The current study is a pilot trial to examine the effects of a nonelective, classroom-based, teacher-implemented, mindfulness meditation intervention on standard clinical measures of mental health and affect in middle school children. A total of 101 healthy sixth-grade students (55 boys, 46 girls) were randomized to either an Asian history course with daily mindfulness meditation practice (intervention group) or an African history course with a matched experiential activity (active control group). Self-reported measures included the Youth Self Report (YSR), (...) a modified Spielberger State-Trait Anxiety Inventory, and the Cognitive and Affective Mindfulness Measure –Revised. Both groups decreased significantly on clinical syndrome subscales and affect but did not differ in the extent of their improvements. Meditators were significantly less likely to develop suicidal ideation or thoughts of self-harm than controls. These results suggest that mindfulness training may yield both unique and non-specific benefits that are shared by other novel activities. (shrink)

Background Thorough information of the patient is an integral part of the process of shared decision making. We aimed to investigate if detailed information about medication may induce nocebo effects. Methods We conducted a randomized, single-blind, pilot-study including n = 51 psychiatric in-patients aged between 18 and 80 years with a depressive disorder and accompanying sleeping disorders. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. In both (...) groups, patients received an open-label placebo pill instead of their sleeping medication. Results No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter. Conclusion In this study, we were not able detect an effect of informed consent vs. simple consent on the emergence of placebo or nocebo effects. This finding is contrary to most assumptions and publications about this topic. Trial registration Trial registration number: DRKS00017653, registered August 30th 2018. Retrosprectively registered. (shrink)

Background This pilot study evaluated the speaking book ‘What it means to be part of a clinical trial’. The book aims at empowering populations with information on their rights and responsibilities when enrolled in clinical research. Wide publication of the book—at significant cost—is anticipated. It is important that the book is evaluated within the communities for whom it is intended, and the necessary changes (if any) are made, before translation and large-scale publication takes place. Objective The objective of (...) the study was to measure the efficacy and ease of use of the book. Methods Participants were recruited from a catering company. Participants were questioned on their knowledge of clinical trials and were then given the book. Instructions for use of the book were given to one group (‘experimental’ group). The other group (‘control’ group) was not given any instructions. A week later, the investigators returned, repeated the knowledge questions and asked ‘ease of use’ questions. Results A two-way repeated measure of covariants showed a statistically significant positive increase in knowledge of clinical trials among the intervention group (p=0.02). Results for the control group displayed trends that were not statistically significant. Percentage analysis of ‘ease of use’ questions proved that the book is easy to use, although some changes would be beneficial. Conclusion This study revealed that the speaking book is easy to use. It significantly increased knowledge of clinical trials among the study sample if instructions on use of the book were provided. (shrink)

Objective: To pilot informed consent materials developed for Aboriginal parents in a vaccine trial, and evaluate their design and the informed consent process.Methods: Cross sectional quantitative and qualitative survey of 20 Aboriginal and 20 non-Aboriginal women in Alice Springs. Information about the proposed research was presented to Aboriginal participants by an Aboriginal researcher, using purpose designed verbal, visual, and written materials. Non-Aboriginal participants received standard materials developed by the sponsor. Questionnaires were used to evaluate recall and understanding immediately (...) and five days later. Qualitative analysis of Aboriginal participants’ interviews was performed.Results: There were no differences between the groups in understanding of diseases prevented by the vaccine, the potential risks of participating, or the voluntary nature of participation. Most Aboriginal participants had difficulty with the concept of a “licensed” versus “unlicensed” vaccine. The non-Aboriginal group had a good understanding of this. Aboriginal participants identified the use of the flipchart, along with a presentation by a doctor and Aboriginal health worker, as preferred delivery modes. Group presentations were preferred rather than one-on-one discussions. The use of the questionnaire posed considerable methodological difficulties.Conclusions: A one-off oral presentation to Aboriginal participants is unlikely to produce “informed consent”. Key but unfamiliar concepts require identification and particularly considered presentation. (shrink)

OBJECTIVE: Pilot study to characterize treatment differences between patients treated in clinical trials and those treated in a clinical setting. Previous studies have shown higher survival rates for participants in trials of cancer therapy. This difference is observed even after rates are adjusted for important covariates such as age and stage of disease. DESIGN: Retrospective chart review. SETTING: Oncology outpatient department in a tertiary care hospital. PATIENTS: Ninety women 18 to 70 years of age with early-stage breast cancer who (...) were diagnosed in 1990. Fifty-one of the women were treated through clinical trials and 39 were treated outside of clinical trials. OUTCOME MEASURES: Number of blood tests, telephone calls, clinic visits and imaging procedures as well as intensity of chemotherapy and use of radiation therapy. The age of the patient and the stage of disease were important covariates. RESULTS: After the analysis was controlled for patient age and stage of disease, patients treated through a clinical trial were more likely to receive standard-dose chemotherapy (p = 0.020, 95% confidence interval 1.20 to 200.73) and more frequent blood tests (p < 0.001, 95% confidence interval 1.02 to 1.13) than other patients treated in the clinic. CONCLUSIONS: Our results provide a plausible mechanism for the observed survival advantage for participants in clinical trials in oncology. Further study is called for. If these results are confirmed, they have important implications for informed consent to participate in clinical trials and for clinical practice. (shrink)

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

Social anxiety disorders are among the most prevalent mental disorders, with high impact on the life of an affected social system and its individual social system members. We developed a manualized disorder-specific integrative systemic and family therapy for SAD, and evaluated its feasibility in a pilot randomized controlled trial. The ISFT is inspired by Helm Stierlin’s concept of related individuation developed during the early 1980s, which has since continued to be refined. It integrates solution-focused language, social network diagnostics, (...) and genogram work, as well as resource- and problem orientation for both case conceptualization and therapy planning. Post-Milan symptom prescription to fluidize the presented symptoms is one of the core interventions in the ISFT. Theoretically, the IFST is grounded in radical constructivism and “Cybern-Ethics,” multi-directional partiality, and a both/and attitude toward a disorder-specific vs. non-disorder-specific therapy approach. SAD is understood from the viewpoint of social systems theory, especially in adaptation to a socio-psycho-biological explanatory model of social anxiety. In a prospective multicenter, assessor-blind pilot RCT, we included 38 clients with SAD : 18 patients participated in the ISFT, and 20 patients in Cognitive Behavioral Therapy. Within-group, simple-effect intention-to-treat analyses showed significant reduction in social anxiety, while intention-to-treat mixed-design ANOVA demonstrated the advantage of ISFT. Per-protocol analyses supported these results. The remission rate based on blind diagnosticians’ ratings was good to satisfactory ; this has yet to be verified in a subsequent confirmatory RCT. The article will present the ISFT rationale and manual, including a special focus on multi-person settings, and the central findings from our pilot RCT. (shrink)

Chronic migraine is a difficult disease to diagnose, and its pathophysiology remains undefined. Its symptoms affect the quality of life and daily living tasks of the affected person, leading to momentary disability. This is a pilot, randomized, controlled, double-blind clinical trial study with female patients between 18 and 65 years old with chronic migraine. The patients underwent twelve mindfulness sessions paired with anodal transcranial direct-current stimulation over the left dorsolateral prefrontal cortex, with current intensity of 2 mA applied (...) for 20 min, three times a week for 4 weeks. In addition, 20 min of mindfulness home practices were performed by guided meditation audio files. A total of 30 participants were evaluated after the treatment, and these were subdivided into two groups—active tDCS and sham tDCS, both set to mindfulness practice. The FFMQ-BR, MIDAS, and HIT-6 questionnaires were used to evaluate the outcomes. After the treatment, the active mindfulness and tDCS group showed better results in all outcomes. The sham group also showed improvements, but with smaller effect sizes compared to the active group. The only significant difference in the intergroup analysis was the outcome evaluated by HIT-6 in the post treatment result. Our results provide the first therapeutic evidence of mindfulness practices associated with left DLPFC anodal tDCS with a consequent increase in the level of full attention and analgesic benefits in the clinical symptoms of patients with chronic migraine. (shrink)

Randomised placebo-controlled trials (RPCTs) are the gold standard for evaluating novel treatments. However, this design is rarely used in the context of orthopaedic interventions where participants are assigned to a real or placebo surgery. The present study examines attitudes towards RPCTs for orthopaedic surgery among 687 orthopaedic surgeons across the USA. When presented with a vignette describing an RPCT for orthopaedic surgery, 52.3% of participants viewed it as ‘completely’ or ‘mostly’ unethical. Participants were also asked to rank-order the value of (...) five different types of evidence supporting the efficacy of a surgery, ranging from RPCT to an anecdotal report. Responses regarding RPCTs were polarised with 26.4% viewing it as the least valuable (even less valuable than an anecdote) and 35.7.% viewing it as the most valuable. Where equipoise exists, if we want to subject orthopaedic surgeries to the highest standard of evidence (RPCTs) before they are implemented in clinical practice, it will be necessary to educate physicians on the value and ethics of placebo surgery control conditions. Otherwise, invasive procedures may be performed without any benefits beyond possible placebo effects. (shrink)

Background: There is a growing interest in using cognitive behavioural therapy with people who have Asperger Syndrome and comorbid mental health problems. Aims: To examine whether modified group CBT for clinically significant anxiety in an AS population is feasible and likely to be efficacious. Method: Using a randomised assessor-blind trial, 52 individuals with AS were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised (...) to treatment were followed-up for 24 weeks. Results: The conversion rate for this trial was high, while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared to those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Conclusions: Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. Declaration of Interest: None Trial Registration: ISRCTN 30265294, UKCRN 8370. (shrink)

Incentivising has shown to improve participation in clinical trials. However, ethical concerns suggest that incentives may be coercive, obscure trial risks and encourage individuals to enrol in cli...

This article presents original empirical data generated from the Crown Prosecution Service (CPS) Pilot Evaluation of pre-trial witness interviewing (PTWI) in England and Wales. Section 1 introduces the PTWI Pilot and describes the methodological strengths and limitations of our qualitative socio-legal study. Forming the richly documented empirical core of the article, Sections 2–5 identify the principal considerations which seemed to influence case selection for Pilot interviews. An overlapping collection of evidentiary, strategic and circumstantial factors encouraged prosecutors (...) to resort to PTWI, whilst other, countervailing considerations were apprehended as disincentives. Assessments of witness credibility were central to prosecutors’ attempts to balance these competing factors. Section 6 concludes by underlining the potential of qualitative socio-legal studies to promote more nuanced understandings of criminal process, and by extension to make practical contributions to evidence-based criminal procedure reform. (shrink)

The aim of the present study is to examine the effect of group-play intervention on executive function in preschoolers. This group-play intervention was integrated as moderate to vigorous physical activity and cognitively loaded exercise to promote EF in preschoolers. An 8-week group-play MVPA intervention program, consisting of a series of outdoor physical and cognitively loaded games, was designed to improve preschoolers’ EF. This intervention program was implemented in group-play form, and conducted by teachers who received standardized training before the intervention. (...) Two classes of second grade preschoolers were randomly allocated to experimental and control groups. The intervention group received the intervention three times a week, while the control group exercised as usual in preschool. Before, in the middle of, and after the intervention, 10-m running, standing broad jump, throwing, body flexion, balance beam, and skip jump were assessed as tests of motor skills. In addition, three components of EF were measured separately before, in the middle of, and after the intervention: inhibitory control was assessed by using the silly sound Stroop task, working memory was tested using the empty house task, and shifting was assessed using the dimensional change card sorting task. Although both groups showed an increasing trend in terms of motor skills and EF during the intervention, the increasing amounts of the intervention group were significantly higher than the control group. The findings of the present study suggested that group-play intervention has positive effects on aspects of EF in addition to motor skills in preschoolers. (shrink)

Background Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients’ knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process. Methods A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of (...) items to forecast outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery. Results The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video. Conclusions Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts’ opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care. Trial registration The ClinicalTrials.gov Identifier is NCT01338480. The date of registration was April 18, 2011. (shrink)

There is growing interest for implementing tools to monitor cognitive performance in naturalistic work and everyday life settings. The emerging field of research, known as neuroergonomics, promotes the use of wearable and portable brain monitoring sensors such as functional near infrared spectroscopy (fNIRS) to investigate cortical activity in a variety of human tasks out of the laboratory. The objective of this study was to implement an on-line passive fNIRS-based brain computer interface to discriminate two levels of working memory load during (...) highly ecological aircraft piloting tasks. Twenty eight recruited pilots were equally split into two groups (flight simulator vs. real aircraft). In both cases, identical approaches and experimental stimuli were used (serial memorization task, consisting in repeating series of pre-recorded air traffic control instructions, easy vs. hard). The results show pilots in the real flight condition committed more errors and had higher anterior prefrontal cortex activation than pilots in the simulator, when completing cognitively demanding tasks. Nevertheless, evaluation of single trial working memory load classification showed high accuracy (>76%) across both experimental conditions. The contributions here are two-fold. First, we demonstrate the feasibility of passively monitoring cognitive load in a realistic and complex situation (live piloting of an aircraft). In addition, the differences in performance and brain activity between the two experimental conditions underscore the need for ecologically-valid investigations. (shrink)

We have been asked to consider the feasibility of piloting a Citizens’ Basic Income : a basic, unconditional, universal, individual, regular payment that would replace aspects of social security and be introduced alongside changes to taxes. Piloting and evaluating a CBI as a Cluster Randomized Control Trial raises the question of whether intervention and comparison groups would be in equipoise, and thus whether randomization would be ethical. We believe that most researchers would accept that additional income, or reduced conditions (...) on receiving income would be likely to improve health, especially at lower income levels. However, there are genuine uncertainties about the impacts on other outcomes, and CBI as a mechanism of providing income. There is also less consensus amongst civil servants and politicians about the impacts on health, and substantial disagreement about whether these would outweigh other impacts. We believe that an RCT is ethical because of these uncertainties. We also argue that the principle of equipoise should apply to randomized and non-randomized trials; that randomization is a fairer means of allocating to intervention and comparison groups; and that there is an ethical case for experimentation to generate higher-quality evidence for policymaking that may otherwise do harm. (shrink)

Objective: Obtaining informed consent for resuscitation research, especially in the newborn, is problematic. This study aimed to evaluate parental preferences for hypothetical consent procedures in neonatal resuscitation research.Design: Mail-out survey questionnaire.Setting/participants: Randomly selected parents who had received obstetrical or neonatal care at a tertiary perinatal centre.Main outcome measures: Parental levels of comfort regarding different methods of obtaining consent in hypothetical resuscitation research scenarios.Results: The response rate was 34%. The respondents were a group of highly educated women with a higher family (...) income than would be expected in the general population. In terms of results, parents valued the impact the research would have on their baby and the importance of a positive interaction with the physicians conducting the research study. Parents felt most comfortable with prospective consent in the setting of prenatal classes or prenatal visits with a physician, but they were somewhat uncomfortable with prospective consent upon admission to hospital after labour had begun. Parents were uncomfortable with waived consent, deferred consent, and opting out, no matter when during the pregnancy consent was requested.Conclusion: This pilot study reports parental preferences for prenatal information and consent for such research trials of neonatal resuscitation. A low response rate and potentially skewed demographics of the respondents prevent generalisability of this result. Interview studies should be performed to better determine parental preferences for informed consent in a more representative population. (shrink)

Chronic pain is of significant global concern. There is growing evidence that body–mind therapies and psychological approaches can contribute toward changing chronic pain perceptions. This is the first model described in the literature that combines a mindfulness-based approach with dance movement therapy and explores the potential psychological and pain-related changes for this client population. In this paper, the results from the pilot study are presented involving patients with chronic headache recruited in an outpatient rehabilitation setting.Methods: In this pilot (...) study, 29 patients with chronic headache were randomized to either the Mindful-Based Dance Movement Therapy group or the waiting list control group. The MBDMT group was offered 10 sessions in a clinical outpatient rehabilitation setting for 5 weeks. Data were collected pre- and post-intervention and 16 weeks after the intervention was finished. The Hospital Anxiety and Depression Scale, Patient Health Questionnaire−9, Five Facet Mindfulness Questionnaire, and Numeric Rating Scale were used as outcome measures.Results: The working model of MBDMT identifies nine therapeutic mechanisms. Per-protocol analysis reveals statistically significant reduction of pain intensity and depression scores in favor of the MBDMT group, and these improvements were maintained in the follow-up assessment.Conclusions: The results suggest that MBDMT is a feasible and promising therapy approach for chronic pain patients. The pilot study offered sufficient information and preliminary results in the desirable direction to enable the researchers to move to a randomized controlled trial stage in order to establish the efficacy of the intervention.Clinical Trial Registration: The study was registered in the www.researchregistry.com, registry. (shrink)

This paper discusses the utilization of pilots' physiological indications such as electroencephalographic signals, ocular parameters, and pilot performance-based quantitative metrics to estimate cognitive workload. The study aims to derive a non-invasive technique to estimate pilot's cognitive workload and study their correlation with standard physiological parameters. Initially, we conducted a set of user trials using well-established psychometric tests for evaluating the effectiveness of pupil and gaze-based ocular metrics for estimating cognitive workload at different levels of task difficulty and lighting (...) conditions. Later, we conducted user trials with the NALSim flight simulator using a business class Learjet aircraft model. We analyzed participants' ocular parameters, power levels of different EEG frequency bands, and flight parameters for estimating variations in cognitive workload. Results indicate that introduction of secondary task increases pilot's cognitive workload significantly. The beta frequency band of EEG, nearest neighborhood index specifying distribution of gaze fixation, L1 Norm of power spectral density of pupil diameter, and the duty cycle metric indicated variations in cognitive workload. (shrink)

ObjectiveStress can play a role in the onset and exacerbation of psoriasis. Psychological interventions to reduce stress have been shown to improve psychological and psoriasis-related outcomes. This pilot randomised study investigated the feasibility of a brief interaction with a Paro robot to reduce stress and improve skin parameters, after a stressor, in patients with psoriasis.MethodsAround 25 patients with psoriasis participated in a laboratory stress task, before being randomised to either interact with a Paro robot or sit quietly for 30 (...) min. Raman spectroscopy and trans-epidermal water loss were measured at baseline, after the stressor and after the intervention as indexes of acute skin changes. Psychological variables, including self-reported stress and affect, were also measured at the three time-points.ResultsNo statistically significant differences between the two conditions were found for any of the outcomes measured. However, effect sizes suggest significance could be possible with a larger sample size. Changes in the psychological and Raman spectroscopy outcomes across the experimental session were found, indicating the feasibility of the procedures.ConclusionThis pilot study showed that a brief interaction with a Paro robot was a feasible intervention for patients with psoriasis, but future trials should broaden the inclusion criteria to try to increase recruitment rates. Studying people who are highly stressed, depressed or who are stress-responders may increase the power of the intervention to show effects using a longer-term intervention. (shrink)

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions (...) in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT. (shrink)

While several recent evaluation studies have shown the efficacy of parent training programs for children with neurodevelopmental disorders, manual-based training in German is still scarce. To address this gap, we developed a specific modularized training program for parents of children from preschool to pre-adolescent age with Autism Spectrum Disorder. The overarching purpose of the FETASS intervention is to enhance social communication behavior and quality of life of the child by coaching parents. As a proximal target, the FETASS training aims to (...) provide families with behavior management and communication strategies. The development of the training was influenced by published behavioral parent trainings and autism-specific interventions. The training comprises eight weekly sessions and targets families whose children have a diagnosis of Autism Spectrum Disorder without intellectual and language impairments. As a preliminary pilot study, the purpose was to evaluate the acceptability of the training. Furthermore, the study aimed at initially evaluating social communication behavior, quality of life of the child, parental stress level, and parenting after training in comparison to a treatment as usual group. Exploratively, long-term effects were investigated after 6 months of training as well. In total, 57 families participated. Questionnaires about social communication behavior and quality of life of the child, parental stress, and parenting were administered at three time points. Primary outcome measures were the social communication behavior of the child and the parent’s proxy report on quality of life of the child. Secondary outcome measures were changes in parental stress and parenting behavior. Acceptability of the training was very high and we had almost no dropouts during training. Results for the primary outcome measure of social communication behavior, overall quality of life of the child, and long-term effects on social communication behavior were not significant. While long-term findings for parent stress reduction and for the quality of life of the child are promising, further research has to be done in a future randomized controlled trial. (shrink)

Developmental Coordination Disorder and Attention-Deficit/Hyperactivity Disorder are unique neurodevelopmental disorders with overlaps in executive functions and motor control. The conditions co-occur in up to 50% of cases, raising questions of the pathological mechanisms of DCD versus ADHD. Few studies have examined these overlaps in adults with DCD and/or ADHD. Therefore, to provide insights about executive functions and motor control between adults with DCD, ADHD, both conditions, or typically developed controls, this study used a stop-signal task and parallel EEG measurement. We (...) assessed executive performance via go accuracy and go reaction time, as well as motor response inhibition via stop-signal reaction time. This was complemented with analysis of event-related potentials. Based on existing investigations of adults with DCD or ADHD, we expected groups would not differ in behavioral performance on stop and go trials, but differences in ERPs, particularly in components N200 and P300 would be evident. The sample included N = 50 adults with DCD, ADHD, DCD + ADHD, and control participants. We replicated that there were no between-group differences for behavioral-level executive performance and motor response inhibition. However, on a physiological level, ERP components N200 and P300 differed between groups, particularly during successful response inhibition. These ERPs reflect potential endophenotypic differences not evident in overt behavior of participants with ADHD and/or DCD. This suggests a disorder specific employment of inhibition or general executive functions in groups of adults with DCD, DCD + ADHD, ADHD, or control participants. (shrink)

Next SectionObjectives To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy. Methods The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, Il), sixth grade level, (...) interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects' anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests. Results The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p<0.0001). Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction, anxiety or number of questions asked in a paediatric endoscopy unit. Conclusions This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required. Clinical trial registration number ClinicalTrials.gov Identifier NCT00899392. (shrink)

Recently a role for the vagus nerve in conditioning food preferences was established in rodents. In a prospective controlled clinical trial in humans, invasive vagus nerve stimulation shifted food choice toward lower fat content. Here we explored whether hedonic aspects of an orally sampled food stimulus can be modulated by non-invasive transcutaneous vagus nerve stimulation (tVNS) in humans. In healthy participants (n= 10, five women, 20–32 years old, no obesity) we tested liking and wanting ratings of food samples with (...) varying fat or sugar content with or without tVNS in a sham-controlled within-participants design. To determine effects of tVNS on food intake, we also measured voluntary consumption of milkshake. Spontaneous eye blink rate was measured as a proxy for dopamine tone. Liking of low-fat, but not high-fat puddings, was higher for tVNS relative to sham stimulation. Other outcomes showed no differences. These findings support a role for the vagus nerve promoting post-ingestive reward signals. Our results suggest that tVNS may be used to increase liking of low-calorie foods, which may support healthier food choices. (shrink)

IntroductionThere is a need to maintain rehabilitation activities and motivate movement and physical activity during quarantine in individuals with Cerebral Palsy.ObjectiveThis paper sets out to evaluate the feasibility and potential benefits of using computer serious game in a non-immersive virtual reality implemented and evaluated completely remotely in participants with CP for Home-Based Telerehabilitation during the quarantine period for COVID-19.MethodsUsing a cross-sectional design, a total of 44 individuals participated in this study between March and June 2020, 22 of which had CP (...) and 22 typically developing individuals, matched by age and sex to the individuals with CP. Participants practiced a coincident timing game1 and we measured movement performance and physical activity intensity using the rating of perceived exertion Borg scale.ResultsAll participants were able to engage with the VR therapy remotely, reported enjoying sessions, and improved performance in some practice moments. The most important result in this cross-sectional study was the significant increasing in rating of perceived exertion in both groups during practice and with CP presenting a higher rating of perceived exertion.ConclusionChildren with CP enjoyed participating, were able to perform at the same level as their peers on certain activities and increased both their performance and physical activity intensity when using the game, supporting the use of serious games for this group for home therapy and interactive games.Clinical Trials Registrationhttps://Clinicaltrials.gov, NCT04402034. Registered on May 20, 2020. (shrink)

Objective: There is a demonstrated link between the mental health and substance use comorbidities experienced by young adults, however the vast majority of psychological interventions are disorder specific. Novel psychological approaches that adequately acknowledge the psychosocial complexity and transdiagnostic needs of vulnerable young people are urgently needed. A modular skills-based program for emotion regulation and impulse control addresses this gap. The current one armed open trial was designed to evaluate the impact that 12 weeks exposure to ERIC alongside usual (...) care had on young people's ability to regulate emotions, as well as examine potential moderating mechanisms.Methods: Seventy nine young people were enrolled to the 12 week intervention period. Twenty one practitioners from youth and community health services delivered relevant ERIC modules adjunct to usual care. Linear mixed effects regression was used to examine change over time across the primary outcome of emotion dysregulation and secondary outcomes of depression, anxiety, stress, experiential avoidance and mindfulness. Moderation analyses were conducted to test whether the magnitude of change in emotion dysregulation moderated change over time in secondary outcomes.Results: Analyses revealed significant improvement in the primary outcome of emotion dysregulation with a moderate effect size, in addition to decreases in the secondary outcomes of depression, anxiety, stress and experiential avoidance. No improvements in mindfulness were reported. Moderation analyses revealed that the residualised change over time in emotion dysregulation moderated the change over time in symptoms of distress, depression, anxiety, stress, experiential avoidance, and mindfulness.Conclusion: Reductions in the severity of emotion dysregulation, depression, anxiety, stress and experiential avoidance are promising, and were evident despite the complexity of the participants and the diversity of the service setting. The improvements found in each outcome were only observed for those young people whose emotion regulation also improved, providing preliminary evidence for the role of emotion regulation as a key treatment target in this population. (shrink)

Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women’s and staff views about the consent procedures used during the internal pilot of a trial, where the protocol permitted staff to gain verbal consent at recruitment. Interviews (...) with staff and participating women. Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants’ views about the consent procedures used. Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for obtaining written consent at recruitment. While alternative consent pathways have an important role to play in advancing emergency medicine research, and may be appreciated by potential recruits, they may give rise to unintended ethical and logistical challenges for staff. Staff would benefit from training and support to increase their confidence and willingness to recruit into trials using alternative consent pathways. This qualitative research was undertaken as part of the GOT-IT Trial. Date of registration 26/03/2014. (shrink)

BackgroundIn many Western countries like Germany, the social integration of children with an immigrant background has become an urgent social tasks. The probability of them living in high-risk environments and being disadvantaged regarding health and education-related variables is still relatively higher. Yet, promoting language acquisition is not the only relevant factor for their social integration, but also the support of earlier developmental processes associated with adequate early parenting in their first months of life. The Emotional Availability Scales measure the quality (...) of caregiver-child-interactions as an indicator of the quality of their relationship and thus of such early parenting, focusing on mutual and emotional aspects of their interaction.MethodThis pilot study examined in a randomized controlled trial the effects of the prevention project First Steps regarding the hypothesis that the Emotional Availability improved to a greater extent in “difficult-to-reach” immigrant mother-child dyads in a psychoanalytically oriented early intervention compared to a usual care intervention offered by paraprofessionals with an immigrant background. A sample of N = 118 immigrant women in Germany from 37 different countries and their children was compared with regard to the parental EA-dimensions sensitivity, structuring, non-intrusiveness and non-hostility and the child dimensions responsiveness to and involvement of the caregiver in the pre-post RCT design.Results and ConclusionDifferent from what was expected, repeated ANOVAs revealed no significant pre-post group differences for the parental dimensions. For the child dimensions the effect of time of measurement was highly significant, which can be interpreted as mostly natural developmental effects. Still, on the level of simple main effects for each intervention, only in the FIRST STEPS groups child responsiveness significantly improved. When controlled for confounding variables, a significant interaction effect for maternal sensitivity in favor of the FIRST STEPS intervention was found. The systematic group differences indicate that the more extensive and professional intervention, focusing on the individual needs of the participants, is more suitable to support the quality of the mother-child-relationship amongst immigrant mother-child dyads than usual care. The results are discussed taking into account the context of the maternal migration process and potential maternal traumatization.Clinical Trial Registration[https://clinicaltrials.gov], identifier [DRKS00004632]. (shrink)

Impairments in executive functioning are prevalent in chronic pain conditions, with cognitive inflexibility being the most frequently reported. The current randomized, cross-over trial, piloted a computerized cognitive training program based on Relational Frame Theory, targeting improvement in cognitive flexibility. At baseline, 73 chronic pain patients completed testing on pre-selected outcomes of executive functioning, alongside IQ measures. When tested three times over the course of 5 months, there was a drop-out rate of 40% at the third time point, leaving 44 (...) patients who had data at all time points. The results showed that there was a substantial learning effect from the MINDFLEX training and a substantial time-dependent improvement on the primary outcomes of increased flexibility, but that this could not be tied to active training. In conclusion, this small study indicated a learning effect as well as improvement on primary outcomes. Based on the current results, a larger trial with improved feasibility of training is warranted. (shrink)

Many opponents of BIG programs believe that receiving guaranteed subsistence income would act as a strong disincentive to work. In contrast, various areas of empirical research in psychology suggest that a BIG would not lead to meaningful reductions in work. To test these competing predictions, a comprehensive review of BIG outcome studies reporting data on adult labor responses was conducted. The results indicate that 93 % of reported outcomes support the prediction of no meaningful work reductions when the criterion for (...) support is set at less than a 5 % decrease in either average hours worked per week or the rate of labor participation. Overall, these results indicate that adult labor responses would show no substantial impact following a BIG intervention. (shrink)