Clinical trials

Sharing Tales That Teach is a randomised study of a shared picturebook reading programme for 4- to 5-year-old children and their primary caregivers. The study will test whether a caregiver-delivered, emotion-focused shared reading programme leads to greater improvements in children's emotion regulation than a standard dialogic shared reading programme. Emotion regulation refers to children's developing ability to understand, express and manage emotions in ways that support learning, relationships and wellbeing. These skills are closely linked with executive function, including children's ability to remember instructions, control impulses and shift flexibly between activities. Shared picturebook reading may provide a natural, low-cost way for caregivers to support these skills through everyday interaction. Families in the randomised part of the study will be allocated to one of two 8-week shared reading programmes. In the emotion-focused group, caregivers will receive training in strategies such as naming emotions, discussing why characters feel as they do, talking about consequences of emotions and modelling ways to manage feelings. In the comparison group, caregivers will receive training in standard dialogic picturebook reading strategies, such as naming, describing, sequencing and asking open questions, without an explicit focus on emotions or emotion regulation. Both groups will use the same picturebooks and will be asked to complete three shared reading sessions per week at home. The main hypothesis is that children in the emotion-focused shared reading group will show greater improvement in emotion regulation from baseline to 12-month follow-up than children in the standard dialogic shared reading group. The study will also examine whether the programme affects children's executive function, caregiver wellbeing and caregiver emotion regulation. Additional exploratory analyses will examine caregiver-child interaction processes and whether caregiver or child characteristics are associated with different intervention effects. The study will recruit caregiver-child dyads through state primary schools in Greater London. Children will complete age-appropriate tasks and caregivers will complete questionnaires at baseline and follow-up. A laboratory subsample may also complete additional behavioural, observational and neurophysiological assessments. The study is low risk, non-invasive and does not involve medical treatment.

* Aim: to analyse the effects of microcurrent treatment alone, and combined with a resistance exercise programme, on muscle strength, body composition and physical functional capacity in middle-aged adults. * Methods * Randomised, balanced, double-blind parallel-group between-participants design. * Participants - non-regularly trained adults (people who do not engage regularly in physical sessions), aged 40 to 65 years old. * All participants will be invited to take part in a 6-week supervised resistance training programme that will be combined with microcurrent (MC) or sham (SH) intervention. The participants who do not accept to undergo the resistance training programme will integrate a non-exercise group involving a 6-week intervention period using the microcurrent (MC) or the sham (SH) device. The devices will be provided by Arc4Health (ARC Microtech Ltd, UK; https://arcmicrotech.com/arc4health/). The device Arc4Health has regulatory approval as a Class IIa medical device in the areas of pain management and tissue repair. The following will be analysed: 1. Microcurrent alone (MC) 2. Microcurrent with exercise (MC + RT) 3. Sham alone (SH) 4. Sham with exercise (SH + RT) * The participants who agree to take part in the training programme will have 2 sessions a week for a period of 6 weeks. The training programme involves elastic bands and is designed to increase strength and muscle mass. * Measurements of body composition (via plethysmography BodPod), strength, functional capacity, muscular structure (via non-invasive ultrasound), and immunological blood markers will be undertaken at baseline and after the 6-week intervention period.