Pilot and Feasibility Studies最新文献

{"title":"Mindfulness-Based Stress Reduction adapted to pregnant women with psychosocial vulnerabilities - a randomized feasibility trial in a Danish hospital-based outpatient setting.","authors":"Sine Skovbjerg, Michelle Kolls, Anette Kjærbye-Thygesen, Lone Overby Fjorback","doi":"10.1186/s40814-025-01670-0","DOIUrl":"10.1186/s40814-025-01670-0","url":null,"abstract":"<p><strong>Background: </strong>Supporting prenatal mental health in women with a preconception history of mental disorders or psychosocial vulnerability is important for a positive transition to parenthood. There is a need for more evidence-based and non-pharmacological mental health interventions in antenatal care. The primary objective of this trial was to evaluate the feasibility of prenatal MBSR, which is an adaption of Mindfulness-based stress reduction (MBSR). This to inform a randomized controlled trial.</p><p><strong>Methods/design: </strong>The trial was conducted at an obstetric outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre, Denmark. The outpatient clinic specializes in antenatal care for pregnant women with psychosocial vulnerabilities. Pregnant women were randomly assigned to an intervention group receiving prenatal MBSR or a waitlist control group. The primary outcome was the feasibility of a full-scale randomized controlled trial (RCT). Second, to examine trends in self-reported outcomes, i.e., mental well-being, perceived stress, anxiety, depression, decentering, reflective functioning, mindfulness, and self-compassion.</p><p><strong>Results: </strong>Of 123 eligible women, 73 consented to participate (59.3%). The majority (75.3%) were nulliparous. The mean age was 30.7 (SD 4.7) years, and most participants were employed (74%) and living with a partner (93.1%) at the time of recruitment. The majority of participants had a history of one or more mental disorders. Most frequently depression or an anxiety disorder. For the intervention group (n = 37), 54.1% completed the prenatal MBSR program. The loss to follow-up was 56.8% for the intervention group (n = 21) and 50% for the waitlist control group (n = 18). For the secondary outcomes, all variables except for reflective functioning pointed in the expected direction, e.g., improved mental well-being, reduced mental distress, and more self-compassion.</p><p><strong>Conclusions: </strong>The results from this trial suggest that prenatal MBSR is a feasible intervention for a clinical setting, supporting the conduct of an RCT. Strategies for improving adherence and reducing the extent of missing data would be advisable in a future RCT. Overall, there is a need for more evidence-based and non-pharmacological interventions addressing prenatal mental health. Results from a future RCT could thus be of relevance to antenatal care.</p><p><strong>Trial registration: </strong>NCT04571190, September 30, 2020 (ClinicalTrials.gov).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"86"},"PeriodicalIF":1.5,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340361","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":"Could a feedback device help manage work-related shoulder disorders?: protocol of a mixed methods pilot study.","authors":"Philippe Meidinger, Quan Nha Hong, Jean Tittley, Alexandre Campeau-Lecours, Jean-Sébastien Roy","doi":"10.1186/s40814-025-01646-0","DOIUrl":"10.1186/s40814-025-01646-0","url":null,"abstract":"<p><strong>Background: </strong>Work-related shoulder disorders (WRSDs) significantly impact workers' health and well-being. Various factors contribute to WRSDs, including work environment, physical workload, psychological stressors, and an aging workforce. Despite numerous interventions proposed to address WRSDs, finding high-quality evidence to support any of them remains challenging. One potential reason is the lack of valid tools to measure physical workload and customize interventions. To address this, we developed a portable feedback system, the ShoulderWatchLoad (SWL), designed to estimate physical work demands on the shoulder. The objectives of this pilot study are (a) to evaluate the feasibility of implementing the SWL in the workplace and conducting a large-scale randomized clinical trial (RCT) by assessing recruitment success, intervention adherence, usability of the technology, and the research team's capacity to refine the SWL and (b) to explore the SWL capacity to reduce disability, pain, work limitations, and physical work demands while increasing pain self-efficacy among workers with WRSDs.</p><p><strong>Methods/design: </strong>A convergent mixed methods pilot study will be conducted. The quantitative component will consist of a two-arm parallel group external pilot RCT involving 42 participants with WRSDs who will be randomized into one of the two study groups. Following baseline evaluation, all participants will attend an education session in the workplace. Following this session, participants of the experimental group will receive a 2-week workplace intervention using feedback from the SWL, while participants in the control group will not receive this intervention. All participants will undergo four evaluations over a 12-week period (baseline, 3rd, 6th, and 12th weeks). The qualitative component will be a interpretative descriptive qualitative study involving three focus groups with 21 participants from the experimental group. An innovative joint display will be used to represent the integration of qualitative and quantitative data, along with progression criteria, to draw meta-inferences about the feasibility of implementing the SWL in the workplace and conducting a full-scale RCT in the future.</p><p><strong>Discussion: </strong>A holistic approach combining qualitative and quantitative elements will enable us to determine the SWL usability and whether the conduct of a full RCT is feasible.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06693479.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"84"},"PeriodicalIF":1.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180215/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144336733","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":"Correction: Rationale for a 4-month, parallel-group, randomized controlled trial to assess the Feasibility and Efficacy of a Remotely delivered exercise training intervention for Hispanics/Latinos with Multiple Sclerosis (FERLA MS).","authors":"Victoria A Flores, Stephanie L Silveira, David X Marquez, Dominique Kinnett-Hopkins, Augusto Miravalle, Fabian Sierra-Morales, Zulma Hernández-Peraza, Robert W Motl","doi":"10.1186/s40814-025-01666-w","DOIUrl":"10.1186/s40814-025-01666-w","url":null,"abstract":"","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"85"},"PeriodicalIF":1.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181881/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144336732","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":"Supporting the mental health of adolescent mothers in Kenya and Mozambique: pilot protocol for the Thriving Mamas programme.","authors":"Tatiana Taylor Salisbury, Maria Suzana Bata Maguele, Fernando Chissale, Málica de Melo, Margrette Hanselmann, Kethakie Lamahewa, Evaline Lang'at, Flávio Mandlate, Lucy Nyaga, Nadine Seward, Marleen Temmerman","doi":"10.1186/s40814-025-01617-5","DOIUrl":"10.1186/s40814-025-01617-5","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Poor mental health among adolescent girls during pregnancy and the year after birth (the perinatal period) has been found to have a significant detrimental effect on girls and their children. The Innovative approaches to adolescent perinatal wellbeing (INSPIRE) project co-designed an intervention (Thriving Mamas) to improve adolescent perinatal mental health in Kenya and Mozambique. The aim of the current study is to pilot test the co-designed intervention to understand how it can be adapted for further testing or scale-up.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A mixed-method, pilot cluster-randomised, effectiveness-implementation Hybrid Type II trial will be conducted among 80 adolescent girls (aged 15-19 years) attending health facilities in Kenya and Mozambique. Girls attending health facilities randomised to the intervention arm will be recruited to receive the intervention in addition to usual care. Girls attending control arm facilities will receive usual care only. Implementation data on feasibility, acceptability, appropriateness, and fidelity of intervention training and delivery will be collected from providers and adolescents. Additional data on provider knowledge, attitudes, and competency will be collected pre- and post-training. Adolescent girls will provide assessments of depression, anxiety, quality of life, social support, parenting competency, and health behaviours before, during, and after delivery of the intervention. At the end of the study, qualitative interviews will be conducted to collect further data on perceptions of the intervention, its implementation, and its impact. Implementation data will be analysed to determine its potential for delivery and success within each context. Individual outcome data analyses will be reported to gain a better understanding of the initial impact of the intervention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;The Thriving Mamas intervention addresses the challenges to maintaining positive mental health during the perinatal period. It was co-designed with adolescents and their communities to address local priorities and needs. The results of this study will provide information on its potential for sustainable implementation as well as initial data on its impact on mental health, parenting, and health behaviour outcomes. These results will inform the further refinement of the intervention and implementation strategies as well as the design of a full trial to test their effectiveness.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Ethical approval for this feasibility study has been obtained in Kenya (Aga Khan University Institutional Scientific and Ethics Review Committee, ref: 2023/ISERC-23 (v2)), Mozambique ( Tete Inter-Institutional Health Bioethics Committee, ref: 24/CIBST/23), and the UK (Psychiatry, Nursing and Midwifery Research Ethics Committee, King's College London, ref: HR/DP-22/23-37,125). It was registered at Clinicaltrials.gov (NCT06040359) on September 15, 2023","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"83"},"PeriodicalIF":1.5,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180160/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144333780","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 of testing the feasibility and acceptability of two brief dyadic sleep interventions for adults with cancer and their bedpartner caregivers.","authors":"Youngmee Kim, Thomas C Tsai, Jennifer L Steel, Alberto R Ramos, Jean-Philippe Laurenceau, Wendy M Troxel","doi":"10.1186/s40814-025-01671-z","DOIUrl":"10.1186/s40814-025-01671-z","url":null,"abstract":"<p><strong>Background: </strong>Sleep disturbance is common and problematic among both patients with cancer and their bedpartner caregivers. Although one's sleep affects the partner's sleep, existing cognitive-behavioral interventions have rarely targeted sleep problems of patients and caregivers simultaneously.</p><p><strong>Methods: </strong>This protocol is to test the feasibility and acceptability of two brief dyadic sleep interventions [My Sleep Our Sleep (MSOS) and Brief Behavioral Treatment for Insomnia for Couples with Cancer (BBTI-CC)] that are designed to reduce sleep disturbance and improve health-related quality of life in adults with cancer and their bedpartner caregivers. Participants (patient-caregiver dyads) will be randomly assigned to either intervention condition. Both interventions will be delivered weekly for 4 weeks. Questionnaire, daily sleep logs, and objectively assessed sleep data will be collected before the intervention (T1), 1-week (T2) and 8-week (T3) after conclusion of the intervention. Participant-reported satisfaction with the intervention will be assessed at the end of each of the four intervention sessions.</p><p><strong>Discussion: </strong>We estimate 50 dyads will be enrolled (50 patients and 50 caregivers; 25 dyads in each intervention condition). In both conditions, we expect > 75% of eligible and screened dyads will consent to participate within the enrollment period, > 80% of enrolled dyads will complete the intervention, and > 80% of participants will report satisfaction across all acceptability measures. Additionally, we will explore if both MSOS and BBTI-CC reveal a similar effect on overall sleep disturbance, insomnia severity, and health-related quality of life. Results will inform the feasibility and acceptability of conducting brief dyadic sleep interventions and provide preliminary data to guide further refinement of intervention content and procedure for adult patients with cancer and their bedpartner caregivers in a full trial.</p><p><strong>Trial registration: </strong>NCT06569693 Clinicaltrials.gov, registered August 22 2024, https://register.</p><p><strong>Clinicaltrials: </strong>gov/prs/app/action/SelectProtocol?sid=S000ESX9&selectaction=Edit&uid=U0005GPT&ts=2&cx=nb0aq5 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"82"},"PeriodicalIF":1.5,"publicationDate":"2025-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12166573/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144294796","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":"Education and Music Intervention to Reduce Anxiety (EMIRA) in cardiac catheterization: intervention development.","authors":"Letícia de Carvalho Batista, Marina de Góes Salvetti, Rita de Cassia Gengo E Silva Butcher","doi":"10.1186/s40814-025-01663-z","DOIUrl":"10.1186/s40814-025-01663-z","url":null,"abstract":"<p><strong>Background: </strong>Anxiety related to cardiac catheterization (ARCC) is highly prevalent and most severe in the immediate preoperative period. ARCC is associated with increased myocardial oxygen consumption, blood pressure variability, and increased risk of arrhythmias, leading to higher rates of intraoperative complications and worse physical, emotional, and cognitive functioning.</p><p><strong>Objective: </strong>To describe a nurse-led complex intervention (CI) designed to reduce ARCC in adults before a cardiac catheterization (CC).</p><p><strong>Methods: </strong>To design the intervention, a concept analysis yielded the identification of ARCC antecedents and attributes, based on which CI components and objectives were determined. For each component, CI procedures, mode of delivery, and dose were established based on empirical evidence. The CI was reported according to the Template for Intervention Description and Replication checklist.</p><p><strong>Results: </strong>The Education and Music Intervention to Reduce Anxiety (EMIRA) consists of two components. The educational component provides the essential information regarding CC purpose, catheterization laboratory features, and what to expect before, during, and after the procedure. The musical component provides individuals with a feeling of comfort and relaxation. EMIRA is delivered in one 30-min session using an audiovisual format. EMIRA's expected primary outcome is a decreased state anxiety level. Additionally, EMIRA might reduce blood pressure, heart and respiratory rates, and chest pain.</p><p><strong>Conclusions: </strong>EMIRA is a CI developed with methodological rigor. Future studies should evaluate the acceptability, feasibility, and efficacy of EMIRA.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"80"},"PeriodicalIF":1.5,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12142818/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144249236","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":"Infant Parent Support (IPS): a multidisciplinary intervention to improve the mental health of children with a social worker - a study protocol for a feasibility randomised controlled trial with embedded process evaluation.","authors":"Jaycee Pownall, Karen Crawford, Lindsay Dalgarno, Judith Fisher, Sharon Graham, Fiona Turner, Helen Minnis, Kathleen Boyd, Abril Seyahian, Alex McConnachie, Nicola Cosgrave, Matt Forde, Carol Atkinson, Janet McCullough, Kapil Sayal, Dennis Ougrin","doi":"10.1186/s40814-025-01616-6","DOIUrl":"10.1186/s40814-025-01616-6","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;In many families where children have a social worker, parents have experienced challenges in their own childhoods or have neurodevelopmental conditions. These families often endure significant stress, which is frequently worsened by financial or housing challenges. This added pressure can strain relationships and increase the risk of child maltreatment, as well as contribute to mental health issues in children. Relationship-focused interventions show promise in preventing child maltreatment, although there are currently no interventions that simultaneously address neurodevelopmental conditions and the impact of poverty. We have co-produced, alongside parent experts-by-experience, local stakeholders, and infant mental health practitioners, a new service called Infant Parent Support (IPS). IPS will i) adopt a relationship-focused approach to comprehensive understanding of family functioning, ii) incorporate child and parent mental health and neurodevelopmental awareness, and iii) ensure a poverty aware approach throughout. The aim of this phase is to investigate the feasibility of a definitive Randomised Controlled Trial (RCT) of IPS compared with services-as-usual (SAU).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study settings are social care services in two local authorities: Glasgow City Council (Scotland) and the London Borough of Bromley (England). Our target population is children on a 'child in need' plan (or the Scottish equivalent) and eligible participants are families where i) the infant(s) are aged 0-5 years and ii) the family has an allocated social worker plus a multi-agency support plan. Thirty participants will be identified by social workers and randomised to receive either IPS or SAU. Families randomised to IPS will receive an intensive multidisciplinary attachment-focused assessment that provides a foundation for relationship-focused interventions. IPS will incorporate child and parent mental health and neurodevelopmental awareness and ensure a poverty aware approach throughout. Families randomised to SAU will receive the assessment and support that social care services normally implement. We will utilise a pre-post and 3/6-month follow-up design with embedded mixed-method process evaluation and exploratory economic analysis. The primary objective is to assess if enough families can be recruited, randomised, and retained in the trial such that a full-scale RCT is likely to be feasible. The secondary objectives are to assess the acceptability and feasibility of the planned outcome measures and the IPS intervention to families and professionals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;A service like IPS, that uses a relationship-focused approach to child and parent mental health, neurodevelopmental and money/housing problems, has never previously been tested. Therefore, there are several areas of uncertainty that need to be addressed before moving onto a definitive RCT. TRIAL REGISTRATION {2A AND 2B}: Register","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"78"},"PeriodicalIF":1.5,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12139322/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144234735","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":"Continuous positive airway pressure versus usual care for obstructive sleep apnoea in pregnancy: a two-step pilot trial.","authors":"Rachael Nugent, Caroline de Costa, Leonie Callaway, Shiv Erigadoo, Elise Gilbertson, Chris Brown, Joanna Perry-Keene, Rebekah Shakhovskoy, Lauren Kearney","doi":"10.1186/s40814-025-01645-1","DOIUrl":"10.1186/s40814-025-01645-1","url":null,"abstract":"<p><strong>Background: </strong>Obstructive sleep apnoea (OSA) is associated with increasing body mass index (BMI) and affects up to 15% of pregnant women. OSA in pregnancy can be associated with adverse maternal and neonatal outcomes. Continuous positive airway pressure (CPAP) may be an effective treatment for OSA during pregnancy.</p><p><strong>Aim: </strong>To examine the feasibility and acceptability of screening women with a BMI ≥ 35 kg/m² for OSA in pregnancy, followed by randomisation to treatment with CPAP or no CPAP for women diagnosed with moderate to severe OSA.</p><p><strong>Methods: </strong>This study was a single-centre, two-stage pilot study. Firstly, all consenting participants were screened for OSA and then, only if diagnosed with moderate to severe OSA (AHI ≥ 15), randomised to CPAP or no CPAP. The feasibility of the OSA screening was determined by recruitment rates. A priori criteria of > 20% recruitment to the sleep study were considered feasible. The acceptability of the sleep study was examined using the completion rate and reasons for withdrawal prior to the sleep study. The acceptability of CPAP randomisation was assessed by completion rates for women randomised, adherence to CPAP, reasons for withdrawal, and the review of quality-of-life measures over the course of pregnancy.</p><p><strong>Results: </strong>Ninety-six women with a BMI ≥ 35 kg/m² before 26 completed weeks of pregnancy were invited to participate from the Sunshine Coast University Hospital and Health Service. Overall, 36 women enrolled, giving a recruitment rate of 37%. A total of 75% (n = 26) of recruited women completed OSA screening (clinical history, questionnaires, and formal sleep study). Subsequently, six (6%) of invited women had an apnoea hypopnoea index (AHI) ≥ 15/h and were diagnosed with moderate to severe OSA and underwent randomisation to receive treatment with CPAP (n = 4) or no CPAP (n = 1) until birth. One woman withdrew after randomisation to treatment. Nine women withdrew prior to full completion of OSA screening and one following an inconclusive sleep study. Women who had a sleep study found it acceptable, and in women randomised to CPAP, adherence averaged 4.86 h/night. Quality-of-life measures were similar when measured over two time points in pregnancy.</p><p><strong>Discussion: </strong>A definitive trial screening women for OSA and subsequent randomisation to treatment or no treatment may be feasible. Future trials should be resourced to expand inclusion criteria, improve accessibility for participants, evaluate clinical and cost-effectiveness, and investigate partial treatment effects.</p><p><strong>Trial registration: </strong>ACTRN, ACTRN12621001523897. Registered 9 September 2021 - retrospectively registered, https://www.anzctr.org.au/Trial/Update/Step8_Update.aspx?id=382640.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"79"},"PeriodicalIF":1.5,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12139340/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144234813","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":"Results from a randomized controlled pilot trial of a home-visiting intervention to reduce child maltreatment.","authors":"Joakim Finne, Anne Grete Tøge, Kjersti Stabell Wiggen, Maria Ekre, Ira Malmberg-Heimonen, Maiken Pontoppidan, Jacinthe Dion, Truls Tømmerås, Eirin Pedersen","doi":"10.1186/s40814-025-01659-9","DOIUrl":"10.1186/s40814-025-01659-9","url":null,"abstract":"<p><strong>Background: </strong>Child maltreatment has severe and lasting consequences, and evidence-based interventions are essential for its prevention. However, few randomized controlled trials (RCTs) have been conducted within child welfare settings in Norway. Pilot trials play an important part in assessing the acceptability and feasibility of such interventions prior to full scale evaluations. This study evaluated the acceptability and feasibility of conducting a full-scale RCT of the Family Partner home-visiting intervention, designed to reduce the risk of child maltreatment.</p><p><strong>Methods: </strong>Families from three child welfare offices in Norway with at least one child under the age of 12 were invited to participate in this pilot trial. A two-arm randomized design was used, with participants allocated in a 1:1 ratio to either the intervention or control group (n = 45). The intervention group received the home-visiting Family Partner intervention, while the control group received treatment as usual. A qualitative process evaluation was conducted alongside the trial, comprising 29 interviews with Family Partners, caseworkers, participating families, and other stakeholders. Statistical and qualitative analyses evaluated participant acceptability, adherence, and retention.</p><p><strong>Results: </strong>Qualitative findings indicate a high level of acceptability for the Family Partner intervention across all stakeholder groups. Adherence was strong, with no participants withdrawing consent and only two opting out of subsequent surveys. However, participant retention declined over time, with survey response rates dropping at each time point and only 42% completing the final assessment.</p><p><strong>Conclusions: </strong>This pilot trial provides preliminary evidence supporting the acceptability of the Family Partner intervention within child welfare services and highlights important considerations regarding the feasibility of conducting RCTs in this setting.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier NCT04957394.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"77"},"PeriodicalIF":1.5,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144216597","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 co-creating and delivering a youth-led noncommunicable diseases risk reduction intervention in schools of slums in Karachi, Pakistan: protocol for a mixed-methods, pre- and post-intervention study.","authors":"Sabahat Naz, Munazzah Ilyas, Romaina Iqbal","doi":"10.1186/s40814-025-01662-0","DOIUrl":"10.1186/s40814-025-01662-0","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Adolescents are more susceptible to the shared risk factors of noncommunicable diseases (NCDs), including physical inactivity, tobacco use (smoking and smokeless), and unhealthy diets. However, there is limited literature from Pakistan that involves school-going adolescents in developing and delivering NCD risk-reduction interventions among their younger peers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to assess the feasibility of co-creating and delivering a youth-led NCD risk reduction intervention in schools of slums in Karachi, Pakistan.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Using a mixed-methods, pre- and post-intervention design approach, we will conduct the study in 10 randomly selected schools (5 government and 5 private) in Azam Basti and Mehmoodabad, the urban slums in Karachi. The study comprises five sequential phases: Phase I involves identifying shared risk factors of NCDs among younger peers aged 9 to 12 (grades 5 and 6 students) (n = 100) using structured diaries, which will also serve as a pre-intervention assessment. Phase II entails conducting qualitative interviews with youth aged 14 to 16 (grades 9 and 10 students) (n = 40), their parents, school head teachers, class teachers, and canteen staff to discuss intervention components, materials, and delivery methods. In Phase III, workshops will be held to co-create the intervention with the help of youth. Phase IV will involve 3 days of comprehensive youth training by a qualified nutritionist on delivering the intervention to their younger peers. Finally, in Phase V, youth will deliver the intervention among all grades 5 and 6 students in their schools, followed by a post-intervention assessment, in which the younger peers will complete the structured diaries for the shared risk factors. Two independent data collectors will also perform fidelity checks of the intervention delivery using a checklist. The expected outcomes will include the feasibility of developing and implementing a culturally relevant youth-led NCD risk reduction intervention and youth training manual. The feasibility of the intervention will be assessed using the recruitment and retention rates for schools, youth, and younger peers, youth attendance at workshops and training sessions, structured diaries completion rates at pre- and post-intervention, the fidelity of delivering the intervention, and the preliminary change in the risk factors at post-intervention compared to the baseline.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Ethics and dissemination: &lt;/strong&gt;The study was approved by the Ethical Review Committee of the Aga Khan University (ref.: 2024-9763-29,256). If the intervention proves feasible, we will disseminate our findings to both academic and nonacademic audiences. Additionally, we will implement a definitive trial across various slum settings in Karachi, Pakistan.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ClinicalTrials.gov, NCT06465771. Registered 20 June 2024-prospectively registered,  h","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"76"},"PeriodicalIF":1.5,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131587/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144209169","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}