Parental psychological challenges and poor well-being are key factors in shaping both the quality of parent-child interactions and child development. Specifically, maternal psychological distress is a central determinant of child development. Elevated levels of distress in mothers are associated with poorer child cognitive, behavioural and social-emotional outcomes, with effects persisting into adolescence and adulthood. While this highlights the critical importance of early prevention and intervention efforts to support parents, postpartum mental healthcare remains limited, despite ongoing and evident needs.

This protocol outlines a 2-year longitudinal follow-up study investigating the impact of a secondary perinatal programme (ie, Toi, Moi, Bébé), completed by mothers during pregnancy, and its impact on children’s cognitive and social-emotional functioning at 24 and 48 months. Further, the study aims to explore whether maternal self-efficacy and emotion regulation may serve as potential mediators or moderators of the relationship between programme participation and child development outcomes. The research aims to leverage the Toi, Moi, Bébé programme, by recruiting mother-child dyads (n=250) in which the mothers participated in the programme during pregnancy. Mothers were randomly assigned to complete the parenting well-being intervention either independently or with added telephone support. Participants who consent will be invited to take part in a two-wave follow-up at 24 months (T1) and 48 months postpartum (T2). At both time points, mothers will complete demographic questionnaires and standardised measures assessing maternal well-being (Generalised Anxiety Disorder-7, Edinburgh Postnatal Depression Scale and Perceived Stress Scale), child cognitive functioning (Ages and Stages Questionnaire-3 and MacArthur-Bates Communicative Development Inventory), child social-emotional functioning (Ages and Stages Questionnaire, Social Emotional—second Edition-2 and Child Behaviour Checklist for Ages 1.5–5), maternal emotion regulation (Cognitive Emotion Regulation Questionnaire) and maternal self-efficacy (Parental Cognitions and Conduct Towards the Infant Scale & Me as a Parent Scale). Parents’ perceptions of their parenting experience will be measured using the Parental Reflective Functioning Questionnaire. Mother-child interaction, parenting quality and cognitive stimulation in the home environment will be measured using a brief virtual interview (StimQ₂-Toddler) and a naturalistic observation assessment (Parenting Interactions with Children: Checklist of Observations Linked to Outcomes). Using RStudio, linear mixed models will be used to assess the impact of the intervention (online intervention only vs only with telephone support) on child cognitive and social-emotional development at T1 and T2. In parallel, separate models will be conducted to examine associations between maternal emotion regulation and self-efficacy on the child development outcomes at the same timepoints. Exploratory analyses will be conducted to examine potential moderating effects of child sex and group assignment on the associations between maternal emotion regulation and self-efficacy and child developmental (cognitive and socioemotional) outcomes, using causal inference models.

The current study has been registered, reviewed and approved (MP-37-2025-10894) by the Research Institute of the McGill University Health Centre Research Ethics Board. Findings from this research will be disseminated through peer-reviewed open access publications, and presentations at national and international conferences.

NCT05110456.

Adenotonsillectomy is the primary treatment for type 1 obstructive sleep apnoea (OSA1). Although polysomnography (PSG) remains the gold standard for measuring Apnoea-Hypopnoea Index, it is a labour-intensive procedure and does not correlate with improvements in quality of life postadenotonsillectomy. Mouth breathing is associated with poorer quality of life in children. Mandibular movement (MM), which measures mouth opening, is a validated measure of respiratory effort that can be easily and safely assessed in children using the JAWAC technology. This study aims to evaluate the relationship between changes in quality of life and changes in mouth opening in children with OSA1 after undergoing adenotonsillectomy. Secondary objectives include evaluating changes in quality of life, clinical symptoms and other MM and PSG metrics in the same population.

This exploratory, non-randomised, monocentric, prospective cohort study with a non-blinded single arm will include 50 children aged 3–7 years, undergoing adenotonsillectomy at the Clinique Saint Jean, Montpellier, France. Quality of life will be measured using the parent version of the Paediatric Quality of Life Inventory and MM metrics will be measured during PSG using the JAWAC system during the inclusion visit and 3 months after adenotonsillectomy. The primary outcome will be the correlation between the changes in quality of life and mouth opening (1/10 mm) postadenotonsillectomy. Secondary analyses will evaluate changes in clinical symptoms, PSG measures and other MM metrics including respiratory effort, as well as the associations between these measures.

This study was approved by an independent ethics committee (Comité de Protection des Personnes Est) on 24 March 2025 (2024-A02761-46) and will be conducted in accordance with French law, good clinical practice and the guidelines of the Declaration of Helsinki. Study findings will be disseminated through international peer-reviewed journal articles as well as public, academic presentations at national and international conferences.

NCT06973928.

Taking multiple medicines can be appropriate but has the potential to be problematic. The Implementing Stimulating Innovation in the Management of Polypharmacy and Adherence THrough the Years (iSIMPATHY) project used the 7-Steps person-centred approach for medication reviews, supporting patients and clinicians to define and achieve realistic goals for drug treatment, and helping enable patients to lead healthy and active lives.

To assess the impact of pharmacist-led comprehensive person-centred medication reviews using the 7-Steps methodology.

iSIMPATHY sought to transform the approach to optimisation of medicinces through the delivery of person-centred medication reviews for people taking multiple medicines in primary care, hospital and outpatient clinics. The reviews were conducted by embedding a single approach for polypharmacy management, building on key recommendations from SIMPATHY.

Interventions made were graded, with 82% being classified as clinically significant and 4% potentially preventing major organ failure, adverse drug reactions or incidents of similar clinical importance. The average number of medications reduced from 12 to 11, with 92% of the reviews resulting in more appropriate medication use, thereby decreasing the likelihood of medication-related harm. Inappropriate medicines were stopped, reduced or altered to improve appropriateness. There were significant healthcare resource utilisation benefits as indicated by a positive return on investment for both medication and healthcare costs with a quality-adjusted life year gain of 7.4 per 100 patients.

Pharmacist-led, person-centred medication review using the 7-Steps approach was delivered across jurisdictions and healthcare settings, with positive impacts on the number and appropriateness of medicines, clinical interventions and cost savings outweighing expenditure on the service. The approach is scalable by means of the tools and resources developed over the duration of the project.

Patients with acute psychiatric symptoms are often referred to the emergency department (ED) for medical evaluation to exclude medical causes before psychiatric admission. The absence of a prospectively validated medical screening tool leads to wide practice variation. This study aims to develop a new, evidence-based and consensus-based medical screening tool through a collaborative, interdisciplinary, international Delphi approach.

This modified Delphi study will include representatives from emergency medicine and psychiatry societies across four continents, as well as patient representatives with prior experience of medical screening in the ED. A minimum sample size of 24 participants is planned to account for potential dropouts. The Delphi procedure consists of four rounds. Round 1 will present current evidence and identify key items for the new medical screening tool. Round 2 will evaluate and refine statements from Round 1. Round 3 will seek consensus on the variables to be included in a medical screening tool. In Round 4, hypothetical clinical vignettes will be used to assess the agreement on the recommendations of the newly developed medical screening tool in order to test for content and construct validity. Surveys will be conducted via Research Electronic Data Capture (REDCap), with participants rating statements on a 6-point Likert scale. Response stability will be evaluated using the intraclass correlation coefficient, and consensus defined as ≥80% agreement. Results will be reported according to the ACcurate COnsensus Reporting Document guidelines and the Guidance for Reporting Involvement of Patients and the Public 2 short form.

The Ethics Committee of Northwestern and Central Switzerland exempted the project from committee approval under the Human Research Act on 11 September 2024. Written consent will be obtained from all participants. Results of this study will be summarised as a medical screening tool which will be validated in a prospective, multicentre study in a second step.

NCT06936826.