Pregnancy and Baby Parenting programme 15 words, the populations at both hospitals obtained similar scores for emotional health before entering the HRP&BP programme, and therefore can be considered a single sample in this respect, thus improving the power of the analyses performed. Having established the homogeneity of the two samples as regards the participants’ emotional health, the effects of the HRP&BP programme were analysed jointly. Effect of the programme on the parents’ emotional health Table 3 shows the RM-GLM results for the emotional health variables of the mothers at each of the time points considered and according to whether or not they participated in the HRP&BP programme. Maternal depression. Differences were observed between the different measures at T1, T2 and T3, with a large time effect F (1.44) = 63.01, p < .001, η2 = .49, β-1 = 1.00. A significant treatment effect for depression was also found. Comparisons by time show that this effect was significant at T2 (6 months CA), since the depression scores for the HRP&BP programme group (M = 4.77, SD = 3.25) were significantly lower than those for the usual care group (M = 6.85, SD = 4.58, p = .03, [95% CI 0.15, 4.01]). At T3 there were no differences in maternal depression between the two groups, but the improvement achieved at T2 compared to T1 was more strongly maintained at T3 in the programme group (11.07 mean T1 vs. 5.10 mean T3) than in the usual care group (9.59 mean T1 vs. 6.93 mean T3) (Figure 3, see Annex). Maternal stress. Similarly, differences were observed between the various measures of maternal stress over time, with a large time effect F (1.66) = 19.64, p < .001, η2 = .25, β-1 = 1.00. A significant treatment effect on the stress experienced by the mothers was detected at T2; in other words, the stress scores for the HRP&BP programme group (M = 13.57, SD = 7.40) were significantly lower than those for the usual care group (M = 15.23, SD = 9.99, p = .01, High-Risk Pregnancy and Baby Parenting programme 16 [CI 95% 0.86, 9.13]). At T3, the same effect was found as for depression, with unchanged differences in stress between the two study groups (Figure 3, see Annex). Maternal anxiety. Differences were observed at T1, T2 and T3, with a large time effect F (1.3) = 32.48, p < .001, η2 = .37, β-1 = 1.00. Although for both groups levels of anxiety fell between T1 and T2 (p = .006 HRP&BP programme group, p < .001 usual care group), there was no such variation, in either group, between T2 and T3. No differences in anxiety were observed between the HRP&BP programme group and the usual care group, for any of the times evaluated (Table 3, see Annex). Maternal resilience. Differences were also found in the different measures of resilience, at each of the times considered, with a large time effect F (2) = 6.21, p = .003, η2 = .11, β-1 = .88. In addition, a treatment effect was recorded at each time point (p = .004); in other words, the mothers in the HRP&BP programme group were more resilient than those in the usual care group, at T1 (p = .02), T2 (p = .01) and T3 (p = .001) (Figure 3, see Annex). Paternal emotional health. Table 4 (see Annex) shows the RM-GLM results for the emotional health variables of the fathers at the different time points, and according to whether or not they participated in the HRP&BP programme. Over time, levels of depression (p < .001) and stress (p < .001) fell among these men, i.e., there was a time effect. However, no treatment effect in this respect was observed at any of the time points. For anxiety, no time or treatment effect was found. For resilience, no time effect was observed, but there was a treatment effect (p < .001), highlighted by inter-group differences at all time points evaluated. Thus, the HRP&BP programme group was more resilient than the usual care group at T1 (p = .02), T2 (p = .002) and T3 (p < .001). In other High-Risk Pregnancy and Baby Parenting programme 17 words, resilience increased over time among the HRP&BP programme group but remained unchanged in the usual care group (Table 4, see Annex). Effect of the programme on the baby’s development during the first year of life The effect of the HRP&BP programme on infant neurodevelopment is summarised in Table 5 (see Annex), which shows the RM-GLM results for relevant variables at each time point considered and according to participation or otherwise in the HRP&BP programme. In brief, the infants’ development had improved in all areas at 6 months and at 12 months, except in that of gross motor skills. Furthermore, a time effect was observed in all areas of development, i.e., cognitive skills (p < .001), language expressivity (p < .001), language receptivity (p < .001), total language skills (p < .001), gross motor skills (p < .001) and fine motor skills (p < .001). In addition, a positive effect of the HRP&BP programme was found at both T2 and at T3 in all areas of development evaluated, except in that of gross motor skills, which presented differences between the HRP&BP programme group and the usual care group at T2 (p = .02, CI 95 % [0.33, 5.49]) but not at T3 (p = .32). DISCUSSION The study results obtained indicate that application of the HRP&BP programme has a positive effect on emotional health, especially that of the mothers, and on infant neurodevelopment, compared to usual care. The main improvements were observed at T2. Thus, the programme’s effect on the risk variables for emotional health (depression and stress) became evident at 6-8 months after the start of the programme and remained present until (at least) 12-15 months after the start. As regards the protective variables (resilience), the High-Risk Pregnancy and Baby Parenting programme 18 programme’s influence remained apparent throughout the study period. Its positive effect on infant neurodevelopment was observed at 6 and 12 months’ CA. Homogeneity of the samples Certain differences were detected in the sociodemographic variables, according to the type of population recruited, which differed from one hospital to the other. Thus, at Hospital 2, the maternal and paternal ages were greater than at Hospital 1 and the babies treated were mainly premature. This finding coincides with Fuchs et al. (2018), who observed a positive relationship between maternal age and the percentage of premature births. Regarding the clinical characteristics, differences were observed in gestational age, pregnancy risk and length of hospitalisation. These were all greater at Hospital 2, as was to be expected due to its larger population of premature infants. Magro-Malosso et al. (2018) reported that the risk of premature birth was associated with that of miscarriage. This was also the case in our own study sample. By type of delivery, operative deliveries were more common at Hospital 1 than at Hospital 2, since most of the babies treated were SGA and thus more likely to require this approach (Rhoades et al., 2017). Other factors that varied between the two hospitals were the type of risk to the baby, the 5-minute Apgar score and the proportion of mothers who were primiparous. Our bibliographic search did not reveal other studies corroborating this finding. However, despite the above differences corresponding to the type of sample recruited at each hospital, at both sites the families that participated in the programme were similar to those who received usual care, and similar patterns of behaviour were observed, with the exception of the type of delivery, which at Hospital 1 was less surgical, with fewer caesarean sections, among the mothers who took part in the programme. Effect of the programme on the parents’ emotional health High-Risk Pregnancy and Baby Parenting programme 19 Our findings show that when appropriate resources are offered to mothers and their partners as soon as a risk to the pregnancy is detected, and a systematic follow-up is carried out, positive changes can be produced in terms of enhanced maternal emotional health, reduced levels of stress and depression, and heightened resilience. These changes, moreover, could enhance the mother’s care of the child and contribute to optimising neurodevelopment. In this respect, studies have shown that the mental health of the main caregiver, the behaviour of the parents and the relationship between parents and children, when they interact with other risk factors, influence the development of preterm infants (Nordheim et al., 2018; Tuovinen et al., 2021) and that of SGA infants (Glover, 2020; Ibrahim and Lobel, 2020). This is an important understanding because, as O’Donnell and Meaney (2017) point out, hypotheses on the evolutionary origins of health and disease suggest that the quality of foetal development determines individual differences in the lifetime risk of chronic disease. For example, prenatal symptoms of anxiety or depression are associated with a more difficult infant temperament, regardless of postnatal maternal mental health. Accordingly, the HRP&BP programme could help prevent these kinds of negative consequences for child development. According to Craig et al. (2015), the standardised use of family-centred developmental care (FCDC) within the NICU would optimise infant development and help establish a solid foundation for the family’s relationship with the child. Studies of intervention programmes applied with this model have highlighted the positive effects of this approach in areas such as early interaction (Porreca et al., 2017), enhanced parenting skills (Sgandurra et al., 2019) and stress reduction (Urech et al., 2019). However, there is a significant problem, namely that most such programmes have had insufficient resources with which to continue providing long-term support for parents. However, the programme we describe is reinforced by the High-Risk Pregnancy and Baby Parenting programme 20 provision of two mobile apps, CAREpregnancy and CAREparenting, which provide users with the means to improve their emotional health and stimulate the development of their babies. These mHealth apps also facilitate periodic self-assessment of the progress made towards these goals, via questionnaires about the family’s daily routines (Balderas-Díaz et al., 2022). In line with our own findings on the programme, and also using a tool based on new technologies, Sgandurra et al. (2019) reported that the participation of parents in early intervention programmes seems to have positive effects both for the parents and for their children. Regarding the study outcomes, the mothers who participated in our programme achieved a higher level of improvement than the fathers, especially at 6 months’ CA. This finding is in line with Sgandurra et al. (2019), whose results showed that the CareToy intervention was managed mainly by the mothers. These authors also measured a significant reduction in the parental distress subscale among the mothers in the CareToy group compared to usual care, but no such difference for the fathers. Our study did not reveal any effect of the programme on the risk factors considered for the fathers (depression, stress and anxiety), which suggests that the mothers, on average, achieved a stronger post-traumatic growth (Tedeschi and Calhoum, 2004). This difference may be because the fathers have not yet assumed a parental role, and hence feel less involved in terms of emotional health and in promoting the baby’s neurodevelopment, or it may reflect their lesser involvement in the programme. Hearn et al. (2020) suggest that if the fathers were present in the NICU this would give them greater confidence and knowledge about childcare, and hence encourage them to take a more active part in this respect. The programme does include specific sessions for fathers, but their participation remained lower than that of the High-Risk Pregnancy and Baby Parenting programme 21 mothers. In other words, the treatment effect was smaller for fathers. Thus, in accordance with Hearn et al. (2020), we believe that fathers should be further encouraged to actively participate in caring for their newborn children. Effect of the programme on the baby’s development during the first year of life The study results show that the infants whose parents followed the HRP&BP programme presented a higher degree of neurodevelopment than those in the usual care group, and that this difference was maintained over time. The only exception to this was in the development of gross motor skills; in this area, no differences between the groups were observed at twelve months of life. The study findings highlight the value of the programme for health, both before and after birth. It not only benefits the emotional state of the mothers taking part, but also enhances the infants’ neurodevelopment. Unlike previous proposals in this field (Khoshnood et al., 2023; Rau et al., 2020), our programme not only provides psychoeducation and emotional support to parents, but also fosters the implementation of their discoveries for emotional management, self-care, and development stimulation. This, together with the fact that the programme spans the period during pregnancy and the first twelve months of postnatal life, seems to provide greater benefit than interventions which focus more narrowly on the prenatal or the postnatal stage. Thus, its impact could extend to the medium and longterm neurodevelopment of children, their emotional regulation and academic performance (Glover, 2020). Finally, the programme provides a family-focused and natural environment-centred approach to care, as each family can adapt the programme to their needs and schedule. Although the evidence suggests that methods such as Family-Centred Developmental Care High-Risk Pregnancy and Baby Parenting programme 22 Practices and Family-Centred Early Intervention provide the best results, their implementation in real-world contexts remains challenging. Our programme seems to offer the necessary resources to equip parents for the new tasks facing them, enabling them to put into daily practice skills that promote and optimise the child’s development (Valero et al., 2020). Conclusions, limitations and implications The main outcome of the present study is the development of a practical instrument, the HRP&BP programme, that facilitates the participation of parents who might otherwise have difficulty in engaging with an in-person training programme. The programme incorporates two differentiated sub-programmes: one focused on pregnancy and the other on caring for infants at risk. The prenatal and postnatal follow-up maintained for fifteen months, with a range of control measures, increases the potential of our study. In addition, the programme offers a guided, structured intervention with practical exercises in each module, together with in-person sessions designed to assess the emotional state of the parents during the pregnancy and subsequent childcare, and also to monitor the neurodevelopment of the child. This dual approach promotes adherence and enhances the effect of the programme, as well as enabling the early detection of any difficulties that may arise. Despite the strengths indicated, this study is not without limitations. The first is the limited size of the study sample, which was partly due to the difficulties encountered in obtaining an appropriate population sample, together with the 15-month follow-up period involved. Furthermore, the differentiated recruitment system employed for each of the hospitals at which the study took place, although explained and justified, is not free of bias. However, analysis of the inter-group comparison showed that the patients recruited at both hospitals were similar in terms of their emotional health, and that the groups that participated in the programme were of a similar nature to those who received usual care, at each hospital. High-Risk Pregnancy and Baby Parenting programme 23 These findings encourage us to extend this line of research, with a longer follow-up to determine whether the changes initially observed become consolidated or decay over time. In addition, the results underpin the use of new, readily accessible technologies for couples with a risky pregnancy, to provide a useful tool for Family-Centred Early Intervention. In future work, it would also be desirable to assess the influence of certain clinical variables, such as birth weight, CA, previous gestational losses or the type of delivery, on maternal emotional health and on infant neurodevelopment. In addition, we should assess which variables are most closely related to mental health during follow-up, with more sensitive instruments (in particular for anxiety) and include an analysis of the parents’ discourse. Finally, if the analysis were based on a larger sample, this would allow other hypotheses to be formulated, such as the impact of participation in this type of programme during pregnancy on the type of delivery subsequently performed. To conclude, we believe that studies of intervention programmes such as HRP&BP, focused on family routines, should be assigned high priority, since they may contribute significantly to enhancing the emotional health of mothers and benefit the neurodevelopment of babies at risk of being SGA. However, a better understanding is needed of the mechanisms that might increase the involvement and active participation of fathers during pregnancy and early childhood. REFERENCES Balderas-Díaz S, Rodríguez-Fórtiz MJ, Garrido JL, et al. (2022) A psycho-educational intervention programme for parents with SGA foetuses supported by an adaptive High-Risk Pregnancy and Baby Parenting programme 24 mHealth system: design, proof of concept and usability assessment. BMC Medical Informatics and Decision Making 22(Suppl 4): 291. Bayley N (2006) Bayley Scales of Infant and Toddler Development–Third Edition. San Antonio, TX: Harcourt assessment. 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In MT Anguera, S Chacón-Moscoso and A. Blanco: Evaluación de programas sociales y sanitarios. Un abordaje metodológico. Madrid: Sìntesis. Cohen S, Kamarck T and Mermelstein R (1983) A global measure of perceived stress. Journal of Health and Social Behavior 24: 385–396. Cook TD, Campbell DT and Shadish W (2002) Experimental and quasi-experimental designs for generalized causal inference (Vol. 1195). USA: Houghton Mifflin. High-Risk Pregnancy and Baby Parenting programme 31 Table 1. Details of the hospital populations. Sociodemographic characteristics (mothers and fathers), pregnancy and perinatal outcomes. Data are given as n (%), mean (SD). P-values were calculated using Student’s t-test and Pearson’s chi-square test. p Hospital 1 vs. Hospital 2. p* Hospital 1 HRP&BP programme vs. Usual care. p† Hospital 2 HRP&BP programme vs. Usual care. PRM, Premature rupture of membranes. SGA, Small for gestational age. Hospital 1 Hospital 2 HRP&BP programme N=27 Usual care N=28 HRP&BP programme N=23 Usual care N=37 p p* p† Maternal age (years) 32.11 (5.85) 29.89 (5.42) 33.91 (4.99) 33.73 (5.00) 0.003 0.08 0.44 Paternal age (years) 32.70 (6.67) 32.11 (7.34) 35.65 (5.15) 37.47 (5.65) <0.001 0.38 0.10 Maternal education Primary school High school College/university 8 (29.6) 7 (25.9) 12 (44.5) 9 (32.1) 9 (32.1) 10 (35.8) 5 (21.7) 6 (26.1) 12 (52.2) 3 (8.1) 16 (43.2) 18 (48.7) 0.08 0.79 0.11 Paternal education Primary school High school College/university 6 (22.2) 13 (48.1) 8 (29.7) 6 (21.4) 13 (46.5) 9 (32.1) 4 (17.4) 12 (52.2) 7 (30.4) 4 (10.8) 19 (51.4) 14 (37.8) 0.40 0.98 0.58 Pregnancy risk PRM SGA PRM + SGA 0 (0) 23 (85.2) 4 (14.8) 1 (3.6) 18 (64.3) 9 (32.1) 18 (78.3) 3 (13.0) 2 (8.7) 26 (70.3) 6 (16.2) 5 (13.5) <0.001 0.11 0.77 Types of delivery Vaginal Assisted vaginal Caesarean 17 (63.0) 8 (29.6) 2 (7.4) 13 (46.4) 4 (14.3) 11 (39.3) 13 (56.5) 8 (34.8) 2 (8.7) 13 (35.1) 16 (43.3) 8 (21.6) 0.11 0.01 0.10 Miscarriage 0.22 (0.50) 0.29 (0.71) 0.52 (0.99) 0.59 (0.89) 0.02 0.35 0.38 Primiparous Yes No 20 (74.1) 7 (25.9) 16 (57.1) 12 (42.9) 8 (34.8) 15 (65.2) 10 (27.0) 27 (73.0) <0.001 0.18 0.52 Gestational age at delivery (weeks) 37.29 (2.36) 37.28 (2.32) 34.52(3.50) 34.52(4.18) <0.001 0.49 1.00 Birth weight (grams) 2234 (523) 2272 (518) 2181 (856) 2145 (914) 0.25 0.39 0.88 5-min Apgar score 8.56 (0.97) 8.89 (0.87) 9.15 (1.06) 9.37 (1.01 0.06 0.09 0.28 Vena artery pH 7.18 (0.15) 7.20 (0.12) 7.21 (0.14) 7.31 (0.09) 0.23 0.24 0.07 Risk to baby Still birth Risk-free Premature SGA SGA + premature 5 (18.5) 1 (3.7) 0 17 (63.0) 4 (14.8) 2 (7.1) 3 (10.7) 3 (10.7) 15 (53.6) 5 (17.9) 0 7 (30.4) 9 (39.1) 1 (4.4) 6 (26.1) 2 (5.4) 12 (32.4) 15 (40.5) 1 (2.7) 7 (19.0) <0.001 0.24 0.78 Hospitalisation (days) 8.25 (7.70) 11.50 (7.29) 31.69 (20.50) 33.74 (36.17) <0.001 0.20 0.42 Gender of baby Male Female 16 (59.3) 11 (40.7) 14 (50.0) 14 (50.0) 14 (60.9) 9 (39.1) 17 (45.9) 20 (54.1) 0.75 0.49 0.26 High-Risk Pregnancy and Baby Parenting programme 32 Table 2. Differences in depression, perceived stress, anxiety and resilience of mothers and fathers at T1, between the two hospitals. Hospital 1 vs. Hospital 2 Emotional health at T1 Mothers Mean (SD) F p Power η 2 partial Depression 10.20 (3.69) / 10.05 (4.67) 0.02 0.90 0.05 0.001 Perceived tress 18.69 (9.56) / 21.84 (8.35) 1.40 0.24 0.21 0.02 Anxiety 1.26 (0.41) / 1.14 (0.60) 0.60 0.44 0.12 0.01 Resilience 28.74 (6.14) / 28.75 (5.83) 0.00 0.96 0.05 0.001 Emotional health at T1 Fathers Mean (SD) F p Power η2partial Depression 7.84 (4.01) / 7.16 (3.74) 0.33 0.57 0.08 0.008 Perceived stress 16.70 (8.25) / 21.06 (7.78) 3.03 0.09 0.40 0.07 Anxiety 0.21 (0.38) / 0.34 (0.46) 3.04 0.11 0.36 0.20 Resilience 30.44 (6.83) / 30.81 (5.51) 0.04 0.84 0.05 0.001 High-Risk Pregnancy and Baby Parenting programme 33 Table 3. RM-GLM results for differences at T1, T2 and T3 by treatment (HRP&BP programme vs. Usual care) with respect to maternal depression, perceived stress, anxiety and resilience. HRP&BP programme vs. Usual care Mothers Measures Mean (SD) F p Power η2partial Depression T1 11.07 (4.09)/9.59 (4.32) 63.01 <0.001 1.00 0.49 Depression T2 4.77 (3.25) / 6.85 (4.58) Depression T3 5.10 (3.30) / 6.93 (4.54) Depres. Time*treatment 6.48 (0.54) / 8.28 (0.65) 4.48 0.04 0.55 0.07 Perceived stress T1 20.08(7.21)/20.67(10.7) 19.64 <0.001 1.00 0.25 Perceived stress T2 13.36(6.69)/16.03(6.07) Perceived stress T3 15.08(8.03)/15.97(7.78) Stress Time*treatment 15.17(1.31)/17.50(1.08) 3.65 0.04 0.32 0.06 Anxiety T1 1.18 (0.47) / 1.27 (0.57) 32.48 <0.001 1.00 0.37 Anxiety T2 0.63 (0.48) / 0.70 (0.68) Anxiety T3 0.60 (0.43) / 0.74 (0.74) Anxiety Time*treatment 0.83 (0.07) /0.88 (0.09) 0.106 0.74 0.06 0.002 Resilience T1 30.78(6.55)/27.28(4.85) 6.21 0.003 0.89 0.11 Resilience T2 32.61(5.43)/29.03(5.17) Resilience T3 33.39(5.15)/28.19(5.80) Resilience Time*treatment 32.26(1.02)/28.16(0.87) 9.32 0.004 0.85 0.15 High-Risk Pregnancy and Baby Parenting programme 34 Table 4. RM-GLM results for differences at T1, T2 and T3 by treatment (HRP&BP programme vs. Usual care) with respect to paternal depression, perceived stress, anxiety and resilience. HRP&BP programme vs. Usual care Fathers Measures Mean (SD) F p Power η2partial Depression T1 6.33(3.43) / 7.52 (4.41) 15.42 <0.001 0.99 0.22 Depression T2 3.87(3.73) / 5.71 (3.96) Depression T3 4.32(3.86) / 4.17 (3.67) Depres. Time*treatment 5.40(0.65) / 5.23 (0.57) 0.036 0.85 0.05 0.001 Perceived stress T1 15.62(6.85)/19.73(8.5) 13.76 <0.001 0.98 0.22 Perceived stress T2 13.57(7.40)/15.23(9.9) Perceived stress T3 12.00(7.83)/14.67(9.2) Stress Time*treatment 13.73(1.70)/16.54(1.4) 1.60 0.21 0.23 0.03 Anxiety T1 0.16(0.40) / 0.26 (0.43) 0.90 0.41 0.19 0.05 Anxiety T2 0.26(0.32) / 0.46 (0.53) Anxiety T3 0.33(0.34) / 0.55 (0.72) Anxiety Time*treatment 0.25(0.13) / 0.43 (0.09) 1.18 0.29 0.18 0.06 Resilience T1 32.28(5.87)/28.85(6.0) 0.44 0.57 0.11 0.01 Resilience T2 33.76(4.41)/28.52(6.4) Resilience T3 34.71(4.30)/28.30(6.6) Resilience Time*treatment 17.50(1.08)/16.17(1.3) 12.46 <0.001 0.93 0.21 High-Risk Pregnancy and Baby Parenting programme 35 Table 5. RM-GLM results for differences at T2 and T3 by treatment (HRP&BP programme vs. Usual care) in the babies’ cognitive, language and motor skills HRP&BP programme vs. Usual care Babies Measures Mean (SD) F p Powe r η2partia l Cognitive T2 28.81 (2.69) / 27.2 (2.53) 1092.7 <0.001 1.00 0.95 Cognitive T3 43.10(2.25)/41.55 (3.18) Cognitive Time*treatment 35.95(0.48)/34.40 (0.36) 6.43 0.014 0.70 0.10 Receptive language T2 10.10 (1.70) / 9.06 (1.34) 839.2 <0.001 1.00 0.94 Receptive language T3 15.10(2.11)/13.39 (1.24) Receptive language Time*treatment 10.77 (0.27) / 9.43 (0.21) 13.09 <0.001 1.00 0.98 Expressive language T2 7.76 (2.11) / 5.87 (1.04) 565.4 <0.001 1.00 0.90 Expressive language T3 14.81 (1.43)/13.39 (2.08) Expresive language Time*treatment 9.04 (0.23) / 7.73 (0.17) 21.26 <0.001 0.99 0.27 Total language T2 42.52(25.86)/17.84(11.8) 14.89 <0.001 0.96 0.21 Total language T3 48.29(17.86)/29.37(13.8) Total language Time*treatment 45.47 (3.2) / 23.31 (2.44) 30.10 <0.001 1.00 0.35 Gross motor skills T2 28.67 (6.11)/25.75 (3.62) 216.72 <0.001 1.00 0.80 Gross motor skills T3 40.33(6.61)/ 41.78 (4.25) Gross motor Time*treatment 27.14 (0.62)/26.40 (0.47) 0.55 0.46 0.11 0.01 Fine motor skills T2 20.81 (3.32)/18.50 (1.87) 328.3 <0.001 1.00 0.86 Fine motor skills T3 28.38 (2.50)/27.47 (1.40) Fine motor skills Time*treatment 24.59 (0.32)/22.98 (0.24) 16.13 <0.001 0.98 0.23 Total motor skills T2 46.24(20.71)/34.72(17.6) 0.25 0.61 0.08 0.005 Total motor skills T3 45.76(21.73)/32.69(13.5) Total motor skills Time*treatment 46.00(3.38)/ 33.70 (2.58) 8.35 0.006 0.81 0.13 Note. Direct scores are presented for all measures, except the Total Language and Total Motor Skills composite measures, for which the percentile score is given.