Pilot and Feasibility Studies最新文献

{"title":"A feasibility trial of a psychological intervention for addressing alcohol problems during pregnancy: a study protocol.","authors":"Petal Petersen Williams, Isabelle L Lange, Jodilee Erasmus, Lesley-Ann Erasmus-Claassen, Maham Saleem, Lisa Sophie Reigl, Meike Wolf, Stefan Schaub, Christoph Buck, Abhijit Nadkarni, Daniela C Fuhr","doi":"10.1186/s40814-026-01932-5","DOIUrl":"10.1186/s40814-026-01932-5","url":null,"abstract":"<p><strong>Background: </strong>South Africa has the highest global prevalence of foetal alcohol spectrum disorders (FASD). Despite guidelines for FASD prevention, there are no community-based psychological interventions to reduce alcohol use during pregnancy. Through formative research, a culturally adapted intervention, the Mommy and Baby Wellness Programme, was developed to address the needs of pregnant women in the setting. The aim of the feasibility trial is to refine the trial methods before conducting a full-scale trial, and explore the feasibility of programme delivery, the acceptability of session content, and participants' perceptions of its effectiveness.</p><p><strong>Methods and analysis: </strong>A parallel-arm, single-blind, individually randomised feasibility trial will be conducted. Forty pregnant women (≥ 18 years) screening positive for hazardous alcohol use (AUDIT score ≥ 8) and confirming past-month alcohol consumption will be randomised 1:1 to receive either the Mommy and Baby Wellness Programme or enhanced usual care. Women will be assessed at baseline and again three months after randomisation. The study uses an embedded mixed-methods design, in which a parallel quantitative feasibility trial is complemented by qualitative interviews with participants and community health workers. Quantitative indicators of trial feasibility, acceptability and implementation (e.g. recruitment, retention, adherence and completeness of outcome data) will be summarised descriptively, and qualitative data will be used in an explanatory role to help interpret these findings and refine trial procedures and intervention delivery. Ethical approval has been obtained from the South African Medical Research Council (SAMRC) and the Technical University of Munich Health Research Ethics Committees. All participants will provide informed consent. Study data will be securely managed using Research Electronic Data Capture software hosted on SAMRC servers.</p><p><strong>Discussion: </strong>The pilot trial of the Mommy and Baby Wellness Programme provides initial evidence on the feasibility and acceptability of a community health worker-delivered psychological intervention to reduce alcohol use among pregnant women in South Africa. Findings will inform the design of a future definitive trial and guide adaptation of recruitment, retention, and counselling strategies for a highly stigmatised population. Insights from the process evaluation will refine approaches to participant engagement and fidelity monitoring, supporting culturally responsive and sustainable implementation. If feasible, the intervention could contribute to improved maternal and child health outcomes and reducing alcohol-related harm in resource-limited settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID NCT06853873. Retrospectively registered: 2025-02-25 https://www.</p><p><strong>Clinicaltrials: </strong>gov/study/NCT06853873.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13651288/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149149256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility, acceptability, and preliminary estimates of a multimodal AKTIVER Heart Delirium Prevention Program in patients indicated for cardiac surgery: study protocol of a randomized controlled PREVENT POstoperative Delirium (PREVENT-POD) Pilot Study.","authors":"Julia Kühnle, Minh Tuan Dong, Joshua Heißenberg, Carlotta Derad, Elke Schettler, Claudia Neitzel, Paul T Itting, Alexei Botnariuc, Thomas Asendorf, Birte Viehmeister, Aschraf El-Essawi, Ahmad-Fawad Jebran, Ruben Evertz, Johanna C Badde, Carolin Steinmetz, Marcus Wuttke, Neele S David, Juliane Spank, Daniel A Schäfer, Ingo Kutschka, Hassina Baraki, Christoph Herrmann-Lingen, Christine Thomas, Christine von Arnim, Christopher M Celano, Monika Sadlonova","doi":"10.1186/s40814-026-01923-6","DOIUrl":"https://doi.org/10.1186/s40814-026-01923-6","url":null,"abstract":"<p><strong>Background: </strong>Postoperative delirium (POD) is a common complication in geriatric patients undergoing cardiac surgery. POD is associated with prolonged length of stay in the intensive care unit and hospital, increased mortality, institutionalization, distress, risk of cognitive impairment and dementia. The non-pharmacological, multimodal AKTIVER intervention from the multicenter PAWEL trial significantly reduced POD incidence and days with POD in older patients undergoing abdominal and orthopedic surgery. However, this positive effect on POD incidence has not yet been demonstrated in elderly patients undergoing cardiac surgery. Therefore, a specific AKTIVER Heart intervention with additional modules was developed.</p><p><strong>Methods: </strong>In the randomized controlled PREVENT-POD pilot study, 60 patients aged 65 years or older undergoing elective cardiac surgery will be recruited and 2:1 randomized in either into the AKTIVER Heart intervention group (AKTIVER Heart) or treatment-as-usual plus (TAU+) group. In total, 40 patients will receive the non-pharmacological and modified AKTIVER Heart intervention, while the other 20 will receive TAU+ with preoperative education. The primary outcome is the feasibility and acceptability of the AKTIVER Heart intervention. Secondary outcomes include the preliminary estimates of the AKTIVER Heart on POD incidence, duration and severity, cognition, quality of life, sleep, treatment- and disease expectations, distress, depression, and anxiety symptoms.</p><p><strong>Discussion: </strong>This randomized controlled pilot study aims to evaluate the feasibility and acceptability of the non-pharmacological, multimodal AKTIVER Heart intervention in elderly patients undergoing elective cardiac surgery. This trial is designed to provide evidence on acceptability and feasibility of the AKTIVER Heart, and to perform a larger, well-powered multicenter POD prevention trial in cardiac surgery.</p><p><strong>Trial registration: </strong>German Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00035091, Registered prospectively on November 4, 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13637325/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149113551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Celebrating the 10th anniversary of Pilot and Feasibility Studies-what have we achieved?","authors":"Gillian A Lancaster, Lehana Thabane, Lawrence Mbuagbaw, Stephen A Bremner","doi":"10.1186/s40814-026-01927-2","DOIUrl":"10.1186/s40814-026-01927-2","url":null,"abstract":"","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13595616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149017753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of and satisfaction with a short-term outpatient preventive medical service for working informal caregivers: a study protocol of a non-randomized prospective pilot study.","authors":"Sophia Boesl, Anna Pendergrass, Elmar Graessel, Natascha Lauer, Annabèlle Mesloh, Elke Hüttenrauch, Antonia Keck, Johanna Schmidt","doi":"10.1186/s40814-026-01925-4","DOIUrl":"10.1186/s40814-026-01925-4","url":null,"abstract":"<p><strong>Background: </strong>About 80% of care receivers (CRs) in Germany are cared for at home by family members or friends. These informal caregivers (CGs) often report a high burden from caregiving, which negatively affects their mental and physical health and often results in reduced work hours. CGs with statutory health insurance can apply for preventive medical services. A change in the law has allowed the duration of service to be split. Recent research postulated specialized digital and analog multi-component interventions to protect CGs' health, which the pAKur project wants to develop and implement into public health. This pilot will focus on the development of and satisfaction with an outpatient preventive medical service for CGs.</p><p><strong>Methods: </strong>The non-randomized, prospective pilot study will be performed on-site in Oberstdorf, Bavaria (Germany) and online from April 2026 to January 2027. Working CGs with a moderate CG burden caring for a CR with a moderate need for assistance will be included. The intervention will be developed in participation with CGs and experts in the corresponding field. Two groups (A and B) will participate in the same on-site treatment but will differ in the intensity of the digital support phase (A: low; B: high) and the location of the refresher treatment (A: on-site; B: digital). Within the framework of a mixed-methods design, quantitative and qualitative data will be collected: the main outcome will be CGs' satisfaction with the outpatient preventive medical service, assessed with the Client Satisfaction Questionnaire and qualitative interviews. For secondary outcomes, several aspects of the CGs' mental and physical health will be assessed via questionnaires and qualitative interviews. Quantitative data will be analyzed descriptively and explored with MANOVA; qualitative data will be examined with content analysis.</p><p><strong>Discussion: </strong>Potential issues regarding recruitment, organization, and dropout due to intervention duration will be addressed with financial incentives, support from the tourism board, and personal contact during the intervention. This pilot marks the first step in integrating the CGs' needs into existing preventive medical services as well as testing components and structures for future interventions.</p><p><strong>Trial registration: </strong>German Clinical Trial Register (DRKS), ID:  DRKS00039025 ; 01/22/2026.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13576231/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148977444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FOR-HEALTH: study protocol for a randomized controlled feasibility trial of Structured Health Dialogues to improve lifestyle habits and metabolic health in forensic psychiatric inpatients.","authors":"Mikael Vestlund, Veronica Milos Nymberg, Peter Andiné, Märta Wallinius","doi":"10.1186/s40814-026-01919-2","DOIUrl":"10.1186/s40814-026-01919-2","url":null,"abstract":"<p><strong>Background: </strong>People with severe mental illness demonstrate markedly reduced life expectancy, largely due to preventable cardiometabolic disease. This burden is particularly pronounced in compulsory forensic psychiatric care, where prolonged inpatient stays, restrictive environments, and long-term antipsychotic treatment contribute to high levels of sedentary behavior, unhealthy diet, tobacco use, and metabolic disturbances. Despite substantial cardiometabolic risk, individuals in forensic psychiatric settings are frequently excluded from preventive health research, resulting in limited evidence regarding the feasibility and acceptability of lifestyle interventions in this context. Recent international recommendations emphasize the need to integrate structured lifestyle interventions as core components of mental healthcare, including in secure and compulsory settings.</p><p><strong>Objectives: </strong>The FOR-HEALTH study aims to assess the feasibility and acceptability of an adapted Structured Health Dialogue intervention delivered in compulsory forensic psychiatric inpatient care. Secondary objectives are to describe cardiometabolic, lifestyle, and patient-reported outcomes to inform the design of a future definitive randomized controlled trial.</p><p><strong>Methods: </strong>This randomized controlled feasibility trial evaluates an adapted version of Structured Health Dialogues, an evidence-based cardiovascular prevention model originally developed for Swedish primary care. Participants are randomized in a 1:1 ratio to receive either Structured Health Dialogues plus treatment as usual or treatment as usual alone. Structured Health Dialogues integrate a systematic assessment of lifestyle behaviors, biological risk markers, psychosocial stress, and heredity into an individualized visual risk profile, which forms the basis for a motivational, person-centered dialogue. The intervention is adapted to the forensic psychiatric context and delivered within a secure inpatient setting. Primary outcomes relate to feasibility, including recruitment, retention, intervention delivery, and acceptability. Secondary outcomes include exploratory changes in lifestyle behaviors, cardiometabolic risk markers, and patient-reported outcomes. A total of 50 participants (25 per group) will be recruited. The study has been approved by the Swedish Ethical Review Authority. The findings are expected to inform the design and implementation of a future definitive randomized controlled trial evaluating Structured Health Dialogues in forensic psychiatric inpatient care.</p><p><strong>Trial registration: </strong>NCT07157813.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13613582/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149063908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FASTINA - protocol for a randomised feasibility trial of time-restricted eating to improve response to multiple myeloma therapy.","authors":"Anna Franziska Hamm, Jan Vorwerk, Mona Maria Merz, Martin Smollich, Christina Schwitlick, Kay Horn, Inke Regina König, Theo Leitner, Lorenz Oelschläger, Helal Ahmed, Felix Sommer, Nikolas von Bubnoff, Cyrus Khandanpour","doi":"10.1186/s40814-026-01914-7","DOIUrl":"10.1186/s40814-026-01914-7","url":null,"abstract":"<p><p>Multiple myeloma (MM) is an incurable plasma cell malignancy with relapses and diminishing response durations. Preclinical studies suggest that time-restricted eating (TRE)-related metabolic changes may enhance chemosensitivity by exploiting cancer cell vulnerabilities to nutrient deprivation. Clinical data in solid tumours remain limited and heterogeneous, mainly supporting feasibility and possible toxicity reduction rather than definitive efficacy. While efficacy has been explored in breast cancer patients, there is a lack of data for haematological patients, including MM. FASTINA (Fasting in Staging of MM - Intervention for Nutritional Adherence) will therefore primarily assess feasibility and safety and will explore preliminary efficacy of incorporating TRE into standard MM therapy. FASTINA is a single-centre, open-label, parallel-group randomised controlled feasibility trial (DRKS00034370). 54 adults with MM will be randomised 1:1 to either 16:8 TRE + nutritional counselling or nutritional counselling alone for 12 weeks during systemic therapy. Primary endpoints are adherence to the diet (adherence ≥ 80%) and complete response with measurable residual disease (MRD) negativity at treatment end. Secondary endpoints include response rates, nutritional status, body composition changes, frequency of ≥ grade 3 adverse events (AEs), progression-free (PFS) and exploratory overall survival (OS), quality of life (QoL), and fatigue. FASTINA will evaluate whether TRE is feasible and safe in selected MM patients and whether there is a hypothesis-generating signal for improved treatment response, informing the design of a subsequent phase II trial.Trial registration Deutsches Register Klinischer Studien (DRKS), DRKS00034370. Registered 21 June 2024, https://drks.de/search/de/trial/DRKS00034370 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13540832/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148887983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lessons from the Danish Vascular (DanVasc) pilot survey: patient-reported outcomes following lower extremity, carotid and aortic artery disease.","authors":"Marie Dahl, Jonas Eiberg, Britt Borregaard, Christian Petersen, Jacob Budtz-Lilly, Saeid Shahidi, Trine Jørgensen, Cecilia Serup Christensen, Henriette Lindholt, Bibi Damsgaard, Jes S Lindholt","doi":"10.1186/s40814-026-01907-6","DOIUrl":"10.1186/s40814-026-01907-6","url":null,"abstract":"<p><strong>Background: </strong>Patient-reported outcomes are insufficiently studied across the three predominant vascular diseases: lower extremity artery disease (LEAD), symptomatic carotid stenosis (SCS) and abdominal aortic aneurysm (AAA). To address this gap, the Danish Vascular (DanVasc) survey was developed and pilot tested before national implementation. Following the National Institutes of Health guidelines for pilot studies, we assessed survey feasibility by evaluating acceptability (response rates, retention, participant time burden), timeliness and data quality (completeness and floor/ceiling effects).</p><p><strong>Methods: </strong>This pilot study recruited a representative cohort from two Danish vascular outpatient clinics between May and November 2023. Participants received four surveys in total, consisting of multiple patient-reported outcome measures (PROMs) and ancillary questions: a baseline survey (T0), sent after the initial outpatient visit, and three follow-up surveys at 1 (T1), 3 (T2) and 12 months (T3). Follow-up surveys were activated according to the patient's care pathway: (a) the date of outpatient visit for newly referred patients treated conservatively and (b) the date of surgery for patients undergoing a vascular procedure. Site staff and hotline staff were trained to support patient engagement and facilitate uptake.</p><p><strong>Results: </strong>Of 468 invited patients, 231 (49.4%) consented to participate; 70.1% responded digitally and 29.9% by postal mail. Among participants, 74.9% had LEAD, 13.0% had SCS and 12.1% had AAA. Of these, 27.7%, 90.0% and 75.0%, respectively, underwent surgery, while the remaining patients received conservative treatment. All four surveys (T0-T3) were completed by 68.8% of participants. None withdrew consent. The median completion time for the digital baseline survey was 16 min (IQR 10.0). Surgical treated patients had a median response time of 5 days before surgery (IQR 43); digital respondents replied 17.5 days pre-operatively (IQR 54), whereas postal respondents 25 days post-operatively (IQR 40). Data completeness ranged from 72.3% to 98.3% across the PROMs. A floor effect was observed for the loneliness scale (61.8%) and a ceiling effect for the medication adherence scale (52.2%).</p><p><strong>Conclusion: </strong>The DanVasc pilot survey demonstrated acceptable feasibility and data quality. Feasibility depended on digital and paper response options, survey hotline support and adequate survey management resources. Timely response was challenged by delays related to postal correspondence.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13599318/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149031147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Braining, structured physical activity in specialized psychiatry for patients with substance use disorders-a feasibility study.","authors":"Åsa Anger, Leida Kaaman, Rebecka Mac, Johan Holmberg, Nitya Jayaram-Lindström, Tobias Lundgren, Maria Hagströmer, Carl Johan Sundberg, Lina Martinsson, Sigrid Salomonsson","doi":"10.1186/s40814-026-01898-4","DOIUrl":"10.1186/s40814-026-01898-4","url":null,"abstract":"<p><strong>Background: </strong>Individuals with substance use disorders (SUD) have poor metabolic and cardiovascular health and a high prevalence of depression and anxiety symptoms. Regular physical activity can improve both somatic and mental health. This study aimed to evaluate the feasibility of an aerobic physical activity intervention (Braining) in psychiatric care services specialized in SUD.</p><p><strong>Methods: </strong>In this uncontrolled open trial with pre-, post-, and 12-month follow-up measures, 22 patients with SUD participated in a 12-week physical activity intervention. Recommended participation was three 30-45-min moderate-to-vigorous interval-based exercise sessions per week combining aerobic and body-weight strength exercises. No minimum session attendance was required for study participation. Feasibility was assessed through recruitment yield, number of exercise sessions attended, and adherence to study procedures. Satisfaction, acceptability, credibility, and negative effects were assessed using self-report questionnaires and adverse event reporting. Physical activity was measured using accelerometry (ActiGraph GT3X) and self-report. Patient-centered outcomes were summarized descriptively.</p><p><strong>Results: </strong>The mean number of attended exercise sessions was 9 (SD = 7.7). Adherence to ActiGraph measurements was 73% at baseline, 46% mid-intervention, and 32% post-intervention. Completion of self-report assessments was 100% at baseline, 86% post-intervention, and 77% at 12-month follow-up. The mean Client Satisfaction Questionnaire (CSQ-8) score was 27 (SD = 3.9), and no serious adverse events were reported. Descriptive trends suggested reductions in psychiatric symptoms and substance use and improvements in functional status and quality of life, whereas changes in somatic measures were limited.</p><p><strong>Conclusions: </strong>Acceptability of the intervention was high in the target patient population; however, exercise attendance was low. Participants engaged adequately in study procedures, but adherence to accelerometer-based measurements was low. With further methodological refinements to enhance patient engagement and adaptations to how physical activity is measured in vulnerable patient populations, Braining remains a relevant intervention and warrants systematic evaluation in future large-scale controlled trials.</p><p><strong>Study registration: </strong>The study was registered on 25/12/2021 at ClinicalTrials.gov under ID NCT05186688.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13445667/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148685402","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the feasibility and acceptability of a school-based non-pharmacological intervention for ADHD: the Flex toolkit.","authors":"Abigail Emma Russell, Suzie Holt, Charlotte Kelman, Tamsin Ford, Darren Moore, Rachel Hayes, Judi Kidger, Edmund Sonuga-Barke, Barney Dunn, Linda Pfiffner, Eleanor Bryant, Rebecca Gudka, Kirsty Cordwell","doi":"10.1186/s40814-026-01879-7","DOIUrl":"10.1186/s40814-026-01879-7","url":null,"abstract":"<p><strong>Background: </strong>Attention deficit/hyperactivity disorder (ADHD) is a prevalent and impairing neurodevelopmental disorder. Traits cause impairment for 5-10% of children. School is a particular challenge for children with ADHD, who are at risk of exclusion, mental health problems and poor attainment. Existing school-based interventions have evidence of effectiveness, however are not implementable in UK mainstream school contexts due to resource constraints. We co-designed an individualised novel non-pharmacological intervention for ADHD (the Flex toolkit) based on principles of behaviour change, using Intervention Mapping. We aimed to assess the feasibility and acceptability of the Flex toolkit, and assess whether a definitive evaluation in schools is feasible.</p><p><strong>Methods: </strong>A multiple baseline case series study was conducted with eight UK primary schools. Teachers, parents and children completed both quantitative and qualitative measures over 1 year, with the intervention being used for approximately 16 weeks. Mixed methods analysis was used to assess feasibility and acceptability, and evidence for perceived impact of the intervention on relevant outcomes as well as mechanisms of action from the intervention logic model was assessed.</p><p><strong>Results: </strong>Forty children with ADHD, 53 teachers and 49 parents/caregivers participated. The intervention was deemed to be highly acceptable and useful; however, it was not feasible for staff to implement with fidelity in schools as an unguided intervention. Those who engaged with the intervention often perceived it to have beneficial impacts for study children as evidenced in qualitative data. The research design was considered to be both acceptable and feasible with some recommendations to streamline procedures for a definitive trial.</p><p><strong>Conclusions: </strong>The Flex toolkit is acceptable to schools. It was perceived to improve a range of outcomes that relate to dimensions of mental health and school-based impairment; however, the study was not powered to detect quantitative change. A definitive evaluation would need to test a supported delivery model of the intervention to ensure that it is delivered with fidelity; we recommend a \"coach\" whose role would be to provide light-touch support to teachers to select and implement intervention components. The research design for a definitive evaluation can mirror many of the aspects of the feasibility study design.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"12 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13425861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148649111","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the feasibility of Preliminary Randomised Evaluation of Singing in Dementia (PRESIDE) in community group settings.","authors":"Linda Elizabeth O'Raw, Becky Dowson, Martin Orrell, Orii McDermott, Lee Haywood, Phillip Bath, Lisa Woodhouse, Justine Schneider","doi":"10.1186/s40814-026-01886-8","DOIUrl":"10.1186/s40814-026-01886-8","url":null,"abstract":"<p><strong>Background: </strong>Community singing interventions have been explored as potential therapeutic activities for people with dementia and their carers. This feasibility study aimed to evaluate the practicality, engagement, and preliminary outcomes of such an intervention.</p><p><strong>Methods: </strong>A total of 72 participants (36 dyads) were recruited across three sites. Participants were randomly assigned to an intervention group, which engaged in community singing sessions, or a waiting list control group. Demographic characteristics were balanced between groups, and baseline musical engagement was low. Recruitment challenges and varying site fidelity were noted.</p><p><strong>Results: </strong>The intervention demonstrated mixed feasibility, with patient-reported outcome measures being practical and successfully administered. Descriptive trends favouring the intervention group were observed on some measures relating to quality of life, well-being, and daily activities, although the study was not powered to evaluate effectiveness. Retention at T1 was 78% in both arms; at T2, retention was 66.7% in the intervention arm and 77.8% in the control arm. Notably, post-intervention, all sites transitioned to independent community singing groups or secured funding for continued activities, suggesting acceptability and ongoing participant interest.</p><p><strong>Conclusions: </strong>The study highlights the possible areas warranting further investigation of community singing interventions for people with dementia and their carers, with descriptive trends observed in selected quality-of-life and well-being measures. However, challenges such as recruitment and control condition engagement must be addressed in future research. Larger sample sizes and extended follow-up periods are necessary to evaluate intervention effectiveness and longer-term implementation outcomes.</p><p><strong>Trial registration: </strong>Funded by NIHR Research for Patient Benefit - Social Care (NIHR202982) and has been registered with ISRCTN (10201482) and IRAS (Project ID: 313298). The University of Nottingham is the trial sponsor.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13673900/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148549690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}