Healthy Parent Carers peer-led group-based health promotion intervention for parent carers of disabled children: protocol for a feasibility study using a parallel group randomised controlled trial design

Abstract Background Parent carers of disabled children are at increased risk of mental and physical health problems. They often experience challenges to maintaining good health which have implications for their well-being and their ability to care for their children. In response to these needs, researchers and parent carers developed the Healthy Parent Carers (HPC) programme. It is a peer-led, group-based intervention that promotes behaviours associated with health and well-being. The aims of this trial are to assess the acceptability of the HPC programme and the feasibility of its delivery in the community and to assess the feasibility and acceptability of the design of the definitive trial to evaluate the programme’s effectiveness and cost-effectiveness. Methods We will establish six research sites and train facilitators to deliver the manualised intervention. Parent carers of children with special educational needs and disabilities will be individually randomised, stratified by group delivery site, to either take part in a group programme and online resources (intervention) or to receive access to the online resources only (control). Measures of mental health; well-being; health-related quality of life; health behaviours; patient activation; protective factors such as resilience, social connections, and practical support; and use of health care, social care, and wider societal resources will be collected before randomisation (baseline), immediately post-intervention, and 6 months later. Recruitment of participants, adherence to the programme, and the dose received will be assessed. Group sessions will be audio-recorded to evaluate the fidelity of delivery and participant engagement. Participants’ and facilitators’ feedback on the programme content and delivery, their experience, and the acceptability of the outcome measures and trial design will be collected through feedback forms, interviews, and focus groups. Discussion This trial will assess whether the programme delivery and evaluative trial design are feasible, to inform whether to progress to a definitive randomised controlled trial to test the effectiveness and cost-effectiveness of the Healthy Parent Carers programme. Trial registration ISRCTN, ISRCTN151144652, registered on 25 October 2018; ClinicalTrials.gov, NCT03705221, registered on 15 October 2018.

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Protocol for an economic evaluation of the randomised controlled trial of culprit lesion only PCI versus immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: CULPRIT-SHOCK trial

BMJ Open ◽

10.1136/bmjopen-2016-014849 ◽

2017 ◽

Vol 7 (8) ◽

pp. e014849 ◽

Cited By ~ 1

Author(s):

Zahidul Quayyum ◽

Andrew Briggs ◽

Jose Robles-Zurita ◽

Keith Oldroyd ◽

Uwe Zeymer ◽

...

Keyword(s):

Economic Evaluation ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Cardiogenic Shock ◽

Controlled Trial ◽

Culprit Lesion ◽

Link Type ◽

Trial Analysis ◽

Life Years ◽

Randomised Controlled

IntroductionEmergency percutaneous coronary intervention (PCI) of the culprit lesion for patients with acute myocardial infarctions is an accepted practice. A majority of patients present with multivessel disease with additional relevant stenoses apart from the culprit lesion. In haemodynamically stable patients, there is increasing evidence from randomised trials to support the practice of immediate complete revascularisation. However, in the presence of cardiogenic shock, the optimal management strategy for additional non-culprit lesions is unknown. A multicentre randomised controlled trial, CULPRIT-SHOCK, is examining whether culprit vessel only PCI with potentially subsequent staged revascularisation is more effective than immediate multivessel PCI. This paper describes the intended economic evaluation of the trial.Methods and analysisThe economic evaluation will be conducted using a pre-trial decision model and within-trial analysis. The modelling-based analysis will provide expected costs and health outcomes, and incremental cost-effectiveness ratio over the lifetime for the cohort of patients included in the trial. The within-trial analysis will provide estimates of cost per life saved at 30 days and in 1 year, and estimates of health-related quality of life. Bootstrapping and cost-effectiveness acceptability curves will be used to address any uncertainty around these estimates. Different types of regression models within a generalised estimating equation framework will be used to examine how the total cost and quality-adjusted life years are explained by patients’ characteristics, revascularisation strategy, country and centre. The cost-effectiveness analysis will be from the perspective of each country’s national health services, where costs will be expressed in euros adjusted for purchasing power parity.Ethics and disseminationEthical approval for the study was granted by the local Ethics Committee at each recruiting centre. The economic evaluation analyses will be published in peer-reviewed journals of the concerned literature and communicated through the profiles of the authors atwww.twitter.comandwww.researchgate.net.Trial registration numberNCT01927549; Pre-results.

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School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE)

BMJ Open ◽

10.1136/bmjopen-2019-029044 ◽

2019 ◽

Vol 9 (8) ◽

pp. e029044 ◽

Cited By ~ 3

Author(s):

Daniel Hayes ◽

Anna Moore ◽

Emily Stapley ◽

Neil Humphrey ◽

Rosie Mansfield ◽

...

Keyword(s):

Mental Health ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Well Being ◽

Implementation Evaluation ◽

Cluster Randomised ◽

Parallel Group ◽

Randomised Controlled

IntroductionThe prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.MethodA three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3–6 months and 9–12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact.Ethics and disseminationThis trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences.Trial registration numberISRCTN17631228.ProtocolV1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).

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Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

Trials ◽

10.1186/s13063-019-3838-x ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Aisha Shafayat ◽

Emese Csipke ◽

Lucy Bradshaw ◽

Georgina Charlesworth ◽

Florence Day ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Usual Care ◽

Rating Scale ◽

Controlled Trial ◽

Randomised Trial ◽

Mild Dementia ◽

Link Type ◽

Feasibility Randomised Controlled Trial ◽

Randomised Controlled

Abstract Background Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management intervention designed to promote living well and enhance independence for people with mild dementia. This study aims to examine the feasibility of conducting a definitive randomised trial comparing the clinical and cost-effectiveness of the PRIDE intervention offered in addition to usual care or with usual care alone. Methods/design PRIDE is a parallel, two-arm, multicentre, feasibility, randomised controlled trial (RCT). Eligible participants aged 18 or over who have mild dementia (defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale) who can participate in the intervention and provide informed consent will be randomised (1:1) to treatment with the PRIDE intervention delivered in addition to usual care, or usual care only. Participants will be followed-up at 3 and 6 month’s post-randomisation. There will be an option for a supporter to join each participant. Each supporter will be provided with questionnaires at baseline and follow-ups at 3 to 6 months. Embedded qualitative research with both participants and supporters will explore their perspectives on the intervention investigating a range of themes including acceptability and barriers and facilitators to delivery and participation. The feasibility of conducting a full RCT associated with participant recruitment and follow-up of both conditions, intervention delivery including the recruitment, training, retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures will be examined. Discussion This study will assess whether a definitive randomised trial comparing the clinical and cost-effectiveness of whether the PRIDE intervention offered in addition to usual care is feasible in comparison to usual care alone, and if so, will provide data to inform the design and conduct of a future trial. Trial registration ISRCTN, ISRCTN11288961, registered on 23 October 2019, http://www.isrctn.com/ISRCTN12345678 Protocol V2.1 dated 19 June 2019.

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WeChat-based vestibular rehabilitation for patients with chronic vestibular syndrome: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042637 ◽

2021 ◽

Vol 11 (3) ◽

pp. e042637

Author(s):

Peixia Wu ◽

Yafang Wan ◽

Yu Zhuang ◽

Chennan Wang ◽

Shuxin Xi ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Dynamic Balance ◽

Controlled Trial ◽

Well Being ◽

Vestibular Rehabilitation ◽

Mobile App ◽

Psychological Consequences ◽

Increased Risk ◽

Vestibular Symptoms ◽

Randomised Controlled

IntroductionDizziness is one of the most common symptoms seen in chronic vestibular syndrome, which has been linked to an increased risk of falls, substantial disability and negative psychological consequences. Recent evidence demonstrated that vestibular rehabilitation therapy (VRT) is effective for treating chronic vestibular symptoms. However, the delivery of VRT remains challenging because of lack of facility, insufficient qualified physiotherapist resources, as well as being in the actual situation of the pandemic. WeChat, the most widely used mobile app in China, offers a more viable way of delivering VRT than traditional office-based approaches do. This study aimed to evaluate the effectiveness of the WeChat-VRT programme for patients with chronic vestibular syndrome.Methods and analysisThis is a parallel-group, assessor-blinded randomised controlled trial. Fifty patients who experienced chronic vestibular symptoms longer than 3 months will be randomised into either the WeChat-VRT group or the usual care (UC) group. Participants in the WeChat-VRT group will receive 8-week VRT mainly through the WeChat app. Participants in the UC group will receive once-weekly VRT in the clinic for 8 weeks and remaining time home-based exercise. Outcome assessments will take place at baseline and at the 8th, 12th and 24th weeks after randomisation. The primary outcome will be the change from baseline to the eighth week on the patients’ functional improvements quantified by the Functional Gait Assessment (FGA). The secondary outcomes will include dynamic balance function, emotional well-being, and vestibular activity and participation level. Intention-to-treat analysis will be performed using generalised estimation equation modelling.Ethics and disseminationThe trial has been reviewed and approved by the Institutional Review Board of Eye and Ear Nose Throat Hospital of Fudan University (reference number 2017047/1). The study findings will be disseminated via peer-reviewed journals and conferences.Trial registration numberChiCTR2000029457; Pre-results.

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Update to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-021-05213-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jesus Montero-Marin ◽

◽

Elizabeth Nuthall ◽

Sarah Byford ◽

Catherine Crane ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Study Protocol ◽

Primary Endpoint ◽

Controlled Trial ◽

Mindfulness Training ◽

Secondary Outcome ◽

Link Type ◽

Randomised Controlled

Abstract Background MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at 10.1186/s13063-017-1917-4). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale. Methods Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up. Discussion These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design. Trial registration International Standard Randomised Controlled Trials ISRCTN86619085. Registered on 3 June 2016.

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Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC4E): the ALIC4E protocol

BMJ Open ◽

10.1136/bmjopen-2017-021032 ◽

2018 ◽

Vol 8 (7) ◽

pp. e021032 ◽

Cited By ~ 6

Author(s):

Emily Bongard ◽

Alike W van der Velden ◽

Johanna Cook ◽

Ben Saville ◽

Philippe Beutels ◽

...

Keyword(s):

Primary Care ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Antiviral Treatment ◽

Duration Of Symptoms ◽

Influenza Like Illness ◽

South Central ◽

Increased Risk ◽

Randomised Controlled

IntroductionEffective management of seasonal and pandemic influenza is a high priority internationally. Guidelines in many countries recommend antiviral treatment for older people and individuals with comorbidity at increased risk of complications. However, antivirals are not often prescribed in primary care in Europe, partly because its clinical and cost effectiveness has been insufficiently demonstrated by non-industry funded and pragmatic studies.Methods and analysisAntivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE is a European multinational, multicentre, open-labelled, non-industry funded, pragmatic, adaptive-platform, randomised controlled trial. Initial trial arms will be best usual primary care and best usual primary care plus treatment with oseltamivir for 5 days. We aim to recruit at least 2500 participants ≥1 year presenting with influenza-like illness (ILI), with symptom duration ≤72 hours in primary care over three consecutive periods of confirmed high influenza incidence. Participant outcomes will be followed up to 28 days by diary and telephone. The primary objective is to determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity with fever, headache and muscle ache reduced to minor severity or less. Secondary objectives include estimating cost-effectiveness, benefits in subgroups according to age (<12, 12–64 and >64 years), severity of symptoms at presentation (low, medium and high), comorbidity (yes/no), duration of symptoms (≤48 hours/>48–72 hours), complications (hospital admission and pneumonia), use of additional prescribed medication including antibiotics, use of over-the-counter medicines and self-management of ILI symptoms.Ethics and disseminationResearch ethics committee (REC) approval was granted by the NRES Committee South Central (Oxford B) and Clinical Trial Authority (CTA) approval by The Medicines and Healthcare products Regulatory Agency. All participating countries gained national REC and CTA approval as required. Dissemination of results will be through peer-reviewed scientific journals and conference presentations.Trial registration numberISRCTN27908921; Pre-results.

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The Reflective Fostering Programme – improving the wellbeing of children in care through a group intervention for foster carers: a randomised controlled trial: study protocol for a randomised controlled trial.

10.21203/rs.3.rs-345315/v1 ◽

2021 ◽

Author(s):

Nick Midgley ◽

Karen Irvine ◽

Beth Rider ◽

Sarah Byford ◽

Antonella Cirasola ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Local Authority ◽

Controlled Trial ◽

Well Being ◽

Randomised Control Trial ◽

Reflective Capacity ◽

Randomised Controlled ◽

Children In Care

Abstract Background: The needs of children in care are a government priority, yet the evidence-base for effective interventions to support the emotional wellbeing of children in care is still lacking. Research suggests that supporting the carer-child relationship, by promoting the carer’s reflective parenting, may be an effective approach to improving the well-being of these children.Methods: The study comprises a definitive, pragmatic, randomised control trial, with embedded process evaluation and economic evaluation, and an internal pilot, to evaluate the effectiveness, and cost effectiveness, of the Reflective Fostering Programme.The study is being conducted in local authority sites across England, and is targeted at foster carers (including kinship carers) looking after children aged four to 13. Consenting participants are randomly allocated to the Reflective Fostering Programme (intervention arm) in addition to usual support or usual support alone (control arm). The primary outcome is behavioural and emotional well-being of the child 12 months post-baseline, and secondary outcomes include: foster carer’s level of stress, quality of life, reflective capacity, compassion fatigue and burnout, placement stability, the quality of the child-carer relationship, child’s capacity for emotional regulation, and achievement of personalised goals set by the carer.Discussion: This study trials one of the first parenting programmes specifically targeting the reflective capacity of foster carers. A feasibility study has indicated effectiveness of the Programme in improving the child-carer relationship and emotional and behavioural wellbeing of children in care. This study will test the effectiveness and cost-effectiveness of implementing the Reflective Fostering Programme as an additional aid to the support already available to local authority foster carers.Trial Registration: ISRCTN 70832140

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Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00881-5 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Gretchen Bjornstad ◽

Beth Cuffe-Fuller ◽

Obioha C. Ukoumunne ◽

Mary Fredlund ◽

Annabel McDonald ◽

...

Keyword(s):

Trial Design ◽

Controlled Trial ◽

Online Resources ◽

Community Settings ◽

Post Intervention ◽

Definitive Trial ◽

Link Type ◽

Randomised Controlled ◽

Group Programme

Abstract Background Parent carers of children with special educational needs or disability are at higher risk of poor mental and physical health. The need for a tailored, peer-led group programme was raised by parent carers, who co-developed the Healthy Parent Carers programme with researchers. This study aimed to test the feasibility of programme delivery in community settings, and the feasibility and acceptability of a randomised controlled trial design. Methods Participants were individually randomised with concealed allocation to a structured group programme and access to online resources (intervention), or access to the online resources only (control). Measures of wellbeing and secondary and economic outcomes were collected before randomisation, immediately post-intervention, and 6 months post-intervention. Descriptive statistics on recruitment and attrition, demographics, attendance, and fidelity of intervention delivery were analysed with feedback on the acceptability of the trial design. Results One hundred and ninety-three parent carers expressed an interest in taking part. Ninety-two participants recruited from across six sites were randomised (47 intervention, 45 control). Lead and assistant facilitators were trained and delivered the group sessions. Sixteen (34%) participants in the intervention arm did not attend any sessions, and attendance varied across sites and sessions. One participant withdrew post-randomisation, and 83 (90%) participants completed outcome measures at the six-month follow-up. Conclusions The study demonstrated that it was feasible to deliver the programme in community settings. The number of parent carers who expressed interest signifies the need for such a programme and the feasibility of recruiting to a definitive trial. Loss to follow-up was low. Further research is needed to explore ways to reduce barriers to participation in person and assess the feasibility and acceptability of programme content and delivery for more ethnically diverse groups, and potentially using interpreters. Given the Covid-19 pandemic and delivery format feedback, there is also a need to investigate remote or blended delivery strategies. Although the results indicate that a definitive trial is feasible, programme impact would be strengthened through exploration of these uncertainties. Trial registration ISRCTN, ISRCTN15144652, registered on 25 October 2018, ClinicalTrials.gov, NCT03705221, registered on 15 October 2018.

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Prevention of child mental health problems through parenting interventions in Southeastern Europe (RISE): study protocol for a multi-site randomised controlled trial

Trials ◽

10.1186/s13063-021-05817-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Diana Tăut ◽

Adriana Băban ◽

Inga Frantz ◽

Ingrid Dănilă ◽

Jamie M. Lachman ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Mental Health Problems ◽

Controlled Trial ◽

Randomised Trial ◽

Parent Report ◽

Behavioural Problems ◽

Control Group ◽

Link Type ◽

Randomised Controlled

Abstract Background Childhood adversities, such as poor parental practices, exposure to violence, and risk behaviours strongly impact children’s future mental and behavioural problems. Adversities affect families living in disadvantaged environments and low- and middle-income countries (LMICs) to a greater extent than in high-income countries. Parenting programmes are an effective way to alleviate them, although their outreach and scalability is still limited in LMICs. Methods/design A multi-site randomised controlled trial will be conducted in North Macedonia, Republic of Moldova and Romania to test the efficacy and cost-effectiveness of an optimised version of the promising Parenting for Lifelong Health Programme for Young Children (PLH-YC, 5 sessions), against a standard lecture on parenting issues (control group, 1 session). At least 864 participants who report having children between 2 and 9 years old who display elevated levels of behavioural difficulties will be randomised on a 1:1 basis to the intervention and control groups. The primary outcome will consist of parent report of child oppositional aggressive behaviour. Post-test (four months) and follow-up (12 months) assessments will provide information on short- and longer-term effects of PLH-YC compared to the parenting lecture in the control group. Discussion This randomised trial will test the efficacy of PLH-YC in alleviating child behavioural problems and assess the cost-effectiveness, transportability across three different cultural contexts, and potential for scalability of the programme. Trial registration ClinicalTrials.gov., Registration number: NCT04721730 (https://clinicaltrials.gov/ct2/show/NCT04721730). Registered 13.01.2021

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