Contemporary Clinical Trials Communications最新文献

{"title":"A randomized controlled trial protocol for evaluating the feasibility, acceptability, and work outcomes of individualized placement and support adapted for autistic adults in the community","authors":"Marjorie Solomon ,&nbsp;Jo A. Yon-Hernández ,&nbsp;Steve Ruder ,&nbsp;Susan R. McGurk ,&nbsp;Daniel Tancredi ,&nbsp;Yukari Takarae ,&nbsp;Aubyn C. Stahmer","doi":"10.1016/j.conctc.2025.101536","DOIUrl":"10.1016/j.conctc.2025.101536","url":null,"abstract":"<div><div>Relatively few autistic adults, including those with average intellectual abilities, are competitively employed, meaning that they hold jobs together with non-disabled workers and receive comparable wages and benefits. In California, for example, most autistic individuals served by the state are placed in programs where they participate in skill-building and socialization but not in actual competitive jobs. Failure to participate in the labor force can diminish autistic workers’ sense of purpose, well-being, and ability to earn a living wage.</div><div>Available research suggests that supported employment that assists autistic adults in finding and keeping jobs, produces the highest sustained competitive employment rates. Thus, our team has been investigating the Individualized Placement and Support (IPS) model, which has an extensive evidence base for increasing competitive employment rates in individuals with chronic mental illnesses. In a California Department of Developmental Services Employment Grant investigating adults with autism and intellectual disabilities, we demonstrated a competitive employment placement rate of 52 % using IPS. Components of IPS were appropriate for this population, however there were implementation challenges related to IPS model fit with the vocational support agencies.</div><div>Based on focus groups and stakeholder input, we have adapted IPS to provide intensive agency training, leadership education, and record keeping support. Herein, we detail a protocol for a randomized controlled trial of the adapted model (IPS-AUT) to evaluate feasibility, acceptability, and work outcomes. We also investigate potential moderators and mediators of treatment effectiveness to provide a foundation for a larger more adequately powered randomized clinical trial.</div><div>This protocol is registered at ClinicalTrials.gov: NCT 06829264.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101536"},"PeriodicalIF":1.4,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144890874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peer delivered, emotion regulation-focused mental health prevention training for fire fighter trainees: Design and methodology of a randomized controlled trial","authors":"Eric C. Meyer ,&nbsp;Todd Farchione ,&nbsp;Nathan A. Kimbrel ,&nbsp;Oi-Man Kwok ,&nbsp;Michelle L. Pennington ,&nbsp;Jessica Rostockyj ,&nbsp;Suzy B. Gulliver","doi":"10.1016/j.conctc.2025.101537","DOIUrl":"10.1016/j.conctc.2025.101537","url":null,"abstract":"<div><div>Fire fighters (FFs) risk their lives, health, and well-being through trauma exposure and other occupational stressors. FFs report concerning rates of mental health challenges, alcohol use disorders, and suicide risk. These problems tend to co-occur, as each is linked with reliance on maladaptive emotion regulation strategies. As FFs advance in their careers, many tend to rely more heavily on these maladaptive emotion regulation strategies, thus exacerbating the problems. Many FFs leave fire service prematurely due to mental and physical health problems. FFs must be equipped with more effective emotion regulation skills to buffer against stressors they will face. FFs may benefit from training in transdiagnostic emotion regulation skills delivered by credible peers upon entry and socialization into the profession, potentially preventing substantial negative outcomes downstream while promoting resilience and wellness. This paper describes a cluster randomized controlled trial to compare peer-delivered emotion regulation training with peer-delivered psychoeducation regarding mental health, both delivered during the fire academy, for preventing symptoms of PTSD (primary outcome), depression, anxiety, alcohol use disorder, and functional impairment. Emotion regulation training is based on the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Participants will be a non-clinical population of FF trainees completing the fire academy at 10–12 cities nationwide (<em>N</em> = 312). Participants will be cluster randomized to training condition by recruit class. Subsequent recruit classes will then alternate between conditions within each city. Assessment measures will be administered at pre-training baseline, post-training, and at 6-, 12-, 18-, and 24 month follow-ups.</div></div><div><h3>Clinical trial registration</h3><div>NCT06290778.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101537"},"PeriodicalIF":1.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144890873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mindfulness vs. sleep education during autologous hematopoietic cell transplantation for multiple myeloma: Feasibility of a randomized controlled pilot study","authors":"Elisabeth C. Henley ,&nbsp;Hannah A. Liphart ,&nbsp;Keayra J. Morris ,&nbsp;Iwalola Awoyinka ,&nbsp;Michael R. Irwin ,&nbsp;Erin S. Costanzo ,&nbsp;Diana Winston ,&nbsp;Anita D'Souza ,&nbsp;Melinda Stolley ,&nbsp;Binod Dhakal ,&nbsp;Meera Mohan ,&nbsp;Marcelo C. Pasquini ,&nbsp;Steven W. Cole ,&nbsp;Erin S. Doerwald ,&nbsp;Peyton C. Bendis ,&nbsp;Kelly E. Rentscher ,&nbsp;Meredith E. Rumble ,&nbsp;Aniko Szabo ,&nbsp;Sridhar Rao ,&nbsp;Jennifer M. Knight","doi":"10.1016/j.conctc.2025.101540","DOIUrl":"10.1016/j.conctc.2025.101540","url":null,"abstract":"<div><h3>Background</h3><div>Sleep disturbance is common in patients receiving hematopoietic stem cell transplantation (HCT). Mindfulness-based interventions (MBIs) can improve sleep quality during and following cancer treatment by reducing treatment-related symptoms and enhancing immune function.</div></div><div><h3>Methods</h3><div>We conducted a randomized controlled pilot study investigating the feasibility of implementing Mindfulness Awareness Practices for Insomnia (MAP-I) in patients with multiple myeloma (MM) undergoing autologous HCT. Patients were randomized to receive either MAP-I or a Sleep Health Education (SHE) intervention, both consisting of six videos viewed pre-HCT and three virtual sessions in the two weeks post-HCT. Feasibility was assessed by meeting an enrollment rate of 35% and a retention rate of 85%.</div></div><div><h3>Results</h3><div>We screened 120 patients; 54 (45%) were deemed ineligible and 42 (35%) declined participation. Twenty-four of the 66 eligible patients approached were enrolled into the study (36.4% enrollment rate) and were randomized to either MAP-I or SHE. Seven patients completed the study (29.2% retention rate). Most participants who withdrew consent cited feeling overwhelmed or too sick to continue post-HCT. Amendments were iteratively implemented to increase enrollment and retention rates including addition of a study incentive, modifications to the video timeline, and earlier introduction of the mindfulness instructor.</div></div><div><h3>Conclusion</h3><div>Study results detail challenges and opportunities in retaining patients with MM in a virtual MBI sleep intervention during the peri-transplant period. While enrollment met feasibility criteria, most patients felt too overwhelmed or sick in the peri-transplant period to complete the intervention and associated study tasks. Future research should investigate MBIs at other time points throughout HCT.</div></div><div><h3>Trial registration</h3><div>NCT04271930, 2/17/2020.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101540"},"PeriodicalIF":1.4,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144890872","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating digital intervention approaches for supporting immigrant women with intimate partner violence experiences: Findings from the It's weWomen plus sequential multiple assignment randomized trial (SMART)","authors":"Bushra Sabri ,&nbsp;Jian Li ,&nbsp;Subhash Aryal ,&nbsp;Theresa Mata ,&nbsp;Sarah M. Murray ,&nbsp;Nancy Glass ,&nbsp;Jacquelyn C. Campbell","doi":"10.1016/j.conctc.2025.101539","DOIUrl":"10.1016/j.conctc.2025.101539","url":null,"abstract":"<div><h3>Background</h3><div>Intimate partner violence (IPV) disproportionately affects immigrant women, who often face barriers to accessing in-person services. Digital interventions offer a promising alternative by providing tailored, remote support.</div></div><div><h3>Methods</h3><div>In this SMART trial, 1265 foreign-born immigrant women across the U.S. were randomized to a personalized online (<em>n</em> = 660) or standard online safety information (<em>n</em> = 605) intervention. At 3 months, low responders (<em>n</em> = 366) were re-randomized to receive text-only (<em>n</em> = 183) or text + phone support (<em>n</em> = 183). Outcomes were assessed at 6 and 12 months.</div></div><div><h3>Results</h3><div>All groups showed reduced physical and sexual IPV over time, with no significant differences between first-stage conditions. Low responders in the text + phone group demonstrated significantly greater reductions in physical and sexual IPV (<em>d</em> = −0.25, <em>p</em> &lt; 0.01), depression (<em>d</em> = −0.22, <em>p</em> &lt; 0.01), and increased empowerment (<em>d</em> = 0.22, <em>p</em> &lt; 0.01), from 3 to 12 months, compared to responders. These between-group effects were supported by significant within-group improvements, with the text + phone group narrowing or closing the gap with responders in most outcomes by 12 months. Among low responders initially assigned to the personalized online intervention, those re-randomized to text + phone support outperformed those receiving text-only support—showing significantly greater reductions in IPV (<em>d</em> = −0.32, <em>p</em> &lt; 0.05), depression (<em>d</em> = −0.33, <em>p</em> &lt; 0.05), and greater gains in empowerment (<em>d</em> = 0.27, <em>p</em> &lt; 0.05). The text-only group also improved, particularly in depression and PTSD, with outcomes approaching those of responders by 12 months. Across conditions, low responders also showed substantial improvements in safety behaviors (<em>d</em> = 0.24–0.25; <em>p</em> &lt; 0.05).</div></div><div><h3>Conclusion</h3><div>These findings highlight the value of stepped-care, adaptive approaches in addressing persistent IPV-related needs. Integrating personalized phone support into digital interventions can enhance outcomes for survivors who do not respond to brief, initial support alone.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101539"},"PeriodicalIF":1.4,"publicationDate":"2025-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144863464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aroxybutynin and atomoxetine (AD109) for the treatment of obstructive sleep apnea: Rationale, design and baseline characteristics of the phase 3 clinical trials","authors":"Luigi Taranto-Montemurro ,&nbsp;Sanjay R. Patel ,&nbsp;Patrick J. Strollo Jr. ,&nbsp;John Cronin ,&nbsp;John Yee ,&nbsp;Huy Pho ,&nbsp;Andrea Werner ,&nbsp;Ron Farkas","doi":"10.1016/j.conctc.2025.101538","DOIUrl":"10.1016/j.conctc.2025.101538","url":null,"abstract":"<div><h3>Introduction</h3><div>Two key factors leading to obstructive sleep apnea (OSA) pathogenesis include relaxation of upper airway muscles at sleep onset and their insufficient reactivation during obstructive events. Medications that address this neuromuscular dysfunction by increasing upper airway tone during sleep represent a potential strategy for mitigating OSA.</div></div><div><h3>Methods</h3><div>AD109 is an investigational, once-daily oral agent taken at bedtime that combines an antimuscarinic, aroxybutynin (2.5 mg), with a selective norepinephrine reuptake inhibitor, atomoxetine (75 mg). LunAIRo (NCT05811247) and SynAIRgy (NCT05813275) are two ongoing, placebo-controlled 51-week and 26-week phase 3 clinical trials, respectively, investigating the efficacy and safety of AD109 to treat mild to severe OSA. Participants include adults with an apnea-hypopnea index with 4% desaturation (AHI₄) &gt;5 who either refuse or fail to tolerate positive airway pressure. Participants (LunAIRo: N = 660; SynAIRgy: N = 646) were randomized 1:1 to receive AD109 or placebo. We hypothesize that AD109 will significantly reduce AHI₄ and symptomatic fatigue compared to placebo in people with OSA. The primary outcome for both trials is the change from baseline to Week 26 in AHI₄ in the AD109 arm versus placebo. Key secondary outcomes include changes from baseline in oxygen desaturation index with 3% desaturation, hypoxic burden based on 4% desaturation, Patient Reported Outcome Measurement Information System (PROMIS)-Fatigue, and proportion of participants with ≥50% reduction in AHI₄ at Week 26.</div></div><div><h3>Discussion</h3><div>LunAIRo and SynAIRgy are fully enrolled, large Phase 3 clinical trials designed to confirm and extend our understanding of the safety and efficacy of AD109, a combination oral drug targeting the underlying neuromuscular dysfunction contributing to upper airway muscle collapse during sleep in adults with OSA.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101538"},"PeriodicalIF":1.4,"publicationDate":"2025-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144895000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study design and methods for the physical activity index (PAI) feasibility pilot trial for breast and colon cancer survivors in North Carolina","authors":"Shirley M. Bluethmann ,&nbsp;Janet Tooze ,&nbsp;Joni K. Evans ,&nbsp;Jeffrey Katula ,&nbsp;Kristy Wood ,&nbsp;Lesley Hitariansingh ,&nbsp;Charlotte Crotts ,&nbsp;Heidi D. Klepin ,&nbsp;Ravi Paluri ,&nbsp;Kunal Kadakia ,&nbsp;Katherine Ansley","doi":"10.1016/j.conctc.2025.101530","DOIUrl":"10.1016/j.conctc.2025.101530","url":null,"abstract":"<div><div>The majority of the 18 million US adults with cancer history (“survivors”) do not meet recommendations for obtaining regular physical activity (PA) or limiting sedentary behavior in their daily lives. Breast cancer survivors (BCS) and colon cancer survivors (CCS) are particularly at risk of insufficient PA and excessive sedentary behavior (i.e., sitting) that may increase physical impairments, worsen cancer treatment symptoms, limit optimal cancer recovery, and limit opportunities to potentially reduce cancer risk. Research has shown that completion of clinical cancer treatment may serve as a ‘teachable moment’ for patients as they transition to recovery at home. Many of these survivors are uncertain about building a healthier lifestyle without guidance from the medical team, but few validated clinical tools exist to assess and counsel survivors on their behavioral choices relative to PA and sedentary behavior.</div><div>Based on our recent findings, a simple screener that collects measures on PA, strength training, and sedentary behavior, the Physical Activity Index (PAI), may be effective for clinical use to monitor patient behaviors and provide specific, tailored recommendations on how to achieve and maintain behavioral goals. We propose a multicomponent, two-arm pilot 1:1 randomized controlled trial with waitlist control in which we will recruit (n = 20) BCS and CCS within three years of diagnosis to leverage the ‘teachable moment’ in early recovery. The PAI intervention will include standard survivorship follow-up care plus a PA assessment using the PAI screener that is supplied to the provider plus five remote coaching consultations with a certified exercise physiologist. All participants will also receive resistance bands to keep and an activity tracker to self-monitor their behaviors at home.</div><div>We will determine feasibility by examining recruitment, retention, acceptability, and PAI intervention adherence goals. Secondarily, we will measure changes/variability in achievement of behavioral outcomes for PA and sedentary behaviors to inform future trial planning.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101530"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144841366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ASSIST in Pitjantjatjara: Protocol for a randomised crossover validation study among Aboriginal and Torres Strait Islander Australians","authors":"Matthew W.R. Stevens ,&nbsp;Sue Bertossa ,&nbsp;Dominic Barry ,&nbsp;Chris Holmwood ,&nbsp;KS Kylie Lee ,&nbsp;John Marsden ,&nbsp;Matt Pedler ,&nbsp;Mark Thompson ,&nbsp;Scott Wilson ,&nbsp;Robert L. Ali","doi":"10.1016/j.conctc.2025.101532","DOIUrl":"10.1016/j.conctc.2025.101532","url":null,"abstract":"<div><h3>Background</h3><div>Substance use significantly contributes to disease burden among Australians, with harms exacerbated among Aboriginal and Torres Strait Islander peoples by colonisation-related factors like stigma and trauma. Addressing this gap requires culturally acceptable, valid and reliable screening tools, available in a familiar language to the participant, to identify and provide support for those at-risk. This protocol describes a study aimed at validating a culturally-adapted screening tool — the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) — into Pitjantjatjara, to detect risk of substance-related harm.</div></div><div><h3>Methods</h3><div>Recruitment will occur at a variety of Aboriginal health and welfare settings across remote, rural and urban South Australia. Eligible participants (aged 18–65) will be briefed and, upon consent, randomly complete the ASSIST app on an iPad and a semi-structured, yarning-style diagnostic interview (see endnote 1) with a health professional and Pitjantjatjara interpreter. The interview will assess for a range of clinically-defined substance use disorders (based on DSM-5-TR and ICD-11 criteria). All participants will be asked to complete the app a second time (between 7 and 28 days) to assess reliability, while a subset of participants at highest-risk will also undergo specialist evaluation from an independent clinician, as a second check for validity.</div></div><div><h3>Discussion</h3><div>Valid and reliable assessment tools are essential for detecting risky and harmful substance use. If valid, this app has the potential to contribute to community-led efforts to bridge the health gap by addressing modifiable health risk factors.</div></div><div><h3>Trial registration</h3><div>ANZCTR: ACTRN12625000413426. Open Science Framework pre-registration: <span><span>https://doi.org/10.17605/OSF.IO/GNZAY</span><svg><path></path></svg></span>.</div></div><div><h3>Version control number</h3><div>Protocol version 1.1, June 23, 2025.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101532"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144860648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"DISYNCRO: Perceived roles of clinical study coordinators and data managers: results from a web-based survey of professionals from contract research organizations","authors":"Susanna Yedro ,&nbsp;Elena Tinari ,&nbsp;Daniele Napolitano ,&nbsp;Giulia Wlderk ,&nbsp;Eleonora Ribaudi ,&nbsp;Luciana Giannone ,&nbsp;Gianluca Ianiro ,&nbsp;Mattia Bozzetti ,&nbsp;Antonio Gasbarrini ,&nbsp;Vincenzina Mora","doi":"10.1016/j.conctc.2025.101533","DOIUrl":"10.1016/j.conctc.2025.101533","url":null,"abstract":"<div><h3>Introduction</h3><div>The evolution of clinical trials has made it essential to introduce specific roles, such as Clinical Study Coordinator (CSC) and Data Manager (DM), into the research process. Their responsibilities sometimes overlap, creating operational challenges in the workplace. This study aims to determine how personnel at Contract Research Organizations (CROs) perceive the differences between the CSC and DM roles, assess their functional overlap, and identify areas where greater role clarity and training are needed to improve operational efficiency.</div></div><div><h3>Methods</h3><div>An online survey instrument was used to gather data from CRO professionals through an internet-based questionnaire. The survey gathered sociodemographic data and included a knowledge assessment of 18 items and a 9-item role responsibilities section. Participants were stratified into three ability groups using Item Response Theory (IRT) analysis based on a Rasch model. McNemar's tests and non-parametric tests analyzed knowledge discrepancies and perceptual contradictions.</div></div><div><h3>Results</h3><div>A total of 122 participants completed the survey. Most partecipants (98.4 %) identified the CSC as the primary figure within a research center, and 77.9 % considered the CSC essential for clinical trial execution. Regarding functional overlap, 57.4 % of respondents believed that the CSC could perform the duties of a DM, whereas only 42.6 % thought the DM could assume the CSC's responsibilities. Participants with lower levels of knowledge demonstrated a higher rate of contradictory responses, indicating greater difficulty distinguishing between the two roles.</div></div><div><h3>Conclusion</h3><div>Study findings demonstrate an overwhelming preference for CSCs, who play a key versatile role in managing clinical trials. The insufficient theoretical understanding of the different duties of CSCs and DMs hampers operational efficiency. Establishing standard training programs combined with harmonization is essential to defining roles, enhancing teamwork, and providing quality clinical research practices.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101533"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144810179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the impact of the ‘Blow, Breathe, Cough’ health promotion intervention in resolving otitis media with effusion in children: An adaptive randomized-controlled trial protocol","authors":"Jaimee R. Rich ,&nbsp;Michael Dymock ,&nbsp;Elke J. Seppanen ,&nbsp;Elena Montgomery ,&nbsp;Tanisha Cayley ,&nbsp;Tamara Veselinović ,&nbsp;Greta Bernabei ,&nbsp;Anri Lester ,&nbsp;Amy Hannigan ,&nbsp;Nicole Irvine ,&nbsp;Kerryn Gidgup ,&nbsp;Edna Ninyette ,&nbsp;Steph Bray ,&nbsp;Tu Trang Tran ,&nbsp;Valerie M. Swift ,&nbsp;Melinda Edmunds ,&nbsp;Natalie Strobel ,&nbsp;Daniel McAullay ,&nbsp;Julie Marsh ,&nbsp;Evelyn Tay ,&nbsp;Christopher G. Brennan-Jones","doi":"10.1016/j.conctc.2025.101531","DOIUrl":"10.1016/j.conctc.2025.101531","url":null,"abstract":"<div><h3>Introduction</h3><div>Otitis media with effusion (OME) affects hearing, speech development, and quality of life (QoL) in children. The ‘Blow, Breathe, Cough’ (BBC) intervention promotes nasal, respiratory, and middle ear clearance through nose blowing, deep breathing, coughing, and hand hygiene. It shows promise in resolving OME but lacks randomized-controlled trial (RCT) evaluation. This paper presents a RCT protocol evaluating BBC's effect on OME resolution, hearing, speech, and QoL in children aged two to seven years.</div></div><div><h3>Methods</h3><div>This parallel-group, 1:1, outcome assessor-blinded, individual adaptive RCT investigates whether completing the BBC intervention plus hand hygiene twice-daily at home increases OME resolution after 4-to-6 weeks in children with OME, compared to hand hygiene alone. Families (n = 250) perform their individually randomized program (BBC plus hand hygiene, or hand hygiene only) at home. The primary outcome is the difference in OME resolution rates between trial arms, assessed using tympanometry (type B to A or C₁ transition) and otoscopy. Secondary outcomes include natural OME resolution, discharges from tertiary care, family satisfaction, hearing thresholds, QoL, bacterial load in the nasopharynx and on hands, cost comparison within the RCT versus standard care, and adverse events. All outcomes are measured by blinded researchers. An intention-to-treat analysis will be performed on all randomized participants. Guided by an Aboriginal Community Advisory Group, the RCT ensures culturally appropriate research whilst addressing community priorities in managing childhood ear disease.</div></div><div><h3>Discussion</h3><div>If efficacious, BBC could reform OME treatment, reduce costs, and improve long-term hearing, speech, and QoL outcomes in some children. Its accessibility offers a globally scalable solution.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101531"},"PeriodicalIF":1.4,"publicationDate":"2025-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144827306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the effect of acupuncture on weight loss in postpartum obese women: a study protocol for a randomized controlled trial","authors":"Han Zhang ,&nbsp;Xinyu Zhang ,&nbsp;Yuejiao Wang ,&nbsp;Ran Yang ,&nbsp;Yanan Zhen ,&nbsp;Yang Zhang ,&nbsp;Qi Zhao ,&nbsp;Yinping Xu ,&nbsp;Zhishun Liu ,&nbsp;Shulan Wang","doi":"10.1016/j.conctc.2025.101528","DOIUrl":"10.1016/j.conctc.2025.101528","url":null,"abstract":"<div><h3>Background</h3><div>Pregnant women gain an average weight of 16.6 ± 4.8 kg during pregnancy, with weight retention of 4 kg at 6 months, 4 kg at 12 months, and 2.9 kg at 18 months postpartum. At 3, 6, 9 and 12 months after delivery, 61.92 %, 68.73 %, 78.18 % and 84.24 % of women whose BMI returned to the normal range, respectively. Obesity has negative effects on postpartum women's physical and mental health. Prior research has suggested that acupuncture may be beneficial for weight loss. This study investigates the effectiveness of manual acupuncture (MA) for treating postpartum obesity (PO), compared to sham acupuncture (SA).</div></div><div><h3>Methods</h3><div>This is a multicenter, randomized, single-blind controlled trial. A total of 82 eligible PO participants will be randomly assigned to either MA (n = 41) or SA (n = 41) group using a 1:1 ratio. The MA group received acupuncture treatment and the control group received sham acupuncture treatment. Both groups received diet and exercise instructions and were treated for 30 min each session, three times a week, for a total of 8 weeks. The primary outcome measure was the change in body mass index (BMI) after 8 weeks of treatment, compared to baseline. Secondary outcome measures include changes in BMI from baseline to 4 weeks of treatment, changes in waist circumference, waist-to-hip ratio (WHR), blood glucose, lipid levels, thyroid function and other serological measures from baseline to 8 weeks of treatment. Secondary measures also included dietary and exercise guidance compliance scales, as well as assessments of depression and anxiety status. The safety of acupuncture was continuously evaluated throughout the study. Follow-up was performed at 14 and 20 weeks after treatment.</div></div><div><h3>Discussion</h3><div>This prospective randomized trial will help evaluate the efficacy and safety of acupuncture in treating PO. The results of this study will provide evidence of the therapeutic effectiveness of acupuncture on PO.</div></div><div><h3>Trial registration</h3><div>chictr.org.cn: ChiCTR2300067658, registered on January 17, 2023.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101528"},"PeriodicalIF":1.4,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144703293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}