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Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10460736 | ||
Declarations | PMC10460736 | |||
Conflict of interest | The authors declare that they have no competing interests. | PMC10460736 | ||
Ethics approval and consent to participate | Ethical approval was obtained from the Regional Ethical Review Committee in Stockholm (Dnr: 2019–04020). All participants signed an informed consent before being enrolled in the study. | PMC10460736 | ||
Consent for publication | There are no photographs of persons in this manuscript that require consent for publication. | PMC10460736 | ||
References | PMC10460736 | |||
Background | Previous studies have investigated the various effects of parenting on infant developmental outcomes. In particular, parental stress and social support have been found to significantly affect the growth of the newborn. Although many parents today use mobile apps to obtain more support in parenting and perinatal care, f... | PMC9996416 | ||
Objective | This study aimed to examine the effectiveness of the Supportive Parenting App (SPA) in improving infant developmental outcomes during the perinatal period. | PMC9996416 | ||
Methods | REGRESSIONS | This study adopted a 2-group parallel prospective longitudinal design and recruited 200 infants and their parents (N=400 mothers and fathers). The parents were recruited at 24 weeks of gestation for a randomized controlled trial conducted from February 2020 to July 2022. They were randomly allocated to either the inter... | PMC9996416 | |
Results | At 9 and 12 months post partum, the infants in the intervention group were found to have better communication and language skills than those in the control group. An analysis of motor development revealed that a larger proportion of the infants in the control group fell under the at-risk category, where they scored app... | PMC9996416 | ||
Conclusions | Overall, the infants whose parents had received the SPA intervention tended to fare better in most developmental outcome measures than those whose parents had received standard care only. The findings of this study suggest that the SPA intervention exerted positive effects on the communication, cognition, motor, and so... | PMC9996416 | ||
Trial Registration | ClinicalTrials.gov NCT04706442; https://clinicaltrials.gov/ct2/show/NCT04706442 | PMC9996416 | ||
Introduction | PMC9996416 | |||
Background | depression | The effects of parenting on infant development are a widely investigated topic. Studies have found that parenting knowledge, parental stress, and parental perceived support have significant impacts on the growth of an infant [The lack of social support has been linked to various parental outcomes, such as postnatal dep... | PMC9996416 | |
Aims and Hypotheses | This study aimed to examine whether the SPA intervention had any indirect effects on the developmental outcomes of the app users’ infants from birth to 12 months of age. The direct effects on parenting outcomes have been reported separately [ | PMC9996416 | ||
Methods | PMC9996416 | |||
Study Design | depression, anxiety | A 2-group parallel prospective longitudinal design was adopted for this study, which was conducted from February 2020 to July 2022. Expecting parents were recruited from 2 public health care institutions in Singapore. The study was part of a randomized controlled trial (RCT) investigating the effectiveness of SPA in im... | PMC9996416 | |
Eligibility Criteria | PREGNANCY-INDUCED HYPERTENSION, HIGH-RISK PREGNANCIES, PLACENTA PREVIA, PREECLAMPSIA | Parents were considered eligible for the study if they met the following criteria: (1) both parents were aged ≥21 years; (2) both parents were able to read and speak English; (3) the pregnancy was at low risk with >24 weeks of gestation (age of viability in Singapore); and (4) both parents owned a smartphone with inter... | PMC9996416 | |
Sample Size Calculation | As this study was part of an RCT investigating the effectiveness of the SPA intervention on parental outcomes, the parents enrolled in the RCT and their infants were recruited for this study. Considering the medium-sized effect of SPA, a Cohen | PMC9996416 | ||
Intervention | depression | RECRUITMENT | The control group parents received the standard perinatal care offered by the hospitals they were recruited from, which consisted of antenatal checkups, optional antenatal classes, care during their stay in the ward, and a postnatal review scheduled 6 weeks post partum. Perinatal care was provided to the parents by obs... | PMC9996416 |
Procedure | Couples were recruited by a research assistant during their scheduled antenatal checkups at 2 tertiary hospitals in Singapore. They were provided with an explanation of the study, and interested couples were screened for eligibility before giving them an informed consent form where they could indicate their willingness... | PMC9996416 | ||
Outcome Measures | Conducting research with very young children involves various challenges regarding the accuracy of the data collected, as infants are not verbal, and thus it is difficult to obtain information directly from them. Therefore, the following instruments were used to measure the constructs examined in this study to provide ... | PMC9996416 | ||
Bayley Scales of Infant and Toddler Development—Fourth Edition | The Bayley-4 consists of 5 scales: cognitive, language, motor, social-emotional, and adaptive behavior (ADBE) [ | PMC9996416 | ||
Brief Infant Toddler Social Emotional Assessment | The 42-item parent-reported Brief Infant Toddler Social Emotional Assessment (BITSEA) was divided into 2 scales: the problem scale (31 items) and the competence scale (11 items) [ | PMC9996416 | ||
Data Analysis | Data analyses were conducted using SPSS (version 27.0; IBM Corp) [ | PMC9996416 | ||
Ethics Approval | Before the commencement of the study, ethics approval was obtained from the National Health Group Domain Specific Review Board (NHG DSRB:2019/00875). The parents of the infants involved in this study were provided with information on the study and its procedures before they provided their written consent. It was commun... | PMC9996416 | ||
Results | PMC9996416 | |||
Motor Skills | REGRESSION | The infants from the control group were significantly more likely to score below the cutoff score of the ASQ gross motor domain at 2 months post partum (risk ratio [RR]=0.417, 95% CI 0.20-0.85; The intervention group infants were found to have better fine motor skills than the control group infants at 6 months post par... | PMC9996416 | |
Cognition | At 6 months post partum, the infants from the control group had a higher chance of being in the at-risk group for the problem solving domain of the ASQ than those from the intervention group (RR=0.34, 95% CI 0.12-0.91; According to | PMC9996416 | ||
Behavioral Outcomes | −10.44, maladaptive behaviors | The ADBE scale of the Bayley-4 and the problem scale of the BITSEA assessed the behavioral outcomes of the infants. The BITSEA problem scale covered externalizing behaviors, dysregulating behaviors, and maladaptive behaviors. The infants from the control group were found to have significantly higher scores on the BITSE... | PMC9996416 | |
Analysis of Covariates | ’ motor skills | SECONDARY | Parents attending prenatal courses was found to significantly influence whether their infants’ ASQ scores on the communication (RR=0.13, 95% CI 0.02-0.75; The education level of the parents was also a predictor of the infants’ motor skills. The infants of parents with secondary educational qualifications had a higher c... | PMC9996416 |
Discussion | PMC9996416 | |||
Principal Findings | This study examined the effects of the SPA intervention on infants’ developmental outcomes during the first 12 months of life. The infants in the intervention group mostly scored better in domains assessing communication, cognition, and social-emotional development. More infants from the control group fell under the at... | PMC9996416 | ||
Communication | From 2 to 12 months post partum, the infants from the intervention group were found to exhibit better communication skills than their control group counterparts. According to Bortfeld and Gabouer [On the basis of the trend graphs, the difference in the communication scores between the 2 groups increased over time. Topp... | PMC9996416 | ||
Motor Skills | Similar to the communication trend graphs, the fluctuations in gross and fine motor skills indicated by the ASQ scores can be attributed to the differences in normative scores. Overall, the motor skills of the intervention group infants developed to a greater extent than those of the control group infants. This might h... | PMC9996416 | ||
Cognition | Results from the problem solving domain of the ASQ revealed that the control group infants generally fared better than the intervention group infants during the first 6 months of their lives. However, the results of the 12-month Bayley-4 assessment revealed that the intervention group infants did better on the cognitio... | PMC9996416 | ||
Social-Emotional Skills | Although there were no statistically significant group differences in the personal-social domain of the ASQ and social-emotional scale of the Bayley-4 assessment, the intervention group generally demonstrated greater social-emotional development. This lack of significance could be attributed to the fact that SPA did no... | PMC9996416 | ||
Behavioral Outcomes | The infants from the intervention group were found to engage in more ADBEs than those from the control group. On the basis of the parents’ responses to the BITSEA, the control group infants exhibited more problem behaviors as well. Maternal responsivity and sensitivity to infant distress are important factors in predic... | PMC9996416 | ||
Prenatal Courses, Education, and Household Income | This study found that prenatal classes had a positive impact on communication, gross motor, and personal-social scores at 2 months post partum. Prior research [The infants from families with higher household incomes were found to have more developed cognition. This is supported by previous literature, where it was foun... | PMC9996416 | ||
Strengths and Limitations | VIRUS | Given that social support has been proven to improve parental well-being and, in turn, promote infant growth in various areas, the SPA intervention was developed. The intervention aimed to meet the support needs of Singaporean parents during the perinatal period, thus helping them adjust to parenting roles and infant-c... | PMC9996416 | |
Conclusions | This study examined the effects of the SPA intervention on infant developmental outcomes. The results showed that the infants from the intervention group generally developed better in terms of communication, motor skills, cognition, and social-emotional skills than those from the control group. The peer support and inf... | PMC9996416 | ||
Abbreviations | adaptive behaviorAges and Stages QuestionnaireBrief Infant Toddler Social Emotional Assessmentmobile healthrandomized controlled trialrisk ratiosocioeconomic statusSupportive Parenting App | PMC9996416 | ||
Purpose | FEP, First-episode psychosis | First-episode psychosis (FEP) is characterised by wide heterogeneity in terms of symptom presentation and illness course. However, the heterogeneity of quality of life (QoL) in FEP is not well understood. We investigated whether subgroups can be identified using participants' responses on four QoL domains (physical hea... | PMC9992035 | |
Method | REGRESSIONS | Demographic and clinical characteristics, QoL, cognition, and functioning were assessed in 100 people with FEP at the 18-month follow-up of a randomised controlled trial of Individual Placement Support, which aims to facilitate vocational recovery. QoL was measured using the World Health Organisation’s QoL-BRIEF. A two... | PMC9992035 | |
Results | social/occupational functioning, depressive symptoms | SENSITIVITY | Three QoL subgroups emerged: a ‘good’ subgroup with relatively high QoL across all domains (31%), an ‘intermediate’ subgroup with relatively low psychological QoL (48%) and a ‘poor’ subgroup with markedly low social relationship QoL (21%). Negative symptoms, depressive symptoms, social/occupational functioning, and soc... | PMC9992035 |
Conclusion | mental ill | Although some individuals with FEP have QoL comparable to individuals without mental ill health, QoL can remain concerningly low despite treatment efforts. Future research on interventions that target factors associated with poor QoL, such as low social inclusion, is required to counteract prolonged poor QoL in FEP. | PMC9992035 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s11136-022-03277-x. | PMC9992035 | ||
Keywords | Open Access funding enabled and organized by CAUL and its Member Institutions | PMC9992035 | ||
Plain English summary | first-episode psychosis, depressive symptoms | Quality of life has emerged as a valuable outcome in first-episode psychosis (FEP) research. Young people with FEP also consider good quality of life to be more important than symptom management. Until recently, previous research into FEP has sought to identify which clinical, cognitive, and functioning factors are ass... | PMC9992035 | |
Introduction | psychotic symptoms, first-episode psychosis, mental ill | REMISSION | Compared to individuals without mental ill health, individuals with first-episode psychosis (FEP) report significantly lower levels of quality of life (QoL) [Understanding variability in QoL in FEP has important clinical implications. For instance, the disparity in QoL between individuals with FEP and the general popul... | PMC9992035 |
Materials and methods | PMC9992035 | |||
Design | IPS | SECONDARY | The current study involved a secondary analysis of baseline and 18-month follow-up data of a single-blinded RCT (Australian and Clinical Trials Registry ACTRN12608000094370), which aimed to investigate the efficacy of Individual Placement and Supporting (IPS) in assisting young people with FEP to achieve vocational rec... | PMC9992035 |
Participants | Psychosis | DISORDERS, RECRUITMENT | Young people with FEP who had expressed an interest in vocational recovery were approached to participate in the original RCT. Participant recruitment took place at the Early Psychosis Prevention and Intervention Centre (EPPIC), a clinic within the Orygen Specialist Programme in Melbourne, Australia, providing time-lim... | PMC9992035 |
Measures | PMC9992035 | |||
QoL | QoL was measured using the WHOQoL-BREF [ | PMC9992035 | ||
Demographics | The demographic characteristics assessed at baseline covered variables such as age, gender, and use of health services. | PMC9992035 | ||
Clinical characteristics | psychotic symptoms, DUP, psychosis | DUP | Duration of untreated psychosis (DUP) was defined as the time between onset of psychotic symptoms and registration at EPPIC [ | PMC9992035 |
Cognition | Based on their association with QoL in FEP [ | PMC9992035 | ||
Functioning | Social and occupational functioning was measured at follow-up using the single-item Social and Occupational Functioning Assessment Scale [ | PMC9992035 | ||
Statistical analysis | depression | REGRESSION, DUP, REGRESSIONS | All analyses were completed using RStudio (Version 1.4.1717) and were chosen to mirror the methods of Liao et al. [The external validity of the QoL subgroups was evaluated using multinominal logistic regressions. A range of clinical, cognitive, and functional variables both at the baseline and follow-up were included i... | PMC9992035 |
Sensitivity analysis | depression | APPENDIX, REGRESSIONS | Due to the high overlap between the psychological domain of the WHOQoL-BREF and depression symptoms (Appendix 1), sensitivity analyses were conducted with the psychological domain of the WHOQoL-BREF excluded from the k-means clustering analysis. Further external validation based on the clustering results not considerin... | PMC9992035 |
Results | PMC9992035 | |||
Sensitivity analysis | APPENDIX | The sensitivity analysis excluding the psychological domain showed very similar results. A k-means partitioning method also suggested a 3-cluster solution to be optimal and three clusters had distinct QoL characteristics (Appendix 10), namely a ‘poor’ cluster ( | PMC9992035 | |
Discussion | The current study aimed to extend the findings of Liao et al. [ | PMC9992035 | ||
The heterogeneity of QoL in FEP | personality disorder, substance disorder, comorbid major depressive disorder | The finding of a ‘good’ QoL subgroup, with average QoL scores that mirror scores reported by healthy controls, contradicts the common finding that the QoL of FEP patients is significantly diminished and highlights the importance of approaching QoL in an individualistic manner [The ‘intermediate’ subgroup mirrors averag... | PMC9992035 | |
Factors associated with QoL in FEP | depressive, cognitive functioning, depressive symptoms | Consistent with previous research on QoL in FEP recovery [Although depressive symptoms emerged as the strongest predictor of the QoL subgroups, the relationship between depressive symptoms and QoL subgroups may be inflated due to measurement overlap [No cognitive measures were associated with the QoL subgroups at follo... | PMC9992035 | |
Strengths and limitations | The current study highlights the use of cluster analysis as an innovative approach to capturing heterogeneity in QoL in an FEP cohort. However, this study is limited by the aims and measures used in the original study, which did not specifically focus on QoL and its correlates [As a follow-up analysis, our study also a... | PMC9992035 | ||
Implications and future directions | We have demonstrated that heterogeneity of QoL in FEP exists at a later stage of FEP recovery. The results highlight that although individuals with FEP may exhibit good QoL, many report lower levels across all four QoL domains, despite months of treatment-as-usual. Currently, the central goal of FEP treatment is to enc... | PMC9992035 | ||
Author contributions | EK, KA, and SC were involved in the design and data collection of the original study from which the current study is based on. KA, SC, EC, CG, and ZL contributed to the design of the current study. EC was responsible for data analysis and drafting of the manuscript. All authors revised and provided critical feedback fo... | PMC9992035 | ||
Funding | Open Access funding enabled and organized by CAUL and its Member Institutions. This work was supported by Australian Rotary Health; the Australian Research Council (LP0883273); Orygen, The National Centre of Excellence in Youth Mental Health; National Health and Medical Research Council Career Development Fellowships t... | PMC9992035 | ||
Data availability | Data might be available on request and after appropriate institutional agreements and ethics approvals. | PMC9992035 | ||
Declarations | PMC9992035 | |||
Conflict of interest | None to declare. | PMC9992035 | ||
Ethical approval | Institutional ethics approval was given by Melbourne Health Human Research and Ethics Committee. All young people (and their guardians if under 18 years of age) provided written informed consent to participate in the study. | PMC9992035 | ||
References | PMC9992035 | |||
Method | MIH | A randomized controlled study design was used in the present study. The study was registered at clinicaltrials.gov with the identification number NCT03829995. Participants were randomized 1:4 (50:200) into a control- and intervention group. Participants in the control group were offered standard care and those in the i... | PMC10602279 | |
Results | MIH | A total of 250 participants were included in the study and 152 participated in the telephone interviews (33 control and 119 intervention). Thirty-seven questions were enquired by 26 participants to the MIH. Of these, 8 were requested before the telephone interviews and these patients all expressed a high satisfaction w... | PMC10602279 | |
Conclusion | MIH | The MIH was appreciated by the participants, indicating that the MIH could be a valuable service for discharged patients in improving the sense of safety in relation to medication and alleviating MRPs. Providing easy access for patients to medicine information may contribute to patient safe medicine use after discharge... | PMC10602279 | |
Data Availability | All relevant data are within the paper and its | PMC10602279 | ||
Introduction | MIH | ADVERSE EVENTS, TRANSITION | Healthcare systems are becoming more and more complex, and patients must navigate between hospitals and the primary sector. Transition from hospitals to private homes is known to challenge patient safety [Importantly, it has been shown that patient education and counseling can reduce the risk of medicine related advers... | PMC10602279 |
Method | PMC10602279 | |||
Setting | MIH | EMERGENCY | The MIH was operated by experienced pharmacists and a pharmacy technician from the Medicine Information Centre (MIC) at the Hospital Pharmacy at Bispebjerg Hospital in the Capital Region of Denmark. Staff was trained in clinical pharmacy and drug information activities. The MIH team consists of 12 medicine information ... | PMC10602279 |
Enrollment of participants | terminally illness, aphasia, dementia | MAY | A total of 250 patients were enrolled in the study from July 2018 to May 2019. The patients were enrolled from the two selected hospital wards by the first three authors from the MIC. All admitted patients at the two wards were assessed and eligible participants were subsequently approached for enrollment. Eligible par... | PMC10602279 |
Study design | MIH | ADVERSE EFFECTS, DRUG INTERACTIONS | A randomized controlled study design was used to explore the study objective [The control group (50 participants) received no intervention beyond standard care which does not include access to any information services post discharge. The intervention group (200 participants) were offered standard care and the opportuni... | PMC10602279 |
Telephone interviews | MIH | A primary outcome of the present study was to evaluate whether the offer to contact the MIH influenced patient’s concerns and perception of safety in relation to their medicines (An interview guide was developed to assess patient satisfaction with the medicine information obtained during hospitalization, at discharge a... | PMC10602279 | |
Clinical impact assessment | Another primary outcome of the present study was the clinical impact of MIH on patient safety. To assess the clinical impact, all enquiries were analyzed and categorized for MRPs and pharmacy interventions according to the Westerlund System; see | PMC10602279 | ||
Clinical impact assessment of MRPs and the pharmacy intervention. | PMC10602279 | |||
Data analysis | No similar studies are available from which a sample size can be calculated.This study used a randomized controlled study design, and it was set to detect a 10% improvement on a 5-point scale measuring patient satisfaction with medicine information and patient concerns about medicine. From the literature, a mean score ... | PMC10602279 | ||
Results | PMC10602279 | |||
Participants | A total of 946 patients were assessed for eligibility at the two hospital wards. Of these, 319 patients failed to meet the inclusion criteria and 377 patients either declined the invitation to participate, were asleep, discharged or transferred to another ward at the time of inclusion.Thus, 250 participants were includ... | PMC10602279 | ||
Consort study diagram showing the flow of invited, included, excluded and dropout patients. | EMERGENCY | The participants were included equally from the Emergency Department and from the Department of Respiratory Medicine, and their characteristics are presented in | PMC10602279 | |
Medicine information during hospitalization and after discharge | A total of 152 participants were interviewed by telephone and the interview guide in In the control group 55% of the participants (18/33) reported a change in their medication during hospitalization, see | PMC10602279 | ||
Patient satisfaction with medicine information provided during hospitalization and after discharge. | Patients scored satisfaction with medicine information provided during hospitalization and at discharge on a 5-point scale where score 1 = not at all and score 5 = to a very great extent. Results are shown as mean of rating ± SD. No significant difference was found between the control- and intervention group with regar... | PMC10602279 | ||
Patient satisfaction with MIH | MIH | One of the primary outcomes was patient satisfaction with MIH. Participants in the intervention group were asked if the opportunity to contact the MIH affected the feeling of safety in relation to their medication, which the majority of the participants acknowledged (72%, 79/110, CI [0.67–0.84[). Patients who contacted... | PMC10602279 | |
Concerns and perception of safety in relation to medication | The other primary outcome focused on patients’ concerns and perception of safety in relation to their medication. Both the control- and the intervention group responded that they felt safe to a great extent regarding their medication after discharge, which equals to a rating 4 or more on a 5-point Likert scale. There w... | PMC10602279 | ||
Concerns and perception of safety about medicine. | Patients scored on a 5-point scale with 1 = not at all and 5 = to a very great extent. Results are shown as mean of rating ± SD. No significant difference was found between control- and intervention group for any of the questions (Mann-Whitney U test, p>0.05 for all questions). | PMC10602279 | ||
Enquiries to the MIH service | MIH | During the study period, the participants from the intervention group were offered the possibility to contact the MIH if they had any questions regarding their medication after discharge.In all, 26 participants raised a total of 37 enquiries to the MIH pre-, post- or during the telephone interviews ( | PMC10602279 | |
Categorization of enquiries to MIH from July 2018 through May 2019 (n = 37). | MIH | MIH: Medicines Information Helpline. “Other” include enquiries about patients’ control/treatment at the hospital and the need to speak with either a hospital- or general physician. | PMC10602279 | |
Clinical impact of MIH on patient safety | MRPs and the clinical impact of the helpline responses were assessed by two clinical pharmacists working at the MIC. All enquiries were included in the assessment regardless of when the patient asked the question relatively to the telephone interview, i.e., pre-, post- or during the telephone interviews. From the 37 en... | PMC10602279 | ||
Categorization of MRPs related to the enquiry according to the Westerlund system [ | MIH | The 43 MRPs extracted from the 37 enquiries to the MIH. Other MRPs included enquiries about vitamins and the need to speak with either a hospital- or general physician.The pharmacy interventions for each MRP were also identified using the Westerlund system. One MRP may trigger several pharmaceutical interventions, and ... | PMC10602279 |
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