Pilot and Feasibility Studies最新文献

{"title":"Adapted Early Adolescent Skills for Emotions (EASE) to decrease psychological distress among urban adolescents in New York City: a feasibility study protocol for a cluster single arm trial.","authors":"Janus Wong, Tina Xu, Karina Gonzalez Perez, Azanah Khadduri, Yakeisha Scott, Frank Watkins, Justine Oswiecimski, Abigail Wang, Eleana Antonaki, Dana Ergas Slachevsky, Eva Wong, Heather Day, Eliot Assoudeh, Ilana Yamin, Nivea Jackson, Melanie Wilkerson, Nicole Manning, Wanda Ascherl, Shonda Murphy, Amanda Flores, Brandon A Kohrt, Adam D Brown","doi":"10.1186/s40814-026-01840-8","DOIUrl":"10.1186/s40814-026-01840-8","url":null,"abstract":"<p><strong>Background: </strong>Given the increasing need for adolescent mental health services, a growing body of research has considered how scalable, transdiagnostic interventions might be implemented in a community-initiated care model to bridge the treatment gap. The purpose of this feasibility study is to assess the feasibility of implementing an adapted version of the World Health Organization's mental health intervention, Early Adolescent Skills for Emotions (EASE) for underserved youth of color in New York City (NYC).</p><p><strong>Methods: </strong>We will conduct a single-arm cluster feasibility study in collaboration with the New York City Mayor's Office of Community Mental Health, the Department of Youth and Community Development, and at least 10 community-based organization sites (CBO sites) in NYC that primarily serve youth of color. We aim to enroll at least 100 youth across these CBOs to participate in an adapted version of EASE over 7 weeks. Youth will complete surveys at baseline, post-intervention, and 3 months after the intervention. We may also invite them to participate in qualitative interviews and focus group discussions following completion of EASE. Additionally, we will recruit 100 caregivers across all CBOs to evaluate the acceptability of the adapted EASE caregiver curriculum. Furthermore, we will recruit 30 staff members (helpers) across all CBOs to participate in EASE training, supervision, and delivery, and we will assess implementation outcomes such as helper fidelity and curriculum acceptability with competency benchmarks and interviews.</p><p><strong>Discussion: </strong>This study will contribute to the burgeoning literature on the implementation of brief, task-sharing interventions to reduce psychological distress for underserved youth of color within urban community contexts. Favorable findings from this trial will offer valuable insight into the ways in which low-cost programs might address the growing adolescent mental health treatment gap, inform government policy, and guide the development of an adequately powered trial.</p><p><strong>Trial registration: </strong>The trial registration number is NCT06934954 (Registered on April 18th, 2025).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13412318/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148056301","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 and pilot study protocol of the SURE programme: a co-designed whole-school approach intervention to promote migrant-background adolescents wellbeing in secondary education.","authors":"Rocío Herrero Romero, Kevin van der Meulen, Laura Granizo, Cristina Del Barrio, Pablo Puyol, Laura Lara, Ricardo Olmos, Miruna Bivol, Kappa Grealy, María Gadea Jiménez, Nidhi Patel, Yi Chen, Margarita Sáenz, Yulia Shenderovich, Anna Bibou, Olga Lucía Hoyos de Los Ríos, Maria Kotova, Vicent Palerm, Nerea Ramos","doi":"10.1186/s40814-026-01853-3","DOIUrl":"10.1186/s40814-026-01853-3","url":null,"abstract":"<p><strong>Background: </strong>Adolescents with a migrant background may be at greater risk of experiencing poor mental health and psychosocial wellbeing. Whole-school approach (WSA) interventions with strong stakeholder commitment are considered to be a promising avenue for improving this population's wellbeing. Using such an approach, the co-designed universal SURE intervention aims to nurture a positive school climate and provide social support for migrant-background adolescents in Madrid, Spain, with the wider objective of bolstering adolescent wellbeing.</p><p><strong>Methods: </strong>Conducted in two medium-sized secondary schools in Getafe (Madrid), this research comprises two distinct components. First, a feasibility study utilises a pragmatic mixed-methods design to assess the implementation process and acceptability of the SURE intervention among students, staff, families, and community stakeholders. Second, an exploratory pilot study employs a quasi-experimental, non-equivalent control group design to estimate parameters for a future trial. During the 2025-2026 academic year, the intervention school will receive the SURE programme, while the comparison school follows the standard curriculum. Quantitative outcome data will be collected via self-report from students in 2° and 3° ESO (aged 13-15). Primary feasibility outcomes include recruitment and retention rates, intervention fidelity, and acceptability; secondary outcomes will be used to descriptively explore clinical mental health indicators (emotional symptoms, conduct problems, positive affect, and life satisfaction), alongside educational engagement and school participation.  DISCUSSION: This pilot and feasibility study aims to determine whether the SURE intervention procedures are acceptable and viable within the secondary education context. Findings will allow the research team to refine the intervention protocols, underlying mechanisms, and outcome measures. This process is essential to ensure the precision of estimates and the robustness of the research techniques before the SURE programme is scaled up and evaluated in a larger, definitive cluster randomised controlled trial.</p><p><strong>Trial registration: </strong>The trial was registered on the Open Science Framework (OSF) (Identifier: https://doi.org/10.17605/OSF.IO/XQ52T ) before the enrolment of the first participant.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13411845/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148056226","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":"Understanding and addressing the obstacles to a trial of face masks in schools: a mixed-methods feasibility study.","authors":"Ru Jia, Sophie Carlisle, Adam W A Geraghty, Sofia Strommer, Kieran Ayling, Jonathan Ball, Kirsty Bolton, Ben Cowling, Lucy Fairclough, Karen Jones, Wei Shen Lim, Paul Little, Tricia McKeever, Joanne Morling, Simon Royal, Paddy Tighe, Katherine Bradbury, Kavita Vedhara","doi":"10.1186/s40814-026-01825-7","DOIUrl":"10.1186/s40814-026-01825-7","url":null,"abstract":"<p><strong>Background: </strong>Face masks are a commonly used public health measure to control the spread of airborne infections, including in school-aged children. However, no trial of their effectiveness has been conducted in school settings to date. We undertook a mixed-method study to explore the feasibility of conducting such a trial.</p><p><strong>Methods: </strong>This study followed a multi-phased mixed-methods approach. We first conducted a secondary analysis of qualitative data (39 young people) and five Patient and Public Involvement focus groups (11 young people, three teachers, two parents), to understand the barriers and facilitators relating to engaging with a trial of face masks. Strategies to enhance recruitment and engagement were generated based on this qualitative work. These were refined further in additional PPI focus groups with young people (n = 7). We then conducted a 6-week two-arm parallel cluster-randomised feasibility trial in a local school. Two year groups were cluster-randomised into one of the two arms: (1) school rules group (SR, control), following school policy at the time on the use of face coverings; (2) face-mask group (FM, intervention), wearing standard lightweight surgical masks while in an indoor setting for the duration of the school day. Primary outcomes were recruitment and adherence to trial procedures: completion of surveys capturing frequency of mask-wearing, impact of mask-wearing, mood and compliance with the provision of weekly saliva samples for the detection of viral infections.</p><p><strong>Results: </strong>A total of 93 pupils (29% of approached) participated in the feasibility trial and were randomised (SR = 46, FM = 47). The number of intervention participants wearing face masks at all times while at school increased from 7% at baseline to an average of 28% over trial weeks 1-5. Completion rate of weekly surveys varied between 15 and 100%, while provision of weekly saliva samples varied between 15 and 38% over the trial period.</p><p><strong>Conclusion: </strong>Recruitment and adherence in the trial were lower than those observed in trials conducted in other community or healthcare settings. Our data suggest that incentivising participants, giving participants greater agency in how to fulfil trial procedures such as giving them choices on where to collect saliva samples, and allowing survey completion during timetabled activities would be important considerations for a future trial.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13383452/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147988215","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 and acceptability of a novel substance use prevention intervention.","authors":"Terrinieka W Powell, Bianca Smith, Wubishet Taye","doi":"10.1186/s40814-026-01839-1","DOIUrl":"10.1186/s40814-026-01839-1","url":null,"abstract":"<p><strong>Background: </strong>Youth exposed to household challenges are among the groups most vulnerable to early substance use. To address the needs of this group, this pilot study assessed the feasibility of participant recruitment and retention, as well as the acceptability of a novel substance use prevention intervention, Better Together, for Black youth exposed to household challenges.</p><p><strong>Methods: </strong>Participants were recruited using school and community presentations, digital flyers, and referrals. One-hundred twenty-seven students from two schools were screened. Participant enrollment, session attendance, and assessment completion were used to determine feasibility. Quantitative and qualitative data were collected after each session; responses were used to assess intervention acceptability. Demographic and substance use data were collected at baseline, post-test, and 1 month follow-up.</p><p><strong>Results: </strong>Fifty-nine youth were eligible, returned their parental permission forms, enrolled, and randomized. Nearly 90% of participants (n = 47) attended at least 5 sessions; the average number of sessions attended across conditions was 6.5. Fifty-four youth (92%) completed 1-month follow-up assessments. Session feedback forms showed that most students were happy after each session (61-85%). Qualitative feedback suggests that students were engaged in discussing the key messages using their own words. There were no significant changes in substance use knowledge or intentions over time or by condition. However, there was a small yet significant increase in substance use behaviors over time.</p><p><strong>Conclusions: </strong>Better Together may be a promising intervention to prevent substance use among Black youth exposed to household challenges. Findings suggest that recruiting, retaining, and engaging participants in the eight-session intervention is possible. Findings will inform plans to implement a full-scale study to evaluate the efficacy and contextual factors affecting program implementation.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov: NCT06594835. Registered: September 10, 2024 - Retrospectively registered, https://clinicaltrials.gov/study/NCT06594835?locStr=Baltimore,%20MD&country=US&state=Maryland&city=Baltimore&intr=Better%20Together&viewType=Card&rank=1 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13366981/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147974616","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":"Protocol for a feasibility study, without control group, of a combined treatment for PTSD and difficulties in emotion regulation for patients with substance use disorder.","authors":"Johanna Vigfusdottir, Edvard Breivik, Erlend Mork, Lars Lien, Håkon Stenmark, Egil Jonsbu","doi":"10.1186/s40814-026-01834-6","DOIUrl":"10.1186/s40814-026-01834-6","url":null,"abstract":"<p><strong>Background: </strong>There are high rates of co-occurring post-traumatic stress disorder (PTSD) among patients in treatment for substance use disorder (SUD). PTSD and SUD should be treated simultaneously, which is rarely the case. The reluctance to offer trauma-focused treatment is partially due to fear of increased risk of dropout. PTSD is related to emotion dysregulation and elevated psychological burden, higher dropout rates and increased risk of relapse. In this project, we plan to assess if it is relevant, feasible, acceptable and safe to add a combination of narrative exposure therapy (NET) and dialectical behaviour therapy for substance use disorder skills training (DBT-SUD Skills) to standard inpatient SUD treatment.</p><p><strong>Methods: </strong>We will recruit patients from a long-term inpatient SUD treatment centre on the west coast of Norway (N approx. = 90). We will assess relevance based on the prevalence of PTSD/Subthreshold-PTSD and traumatic experiences, suicidal behaviour, self-harm, and the severity of difficulties in emotion regulation. We will assess acceptability with treatment participation among patients and the subjective experience of the treatment. We will measure safety with the rate of dropout and destructive behaviour in the treatment period.</p><p><strong>Discussion: </strong>It is important to develop and evaluate treatment options for this vulnerable patient population, often excluded from clinical research. Strengths include a naturalistic setting and historical data for comparison. Limitations are the absence of a control group and inability to isolate component effects. The results can be used to develop a treatment protocol for combining NET and DBT-skills training to in patient SUD treatment for further development and testing in a multicentre Protocol following SPIRIT 2025 guidelines.</p><p><strong>Trial registration: </strong>This trial was retrospectively registered at ClinicalTrials.gov on 3 April 2024 (#203,428).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13343655/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942003","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":"Nephron Sparing Treatment (NEST) for small renal masses: understanding patients' and clinicians' experiences of a cohort-embedded randomised control trial.","authors":"Veronica Ranieri, Hannah Warren, Joana B Neves, Joseph Santiapillai, Nicola Rode, David Cullen, Graham Munneke, Miles Walkden, Prasad Patki, Ravi Barod, Faiz Mumtaz, Michael Aitchison, Elena Pizzo, Norman R Williams, William H Wildgoose, Kurinchi Gurusamy, Mark Emberton, Axel Bex, Maxine G B Tran","doi":"10.1186/s40814-026-01833-7","DOIUrl":"10.1186/s40814-026-01833-7","url":null,"abstract":"<p><strong>Background: </strong>To understand the perspectives and experiences of patients and healthcare professionals regarding the trial design, recruitment and randomisation process to a novel cohort-embedded RCT design for Nephron Sparing Treatment (NEST) for small renal masses.</p><p><strong>Methods: </strong>Participants were adult patients with a small renal mass (< 4 cm) randomised to receive either percutaneous cryotherapy (CRO) or robot-assisted partial nephrectomy (PRN), and clinicians involved in a trial comparing the two treatments. Semi-structured interviews followed a phenomenological approach and were transcribed verbatim and analysed using thematic analysis.</p><p><strong>Results: </strong>Interviews were conducted with 37 patients and 10 clinicians. Wanting to 'give back' influenced participants' decisions to take part in the trial. Most patients expressed that they had a positive and informed experience of the trial. Patients who accepted randomisation to cryotherapy (experimental intervention) were influenced by information provided regarding a potentially shorter recovery timeframe, length of hospitalisation, and lower risk of complication. Those who were randomised to receive partial nephrectomy (standard of care intervention) stated that they felt less anxious receiving 'non-experimental' treatment and felt safer in the knowledge that the tumour was removed. Clinicians expressed that the trial presented an opportunity to work collegially in identifying the best treatment for patients presenting with SRMs, though highlighted that limited consultation time was a challenge to recruitment.</p><p><strong>Conclusions: </strong>Findings support the potential feasibility of a future multicentre trial comparing percutaneous cryoablation to robot-assisted partial nephrectomy in the treatment of small renal masses. The study's design, process and intervention were accepted by most, though not all, participants.</p><p><strong>Trial registration: </strong>ISRCTN18156881.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13335343/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147932561","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":"Examining predictors of scale-up penalty in preliminary studies of health behavior interventions and subsequent larger trials: a meta-epidemiological review of diverse fields.","authors":"Lauren von Klinggraeff, Christopher D Pfledderer, Sarah Burkart, Kaitlyn Ramey, Michal Smith, Alexander C McLain, Bridget Armstrong, R Glenn Weaver, Anthony Okely, David Lubans, John P A Ioannidis, Russell Jago, Gabrielle Turner-McGrievy, James Thrasher, Xiaoming Li, Michael W Beets","doi":"10.1186/s40814-026-01836-4","DOIUrl":"10.1186/s40814-026-01836-4","url":null,"abstract":"<p><strong>Background: </strong>Scale-up penalty, a common phenomenon in which the promising effects found in early preliminary studies are substantially reduced when evaluated in a subsequent larger trial, can stall the advancement of health behavior interventions. In obesity-related behavioral interventions, changes to key features between a preliminary study and subsequent larger trials inflate scale-up penalty. The purpose of this study is to examine whether changes in intervention features occur in other behavioral disciplines that utilize a similar developmental continuum wherein smaller-scale preliminary studies inform larger-scale trials, and whether changes in key features inflate scale-up penalty.</p><p><strong>Methods: </strong>We conducted a systematic review identifying preliminary studies followed by a larger trial conducted by the same author(s) (i.e., a study pair) in four areas-tobacco/smoking cessation, alcohol use, interpersonal violence, and sexually transmitted diseases. We coded intervention features in the preliminary study and larger trial to capture changes in key study features (e.g., who delivered the intervention). Multi-level meta-regressions estimated the association between the changes to key study features and change in standardized mean difference for health outcomes and calculated scale-up penalty.</p><p><strong>Results: </strong>We identified 222 effects across 69 study pairs of preliminary studies with subsequent larger trials. Fifty-eight study pairs (84%) contained at least one change to a key study feature. Forty-nine study pairs were included in the meta-regressions (k = 154 effects). Changing the delivery agent, outcome measure, intervention duration, or implementation support in subsequent larger trials followed the hypothesized pattern with larger scale-up penalty (i.e., less effective at-scale) relative to study pairs that did not change those features.</p><p><strong>Conclusions: </strong>Multiple disciplines outside the obesity field make changes to key study features between preliminary studies and subsequent larger trials. Across disciplines, changes to the intervention delivery agent, intervention duration, outcome measurement, and reducing implementation support in subsequent larger trials are associated with inflated scale-up penalty. Recognition of the importance of key study features in preliminary studies and iterative intervention development could improve intervention scale-up.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13340402/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147932533","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":"Just in Time Adaptive Interventions for Behavioral Activation in Patients with Depression (JADE): protocol of a design, feasibility and preliminary effectiveness study.","authors":"Farid Chakhssi, Chani Nuij, Nadine Köhle, Eva Goedendorp, Jorge Piano Simoes, Alyssa Jongeneel, Gerben J Westerhof, Jannis Kraiss","doi":"10.1186/s40814-026-01835-5","DOIUrl":"10.1186/s40814-026-01835-5","url":null,"abstract":"<p><strong>Background: </strong>Depression is a major public health problem with a rising prevalence and a negative impact on quality of life, mortality, and morbidity. While effective treatments, such as behavioral activation, are available, they are only effective for approximately half of the patients. Adherence to activities between therapy sessions is associated with better outcomes in behavioral activation, yet adherence rates could be improved. Just-in-time adaptive interventions (JITAIs) offer the potential to improve adherence to activities and thus improve outcomes in behavioral activation for depression; however, to date, they have not yet been studied.</p><p><strong>Methods: </strong>This mixed-methods study uses a participatory design phase with 12 participants with depression and 4 therapists to develop JITAIs for behavioral activation in depression, through focus groups and thematic analyses to answer the specific design question. A subsequent evaluation phase consists of a micro-randomized trial to assess the proximal effects of JITAIs and a nonrandomized quasi-experimental design to evaluate the feasibility and changes in distal outcomes compared with treatment as usual (TAU). Participants diagnosed with depression will be recruited from a mental health institution: 52 receiving TAU plus JITAIs and 52 receiving TAU only. The primary outcome is feasibility, and JITAIs are considered feasible when the dose-received adherence rate is greater than 60%. The secondary outcomes are acceptance as measured via the System Usability Scale, the Client Satisfaction Questionnaire and the Twente Engagement with E-health Technologies Scale. Ecological momentary assessments of depression and well-being are used as proximal outcomes, and the Patient Health Questionnaire-9, the Mental Health Continuum-Short Form, the Questionnaire about the Process of Recovery, and the EuroQol-5 Dimension are used as distal outcomes at the end of treatment.</p><p><strong>Discussion: </strong>This study aims to develop and evaluate JITAIs to support behavioral activation in the treatment of depression. If feasible, JITAIs have the potential to be further examined in randomized controlled trials and benefit people with depression by providing a scalable way to improve adherence and outcomes in behavioral activation.</p><p><strong>Trial registration: </strong>The Netherlands Clinical Trial Register (NL-OMON57144), prospectively registered on October 22, 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13339454/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147932519","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":"Identifying biomarkers of neurodevelopmental and mental health outcomes in a prospective longitudinal cohort of South African children: design and feasibility of the Safe Passage BONO study.","authors":"Priscilla E Springer, Lucy T Brink, Mandy Potter, Wendy Mackay, Petrusa C Smit, Carlie du Plessis, Julia Koziel, Teresa Del Bianco, Bethany F M Oakley, Rianne Haartsen, Emily J H Jones, Marcus Munafò, Hein J Odendaal, Declan G Murphy, Eva Loth","doi":"10.1186/s40814-026-01790-1","DOIUrl":"10.1186/s40814-026-01790-1","url":null,"abstract":"<p><strong>Background: </strong>Early adversities before and after birth can impact children's cognitive and socioemotional development by altering critical brain maturational and functional processes. Some of these processes may be linked to later neurodevelopmental and/or mental health conditions. While most research is conducted in high-income countries, the majority of children live in low- and middle-income countries (LMICs) where they are more frequently exposed to poverty-related adversities. To address this gap, well-characterised longitudinal pregnancy cohorts in LMICs are needed to track trajectories of neurodevelopmental and mental health conditions in children exposed to cumulative environmental adversities. The Safe Passage Study (SPS) originally enrolled 7060 pregnant women from socioeconomically disadvantaged peri-urban communities in Cape Town, South Africa, to investigate the association between prenatal alcohol, multiple environmental risk factors and pregnancy outcome. The Safe Passage-Biomarkers of Neurodevelopmental Outcomes (BONO) study aims to follow up 2000 SPS children, aged 4-16 years, to assess the role of pre- and postnatal environmental factors in cognitive, neurodevelopmental and mental health outcomes. This report outlines the design and results of a feasibility study with 100 children, primarily aimed to confirm recruitment, assess participant retention, select measures and establish criteria for a deep-phenotyping visit.</p><p><strong>Methods: </strong>Between March and October 2019, 100 SPS children were screened during a \"broad-phenotyping visit\" for adverse childhood experiences and protective factors, autistic traits and socioemotional and behavioural symptoms, and they completed cognitive tests and eye-tracking and electroencephalography assessments to measure brain function. Criteria for a second \"deep-phenotyping\" visit were established based on autistic traits, internalising/externalising scores and/or cognitive difficulties, to assess children and their mothers in terms of clinical and neurocognitive profile.</p><p><strong>Results: </strong>Recruitment was adequate with a 96% retention rate for the deep-phenotyping visit. Feasibility study participants resembled the larger SPS cohort in most demographic and prenatal factors, except for higher prenatal depression and overcrowding indices. Most clinical and experimental measures were deemed suitable with minor modifications, and acquisition rates were high. The nature and length of visits were acceptable to families and testers. Threshold scores were adjusted to include 30% of participants for deep phenotyping.</p><p><strong>Conclusions: </strong>The feasibility study fulfilled progression criteria for the planned multimodal study.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13162464/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147875282","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 of early interval training in patients recovering from heart valve surgery due to infective endocarditis.","authors":"Margrethe Müller, Tove Aminda Hanssen, David Johansen, Øyvind Jakobsen, John Erling Pedersen, Inger Lise Aamot Aksetøy, Trine Bernholdt Rasmussen, Gunnar Hartvigsen, Vegard Skogen, André Henriksen, Gyrd Thrane","doi":"10.1186/s40814-026-01830-w","DOIUrl":"10.1186/s40814-026-01830-w","url":null,"abstract":"<p><strong>Background: </strong>Infective endocarditis is an infectious heart disease strongly associated with morbidity and mortality. Up to half of the patients with infective endocarditis require heart valve surgery. While early exercise-based rehabilitation is well documented for patients recovering from heart surgery for non-infective endocarditis, there is limited research on those who have undergone valve surgery due to this infection. This study aimed to explore the early aerobic training in this patient population.</p><p><strong>Methods: </strong>A single-centre prospective feasibility study was conducted using the UK Medical Research Council's framework for complex interventions. The study investigated the feasibility (recruitment, retention, adherence), safety, acceptability, and preliminary functional outcomes of 4 × 4 interval training in this patient population. Training session data included the number, duration, and intensity, which were monitored via the Apple Watch S5 (Present Age-Predicted Maximum Heart Rate) and the Borg RPE scale. Functional outcomes were evaluated at baseline and 3 months post-surgery, including sub-maximal oxygen uptake (treadmill protocol), 6-min walk test, and quality of life (HeartQoL, EQ-5D-5L).</p><p><strong>Results: </strong>Sixteen patients consented to participate, with 12 initiating the intervention and 11 completing it, yielding a retention rate of 91.7%. Training adherence averaged 73.1% of the minimum expected sessions, with high participant satisfaction and no serious adverse events reported. At the 12-week follow-up, participants demonstrated measurable change in functional capacity, including an increase in workload capacity (+ 95 W), METs (+ 3.4), and 6-min walk test distance (+ 219 m). Health-related quality of life also showed a noticeable increase, with HeartQoL physical and emotional scores increasing by 1.0 and 1.3, respectively, and EQ-5D-5L VAS scores rising by 17.2. The EQ-5D-5L index increased from 0.61 at baseline to 0.87 after 12 weeks.</p><p><strong>Conclusion: </strong>Interval training, when conducted with appropriate safeguards and tailored to individual needs, is a feasible and safe intervention for patients recovering from endocarditis and cardiac surgery. The observed improvements in functional capacity, quality of life, and patient satisfaction support the need for larger controlled studies.</p><p><strong>Trial registration: </strong>Clinical Trials, ID NCT05703022. Registered on 25 November 2021, http://www.</p><p><strong>Clinicaltrials: </strong>gov.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13335363/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147875301","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}