Family-centred care interventions in neonatal intensive care units: a scoping review of randomised controlled trials providing a menu of interventions, outcomes and measurement methods

Study design and study selection

Study design and study selection were already described in the first review21 and are reported in online supplemental files S1 and S2.

The Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR)28 was followed for reporting, the PRISMA-ScR checklist is annexed as online supplemental file S3.

Data extraction and synthesis

Data extraction forms were developed through an iterative process, prepiloted and further optimised until considered satisfactory. Characteristics of FCC interventions — such as the intervention category, the intervention name when available and other key characteristics — were extracted using a REDCap V.8.5.21-2021 Vanderbilt University-form.

For outcomes, measurement methods and timings, an ad hoc Excel spreadsheet was developed. Data were extracted and organised in steps. First, for each included study, we tabulated all measured outcomes and identified the population in which each outcome was measured: parents, infants, siblings or health workers. To simplify reporting, outcomes measuring the parent–infant interaction were classified under the identified population of ‘parents’ although they involved both infants and parents. Second, to synthesise the high number of measured outcomes, given the lack of pre-existing categories of FCC outcomes, and the high heterogeneity in the wording used to describe similar outcomes, we tabulated keywords used to describe each outcome (online supplemental file S4). These were subsequently grouped in 13 categories by a team of senior neonatologists (JB, CLJV) and researchers (IM, MG, ML). For example, ‘neurobehavioural’, ‘behaviour’, ‘development’ and ‘cognitive’ were terms used to identify similar outcomes, and these were grouped in the infant ‘neurobehavioural and developmental outcome’ category. Third, we extracted number, type and name (when available) of measurement methods used for outcome assessment. We grouped these methods in four main types: (1) parent/self-completed questionnaire, (2) clinical/medical data and costs, (3) instrumental measures and (4) assessments conducted by specialists (videos, interviews, tests or observations). Lastly, we extracted information related to the timings when outcome was measured, recording if outcome was assessed in multiple time points (yes/no); the presence of (at least one) intrahospital assessments (yes/no); the presence of a postdischarge outcome assessment; and the timing of the last postdischarge follow-up assessment if performed (≤3 months after birth, 4–11 months, 12–23 months, ≥24 months).

Data extraction was independently performed by CLJV, JB, IM and MG. To ensure alignment in data tabulation and synthesis and solve disagreements, regular discussion sessions were planned. Disagreements were solved by either consensus or through further involvement of a fourth expert reviewer (ML).

This being a scoping review, it did not aim at assessing risk of bias and effectiveness of different interventions.

Data collected in both Excel spreadsheet and REDCap form were imported on R V.4.1.1 (R Foundation for Statistical Computing, Vienna, Austria; URL: https://www.R-project.org/) and summarised in tables and figures to provide menus of FCC interventions, evaluated outcomes and measurement methods, and timings.

Subgroup analysis

Subgroup analyses were performed to analyse populations and timings of outcome measurements by time periods (RCTs published up to 2016 vs after 2016) and by income level (RCTs conducted in high-income countries (HICs) vs middle-income countries (MICs)). MICs included both upper and lower MICs as per the World Bank categorisation.29 No comparison was performed with low-income economies because no study was conducted in that setting.21 To test differences, a χ² test was performed. All tests were two tailed and a p value <0.05 was considered statistically significant.

Identified studies

The database search retrieved a total of 9866 records, and after excluding duplicates, 6583 studies were screened. An additional 31 records were identified from citation searching. After full-text assessment of 260 articles, 146 RCT studies were deemed eligible for inclusion in the scoping review. A flow chart of the data selection, all included studies and extracted data are detailed in online supplemental files S5–S9.

Categories of intervention identified

Overall, an educational intervention was included in almost all RCTs (138 RCTs, 94.5%), either alone (86 RCTs, 58.9%) or in combination with other approaches (52 RCTs, 35.6%). Family support interventions were tested in 48 RCTs (32.9%), environmental interventions in 39 RCTs (26.7%), communication interventions in 32 RCTs (21.9%) and family-centred policies in 26 RCTs (17.8%).

Among the 146 RCTs identified, 52 (35.6%) tested more than one category of FCC interventions, with a large variety of intervention combinations (table 1). The most frequent combination of interventions included all five possible categories of FCC interventions (24 RCTs, 16.4%). While the educational category was included in all multifaceted interventions, the other four categories of interventions were rarely tested alone (two RCTs for each category).

Identified interventions

We identified a total of 77 different interventions (table 2) of which 16 were multifaceted intervention packages described in more than one RCT (specifically in 85 RCTs). The remaining 61 interventions — either single category (48 RCTs) or multifaceted (13 RCTs) — were described each by a single RCT (tables 1 and 2, online supplemental files S7 and S8).

The menu of the interventions available for each of the five FCC categories is depicted in figure 1.

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Characteristics of educational interventions

All educational interventions targeted parents (138 RCTs, 94.5% of total RCTs), with 81 RCTs (55.5%) including also an educational intervention for staff (figure 1).

Educational interventions targeting parents were most often dedicated to mothers (55 RCTs, 37.7%) or both parents (82 RCTs, 56.2%), while no educational intervention was dedicated to fathers only. Only a minority involved additional family members (eg, siblings, grandparents) (15 RCTs, 10.3%).

Educational interventions for parents had a multitude of formats, settings, delivery methods, frequencies, durations and training topics (figure 1). The most reported formats were one-to-one educational sessions (106 RCTs, 72.6%) and practical sessions (121 RCTs, 82.9%). These were organised in mini courses (67 RCTs, 45.9%), most usually including more than three sessions (92 RCTs, 63%). Courses were most often delivered either orally (118 RCTs, 80.8%) and/or in written form (66 RCTs, 45.2%). Several interventions included digital technologies, such as digital/online resources (19 RCTs, 13.0%) and apps (3 RCTs, 2.1%).

The most frequent educational topics were: parental role and interaction with the baby (127 RCTs, 87%), especially with regard to parent response to infant cues (106 RCTs, 72.6%) and touch stimulation (96 RCTs, 65.8%); infant behaviours (116 RCTs, 79.5%), focusing mainly on infant cues (114 RCTs, 78.1%) (figures 1 and 2). Parental mental well-being and transition to home were other frequent topics (65 and 63 RCTs, 44.5% and 43.2%, respectively) and they mainly focused on, respectively, parent–staff discussion of parental emotional issues related to pregnancy, NICU environment or infant health condition (46 RCTs, 31.5%) and infant and family special care needs at discharge (35 RCTs, 24.0%). Education on baby care after discharge was reported in 19 RCTs (13.0%).

Educational interventions for staff, despite being reported in 81 RCTs, were less well described (figure 1). Across the 81 RCTs reporting educational interventions for staff, many did not specify the format (44 RCTs, 54.3%), setting (45 RCTs, 55.5%), frequency (22 RCTs, 27.2%), duration (50 RCTs, 61.7%) or delivery methods (46 RCTs, 56.8%). Based on reported data, educational interventions were usually practical (37 RCTs, 45.7%), with more than three sessions (25 RCTs, 30.9%), and a retraining event (21 RCTs, 25.9%). Health professionals receiving the educational intervention most frequently were nurses (59 RCTs, 40.4%) and social workers (27 RCTs, 32.2%), with the minority of RCTs involving physicians (26 RCTs, 17.8%), psychologists (20 RCTs, 13.7%), physical therapists (25 RCTs, 17.1%) and respiratory therapists (24 RCTs, 16.4%). From the minority of RCTs specifying the delivery methods, staff education was delivered through written (35 RCTs, 24.0%), oral (34 RCTs, 23.3%) or practical (eg, bedside observation, guidance, role-play) (31 RCTs, 21.2%) methods. Common educational topics were: education on the intervention implemented in the NICU (49 RCTs, 33.6%); communication and parental/family inclusion in care (37 RCTs, 25.3%); infant interaction with the environment and/or caregivers (35 RCTs, 24.0%); and infant development and/or behaviour (34 RCTs, 23.3%). Parent mental health was also included in staff educational interventions in 17 RCTs (11.6%).

Characteristics of family support interventions

The most frequent family support interventions were peer-to-peer support (26 RCTs, 17.8%) and sociopsychological support (eg, referral to social services/psychologists) (16 RCTs, 11%) (figure 1). Material support (11 RCTs, 7.5%) included delivery of equipment, such as a baby carrier.

Examples of economical supports (10 RCTs, 6.8%) included vouchers for parking or for public transports (7 RCTs in HICs and 1 in China), parking pass (1 RCT from Canada) and money transfer — $200-$600 per week —(1 RCT from the USA).

Other RCTs provided religious support (one RCT) or a contact number for emergency or parent guidance (two RCTs).

Characteristics of environmental interventions

Environmental interventions included relatively simple interventions with no need for major changes in the environment, interventions with major changes in the environment or a combination of both. Examples of minor changes included: provision of equipment (eg, rocking chairs, kangaroo care chair) (35 RCTs, 24%); reducing noise/light (28 RCTs, 19.2%); parent minor personalisation of infant bed area (17 RCTs, 11.6%); and infant developmental care accessories (eg, specialised hugging pillow, special pacifiers) (24 RCTs, 16.4%). Examples of major NICU structural changes included: the implementation of parent rest rooms (7 RCTs, 4.8%) or single-family rooms (2 RCTs, 1.4%) (figure 1).

Characteristics of communication interventions

The most frequent intervention types in this category included: parental involvement in medical rounds (29 RCTs, 19.9%); parental encouragement to seek information (22 RCTs, 15.1%); and parental participation in advisory councils (17 RCTs, 11.6%). Other interventions included parental involvement in filling in medical files (7 RCTs, 4.8%) and in interacting with nurses (one RCT). A checklist for staff named ‘reflection sheets’ (59) was developed in one RCT to guide dialogues with parents (figure 1).

Characteristics of family-centred policy interventions

Dedicated salaried staff to promote FCC interventions and a financial plan to implement FCC were both tested in 17 RCTs (11.6%). Nursery certification of FCC curricula (eg, Newborn Individualized Developmental Care and Assessment Program) and Family Advisory Councils or similar bodies were also reported in 17 RCTs (11.6%). Other interventions in this group included: policies to operationalise parental involvement in caregiving (7 RCTs, 4.8%) as well of other family members (two RCTs) (figure 1).

Health professionals involved in the intervention

Across the 146 RCTs identified, the populations of health professionals most frequently involved in any stage of the intervention, including in the delivering, receiving and assessing the FCC intervention, were nurses (92 RCTs, 63.0%), researchers (60 RCTs, 41.1%) and psychologists (51 RCTs, 34.9%), followed by volunteers and physical therapists (online supplemental file S10). Physicians (ie, doctors) were explicitly reported to be involved in an intervention only in 8.2% of RCTs (12 RCTs), while in 6.2% of RCTs (9 RCTs) the type of involved health professional was not specified.

List of outcomes and measurement populations

Among the 146 included RCTs, a total of 425 different outcomes were retrieved (online supplemental file S9). A total of 94 RCTs (64.4%) measured outcomes on infants or related to infant healthcare, and 93 RCTs (63.7%) on parents. Outcomes were either measured on infants only (53 RCTs, 36.3%), on parents only (51 RCTs, 34.9%) or on both infants and parents (39 RCTs, 26.7%) (figure 3). Among parents, mothers were the most represented (60 RCTs, 41.1% of the total RCTs), 32 RCTs (21.9%) reported on both parents, with one RCT focusing only on fathers. Two studies reported outcomes measured on siblings while no study reported on caregivers other than parents. Outcomes measured on health workers were reported only in one RCT.

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Categories of outcomes

In parents, the two most frequent categories of outcomes were: (1) parental mental health (61 RCTs, 41.8% of total RCTs) — in particular stress (47 RCTs, 32.2% of total RCTs), depression (29 RCTs, 19.8%) and anxiety (28 RCTs, 19.2%) — and (2) participation/interaction/attachment (47 RCTs, 32.2%) (figure 4).

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In newborns, the most frequent category of outcomes was the neurobehavioural and developmental (62 RCTs, 42.5% of total RCTs), followed by any health outcome (abbreviated ‘Health’ in figures) (40 RCTs, 27.4%), and outcomes related to infant healthcare (abbreviated ‘Healthcare’ in figures) (29 RCTs, 19.9%). Most frequent health outcomes were: growth (22 RCTs, 56.4% of RCTs reporting on any health outcome); nutrition (15 RCTs, 38.5%); and bronchopulmonary dysplasia (8 RCTs, 20.5%) (online supplemental file S11). Hospitalisation information and any respiratory support were two most frequent outcomes in the healthcare category (online supplemental file S11).

In health workers, satisfaction was the only outcome described (one RCT), while in siblings it was emotions (two RCTs).

Measurement methods

Across the 146 RCTs, the total number of reported measurement methods/tools amounts to a total of at least 160 different methods/tools — 88 for parental outcomes (figure 5) and 72 for infant outcomes (figure 6). Totals were considered underestimated because for some outcomes, in particular health and healthcare outcomes, methods for data collection and tools were poorly reported. For several categories of outcomes, almost each RCT used a different method. For example, in 62 studies reporting infant neurobehavioural and developmental outcomes, 62 distinct methods (of which 40 reported in a single RCT) were used (figure 6). A total of 31 RCTs (21.2%) developed tools ad hoc for the study, such as a questionnaire, or other methods which were not further specified (eg, ‘video assessments’ without referencing to a specific tool). Multiple measurement methods for the same outcome were used in 63 RCTs (43.1%) (online supplemental file S9).

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Timings of outcome measurements

56 RCTs (38.4%) included multiple time point outcome assessments. A total of 104 RCTs (71.2%) measured outcomes during hospitalisation, 93 RCTs (63.7%) included postdischarge measurements (online supplemental file S12). Postdischarge follow-up periods were: ≤3 months from birth in 26 RCTs (27.9% of RCTs including postdischarge follow-up); 4–11 months from birth in 25 RCTs (26.9%); 12–23 months from birth in 19 RCTs (71.2%); and ≥24 months from birth in 23 RCTs (24.7%).

Subgroup analyses for populations and timings of outcome measurements

Results of the comparison of studies in HICs (118 RCTs, 80.8%) versus MICs (28 RCTs, 19.2%) and studies published up to 2016 (93 RCTs, 63.7%) versus after 2016 (53 RCTs, 36.3%) are shown in online supplemental file S12.

In MICs, outcomes were significantly more often measured on parents (25 RCTs in MICs, 89.3% vs 68 RCTs in HICs, 57.6%; p=0.002), in particular on mothers only (22 RCTs in MICs, 78.6% vs 38 RCTs in HICs, 32.2%; p<0.001). RCTs in MICs had significantly less multiple time point assessments than RCTs in HICs (4 RCTs in MICs, 14.3% vs 52 RCTs in HICs, 44.1%; p=0.004) and a higher frequency of outcomes measured during hospitalisation (27 RCTs in MICs, 96.4% vs 77 RCTs in HICs, 65.3%; p<0.001) or in the first three postdischarge follow-up months (78.6% in MICs vs 19.0% in HICs; p=0.001). No study in MICs had a follow-up >2 years.

RCTs published after 2016 compared with up to 2016 reported significantly more frequently outcomes on mothers only (28 RCTs, 52.8% vs 32 RCTs, 34.4%; p=0.017) and less multiple time point assessments (11 RCTs, 20.8% vs 45 RCTs, 48.4%; p=0.001).

Head-to-head comparisons

Overall, 119 RCTs (81.5%) compared the FCC intervention with the existing NICU standard care, while the remaining 27 RCTs (18.5%) included a comparison with another intervention. However, among these latter, all RCTs compared different interventions or were pilot studies or secondary publications/long-term extension studies of the same RCT (online supplemental file S13).