Identifying Child Anxiety Through Schools-Identification to Intervention (iCATS-i2i): Protocol for Single-Arm Feasibility Trial

2021 ◽  
Author(s):  
Tessa Reardon ◽  
Susan Ball ◽  
Maria Breen ◽  
Paul Brown ◽  
Emily Day ◽  
...  
Keyword(s):  
Primary Schools ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Child Anxiety ◽  
Parent Report ◽  
Retention Rates ◽  
Feasibility Trial ◽  
School Staff ◽  
Evidence Based ◽  
Treatment Access

Abstract Background: Anxiety disorders are common among primary-school aged children, but few affected children receive evidence-based treatment. Identifying and supporting children who experience anxiety problems through schools would address substantial treatment access barriers that families and school staff often face. We have worked with families and school staff to co-design procedures that incorporate screening, feedback for parents, and the offer of a brief intervention in primary schools. This study sets out to assess the feasibility of a subsequent school-based cluster randomised controlled trial to evaluate these procedures. Our objectives are to ensure our procedures for identifying and supporting children with anxiety difficulties through primary schools are acceptable and there are no negative impacts, to estimate recruitment and retention rates, and to identify any changes needed to study procedures or measures. Methods: We will recruit six primary/junior schools in England (2 classes per school), and invite all children (aged 8-9) (n=360) and their parent/carer and class teacher in participating classes to take part. Children, parents and class teachers will complete questionnaires at baseline and 12-week follow-up. Children who ‘screen positive’ on a 2-item parent-report child anxiety screen at baseline will be the target population (expected n=43). Parents receive feedback on screening questionnaire responses, and where the child screens positive the family is offered support (OSI: Online Support and Intervention for child anxiety). OSI is a brief, parent-led online intervention, supported by short telephone sessions with a Children’s Wellbeing Practitioner. Participants’ experiences of study procedures will be assessed through qualitative interviews/discussion groups. Discussion: Evidence-based procedures for identifying and supporting children with anxiety difficulties through primary schools would improve children’s access to timely, effective intervention for anxiety difficulties.Trial registration: ISRCTN registry: ISRCTN30032471. Retrospectively registered on 18.5.2021. https://www.isrctn.com/ISRCTN30032471

scholarly journals Development and implementation of a nurse-led allergy clinic model in primary care: feasibility trial protocol

2019 ◽  
Vol 29 (1) ◽  
Author(s):  
Margaret Kelman ◽  
Victoria Hammersley ◽  
Marilyn Kendall ◽  
Mome Mukherjee ◽  
Lynn Morrice ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Allergy Clinic ◽  
Randomised Controlled

AbstractIn the United Kingdom, there are acknowledged short comings in allergy care provision for patients seen in primary care. There is a lack of allergy training for healthcare professionals and this leads to inappropriate referrals to the limited number of allergy specialists. The primary aims of this study are to assess the feasibility of delivering and evaluating a new nurse-led allergy service in primary care, measured by recruitment, retention and quality of life. This is a single arm feasibility trial in which up to 250 participants referred to the nurse-led allergy clinic will receive the intervention and complete 6–12 weeks follow-up before being referred back to their usual care. Primary outcomes for this study will be establishment of clinics, recruitment and retention rates, and estimates of change in disease-specific quality of life measures. Secondary outcomes will be acceptability of the new service to participants/carers and healthcare professionals. A sample of participants and professional stakeholders will take part in more in-depth semi-structured qualitative interviews. Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.

scholarly journals A Qualitative Examination of a School-Based Implementation of Computer-Assisted Cognitive-Behavioral Therapy for Child Anxiety

2021 ◽  
Author(s):  
Margaret Ellen Crane ◽  
Katherine E. Phillips ◽  
Colleen A. Maxwell ◽  
Lesley A. Norris ◽  
Lara S. Rifkin ◽  
...  
Keyword(s):  
Mental Health Treatment ◽  
Service Providers ◽  
Behavioral Therapy ◽  
Qualitative Interviews ◽  
Child Anxiety ◽  
School Staff ◽  
Computer Assisted ◽  
Treatment Access ◽  
School Based ◽  
Second Year

Mental health treatment in schools has the potential to improve youth treatment access. However, school-specific barriers can make implementing evidence-based interventions difficult. Task-shifting (i.e., training lay staff to implement interventions) and computer-assisted interventions may mitigate these barriers. This paper reports on a qualitative examination of facilitators and barriers of a school-based implementation of a computer-assisted intervention for anxious youth (Camp Cope-A-Lot; CCAL). Participants (N = 45) included school staff in first through fourth grades. Providers attended a training in CCAL and received weekly, hour-long group consultation calls for three months. In the second year, the sustainability of CCAL use was assessed. Qualitative interviews were conducted after the first year (initial implementation) and second year (sustainability). Interviews were analyzed using the Consolidated Framework for Implementation Research domains to classify themes. Although participants reported that CCAL included useful skills, they expressed concerns about recommended session length (45 minutes) and frequency (weekly). Time burden of consultation calls was also a barrier. School staff facilitated implementation by enabling flexible scheduling for youth to be able to participate in the CCAL program. However, the sustainability of the program was limited due to competing school/time demands. Results suggest that even with computer assisted programs, there is a need to tailor interventions and implementation efforts to account for the time restrictions experienced by school-based service providers. Optimal fit between the intervention and specific school is important to maintain the potential benefits of computer-assisted treatments delivered by lay service providers in schools.

scholarly journals Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design—a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e035787
Author(s):  
Dumbor Ngaage ◽  
Natasha Mitchell ◽  
Alexandra Dean ◽  
Claire Hirst ◽  
Enoch Akowuah ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Cardiac Rehabilitation ◽  
Hospital Discharge ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Median Sternotomy ◽  
Retention Rates ◽  
Upper Body ◽  
Feasibility Trial ◽  
Randomised Controlled

IntroductionFollowing cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier.Methods and analysesThis is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18–80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial.Ethics and disseminationEthics approval was granted by East Midlands—Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders.Trial registration numberISRCTN80441309

scholarly journals Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study)

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e032924
Author(s):  
Natasha Mitchell ◽  
Elizabeth Coleman ◽  
Judith Watson ◽  
Kerry Bell ◽  
Catriona McDaid ◽  
...  
Keyword(s):  
Sample Size ◽  
Older Patients ◽  
Large Scale ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Cochrane Review ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Advisory Group ◽  
Transtibial Amputation

IntroductionThe majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any individual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related amputations and other health issues compared with a standard prosthesis.Methods and analysisThis feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target sample size is 90 patients, who are aged 50 years and over, and have a transtibial amputation, where amputation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future sample size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT.Ethics and disseminationEthical approval was granted by Yorkshire and the Humber—Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group.Trial registration numberISRCTN15043643.

scholarly journals Codesign and development of a primary school based pathway for child anxiety screening and intervention delivery: a protocol, mixed-methods feasibility study

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e044852
Author(s):  
Victoria Williamson ◽  
Michael Larkin ◽  
Tessa Reardon ◽  
Samantha Pearcey ◽  
Claire Hill ◽  
...  
Keyword(s):  
Mental Health ◽  
Mixed Methods ◽  
Feasibility Study ◽  
Primary Schools ◽  
Mental Health Problems ◽  
Child Anxiety ◽  
Health Problems ◽  
School Staff ◽  
Evidence Based ◽  
School Based

IntroductionAnxiety difficulties are among the most common mental health problems in childhood. Despite this, few children access evidence-based interventions, and school may be an ideal setting to improve children’s access to treatment. This article describes the design, methods and expected data collection of the Identifying Child Anxiety Through Schools – Identification to Intervention (iCATS i2i) study, which aims to develop acceptable school-based procedures to identify and support child anxiety difficulties.Methods and analysisiCATS i2i will use a mixed-methods approach to codesign and deliver a set of procedures—or ‘pathway’—to improve access to evidence-based intervention for child anxiety difficulties through primary schools in England. The study will consist of four stages, initially involving in-depth interviews with parents, children, school staff and stakeholders (stage 1) to inform the development of the pathway. The pathway will then be administered in two primary schools, including screening, feedback to parents and the offer of treatment where indicated (stage 2), with participating children, parents and school staff invited to provide feedback on their experience (stages 3 and 4). Data will be analysed using Template Analysis.Ethics and disseminationThe iCATS i2i study was approved by the University of Oxford’s Research Ethics Committee (REF R64620/RE001). It is expected that this codesign study will lead on to a future feasibility study and, if indicated, a randomised controlled trial. The findings will be disseminated in several ways, including via lay summary report, publication in academic journals and presentation at conferences. By providing information on child, parent, school staff and other stakeholder’s experiences, we anticipate that the findings will inform the development of an acceptable evidence-based pathway for identification and intervention for children with anxiety difficulties in primary schools and may also inform broader approaches to screening for and treating youth mental health problems outside of clinics.

scholarly journals A parent-led intervention to reduce anxiety in autistic children with a severe to profound intellectual disability: protocol for the LADDERS pilot feasibility trial

2022 ◽  
Author(s):  
Jane Waite ◽  
Joanne Tarver ◽  
Effie Pearson ◽  
Jessica Hughes ◽  
Georgina Edwards ◽  
...  
Keyword(s):  
Intellectual Disability ◽  
Emotional Regulation ◽  
Single Case ◽  
Child Anxiety ◽  
Research Participant ◽  
Anxiety Reduction ◽  
Feasibility Trial ◽  
Evidence Based ◽  
Autistic Children ◽  
Graded Exposure

Abstract Background There is a need for evidence-based approaches to reduce anxiety experienced by autistic children with severe to profound intellectual disability (ID). Avoidance of anxiety triggers, as a response to pronounced anxiety, occurs irrespective of age, background and neurodiversity. When avoidance is unhelpful, evidence-based anxiety reduction approaches aim to reduce it gradually (graded exposure), subsequently reducing anxiety. Combining graded exposure with emotional regulation techniques may be effective and acceptable for autistic children with severe to profound ID, if sensitive to needs and characteristics of autistic children. We have developed a 16-week, parent-led intervention (LADDERS) to reduce anxiety in this population of autistic children. LADDERS consists of psychoeducation, graded exposure-based tasks, and skills building, delivered utilising a person-centred approach. This study aims to assess whether LADDERS 1) reduces anxiety and 2) whether autistic children and parents find it acceptable and feasible. Method A single-site, multiple baseline, single case experimental study will be conducted. Participants will be parents of autistic children aged between 4-15 years. A minimum of 8 participants will be recruited through a research participant database, the Autistica Discover Network and social media. Once eligibility is confirmed, participants will be assessed at baseline, during the intervention and at a 2-month follow-up (week 24). The primary outcome measure will be a daily diary that assesses child anxiety. Discussion The study will provide preliminary evidence of whether LADDERS reduces anxiety in autistic children with severe to profound ID. Qualitative data from parents and child engagement will provide data on acceptability and feasibility.

scholarly journals From Evidence-based to Market-based mHealth: Itinerary of a Mobile (for) Development Project

2019 ◽  
Vol 44 (6) ◽  
pp. 1048-1067 ◽  
Author(s):  
Marine Al Dahdah
Keyword(s):  
Information And Communication Technologies ◽  
Science And Technology Studies ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Communication Technologies ◽  
Global South ◽  
Development Project ◽  
Mobile Technologies ◽  
Evidence Based ◽  
Information And Communication

Information and communication technologies are increasingly used for development in the Global South, and mHealth (health assisted by mobile technologies) plays key role. This paper analyzes the particular relationship to science that characterizes a global maternal mHealth program deployed in Ghana and India. Using science and technology studies (STS), this research relies on qualitative interviews conducted between 2014 and 2016 with funders, implementers, and beneficiaries of this mHealth program. This story begins with a randomized controlled trial, a biomedical experiment with a strong positioning regarding science and the production of evidence. But rapidly the scientific stance disappears to give way to the testing and marketing of a product for the digital economy. From science to market, this paper offers to revisit a classical STS topic through the lens of mHealth. It shows how the various experimental forms taken by this project fundamentally diverge from scientific methods and evidence production and at the same time how it nurtures an ongoing instrumental relationship with science. Thus, from clinical research to product marketing, this paper highlights the tenuous link between evidence-based and market-based mHealth in the Global South.

scholarly journals Recruiting men from across the socioeconomic spectrum via GP registers and community outreach to a weight management feasibility randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Matthew D. McDonald ◽  
◽  
Stephan U. Dombrowski ◽  
Rebecca Skinner ◽  
Eileen Calveley ◽  
...  
Keyword(s):  
Weight Management ◽  
Public Involvement ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Community Outreach ◽  
Recruitment Strategy ◽  
Feasibility Trial ◽  
Recruitment Strategies ◽  
Management Interventions ◽  
Co Morbidity

Abstract Background Men, particularly those living in disadvantaged areas, are less likely to participate in weight management programmes than women despite similar levels of excess weight. Little is known about how best to recruit men to weight management interventions. This paper describes patient and public involvement in pre-trial decisions relevant to recruitment and aims to report on recruitment to the subsequent men-only weight management feasibility trial, including the: i) acceptability and feasibility of recruitment; and ii) baseline sample characteristics by recruitment strategy. Methods Men with BMI ≥30 kg/m2 and/or waist circumference ≥ 40 in. were recruited to the feasibility trial via two strategies; community outreach (venue information stands and word of mouth) and GP letters, targeting disadvantaged areas. Recruitment activities (e.g. letters sent, researcher venue hours) were recorded systematically, and baseline characteristics questionnaire data collated. Qualitative interviews (n = 50) were conducted three months post-recruitment. Analyses and reporting followed a complementary mixed methods approach. Results 105 men were recruited within four months (community n = 60, GP letter n = 45). Community outreach took 2.3 recruiter hours per participant and GP letters had an opt-in rate of 10.2% (n = 90/879). More men were interested than could be accommodated. Most participants (60%) lived in more disadvantaged areas. Compared to community outreach, men recruited via GP letters were older (mean = 57 vs 48 years); more likely to report an obesity-related co-morbidity (87% vs 44%); and less educated (no formal qualifications, 32% vs 10%, degree educated 11% vs 41%). Recruitment strategies were acceptable, a sensitive approach and trusting relationships with recruiters valued, and the ‘catchy’ study name drew attention. Conclusions Targeted community outreach and GP letters were acceptable strategies that successfully recruited participants to a men-only weight management feasibility trial. Both strategies engaged men from disadvantaged areas, a typically underserved population. Using two recruitment strategies produced samples with different health risk profiles, which could add value to research where either primary or secondary prevention is of interest. Further work is required to examine how these strategies could be implemented and sustained in practice. Trial registration ClinicalTrials.gov: NCT03040518, 2nd February 2017.

scholarly journals The INCLUDE study

2018 ◽  
Vol 8 (1) ◽  
pp. 2235042X1879237 ◽  
Author(s):  
Samantha L Hider ◽  
Milica Bucknall ◽  
Kelly Cooke ◽  
Kendra Cooke ◽  
Andrew G Finney ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Primary Care ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Retention Rates ◽  
Anxiety And Depression ◽  
Long Term Conditions ◽  
Inflammatory Conditions ◽  
Increased Risk

Background: Patients with inflammatory rheumatic conditions such as rheumatoid arthritis, polymyalgia rheumatica and ankylosing spondylitis are at increased risk of common comorbidities such as cardiovascular disease, osteoporosis and anxiety and depression which lead to increased morbidity and mortality. These associated morbidities are often un-recognized and under-treated. While patients with other long-term conditions such as diabetes are invited for routine reviews in primary care, which may include identification and management of co-morbidities, at present this does not occur for patients with inflammatory conditions, and thus, opportunities to diagnose and optimally manage these comorbidities are missed. Objective: To evaluate the feasibility and acceptability of a nurse-led integrated care review (the INtegrating and improving Care for patients with infLammatory rheUmatological DisordErs in the community (INCLUDE) review) for people with inflammatory rheumatological conditions in primary care. Design: A pilot cluster randomized controlled trial will be undertaken to test the feasibility and acceptability of a nurse-led integrated primary care review for identification, assessment and initial management of common comorbidities including cardiovascular disease, osteoporosis and anxiety and depression. A process evaluation will be undertaken using a mixed methods approach including participant self-reported questionnaires, a medical record review, an INCLUDE EMIS template, intervention fidelity checking using audio-recordings of the INCLUDE review consultation and qualitative interviews with patient participants, study nurses and study general practitioners (GPs) Discussion: Success of the pilot study will be measured against the engagement, recruitment and study retention rates of both general practices and participants. Acceptability of the INCLUDE review to patients and practitioners and treatment fidelity will be explored using a parallel process evaluation. Trial Registration: ISRCTN12765345.

scholarly journals Study protocol for the ‘HelpMeDoIt!’ randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017159 ◽  
Author(s):  
Lynsay Matthews ◽  
Juliana Pugmire ◽  
Laurence Moore ◽  
Mark Kelson ◽  
Alex McConnachie ◽  
...  
Keyword(s):  
Social Support ◽  
Weight Loss ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Intervention Group ◽  
Ethics Committee ◽  
Feasibility Trial ◽  
Control Group ◽  
Weight Loss Intervention ◽  
Randomised Controlled

IntroductionHelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite ‘helpers’ from their social circle to help them achieve their goal(s).AimTo test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals.Methods and analysis12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)>30 kg/m2and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention.Ethics and disseminationThe protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations.Trial registration numberISRCTN85615983.

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