scholarly journals Evaluating Palin Stammering Therapy for School Children (Palin STSC 8-14): Protocol for a Feasibility Randomised Control Trial Comparing Palin STSC(8-14) with Usual Treatment

2021 ◽  
Author(s):  
Sharon K Millard ◽  
Suzanne Murphy ◽  
Garry Barton ◽  
Maria Lethersich ◽  
Lorna Rixon ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Relations ◽  
School Children ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Randomised Control Trial ◽  
Treatment As Usual ◽  
Children And Parents ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Having a stammer can have a significant effect on a child’s social, emotional and educational development. With approximately 66,000 children in the UK having a stammer, there is a need to establish an adequate evidence base to inform clinical practise. We describe a feasibility trial to explore the effectiveness of a new therapy programme for children aged 8-14: Palin Stammering Therapy for School Children (Palin STSC(8-14)). Preliminary data from the Michael Palin Centre, where the programme was developed, indicate that Palin STSC(8-14) is effective in reducing stammering frequency and impact for children, with beneficial effects for parents too. We will investigate the feasibility of the methods required for a definitive randomised control trial to investigate the application of this therapy by NHS speech and language therapists (SLTs), compared with ‘treatment as usual’ (TAU), beyond the specialist context in which it was developed.Methods: This is a two-arm feasibility cluster-randomised controlled trial of Palin STSC(8-14) with TAU control arm, and randomisation at the level of the SLT. Quantitative and qualitative data will be collected to examine: the recruitment and retention of therapists and families; the acceptability of the research processes and the therapeutic intervention; the appropriateness of the therapy outcome measures. Assessments will be completed by children and parents at baseline and six months later, including measures of: stammering severity; the impact of child’s stammering on both children and parents; child temperament, behaviour, peer relations, anxiety; quality of life; and, economic outcomes. There will also be a qualitative process evaluation, including interviews with parents, children, SLTs and SLT managers to explore the acceptability of both the research and therapy methods. Treatment fidelity will be examined through analysis of therapy session records and recordings. Discussion: The findings of this feasibility trial will inform the decision as to whether to progress to a full-scale randomised controlled trial to explore the effectiveness of Palin STSC(8-14) when compared to Treatment as Usual in NHS SLT services. There is a strong need for an evidence based intervention for school age children who stammer. Trial registration: ISRCTN. ISRCTN17058884. Registered 18th December 2019. https://www.isrctn.com/ISRCTN17058884

scholarly journals A randomised controlled trial of energetic activity for depression in young people (READY): a multi-site feasibility trial protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
N. Howlett ◽  
L. Bottoms ◽  
A. Chater ◽  
A. B. Clark ◽  
T. Clarke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Large Scale ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Exercise Session ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Prevalence of depression is increasing in young people, and there is a need to develop and evaluate behavioural interventions which may provide benefits equal to or greater than talking therapies or pharmacological alternatives. Exercise could be beneficial for young people living with depression, but robust, large-scale trials of effectiveness and the impact of exercise intensity are lacking. This study aims to test whether a randomised controlled trial (RCT) of an intervention targeting young people living with depression is feasible by determining whether it is possible to recruit and retain young people, develop and deliver the intervention as planned, and evaluate training and delivery. Methods The design is a three-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be help-seeking young people, aged 13–17 years experiencing mild to moderate low mood or depression, referred from three counties in England. The intervention will be delivered by registered exercise professionals, supported by mental health support workers, twice a week for 12 weeks. The three arms will be high-intensity exercise, low-intensity exercise, and a social activity control. All arms will receive a ‘healthy living’ behaviour change session prior to each exercise session and the two exercise groups are energy matched. The outcomes are referral, recruitment, and retention rates; attendance at exercise sessions; adherence to and ability to reach intensity during exercise sessions; proportions of missing data; adverse events, all measured at baseline, 3, and 6 months; resource use; and reach and representativeness. Discussion UK National Health Service (NHS) policy is to provide young people with advice about using exercise to help depression but there is no evidence-based exercise intervention to either complement or as an alternative to medication or talking therapies. UK National Institute for Health and Care Excellence (NICE) guidelines suggest that exercise can be an effective treatment, but the evidence base is relatively weak. This feasibility trial will provide evidence about whether it is feasible to recruit and retain young people to a full RCT to assess the effectiveness and cost-effectiveness of an exercise intervention for depression. Trial registration ISRCTN, ISRCTN66452702. Registered 9 April 2020.

scholarly journals A randomised controlled trial of the Nextdoor Kind Challenge: a study protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Michelle H. Lim ◽  
Pamela Qualter ◽  
Alexandra Hennessey ◽  
Ben J. Smith ◽  
Taylah Argent ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Social Isolation ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Randomised Control Trial ◽  
Community Interventions ◽  
Health Crisis ◽  
Health And Wellbeing ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Community interventions are often promoted as a way of reducing loneliness and social isolation in our neighbourhoods. However, those community interventions are rarely examined within rigorous study designs. One strategy that holds the potential to reduce loneliness and can promote health and wellbeing is doing acts of kindness. The current study involves evaluating the impact of kindness acts on loneliness in community-dwelling individuals using an online social networking platform. Methods This study is made up of three randomised controlled trials conducted in three countries. Each randomised controlled trial has two arms (intervention vs waitlist control) and is designed to compare the effectiveness of the KIND challenge, which involves doing at least one act of kindness per week within a four-week period. This study will recruit users of an online community, be randomised online, and will be conducted using online assessments. We will first explore the effects of the intervention on the primary outcome of loneliness, followed by secondary outcomes, social isolation, neighbour relationship quality and contact, mental health symptoms, stress, quality of life, and positive affect. Further, we will assess the feasibility, acceptability, and safety of the KIND Challenge. Discussion This study, designed to evaluate the impact of kindness on the community, will be the first large scale randomised control trial conducted across three countries, Australia, UK, and USA. It will examine the potential of community-led interventions to reduce loneliness, improve social isolation, and promote neighbourhood cohesion, health, and wellbeing, which is especially crucial during the COVID-19 public health crisis. Trial registration Clinical Trials Registry. NCT04398472. Registered 21st May 2020.

scholarly journals Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041500
Author(s):  
Zoe Menczel Schrire ◽  
Craig L Phillips ◽  
Shantel L Duffy ◽  
Nathaniel S Marshall ◽  
Loren Mowszowski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Blood Pressure ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Controlled Study ◽  
Brain Oxidative Stress ◽  
Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

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