Wait-list Design Research Articles

Students and Teachers Benefit from Mindfulness-Based Stress Reduction in a School-Embedded Pilot Study.

Objective: There is a research gap in studies that evaluate the effectiveness of a school-embedded mindfulness-based intervention for both students and teachers. To address this gap, the present pilot study reviews relevant literature and investigates whether students and teachers who participate in separate Mindfulness-Based Stress Reduction (MBSR) courses show improvements across a variety of psychological variables including areas of mental health and creativity.Methods: The study applied a controlled waitlist design with three measurement points. A total of 29 students (n = 15 in the intervention and n = 14 in the waitlist group) and 29 teachers (n = 14 in the intervention and n = 15 in the waitlist group) completed questionnaires before and after the MBSR course. The intervention group was also assessed after a 4-month follow-up period.Results: Relative to the control group, significant improvements in self-reported stress, self-regulation, school-specific self-efficacy and interpersonal problems were found among the students who participated in the MBSR course (p < 0.05, Cohens' d ranges from 0.62 to 0.68). Medium effect sizes on mindfulness, anxiety and creativity indicate a realistic potential in those areas. By contrast, teachers in the intervention group showed significantly higher self-reported mindfulness levels and reduced interpersonal problems compared to the control group(p < 0.05, Cohens' d = 0.66 and 0.42, respectively), with medium effect sizes on anxiety and emotion regulation.Conclusion: The present findings contribute to a growing body of studies investigating mindfulness in schools by discussing the similarities and differences in the effects of MBSR on students and teachers as well as stressing the importance of investigating interpersonal effects.

Effectiveness of Mental Health First Aid training in Denmark: a randomized trial in waitlist design.

To examine the effect of the Australian educational intervention Mental Health First Aid (MHFA) in a Danish context. Primary outcome was improvement concerning confidence in help-giving behavior towards people suffering from mental illness. Secondary outcomes were increased knowledge and ability to recognize mental illness and improved positive attitudes towards people suffering from mental health problems. Study design was a randomized trial with a waitlist control group. The intervention group was compared with the control group at 6-month follow-up. Both groups completed at baseline and at 6-month follow-up. A significant difference was found between employees trained in the intervention group compared to the control group at 6-month follow-up on the items of confidence in making contact to (Cohen's d 0.17), talking to (Cohen's d 0.18) and providing help to (Cohen's d 0.31) people suffering from a mental health illness. Further, participants improved in knowledge (Cohen's d depression vignette 0.40/Cohen's d schizophrenia vignette 0.32) and in the ability to recognize schizophrenia OR = 1.75 (95 % CI 1.00-3.05), p = 0.05. A significant difference between the intervention group and control group at follow-up concerning actual help offered was not found. Changes in attitudes were limited. The MHFA training was effective in a Danish context.

Effects of Cooperative Learning Methods in German Language Arts on Reading Ability and Social Behavior of High School Students

This study examined the implementation and outcomes of cooperative learning methods in daily school life. In the context of an intervention wait-list control group research design lasting over two years, a group of Austrian students was taught using mainly cooperative learning methods in German language arts. In addition to standardized tests, self and peer report questionnaires assessed reading ability and aspects of social behavior before and after the intervention. Focus group interviews of teachers were used to investigate the implementation of cooperative learning methods in daily class life. The participants were nineteen teachers and 294 fifth and sixth graders from eight different schools at the secondary level. The results show that teachers prefer relatively specific cooperative learning methods. The results also illustrate that students who used cooperative learning methods in German language classes developed significantly better in reading comprehension than the students in the wait-list control group. However, concerning the reports of social behavior, most differences between the two groups failed to reach statistical significance.

Research Protocol: Development, implementation and evaluation of a cognitive behavioural therapy-based intervention programme for the management of anxiety symptoms in South African children with visual impairments.

BackgroundChildhood anxiety presents a serious mental health problem, and it is one of the most common forms of psychological distress reported by youth worldwide. The prevalence of anxiety symptoms amongst South African youth is reported to be significantly higher than in other parts of the world. These high prevalence rates become even more significant when viewed in terms of children with visual impairments, as it is suggested that children with physical disabilities may be more prone, than their non-disabled peers, for the development of psychological difficulties.ObjectivesThe main aim of this study is to develop, implement and evaluate a specifically tailored anxiety intervention programme for use with South African children with visual impairments.MethodA specifically tailored cognitive-behavioural therapy-based anxiety intervention, for 9–13 year old South African children with visual impairments, will be evaluated in two special schools. The study will employ a randomised wait-list control group design with pre- post- and follow-up intervention measures, with two groups each receiving a 10 session anxiety intervention programme. The main outcome measure relates to the participants’ symptoms of anxiety as indicated on the Revised Child Anxiety and Depression Scale.ConclusionIf the anxiety intervention programme is found to be effective in reducing symptoms of anxiety, this universal intervention will lay down the foundation upon which future contextually sensitive (South African) anxiety intervention programmes can be built.

Research Designs for Intervention Research with Small Samples II: Stepped Wedge and Interrupted Time-Series Designs.

The stepped wedge design (SWD) and the interrupted time-series design (ITSD) are two alternative research designs that maximize efficiency and statistical power with small samples when contrasted to the operating characteristics of conventional randomized controlled trials (RCT). This paper provides an overview and introduction to previous work with these designs and compares and contrasts them with the dynamic wait-list design (DWLD) and the regression point displacement design (RPDD), which were presented in a previous article (Wyman, Henry, Knoblauch, and Brown, Prevention Science. 2015) in this special section. The SWD and the DWLD are similar in that both are intervention implementation roll-out designs. We discuss similarities and differences between the SWD and DWLD in their historical origin and application, along with differences in the statistical modeling of each design. Next, we describe the main design characteristics of the ITSD, along with some of its strengths and limitations. We provide a critical comparative review of strengths and weaknesses in application of the ITSD, SWD, DWLD, and RPDD as small sample alternatives to application of the RCT, concluding with a discussion of the types of contextual factors that influence selection of an optimal research design by prevention researchers working with small samples.

The effect of the mental health first-aid training course offered employees in Denmark: study protocol for a randomized waitlist-controlled superiority trial mixed with a qualitative study.

BackgroundStudies show a high and growing prevalence of mental disorders in the population worldwide. 25% of the general population in Europe will during their lifetime experience symptoms related to a mental disorder. The Mental Health First Aid concept (MHFA) was founded in 2000 in Australia by Kitchener and Jorm, in order to provide the population with mental health first aid skills. The aim of the concept is, through an educational intervention (course), to increase confidence in how to help people suffering from mental health problems. Further, secondary aims are to increase the mental health literacy of the public by increasing knowledge, reduce stigma and initiate more supportive actions leading towards professional care. An investigation of the effect of MHFA offered a Danish population is needed.MethodsThe design is a randomized waitlist-controlled superiority trial, in which 500 participants will be allocated to either the intervention group or the control group. The control group will attend the course six months later, hence waiting list design. From fall 2013 to spring 2014 participants will be educated to be “mental health first-aiders” following a manualized, two days MHFA course. All the participants will answer a questionnaire at base-line and at 6 months follow-up. The questionnaire is a back-translation of the questionnaire used in Australian trials. The trial will be complemented by a qualitative study, in which focus groups will be carried out.DiscussionOutcomes measured are sensitive to interpretation, hence a challenge to uniform. This trial will add to the use of a mixed-methods design and exemplify how it can strengthen the analysis and take up the challenge of a sensitive outcome.Trial registrationhttps://clinicaltrials.gov identifier NCT02334020.

Designs for Testing Group-Based Interventions with Limited Numbers of Social Units: The Dynamic Wait-Listed and Regression Point Displacement Designs.

The dynamic wait-listed design (DWLD) and regression point displacement design (RPDD) address several challenges in evaluating group-based interventions when there is a limited number of groups. Both DWLD and RPDD utilize efficiencies that increase statistical power and can enhance balance between community needs and research priorities. The DWLD blocks on more time units than traditional wait-listed designs, thereby increasing the proportion of a study period during which intervention and control conditions can be compared, and can also improve logistics of implementing intervention across multiple sites and strengthen fidelity. We discuss DWLDs in the larger context of roll-out randomized designs and compare it with its cousin the Stepped Wedge design. The RPDD uses archival data on the population of settings from which intervention unit(s) are selected to create expected posttest scores for units receiving intervention, to which actual posttest scores are compared. High pretest-posttest correlations give the RPDD statistical power for assessing intervention impact even when one or a few settings receive intervention. RPDD works best when archival data are available over a number of years prior to and following intervention. If intervention units were not randomly selected, propensity scores can be used to control for non-random selection factors. Examples are provided of the DWLD and RPDD used to evaluate, respectively, suicide prevention training (QPR) in 32 schools and a violence prevention program (CeaseFire) in two Chicago police districts over a 10-year period. How DWLD and RPDD address common threats to internal and external validity, as well as their limitations, are discussed.

Effectiveness of a fundamental motor skill intervention for 4-year-old children with autism spectrum disorder: A pilot study

A wait-list control experimental design was employed to investigate the effectiveness of a fundamental motor skill intervention at improving the motor skills, adaptive behavior, and social skills of 4-year-old children with autism spectrum disorder (experimental n = 5, control n = 4); the impact of intervention intensity was also explored. The experimental group significantly improved their object manipulation and overall motor scores from pre- to post-intervention. The wait-list control design revealed no group-by-time interactions; however, with the groups combined time was a significant factor for all motor variables. There were no significant changes in adaptive behavior and social skills. These preliminary findings suggest that a fundamental motor skill intervention may benefit young children with autism spectrum disorder. Future research with larger samples is warranted.

Joint modeling, quality of life, and survival in fast-track (or delayed-start) palliative care trials.

49 Background: Randomized “early intervention” or “fast-track” trials (also sometimes called delayed intervention, delayed-start, or wait list designs) have been proposed as an alternative to traditional RCTs comparing palliative care interventions to non-palliative or other supportive care groups. The fast-track arm receives intervention immediately after randomization and the control arm receiving intervention after a certain period following randomization during which time standard care is provided. Such trials are more acceptable to patients, families and physicians because no one is denied access to the intervention, while still allowing for a rigorous assessment of a palliative care intervention. Many issues remain with respect to implementing such designs and analyzing the longitudinal quality of life and survival. Methods: We have developed a terminal decline model (Li et al. 2013) for jointly modeling quality of life and survival in palliative care studies. This model can be implemented on an intention to treat basis for the overall comparison in fast track design. For time periods beyond the delayed start period, we modify the model to include a time-varying treatment variable in the model to account for the treatment change in the control arm, including an interaction between the treatment and the time period. Terminal declines and quality-adjusted life years are estimated for both the intention to treat and the modified model. Results: ENABLE III is a recently completed fast-track trial in our institution at Dartmouth. After applied to ENABLE III study, the novel statistical joint modeling approach indicates that the effect of the ENABLE intervention on the terminal decline increases when combined with intervention effect seen for fast track arm. Conclusions: The terminal decline joint modeling approach is an efficient and interpretable method for fast-track study designs.

Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.

BackgroundEstimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards.Methods/designA multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. Methods: fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection of key data about intervention wards. Intervention fidelity will be assessed primarily by adherence to the intervention via scoring based on an adapted framework.DiscussionThis study will be one of the largest patient safety trials ever conducted, involving 32 hospital wards. The results will further understanding about how patient feedback on the safety of care can be used to improve safety at a ward level. Incorporating the ‘patient voice’ is critical if patient feedback is to be situated as an integral part of patient safety improvements.Trial registrationISRCTN07689702, 16 Aug 2013Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-420) contains supplementary material, which is available to authorized users.

Sexual Behaviour Profile of Gay and Other Men Who Have Sex with Men Enrolled in the PROUD Pre-exposure Prophylaxis Open-label Pilot Study in England

AIDS Research and Human RetrovirusesVol. 30, No. S1 Risk and Prevention for MSMSexual Behaviour Profile of Gay and Other Men Who Have Sex with Men Enrolled in the PROUD Pre-exposure Prophylaxis Open-label Pilot Study in EnglandMitzy Gafos, David Dolling, Monica Desai, Gemma Wood, David Dunn, John Saunders, Nicola E. Mackie, Alexandra Meijer, Amanda Clarke, Christine Bowman, Charles Lacey, Lisa Southon, Clare Oakland, Chris Higgs, David White, Iain Reeves, Michael Brady, Julie Fox, Anthony Nardone, and on behalf of the PROUD Study TeamMitzy GafosMRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, London, United KingdomSearch for more papers by this author, David DollingMRC Clinical Trials Unit at UCL, London, United KingdomSearch for more papers by this author, Monica DesaiMRC Clinical Trials Unit at UCL, London, United KingdomSearch for more papers by this author, Gemma WoodMRC Clinical Trials Unit at UCL, London, United KingdomSearch for more papers by this author, David DunnMRC Clinical Trials Unit at UCL, London, United KingdomSearch for more papers by this author, John SaundersAmbrose King Centre/Barts Sexual Health Centre, London, United KingdomSearch for more papers by this author, Nicola E. MackieJefferiss Wing, St Mary's Hospital, London, United KingdomSearch for more papers by this author, Alexandra Meijer56 Dean Street Clinic, London, United KingdomSearch for more papers by this author, Amanda ClarkeElton John Centre, Brighton & Sussex University Hospital Trust Sussex House, Brighton, United KingdomSearch for more papers by this author, Christine BowmanRoyal Hallamshire Hospital, Dept of GU Medicine, Sheffield, United KingdomSearch for more papers by this author, Charles LaceyMonkgate Health Centre, Dept of GU Medicine, York, United KingdomSearch for more papers by this author, Lisa SouthonManchester Centre for Sexual Health, Manchester, United KingdomSearch for more papers by this author, Clare OaklandCentre for Sexual Health & HIV Research, Mortimer Market Centre, London, United KingdomSearch for more papers by this author, Chris HiggsJohn Hunter Clinic, St. Stephen's Centre, Chelsea & Westminster Hospital, London, United KingdomSearch for more papers by this author, David WhiteMedical Innovation Development Research Unit (MIDRU), Birmingham Heartlands Hospital, Birmingham, United KingdomSearch for more papers by this author, Iain ReevesHomerton Sexual Health Services, London, United KingdomSearch for more papers by this author, Michael BradyCaldecot Centre, London, United KingdomSearch for more papers by this author, Julie FoxSt Thomas' Hospital, London, United KingdomSearch for more papers by this author, Anthony NardonePublic Health England, London, United KingdomSearch for more papers by this author, and on behalf of the PROUD Study TeamSearch for more papers by this authorPublished Online:30 Oct 2014https://doi.org/10.1089/aid.2014.5030.abstractAboutSectionsView articleView Full TextPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"Sexual Behaviour Profile of Gay and Other Men Who Have Sex with Men Enrolled in the PROUD Pre-exposure Prophylaxis Open-label Pilot Study in England." AIDS Research and Human Retroviruses, 30(S1), p. A22FiguresReferencesRelatedDetailsCited ByAcceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study20 April 2017 | PLOS ONE, Vol. 12, No. 4 Volume 30Issue S1Oct 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:Mitzy Gafos, David Dolling, Monica Desai, Gemma Wood, David Dunn, John Saunders, Nicola E. Mackie, Alexandra Meijer, Amanda Clarke, Christine Bowman, Charles Lacey, Lisa Southon, Clare Oakland, Chris Higgs, David White, Iain Reeves, Michael Brady, Julie Fox, Anthony Nardone, and on behalf of the PROUD Study Team.Sexual Behaviour Profile of Gay and Other Men Who Have Sex with Men Enrolled in the PROUD Pre-exposure Prophylaxis Open-label Pilot Study in England.AIDS Research and Human Retroviruses.Oct 2014.A22-A22.http://doi.org/10.1089/aid.2014.5030.abstractPublished in Volume: 30 Issue S1: October 30, 2014PDF download

Corrigendum

In the article by Madelyn Gould and colleagues titled “Impact of Applied Suicide Intervention Skills Training on the National Suicide Prevention Lifeline” (Suicide and Life-Threatening Behavior 43(6): 676–691), two in-text citations were inadvertently transposed. On page 679, the dynamic wait-list design for randomized trials should have been attributed to Hendricks Brown, et al. (2006), and not to Gregory Brown, et al. (2005). On page 688, cognitive therapy interventions for preventing suicide attempts should have been attributed to Gregory Brown, et al. (2005), and not to Hendricks Brown, et al. (2006). The authors wish to apologize for this error.

Waiting list randomized controlled trial within a case-finding design: methodological considerations.

Randomized controlled trials (RCTs) are widely used in health care research to provide high-quality evidence of effectiveness of an intervention. However, sometimes a study does not require an RCT in order to answer its primary objective; a case-finding design may be more appropriate. The aim of this paper was to introduce a new study design that nests a waiting list RCT within a case-finding study. An example of the new study design is the DOC Study, which primarily aims to determine the diagnostic accuracy of lung function tests for chronic obstructive pulmonary disease. It also investigates the impact of lung function tests on smoking behaviour through use of a waiting list design. The first step of the study design is to obtain participants' consent. Individuals are then randomized to one of two groups; either the 'intervention now' group or the 'intervention later' group, that is, participants are placed on a waiting list. All participants receive the same intervention; the only difference between the groups is the timing of the intervention. The design addresses patient preference issues and recruitment issues that can arise in other trial designs. Potential limitations include differential attrition between study groups and potential demoralization for the 'intervention later' group. The 'waiting list case-finding trial' design is a valuable method that could be applied to case-finding studies; the design enables the case-finding component of a study to be maintained while simultaneously exploring additional hypotheses through conducting a trial.

Efficacy of pharmacotherapy and psychotherapy for adult psychiatric disorders: a systematic overview of meta-analyses.

There is debate about the effectiveness of psychiatric treatments and whether pharmacotherapy or psychotherapy should be primarily used. To perform a systematic overview on the efficacy of pharmacotherapies and psychotherapies for major psychiatric disorders and to compare the quality of pharmacotherapy and psychotherapy trials. We searched MEDLINE, EMBASE, PsycINFO, and the Cochrane Library (April 2012, with no time or language limit) for systematic reviews on pharmacotherapy or psychotherapy vs placebo, pharmacotherapy vs psychotherapy, and their combination vs either modality alone. Two reviewers independently selected the meta-analyses and extracted efficacy effect sizes. We assessed the quality of the individual trials included in the pharmacotherapy and psychotherapy meta-analyses with the Cochrane risk of bias tool. The search yielded 45,233 results. We included 61 meta-analyses on 21 psychiatric disorders, which contained 852 individual trials and 137,126 participants. The mean effect size of the meta-analyses was medium (mean, 0.50; 95% CI, 0.41-0.59). Effect sizes of psychotherapies vs placebo tended to be higher than those of medication, but direct comparisons, albeit usually based on few trials, did not reveal consistent differences. Individual pharmacotherapy trials were more likely to have large sample sizes, blinding, control groups, and intention-to-treat analyses. In contrast, psychotherapy trials had lower dropout rates and provided follow-up data. In psychotherapy studies, wait-list designs showed larger effects than did comparisons with placebo. Many pharmacotherapies and psychotherapies are effective, but there is a lot of room for improvement. Because of the multiple differences in the methods used in pharmacotherapy and psychotherapy trials, indirect comparisons of their effect sizes compared with placebo or no treatment are problematic. Well-designed direct comparisons, which are scarce, need public funding. Because patients often benefit from both forms of therapy, research should also focus on how both modalities can be best combined to maximize synergy rather than debate the use of one treatment over the other.

Testing the effectiveness of group-based memory rehabilitation in chronic stroke patients

Memory complaints are common after stroke, yet there have been very few studies of the outcome of memory rehabilitation in these patients. The present study evaluated the effectiveness of a new manualised, group-based memory training programme. Forty outpatients with a single-stroke history and ongoing memory complaints were enrolled. The six-week course involved education and strategy training and was evaluated using a wait-list crossover design, with three assessments conducted 12 weeks apart. Outcome measures included: tests of anterograde memory (Rey Auditory Verbal Learning Test: RAVLT; Complex Figure Test) and prospective memory (Royal Prince Alfred Prospective Memory Test); the Comprehensive Assessment of Prospective Memory (CAPM) questionnaire and self-report of number of strategies used. Significant training-related gains were found on RAVLT learning and delayed recall and on CAPM informant report. Lower baseline scores predicted greater gains for several outcome measures. Patients with higher IQ or level of education showed more gains in number of strategies used. Shorter time since onset was related to gains in prospective memory, but no other stroke-related variables influenced outcome. Our study provides evidence that a relatively brief, group-based training intervention can improve memory functioning in chronic stroke patients and clarified some of the baseline factors that influence outcome.

The Girlfriends Project: Results of a Pilot Study Assessing Feasibility of an HIV Testing and Risk Reduction Intervention Developed, Implemented, and Evaluated in Community Settings

African American women in the United States experience significant HIV health disparities. The majority of evidence-based risk reduction interventions do not incorporate HIV testing, and most are targeted only to narrow segments of the population such as women who are pregnant or seen in STI clinics. This pilot study assessed the feasibility and efficacy of The Girlfriends Project (TGP), a community developed and community evaluated HIV risk reduction and testing intervention. A group randomized wait-list design was used to recruit 149 women and to compare findings for intervention group versus control group participants. Women in the intervention group demonstrated statistically-significant increases in HIV knowledge scores and in condom use during vaginal sex. Eighty-seven percent of participants accessed HIV testing with a 100% return rate for results. Study findings suggest that TGP has the potential to be an effective intervention and to increase number of African American women who access HIV testing.

Every Child Counts: testing policy effectiveness using a randomised controlled trial, designed, conducted and reported to CONSORT standards

We report a randomised controlled trial evaluation of an intensive one-to-one numeracy programme – Numbers Count – which formed part of the previous government's numeracy policy intervention – Every Child Counts. We rigorously designed and conducted the trial to CONSORT guidelines. We used a pragmatic waiting list design to evaluate the intervention in real life settings in diverse geographical areas across England, to increase the ecological validity of the results. Children were randomly allocated within schools to either the intervention (Numbers Count in addition to normal classroom practice) or the control group (normal classroom practice alone). The primary outcome assessment was the Progress in Maths (PIM) 6 test from GL Assessment. Independent administration ensured that outcome ascertainment was undertaken blind to group allocation. The secondary outcome measure was the Sandwell test, which was not undertaken and marked blind to group allocation. At post-test the effect size (standardised mean difference between intervention and control group) on the PIM6 was d = 0.33 95% confidence intervals [0.12, 0.53], indicating strong evidence of a difference between the two groups. The effect size for the secondary outcome (Sandwell test) was d = 1.11 95% CI [0.91, 1.31]. Our results demonstrate a statistically significant effect of Numbers Count on our primary, independently marked, mathematics test. Like many trials, our study had both strengths and limitations. We feel, however, due to our a priori decision to report these in an explicit manner, as advocated by the CONSORT guidelines, that we could maximise rigour (e.g., by using blinded independent testing) and report potential problems (e.g., attrition rates). We have demonstrated that it is feasible to conduct an educational trial using the rigorous methodological techniques required by the CONSORT statement.

Evaluation of an intervention to reduce health professional stigma toward drug users: A pilot study

Background: Stigma underpins unfavorable attitudes toward many traditionally underserved groups in health care. Although training for Screening, Brief Intervention, and Referral to Treatment (SBIRT) has been shown to change provider attitudes, none have to date examined the effectiveness of training modules that directly address stigma toward drug users. The aim of this paper is to evaluate the impact of SBIRT training plus the addition of 2 anti-stigma training modules on stigma regarding drug use and drug users among Brazilian health professionals. Participants included community health workers, nursing assistants, nurses and other health professionals. Methods: A pretest-posttest wait-list design with intervention and comparison cities. The follow-up was 3 months. Participants included 95 primary health care professionals, of whom 54 received SBIRT training plus training in two anti-stigma modules (intervention group) and 41 received assessments only (comparison group). The posttest was administered 3 months following the training. Baseline and outcome included validated and non-validated measures of general attitudes and beliefs about drug users. In addition, participants responded to vignettes designed to assess stigma in the context of ethical issues, which assessed how much participants attributed responsibility for the onset and resolution of substance abuse to the patients themselves—the degree to which they “moralized” drug use. Results: There were marked baseline differences between experimental and comparison communities. However, nearly all (range 72%-90%) providers held a uniformly high “moralized” view of drug dependence. These attributions were not changed by the trainings. Likewise, there were no significant differences between intervention and control groups when we examined how much their stigma toward drug users changed after the anti-stigma module. Conclusions: This preliminary study found no intervention effects; it did find, however, that most professionals blamed drug users for their addiction. Because SBIRT seeks to embed intervention into settings that have historically overlooked and undertreated substance abuse, we believe that future research is warranted in order to better understand and address stigma. Research could explore what predicts stigmatized views of drug users, and what sorts of interventions reduce stigma.

Effects of qigong on performance-related anxiety and physiological stress functions in transverse flute music schoolchildren: a feasibility study

Based on individual cases of treatment, we were interested in whether the effects of a special kind of qigong, the "White Ball" exercises, can be objectified by physically measurable parameters and psychological scores. We performed a preliminary prospective controlled interventional study with the waiting list design. In the qigong group eight children were included. They received specific qigong lessons of the "White Ball" qigong over seven weeks, twice a week, for 30 min with a waiting list design and instructions to perform the same exercises at home daily. In the control group eight children were included in a waiting list design with no qigong instruction. Subjective perception of anxiety was measured by the Portuguese version of the Depression, Anxiety and Stress Scale adapted for children. In addition, salivary cortisol, heart rate variability, blood pressure, surface electromyography of the trapezius muscle and reaction time were measured at the beginning and the end of the study prior to the regular public auditions. In comparison to the changes in the control group, the qigong group scored significantly lower in heart rate. Otherwise the groups did not differ significantly; however, the effect size was large for salivary cortisol, surface electromyography of the trapezius muscle and blood pressure. There were relevant reductions of subjective perception of anxiety, salivary cortisol levels and heart rate. The heart rate of performing schoolchildren can be potentially reduced by "White Ball" exercises. Based on a sample of 8/8, positive tendencies were also observed for anxiety and blood pressure. The next steps of objectifying possible qigong effects are to increase the sample size, to study young people in other situations arousing anxiety, to develop an appropriate control intervention, to solve the problem of blinding and double blinding, to find additional parameters that may be influenced by the "White Ball" qigong, and to compare the qigong effects with other methods reducing anxiety such as more traditional biofeedback or systematic desensitization.

A Pilot Study of the Efficacy of a Computerized Executive Functioning Remediation Training With Game Elements for Children With ADHD in an Outpatient Setting

Objective: This pilot study tested the short- and long-term efficacy (9 weeks follow-up) of an executive functioning (EF) remediation training with game elements for children with ADHD in an outpatient clinical setting, using a randomized controlled wait-list design. Furthermore, in a subsample, that is, those treated with methylphenidate, additive effects of the EF training were assessed. Method: A total of 40 children (aged 8-12 years) were randomized to the EF training or wait-list. The training consisted of a 25-session training of inhibition, cognitive flexibility, and working memory. Treatment outcome was assessed by parent- and teacher-rated EF, ADHD, oppositional deviant disorder, and conduct disorder symptoms. Results: Children in the EF training showed significantly more improvement than those in the wait-list condition on parent-rated EF and ADHD behavior in the total sample and in the subsample treated with methylphenidate. Effects were maintained at follow-up. Conclusion: This pilot study shows promising evidence for the efficacy of an EF training with game elements.