Ensuring adequate early childhood development is necessary for countries to move forward in an equitable and sustainable way; therefore, interventions to support early childhood development are essential to realize the United Nations Sustainable Development Goals [1]. The experience that best facilitates adequate child development is responsive caregiving provided by parents or primary caregivers [2], and one of the most relevant predictors of child development is the quality of the mother-child interaction [3]. The more sensitive, responsive, attentive, and cognitively stimulating the mother is, the better the results in her child. The main risk factors associated with the presence of low maternal sensitivity are maternal depression [4-6], low socioeconomic status, and other psychosocial risk factors [7], which are mediated by the high levels of stress experienced by these families [8].

Before 2020, mental health disorders were leading causes of global health-related burdens. With the emergence of the COVID-19 pandemic, mental health disorders have greatly increased across the world [9], especially in high-risk populations [10]. Pregnancy and postpartum are periods of special vulnerability for mental health. There are short- and long-term negative consequences to the physical, cognitive, and psychological development of children associated with prenatal and postpartum stress, anxiety, and depression [11], which are mainly due to a decrease in the quality of mother-child interactions. A recent Canadian study [12] carried out in pregnant women and those with children under 1 year of age showed an increase in anxiety symptoms from 29% to 72% after the COVID-19 pandemic and postpartum depression symptoms from 15% to 47%. The risk of mental health problems in pregnancy and the first year postpartum in the context of the pandemic has increased due to concerns related to the well-being of the child and aggravated by the consequences of preventive measures such as confinement, physical distance, reduced health checks, and difficulty obtaining support from the usual networks [13]. Moreover, these mental health problems are present at a greater extent in women of low socioeconomic status. Countries are recommended to implement mitigation strategies to reduce the mental health burden imposed by COVID-19, considering their local context and vulnerable populations [9].

For mothers to provide the responsive caregiving that their children need, they must have adequate mental health and a support network. Early interventions focused on supporting parents in providing responsive caregiving have proven to be effective [14-16]. Health services provide a critical starting point for these interventions, given their reach to pregnant women, families, and young children [16,17]. Thus, it is imperative to implement supportive interventions for pregnant and postpartum women that promote adequate sensitivity toward their children.

Global lockdown measures have disrupted routine health care for non–COVID-19 patients, so telemedicine has been escalated to reduce the risks of disease transmission [18]. Electronic mental health care is one of the most widely offered methods of health care, with evidence of applicability and efficacy in a wide range of formats [19]. A systematic review showed that group video conferencing interventions are feasible, improve access to health care, and have results similar to those obtained in face-to-face groups [20]. There is an interest in retaining or further incorporating virtual components devised in response to the COVID-19 pandemic into the standard delivery of interventions in the future [21]. In this context, it is important to implement remote interventions in primary health care (PHC) for mothers of children under 1 year of age that promote responsive caregiving.

Chile is a Latin American country that presents an important burden of mental health problems. The World Health Organization places Chile among the countries with the highest burden of morbidity from psychiatric diseases [22], and it has the world’s highest rates of postpartum depression [23,24] and preschool mental health problems [25]. Despite this, only 38.5% of those diagnosed receive some type of mental health service [22]. Chile has a comprehensive protection system for children from the prenatal period to 4 years of age known as Chile Crece Contigo (translated as “Chile Grows With You”) that aims to help all children reach their full potential for development through universal and targeted support services [26]; however, no specific interventions are offered to promote maternal sensitivity.

In 2 previous research projects, we developed and evaluated a face-to-face group intervention to promote maternal sensitivity during the child's first year of life [27]. The results, which will be published soon, showed positive effects on maternal sensitivity in mother-infant dyads attending PHC centers but low adherence rates. We also found a significant reduction in maternal depression symptoms and infant socioemotional development difficulties of resident dyads at Chilean female penitentiary centers [28].

The primary aim of this paper is to report on the protocol comprising a pilot randomized feasibility trial to evaluate the feasibility and acceptability of C@nnected, a group videoconferencing intervention that aims to improve maternal sensitivity in mother-infant dyads attending PHC centers in Chile. Along with detailing the intervention, this paper provides an account of the plan to collect both quantitative and qualitative measurements of outcomes.

The secondary aims are to (1) to estimate the effect size in clinical outcomes between the groups after the intervention in terms of maternal sensitivity, postpartum depressive symptoms, postpartum attachment, and socioemotional development; and (2) identify the key parameters for the implementation and evaluation of the intervention, which will enable the design of an effectiveness study in the future.

This is a data analyst–blind, superiority, pilot feasibility study with a mixed design. The quantitative component is a 2-arm randomized parallel group of 50 mothers of infants aged 6-12 months who receive health care in 2 PHC centers in Santiago, Chile. Mothers will be randomized into the intervention or control group in a to 3:2 ratio (with more people allocated to the intervention arm). Both groups will receive the usual treatment and educational brochures provided by the PHC center, with the intervention group also receiving the C@nnected videoconferencing intervention. The qualitative component will consist of semistructured interviews with intervention providers to identify possible improvements and core components of the intervention as well as focus groups with mothers participating in the intervention to evaluate user acceptability and satisfaction with the implementation.

This type of study is suggested by the literature as an initial requirement for the implementation of an innovative intervention before applying it on a larger scale. It is also recommended to use quantitative and qualitative methodologies to evaluate feasibility and acceptability [29]. This clinical trial protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and [30] and CONSORT (Consolidated Standards of Reporting Trials) guidelines [31]. Figure 1 provides a flowchart of the study process.

This study will be conducted at 2 PHC centers located in La Pintana and Puente Alto, 2 counties in Santiago, Chile, with low socioeconomic status. These counties have higher levels of poverty, overcrowding, and illiteracy than the national average.

The population eligible for this study will be mothers with infants between 6 and 12 months of age attending either of the participating PHC centers. This age group was chosen because in the meta-analysis of the effectiveness of interventions to improve maternal sensitivity by Bakersman-Kranenburg et al [14], better results were observed with infants aged between 6 and 12 months than those under 6 months of age.

The inclusion criteria are mothers of infants between 6 and 12 months who (1) attend 1 of the participating PHC centers, (2) are older than 18 years, (3) can speak Spanish fluently, and (4) have an electronic device that allows videoconferencing (ie, computer, tablet, or smart cell phone). In the case that a participant does not have internet access at home, we will consider supplying them with a prepaid card with internet gigabytes.

The exclusion criteria are mothers with severe intellectual deficits or current psychotic symptoms and those participating in another early intervention at the PHC center.

The study duration for the participants will be 3 months, regardless of study arm allocation. This study does not have a follow-up phase. The total trial data collection period will be approximately 14 months.

As this is a feasibility study, no hypotheses will be tested, and a formal power calculation is not required [44,45]. However, the evidence suggests a sample size of 25 people per arm for a small effect size of 0.2, which is suitable for clinical feasibility trials [45]. Therefore, a sample size of 50 participants was established, and the 3:2 allocation was chosen considering possible partial adherence to the intervention.

Potential study participants will be identified from a list provided by each PHC center. Two research assistants (Rs), both clinical psychologists, will be in charge of calling the mothers included in the list, verify by telephone whether they meet the inclusion criteria, and explain the study in detail. Mothers who meet the inclusion criteria and are interested in participating will be sent an online protocol that will include informed consent. Mothers who do not wish to participate will be asked for the reasons. Once the mother provides electronic consent, the initial evaluation scales (EPDS, ASQ:SE- 2, MPAS, and CEQ) and a sociodemographic survey will be sent to her electronically. Finally, the mother and RA will agree upon at a time to make a video call to record 5 minutes of free play required by the ESA.

Data obtained from the sociodemographic survey and the quantitative evaluations will be stored electronically and will not be linked to the identities of the participants. The data will be in a different spreadsheet than the one with personal data, which only 1 RA has access to, thus ensuring that the identity of the participants is protected.

Once the intervention is complete, both groups will complete the scales again (EPDS, ASQ:SE- 2, MPAS, and CEQ), and a new video recording (ESA) will be made by an RA different from the one who provided the intervention. Finally, the qualitative evaluation of the process will be carried out.

Data obtained from the qualitative information (the interviews and focus groups) will be recorded, transcribed, and assigned codes that will ensure the anonymization and protection of the participants’ identities.

For the quantitative analysis, descriptive statistics will be used for the clinical and sociodemographic variables of the groups, eligibility rate, recruitment, and adherence. Analysis of covariance (ANCOVA) will be used to determine differences in clinical outcomes between the groups. Data analysis will be conducted using SPSS Statistics 27 software (IBM Corp).

For the qualitative analysis, interviews and focus groups will be analyzed considering the conceptual basis of the Framework Analysis Approach [46], which is commonly used for thematic analysis of semistructured interview transcripts. It allows for the identification of commonalities and differences in qualitative data to draw descriptive and explanatory conclusions grouped around themes. It is different from Grounded Theory, which involves making systematic comparisons between cases to refine each topic and is aimed at generating social theory [47]. The Framework Analysis Approach is best suited to research that has specific questions, a limited time frame, a predesigned sample (eg, mothers and professionals participating in the intervention), and a priori issues (eg, evaluation of implementation of an intervention)

All procedures and informed consent were approved by the Scientific Ethics Committee of Health Science of Pontificia Universidad Católica de Chile. The study was approved on March 11, 2021, and renewed on January 6, 2022, with validity of 1 year (# 200813008).

The participants will not receive any incentive for participating in this study. An incentive equivalent to US $12 will be offered to participants who complete the postintervention assessment.

The objective of this study is to assess the feasibility and acceptability of the C@nnected group videoconferencing intervention, which aims to improve maternal sensitivity in mother-infant dyads attending PHC centers in Chile and was adapted from a face-to-face intervention. We expect to find an adequate feasibility of this intervention in terms of achieving good recruitment rates (around 60% mothers will accept the invitation to participate in the study with respect to those who meet eligibility criteria), good adherence to group intervention (around 60% in the intervention arm will receive the intervention), and adequate adherence to the sessions (the average expected attendance is 3 out of 4 sessions). We expect to find a very good acceptability of the intervention with high scores in the satisfaction questionnaire and positive evaluation in the qualitative assessment. We also expect to find favorable results of the intervention in terms of clinical outcomes, especially relating to maternal sensitivity, which will allow us to estimate the sample size for the future RCT to evaluate effectiveness. The results of this study will inform the key parameters for the implementation and evaluation of the intervention and facilitate the design of an effectiveness study in the future.

The COVID- 19 pandemic has led health teams to adapt some interventions to the eHealth format, and it is likely that many of these interventions will remain in this format even after the pandemic is over. Nevertheless, we should not assume that interventions will work equally as well when delivered through virtual methods. Existing interventions must be carefully adapted and include a focus on identifying the core components that must be maintained [21].

Internationally, there are some group parenting interventions with proven efficacy to increase maternal sensitivity; however, one of the main problems of this type of intervention is low adherence [48]. The development of eHealth interventions may improve the accessibility and flexibility of group-based interventions, which are important for parents. If this group intervention delivered by videoconference is shown to be feasible, it will be particularly useful for mothers that face barriers to attending face-to-face interventions.

This is a small pilot study in a highly vulnerable area of Santiago, Chile, so its results cannot necessarily be extrapolated to other contexts.

The main strengths of this study are as follows: 1) the intervention has proven effectiveness and was designed locally using a framework that was later adapted for the electronic format; 2) it will evaluate the acceptability and feasibility of the intervention both quantitatively and quantitatively; and 3) it will evaluate clinical outcomes. In our opinion, these are essential steps to take before conducting a randomized controlled study, and they will subsequently allow us to scale up this intervention in similar contexts once its effectiveness is evaluated.

This study will lay the foundation for a randomized clinical trial to examine the effectiveness of an intervention to improve maternal sensitivity in mothers attending PHC centers.