Conectar
Communication is a professional competence that all paediatric healthcare professionals must learn and maintain to provide age and developmentally appropriate care. Child-centred communication encourages direct communication with children and adolescents, incorporating the use of play as a communicative strategy. Still, many paediatric healthcare professionals receive little or no formal training in communication and play. A critical barrier to communication training is the limited possibilities for healthcare professionals to take time from their clinical duties. Moreover, few randomised controlled trials have evaluated educational programmes on communication and play for paediatric healthcare professionals, and existing programmes vary significantly in design and duration. This study aims to compare the effects of a 45-min and a 3-hour educational intervention for healthcare professionals on age-appropriate communication and the use of play in clinical paediatric practice.
We will describe a single-centre, randomised, controlled, two-arm, non-inferiority trial. We will recruit 150 healthcare professionals with different professional backgrounds who will be randomised to one of two arms: a 45-min or 3-hour educational intervention on communication and play in paediatric clinical practice. The primary outcome will be their self-efficacy in patient-centredness at 12-week post-intervention, while secondary outcomes will be self-efficacy immediately after the intervention, motivation to engage in the educational activity, cognitive load, self-evaluated knowledge, satisfaction and the impact on individual practice and training needs. Data will be collected through questionnaires at baseline, immediately after the intervention, and 12 weeks post-intervention and will be analysed using linear mixed models with random effects to account for clustering and within-subject correlation.
The Danish Data Protection Agency approved the study (P-2020–1144), which will be conducted in accordance with the Declaration of Helsinki. Findings will be published in a peer-reviewed open-access scientific journal and presented at international conferences.
NCT06859632 (ClinicalTrials.gov).
The evidence for the optimal duration of psychotherapy for borderline personality disorder (BPD) is scarce. Two previous trials have compared different durations of psychotherapy. The first compared 6 months versus 12 months of dialectical behaviour therapy for BPD (the FASTER trial). The second compared 5 months versus 14 months of mentalisation-based therapy for BPD (the MBT-RCT trial). The primary objective of the present study will be to provide an individual patient data pooled analysis of two randomised clinical trials by combining the two short-term groups and the two long-term groups from the FASTER and MBT-RCT trials, thereby providing greater statistical power than the individual trials. Accordingly, we will evaluate the overall evidence on the effects of short-term versus long-term psychotherapy for BPD and investigate whether certain subgroups might benefit from short-term versus long-term psychotherapy.
An individual patient data pooled analysis of the FASTER trial and the MBT-RCT trial will be conducted. The primary outcome will be a composite of the proportion of participants with a suicide, a suicide attempt or a psychiatric hospitalisation. The secondary outcome will be the proportion of participants with self-harm. Exploratory outcomes will be BPD symptoms, symptom distress, level of functioning and quality of life. We will primarily assess outcomes at 15 months after randomisation for the FASTER trial and at 16 months after randomisation for the MBT-RCT trial. Predefined subgroups based on the design variables in the original trials will be tested for interaction with the intervention as follows: trial, sex (male compared with female), age (below or at 30 years compared with above 30 years) and baseline level of functioning (Global Assessment of Functioning baseline score at 0–49 compared with 50–100).
The statistical analyses will be performed on anonymised trial data that have already been approved by the respective ethical committees that originally assessed the included trials. The final analysis will be published in a peer-reviewed scientific journal and the results will be presented at national seminars and international conferences.
CRD42024612840.
by Grant L. Austin, Feng Wang, Steven Q. Le, Alexander Sorensen, Shan Li, Lai C. Foong, Srikanth Singamsetty, Jill Wood, Tsui-Fen Chou, Patricia I. Dickson
Mucopolysaccharidosis type IIID (MPS IIID; Sanfilippo D) is caused by biallelic pathogenic variants in N-acetylglucosamine-6-sulfatase (GNS), which participates in catabolism of heparan sulfate (HS) glycosaminoglycans. Characterization of MPS IIID disease at a cellular level has not been robustly achieved. We used unbiased quantitative proteomics to establish a cellular phenotype for MPS IIID mice. Recombinant human GNS (rhGNS), a variant of which previously demonstrated single dose efficacy in MPS IIID human fibroblasts and in MPS IIID neonatal mice, was used to establish a repeat dosing schedule to treat MPS IIID mice. Adult Gns KO mice or heterozygous carriers were treated via intracerebroventricular (ICV) injections and received 3, 30, or 200 μg rhGNS in 4 doses over 2 weeks or vehicle. Twenty-four hours after the final dose, HS in brain and CSF showed dose-dependent reductions, reaching carrier levels in the higher dose groups. Furthermore, the proteomic perturbations that we described were corrected by rhGNS treatment. Next, Gns KO or carrier adult mice were treated via ICV and received 3, 30 or 200 μg rhGNS or vehicle once every two weeks (Day 1, 15, 29, 43, 57, 71, 85) and were euthanized on day 91. Following treatment, total HS and MPS IIID-specific HS (GlcNAc6S) showed dose-dependent reductions in brain and CSF and markers of neuroinflammation were substantially reduced. ICV enzyme replacement therapy with rhGNS restores CNS pathology of adult MPS IIID mice even with treatment at 14-day intervals, demonstrating preclinical efficacy for MPS IIID.Over half of children and adolescents with attention-deficit/hyperactivity disorder (ADHD) have difficulties with emotion dysregulation (EDR) and/or sleep, yet the interrelations between emotional regulation and sleep are not well-characterised in this population. This systematic review will address the relationship between these difficulties and investigate whether specific aspects of EDR are more strongly related to sleep problems in youth with ADHD.
We will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-analysis guideline for systematic reviews. A wide set of electronic databases will be searched for peer-reviewed quantitative studies investigating the relationship between EDR and sleep in children and adolescents (ages 5 to 18 years) with ADHD. In addition, the reference list of all studies will be searched for other relevant studies, and Scopus will be used to search for citations of the included studies. We will also contact experts in the field to request published and unpublished studies. The primary outcome will be the effect size of the relationship between EDR and sleep in children and adolescents with ADHD. We will look at EDR and sleep broadly and also consider the multifaceted nature of both terms. Secondary outcomes will include which facets of EDR and sleep have been measured and how they have been measured, developmental differences between children and adolescents with ADHD and how—and the extent to which—studies controlled for the use of CNS medications and cooccurring disorders in their study design and/or statistical analyses. The quality and risk of bias of the included studies will be assessed using the Mixed Methods Appraisal Tool.
This protocol is for a review of studies and does not involve any new data collection and therefore does not need ethical or human subjects approval. The results will be presented at international conferences and in a peer-reviewed journal.
CRD42024612984.
Insomnia is prevalent in psychiatric populations and may contribute to maintain and exacerbate psychiatric symptoms. Cognitive behavioural therapy for insomnia (CBTi) is the treatment of choice also for insomnia comorbid to psychiatric illness. However, patients are rarely offered CBTi in psychiatric outpatient clinics. The aim of this randomised controlled trial is to investigate whether CBTi delivered in groups in a psychiatric outpatient clinic is superior to treatment as usual (TAU).
In the Sleep in Psychiatric Care trial, 60 patients with moderate to severe psychiatric illness who meet the criteria for insomnia disorder will be recruited from an outpatient psychiatric clinic in Norway. The patients will be randomised (1:1) either to group-based CBTi (Sleep School Wake Up for Insomnia; SSWU-I) or to a wait list (WL) while they are all receiving TAU for their psychiatric disorder. SSWU-I will comprise five bi-weekly sessions, each lasting 120 min, hence the treatment period is 8 weeks. Assessment will be conducted at baseline (T1) and after 8 weeks (T2). The primary outcome will be self-rated insomnia symptoms using the Insomnia Severity Index and the Bergen Insomnia Scale. Secondary outcomes include measures of symptoms of dysfunctional beliefs and attitudes about sleep, depression, anxiety, fatigue, problems with work and social adjustment and well-being. Mixed model analyses will be conducted to test the hypotheses.
Ethical approval has been granted by the Regional Committee for Medical and Health Research Ethics, in Western Norway (REK 2020/66304). Findings will be published in peer-reviewed journals and presented at research conferences and in relevant media. The results may document the need for specific sleep-directed treatments in psychiatric clinics as a way of treating insomnia disorder as well as to alleviate psychiatric symptoms.
Circadian rhythm sleep–wake disturbances appear to be prevalent in psychiatric populations and may maintain and exacerbate psychiatric symptoms. Bright light therapy (BLT) is, in addition to exogenous melatonin, the treatment of choice for circadian rhythm disorders like delayed sleep–wake phase disorder (DSWPD) and has yielded promising results in patients with comorbid psychiatric illness. However, such patients are rarely offered this treatment in outpatient clinics. The aim of this randomised controlled trial is to investigate whether group BLT for psychiatric outpatients is superior to treatment as usual (TAU).
60 patients with moderate-to-severe psychiatric illness who meet the criteria for DSWPD will be recruited from an outpatient psychiatric clinic in Norway. They will be randomised (1:1) to a group-based Sleep School Wake Up! For Circadian (SSWU-C) programme conjointly with TAU or to TAU while on a wait list for SSWU-C. The SSWU-C will be delivered over four biweekly sessions, each lasting 120 min; hence treatment will last 6 weeks. Assessments will be collected at baseline (T1) and after the intervention (T2). The primary outcome will be changes in sleep timing using measures such as sleep diaries, actigraphy and dim light melatonin onset (DLMO) at 6 weeks postintervention. Secondary outcomes include changes in other sleep metrics, symptoms of depression, anxiety, fatigue, problems with work and social adjustment and well-being. Mixed models will be used for data analyses.
Ethical approval was granted in 2020 by the Regional Ethics Committee in Western Norway (REK 2020/66304). Findings will be published in peer-reviewed journals and be presented at research conferences and in relevant media. The results may document the need for more specific sleep-directed treatments in psychiatric clinics as a way of treating not only circadian rhythm sleep–wake disorders but also as a treatment to alleviate psychiatric symptoms.
FreshRSS 