Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

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Evaluation of an Ultrasound-Guided Palpation Intervention for Palpation Skill Training: A Single-Blind, Parallel Group, Randomised Controlled Trial

10.21203/rs.3.rs-832314/v1 ◽

2021 ◽

Author(s):

Takashi Kitagawa ◽

Yuma Aoki ◽

Hotaka Sugimoto ◽

Natsumi Ozaki

Keyword(s):

Medical Students ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Parallel Group ◽

Randomised Controlled ◽

Single Blind

Abstract Although there are increasing reports on the usefulness of sonopalpation with ultrasound imaging, many previous studies have reported interventions without a control group. This single-blind, parallel group randomised controlled trial aimed to determine whether educational instruction with sonopalpation for medical students has a superior effect on skill improvement than traditional instruction without ultrasonography. Twenty-nine medical students participated in the study and were randomised using block randomisation into an ultrasound imaging group (n = 15) and a control group (n = 14). Then, they underwent three training sessions focusing on the shoulder joint. Participants underwent a scoring assessment of their palpation skills at pre-intervention, post-intervention, and follow-up 3 months after training. The raters were blinded to the subjects’ group. The Friedman and Mann–Whitney U tests were used for data analysis. The intervention group showed a significant increase in scores at post-intervention and at the 3-month follow-up when compared with the pre-intervention group (p < 0.05); the effect sizes were large (0.849 and 0.849, respectively). A comparison of the scores at different time points after the intervention at the 3-month follow-up revealed that there was no significant difference between the groups. Education using ultrasound images may improve the sonopalpation skills of medical students.

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A randomised controlled trial to reduce highest priority critically important antimicrobial prescription in companion animals

Nature Communications ◽

10.1038/s41467-021-21864-3 ◽

2021 ◽

Vol 12 (1) ◽

Author(s):

David A. Singleton ◽

Angela Rayner ◽

Bethaney Brant ◽

Steven Smyth ◽

Peter-John M. Noble ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Companion Animals ◽

Intervention Group ◽

Control Group ◽

Prescription Data ◽

Post Intervention ◽

Electronic Prescription ◽

Randomised Controlled

AbstractRobust evidence supporting strategies for companion animal antimicrobial stewardship is limited, despite frequent prescription of highest priority critically important antimicrobials (HPCIA). Here we describe a randomised controlled trial where electronic prescription data were utilised (August 2018–January 2019) to identify above average HPCIA-prescribing practices (n = 60), which were randomly assigned into a control group (CG) and two intervention groups. In March 2019, the light intervention group (LIG) and heavy intervention group (HIG) were notified of their above average status, and were provided with educational material (LIG, HIG), in-depth benchmarking (HIG), and follow-up meetings (HIG). Following notification, follow-up monitoring lasted for eight months (April–November 2019; post-intervention period) for all intervention groups, though HIG practices were able to access further support (i.e., follow-up meetings) for the first six of these months if requested. Post-intervention, in the HIG a 23.5% and 39.0% reduction in canine (0.5% of total consultations, 95% confidence interval, 0.4-0.6, P = 0.04) and feline (4.4%, 3.4-5.3, P < 0.001) HPCIA-prescribing consultations was observed, compared to the CG (dogs: 0.6%, 0.5-0.8; cats: 7.4%, 6.0-8.7). The LIG was associated with a 16.7% reduction in feline HPCIA prescription (6.1% of total consultations, 5.3-7.0, P = 0.03). Therefore, in this trial we have demonstrated effective strategies for reducing veterinary HPCIA prescription.

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A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

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Effectiveness of E-SBIRT intervention in community healthcare institution in China: study proposal for a randomised controlled trial

General Psychiatry ◽

10.1136/gpsych-2021-100486 ◽

2021 ◽

Vol 34 (5) ◽

pp. e100486

Author(s):

Rao Fu ◽

Chenxin Yuan ◽

Wei Sun ◽

Wenzheng Wang ◽

Lei Zhang ◽

...

Keyword(s):

Substance Use ◽

Randomised Controlled Trial ◽

Primary Healthcare ◽

Negative Emotion ◽

Controlled Trial ◽

Intervention Group ◽

Addiction Severity Index ◽

Control Group ◽

Community Healthcare ◽

Randomised Controlled

BackgroundMany studies have demonstrated the effectiveness of Screening, Brief Intervention and Referral to Treatment (SBIRT) in addressing substance use problem. However, owing to the shortage of counsellors, it has not been widely used in China. With the development of smart medicine, we developed a web-based electronic SBIRT (E-SBIRT) program and explored the effectiveness of E-SBIRT in reducing substance use in China.MethodsA randomised controlled trial will be conducted in primary healthcare institutions. Four primary healthcare institutions will be selected and randomly divided into an intervention group and a control group (each institution will recruit 60 participants, and in total, 240 participants will be recruited). The control group will get a pamphlet of drug abuse prevention, and the intervention group will get the E-SBIRT intervention and the pamphlet. Both groups will receive baseline and follow-up assessment at 1 and 3 months after the intervention. The primary outcome is the change in scores on the Alcohol, Smoking and Substance Use Involvement Screening Test, and the secondary outcomes include changes in motivation, depression, anxiety, positive/negative emotion, self-esteem, addiction knowledge and addiction severity index.ConclusionsIf the ‘E-SBIRT’ program is found to be effective, it will be an accessible, affordable and widely implementable intervention to help participants at moderate risk of substance use to reduce their consumption. The potential benefit is to provide early intervention to high-risk patients in time and reduce the harmful consequences to individuals and society.Trial registration numberNCT03452241.

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Effect of a financial incentive (shopping point) on increasing the number of daily walking steps among community-dwelling adults in Japan: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-037303 ◽

2020 ◽

Vol 10 (11) ◽

pp. e037303

Author(s):

Fumiya Tanji ◽

Yasutake Tomata ◽

Saho Abe ◽

Sanae Matsuyama ◽

Yumika Kotaki ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Financial Incentive ◽

Controlled Trial ◽

Intervention Group ◽

Community Dwelling ◽

Control Group ◽

Intervention Period ◽

The Mean ◽

Randomised Controlled

ObjectiveThe aim of this study was to investigate the effect of a financial incentive on the number of daily walking steps among community-dwelling adults in Japan.Study designTwo-arm, parallel-group randomised controlled trial.Setting/participantsWe recruited physically inactive community-dwelling adults from Sendai city, Japan. Eligible participants were randomly allocated to an intervention or a wait list control group. Pedometers were used to assess the mean number of daily steps in three periods: baseline (weeks 1–3), intervention (weeks 4–6) and follow-up (weeks 7–9).InterventionThe intervention group was offered a financial incentive (shopping points) to meet the target number of increased daily steps in the intervention period.Main outcome measuresThe primary outcome was an increase in the mean number of daily steps in the intervention and follow-up periods compared with baseline.ResultsSeventy-two participants (69.4% women; mean age, 61.2±16.2 years; mean number of daily steps at baseline, 6364±2804) were randomised to the intervention (n=36) and control groups (n=36). During the intervention period, the increase in mean daily steps was significantly higher in the intervention group (1650, 95% CI=1182 to 2119) than in the control group (514, 95% CI=136 to 891; p<0.001). However, the difference between groups was not significant at follow-up after the incentives were removed (p=0.311). In addition, compared with controls, a significantly higher proportion of participants in the intervention group showed an increase in mean daily steps of ≥1000 (69.4% vs 30.6%, respectively; OR=5.17, 95% CI=1.89 to 14.08). There were no adverse effects from the intervention.ConclusionsThe present results suggest that financial incentives are effective in promoting short-term increases in physical activity.Trial registration numberUMIN000033276.

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Triaging and Referring In Adjacent General and Emergency Departments (the TRIAGE trial): a cluster randomised controlled trial

10.1101/2021.08.16.21261782 ◽

2021 ◽

Author(s):

Stefan Morreel ◽

Hilde Philips ◽

Diana De Graeve ◽

Koenraad G Monsieurs ◽

Jarl Kampen ◽

...

Keyword(s):

Primary Care ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Secondary Outcome ◽

Control Group ◽

Predictive Values ◽

Randomised Controlled

Objectives: To determine the effectiveness and safety of a tool diverting low urgency patients eligible for primary care from an emergency department (ED) to the adjacent general practitioner cooperative (GPC). Methods: Unblinded, randomised controlled trial with weekends serving as clusters (three intervention clusters for each control). The intervention was nurse-led triage using a new tool assigning patients to either ED or GPC. During intervention weekends, patients were encouraged to follow this assignment while it was not communicated to the patients during control weekends (they remained at the ED). The primary outcome was the proportion of patients assigned to and handled by the GPC during intervention weekends. The trial was randomised for the secondary outcome: the proportion of patients assigned to the GPC during intervention and control weekends. Additional outcomes were association of these outcomes with possible confounders (study tool parameters, nurse, and patient characteristics), proportion of patients referred back to the ED by the GPC, hospitalisations, and performance of the study tool to detect primary care eligible patients (with the opinion of the treating physician as the gold standard). Results: In the intervention group, 838/6374 patients (13.3%, 95% CI 12.5 to 14.2) were assigned to the GPC (secondary outcome), in the control group 431/1744 (24.7%, 95% CI 22.7 to 26.8). In the intervention group, 599/6374 patients (9.5%, 95% CI 8.8 to 10.3) experienced the primary outcome which was influenced by the chosen MTS presentational flowchart, patient's age, and the nurse. 24/599 patients (4.0%, 95% CI 2.7 to 5.9) patients were referred back to the ED of which three were hospitalised. Positive and negative predictive values of the studied tool during intervention weekends were 0.96 (95%CI 0.94 to 0.97) and 0.60 (95% CI 0.58 to 0.62). Out of the patients assigned to the GPC, 2.4% (95% CI 1.7 to 3.4) were hospitalised. Conclusions: ED nurses using a new tool safely diverted 9.5% of the included patients to primary care. ClinicalTrials.gov Identifier: NCT03793972 Funding: Research Foundation, Flanders (FWO)

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Effect of an editorial intervention to improve the completeness of reporting of randomised trials: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-036799 ◽

2020 ◽

Vol 10 (5) ◽

pp. e036799 ◽

Cited By ~ 1

Author(s):

David Blanco ◽

Sara Schroter ◽

Adrian Aldcroft ◽

David Moher ◽

Isabelle Boutron ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Peer Review ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Randomised Trials ◽

Randomised Controlled ◽

The Impact ◽

Completeness Of Reporting

ObjectiveTo evaluate the impact of an editorial intervention to improve completeness of reporting of reports of randomised trials.DesignRandomised controlled trial (RCT).SettingBMJ Open’s quality improvement programme.Participants24 manuscripts describing RCTs.InterventionsWe used an R Shiny application to randomise manuscripts (1:1 allocation ratio, blocks of 4) to the intervention (n=12) or control (n=12) group. The intervention was performed by a researcher with expertise in the content of the Consolidated Standards of Reporting Trials (CONSORT) and consisted of an evaluation of completeness of reporting of eight core CONSORT items using the submitted checklist to locate information, and the production of a report containing specific requests for authors based on the reporting issues found, provided alongside the peer review reports. The control group underwent the usual peer review.OutcomesThe primary outcome is the number of adequately reported items (0–8 scale) in the revised manuscript after the first round of peer review. The main analysis was intention-to-treat (n=24), and we imputed the scores of lost to follow-up manuscripts (rejected after peer review and not resubmitted). The secondary outcome is the proportion of manuscripts where each item was adequately reported. Two blinded reviewers assessed the outcomes independently and in duplicate and solved disagreements by consensus. We also recorded the amount of time to perform the intervention.ResultsManuscripts in the intervention group (mean: 7.01; SD: 1.47) were more completely reported than those in the control group (mean: 5.68; SD: 1.43) (mean difference 1.43, 95% CI 0.31 to 2.58). We observed the main differences in items 6a (outcomes), 9 (allocation concealment mechanism), 11a (blinding) and 17a (outcomes and estimation). The mean time to perform the intervention was 87 (SD 42) min.ConclusionsWe demonstrated the benefit of involving a reporting guideline expert in the editorial process. Improving the completeness of RCTs is essential to enhance their usability.Trial registration numberNCT03751878.

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Evaluating the effectiveness of a ‘real-world’ shared reading intervention for preschool children and their families: A randomised controlled trial.

10.31234/osf.io/habg9 ◽

2018 ◽

Author(s):

Jamie Lingwood ◽

Josie Billington ◽

Caroline F Rowland

Keyword(s):

Randomised Controlled Trial ◽

Reading Interventions ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Shared Reading ◽

Control Group ◽

Post Intervention ◽

Reading Groups ◽

Randomised Controlled

Background: Shared reading interventions can impact positively on preschool children’s language development and on their caregiver’s attitudes/behaviours towards reading. However, a number of barriers may discourage families from engaging with these interventions, particularly families from lower socioeconomic (SES) backgrounds. We investigated how families from such backgrounds responded to an intervention designed explicitly to overcome these barriers. Methods: In a pre-registered cluster randomised controlled trial, 85 lower SES families and their 3- to 4-year old children from 10 different preschools were randomly allocated to take part in The Reader’s Shared Reading programme (intervention) or an existing ‘Story Time’ group at a library (control), once a week for eight weeks. Three outcome measures were assessed at baseline and post-intervention: (i) attendance, (ii) enjoyment of the reading groups, and (iii) caregivers’ knowledge of, attitudes and behaviours towards reading. A fourth, - children’s vocabulary - was assessed at baseline and four weeks post-intervention. Results: Families were significantly more likely to attend the intervention group and rated them more favourably, compared to the control group. However, there were no significant effects on caregivers’ knowledge, attitudes and behaviours, or on children’s language. Conclusion: The intervention was only successful in engaging families from disadvantaged backgrounds in shared reading. Implications for the use, duration and intensity of shared reading interventions are discussed.

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Medication reconciliation knowledge among hospital pharmacists in Nigeria: A non-randomised controlled trial

Pharmacy Education ◽

10.46542/pe.2021.211.528537 ◽

2021 ◽

pp. 528-537

Author(s):

Akinniyi A. Aje ◽

Segun J. Showande ◽

Titilayo O. Fakeye

Keyword(s):

Randomised Controlled Trial ◽

Educational Intervention ◽

Medication Reconciliation ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

College Hospital ◽

Tertiary Hospitals ◽

Randomised Controlled

Background: Medication reconciliation (MR) is a patient-centred evolving role of pharmacists that improves patient’s health outcomes. Aim: To assess the effect of an educational intervention on pharmacists’ MR knowledge in two Nigerian tertiary hospitals. Methods: A two-arm parallel non-randomised controlled trial was carried out at two tertiary hospitals in Nigeria, one as intervention and the other as control site. Pharmacists’ MR knowledge was assessed pre-intervention and at one-, three- and six-month post-intervention. The intervention consisted of seminar and role-plays. Data were summarised with descriptive and inferential statistics. Results: A total of 75 pharmacists completed the study. Scores for pre-intervention out of a total of 38 was 19.31±4.76 in the intervention group and 17.50±6.86 in the control group. Post-intervention assessment scores (University College Hospital vs University of Ilorin Teaching Hospital) at one, three and six months were 29.82±5.01 vs 25.97±5.31, 31.53±4.99 vs 26.10±5.20, and 31.69±4.10 vs 23.07±3.98, respectively (p < 0.01). Conclusion: The educational intervention led to improved pharmacists’ MR knowledge.

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Using laxatives and/or enemas to accelerate the diagnosis in children presenting with acute abdominal pain: a randomised controlled trial study protocol

BMJ Paediatrics Open ◽

10.1136/bmjpo-2018-000341 ◽

2018 ◽

Vol 2 (1) ◽

pp. e000341

Author(s):

Marjolijn E W Timmerman ◽

Monika Trzpis ◽

Paul M A Broens

Keyword(s):

Abdominal Pain ◽

Randomised Controlled Trial ◽

Acute Appendicitis ◽

Acute Abdominal Pain ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Adequate Treatment ◽

Randomised Controlled

IntroductionMany children with acute abdominal pain and suspicion of appendicitis are diagnosed with constipation. Nevertheless, it can be difficult to differentiate between acute constipation and acute appendicitis because of similar symptoms and lack of diagnostic criteria. Consequently, constipation is often missed despite repeated consultations at the emergency department. We hypothesise that the diagnostic process can be improved and adequate treatment accelerated by supporting faecal evacuation in children with acute abdominal pain.Methods and analysisAn unblinded randomised controlled trial including children aged between 5 years and 18 years with acute abdominal pain and suspicion of acute appendicitis. Children who do not have a definitive diagnosis after the first consultation and who need to return for a second consultation will be randomised. The intervention group will receive laxatives and enemas, while the control group will receive no medication. If, after the second consultation, still no diagnosis is established, and a third consultation is needed, then the intervention group will receive only laxatives, and the control group will again not receive medication. The primary outcome will be the differences in abdominal pain scores obtained with FACES Pain Rating Scale and the visual analogue scale at first, second and possibly third consultation. The secondary outcome will be the number of consultations needed to reach final diagnosis.Ethics and disseminationLaxatives and enemas have proven to be safe and effective treatments for constipation in children. Adverse events are therefore not expected, however, should they occur, then the child concerned shall be properly followed and treated until the event is over. The local Medical Research Ethics Committee approved of this study and waived the otherwise mandatory insurance for human test subjects.Trial registration numbersPre-results: CCMO NL44710.042.12 andEudraCT 2013-000498-56.

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