DHA supplementation in infants born preterm and the effect on attention at 18 months’ corrected age: follow-up of a subset of the N3RO randomised controlled trial

2020 ◽  
pp. 1-12 ◽  
Author(s):  
Erandi Hewawasam ◽  
Carmel T. Collins ◽  
Beverly S. Muhlhausler ◽  
Lisa N. Yelland ◽  
Lisa G. Smithers ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
High Dose ◽  
Peak Period ◽  
Soya Oil ◽  
Randomised Controlled ◽  
To Receive ◽  
The Brain

Abstract Infants born preterm miss out on the peak period of in utero DHA accretion to the brain during the last trimester of pregnancy which is hypothesised to contribute to the increased prevalence of neurodevelopmental deficits in this population. This study aimed to determine whether DHA supplementation in infants born preterm improves attention at 18 months’ corrected age. This is a follow-up of a subset of infants who participated in the N3RO randomised controlled trial. Infants were randomised to receive an enteral emulsion of high-dose DHA (60 mg/kg per d) or no DHA (soya oil – control) from within the first days of birth until 36 weeks’ post-menstrual age. The assessment of attention involved three tasks requiring the child to maintain attention on toy/s in either the presence or absence of competition or a distractor. The primary outcome was the child’s latency of distractibility when attention was focused on a toy. The primary outcome was available for seventy-three of the 120 infants that were eligible to participate. There was no evidence of a difference between groups in the latency of distractibility (adjusted mean difference: 0·08 s, 95 % CI –0·81, 0·97; P = 0·86). Enteral DHA supplementation did not result in improved attention in infants born preterm at 18 months’ corrected age.

scholarly journals Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

scholarly journals An intervention to optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE): a three-country cluster randomised controlled trial

2020 ◽  
pp. bjsports-2019-101963
Author(s):  
Nikos Ntoumanis ◽  
Eleanor Quested ◽  
Laurie Patterson ◽  
Stella Kaffe ◽  
Susan H Backhouse ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
Perceived Effectiveness ◽  
Cluster Randomised ◽  
Randomised Controlled

ObjectivesCoach-centred antidoping education is scarce. We tested the efficacy of a motivationally informed antidoping intervention for coaches, with their athletes’ willingness to dope as the primary outcome.MethodsWe delivered a cluster randomised controlled trial in Australia, the UK and Greece. This study was a parallel group, two-condition, superiority trial. Participants were 130 coaches and 919 athletes. Coaches in the intervention group attended two workshops and received supplementary information to support them in adopting a motivationally supportive communication style when discussing doping-related issues with their athletes. Coaches in the control condition attended a standard antidoping workshop that provided up-to-date information on antidoping issues yet excluded any motivation-related content. Assessments of willingness to dope (primary outcome) and other secondary outcomes were taken at baseline, postintervention (3 months) and at a 2-month follow up.ResultsCompared with athletes in the control group, athletes in the intervention group reported greater reductions in willingness to take prohibited substances (effect size g=0.17) and psychological need frustration (g=0.23) at postintervention, and greater increases in antidoping knowledge (g=0.27) at follow-up. Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations. They also reported greater decreases in doping attitudes (g=0.24) and perceived effectiveness of need thwarting behaviours (g=0.35).ConclusionsAntidoping education programmes should consider incorporating principles of motivation, as these could be beneficial to coaches and their athletes. We offer suggestions to strengthen these programmes, as most of the effects we observed were not sustained at follow-up.Trial registration numberThis trial has been registered with the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371465&isReview=true).

scholarly journals Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette’s disorder: a pilot randomised controlled trial with long-term follow-up

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024685 ◽  
Author(s):  
Per Andrén ◽  
Kristina Aspvall ◽  
Lorena Fernández de la Cruz ◽  
Paulina Wiktor ◽  
Sofia Romano ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Behaviour Therapy ◽  
Tic Severity ◽  
Randomised Controlled

ObjectiveBehaviour therapy (BT) for Tourette’s disorder (TD) and persistent (chronic) motor or vocal tic disorder (PTD) is rarely available. We evaluated the feasibility of adapting two existing BT protocols for TD/PTD (habit reversal training (HRT) and exposure and response prevention (ERP)) into a therapist-guided and parent-guided online self-help format.DesignA pilot, single-blind, parallel group randomised controlled trial.SettingA specialist outpatient clinic in Sweden.ParticipantsTwenty-three young people with TD/PTD, aged 8–16.InterventionsTwo 10-week therapist-guided and parent-guided internet-delivered programmes (called BIP TIC HRT and BIP TIC ERP).OutcomeThe primary outcome measure was the Yale Global Tic Severity Scale. Blinded evaluators rated symptoms at baseline, post-treatment and 3-month follow-up (primary endpoint). All participants were naturalistically followed up to 12 months after treatment.ResultsPatients and parents rated the interventions as highly acceptable, credible and satisfactory. While both interventions resulted in reduced tic-related impairment, parent-rated tic severity and improved quality of life, only BIP TIC ERP resulted in a significant improvement on the primary outcome measure. Within-group effect sizes and responder rates were, respectively: d=1.12 and 75% for BIP TIC ERP, and d=0.50 and 55% for BIP TIC HRT. The therapeutic gains were maintained up to 12 months after the end of the treatment. Adverse events were rare in both groups. The average therapist support time was around 25 min per participant per week.ConclusionsInternet-delivered BT has the potential to greatly increase access to evidence-based treatment for young people with TD/PTD. Further evaluation of the efficacy and cost-effectiveness of this treatment modality is warranted.Trial registration numberNCT02864589; Pre-results.

scholarly journals Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036300
Author(s):  
Shoumitro Deb ◽  
Lina Aimola ◽  
Verity Leeson ◽  
Mayur Bodani ◽  
Lucia Li ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Process Evaluation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

ObjectivesTo conduct a feasibility randomised controlled trial of risperidone for the treatment of aggression in adults with traumatic brain injury (TBI).DesignMulticentre, parallel design, placebo controlled (1:1 ratio) double-blind feasibility trial with an embedded process evaluation. No statistical comparison was performed between the two study groups.SettingFour neuropsychiatric and neurology outpatient clinics in London and Kent, UK.ParticipantsOur aim was to recruit 50 patients with TBI over 18 months. Follow-up participants at 12 weeks using a battery of assessment scales to measure changes in aggressive behaviour and irritability (Modified Overt Aggression Scale (MOAS)-primary outcome, Irritability Questionnaire) as well as global functioning (Glasgow Outcome Scale-Extended, Clinical Global impression) and quality of life (EQ-5D-5L, SF-12), mental health (Hospital Anxiety and Depression Scale) and medication adverse effects (Udvalg for Kliniske Undersøgelser).ResultsSix participants were randomised to the active arm of the trial and eight to the placebo arm over a 10-month period (28% of our target). Two participants withdrew because of adverse events. Twelve out of 14 (85.7%) patients completed a follow-up assessment at 12 weeks. At follow-up, the scores of all outcome measures improved in both groups. Placebo group showed numerically better score change according to the primary outcome MOAS. No severe adverse events were reported. The overall rate of adverse events remained low. Data from the process evaluation suggest that existence of specialised TBI follow-up clinics, availability of a dedicated database of TBI patients’ clinical details, simple study procedures and regular support to participants would enhance recruitment and retention in the trial. Feedback from participants showed that once in the study, they did not find the trial procedure onerous.ConclusionsIt was not feasible to conduct a successful randomised trial of risperidone versus placebo for post-TBI aggression using the methods we deployed in this study. It is not possible to draw any definitive conclusion about risperidone’s efficacy from such a small trial.Trial registration numberISRCTN30191436

scholarly journals Does addition of craving management tools in a stop smoking app improve quit rates among adult smokers? Results from BupaQuit pragmatic pilot randomised controlled trial.

2019 ◽  
Author(s):  
Aleksandra Herbec ◽  
Lion Shahab ◽  
Jamie Brown ◽  
Harveen Kaur Ubhi ◽  
Emma Beard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Point Prevalence ◽  
Management Tools ◽  
Exact Test ◽  
Significant Difference ◽  
Continuous Abstinence ◽  
Randomised Controlled

Introduction: Delivery of craving management tools (CMTs) via smartphone applications (apps) may improve smoking cessation rates, but research on such programmes remainslimited, especially in real-world settings. This study evaluated the effectiveness of adding CMTs in a cessation app (BupaQuit).Methods: The study was a two-arm pragmatic pilot parallel randomised controlled trial, comparing a fully-automated BupaQuit app with CMT with a control app version withoutCMT. A total of 425 adult UK-based daily smokers were enrolled through open online recruitment (February 2015-March 2016), with no researcher involvement, and individually randomised within the app to the intervention (n=208) or control (n=217). The primary outcome was self-reported 14-day continuous abstinence assessed at 4-week follow-up. Secondary outcomes included 6-month point-prevalence and sustained abstinence, and app usage. The primary outcome was assessed with Fisher’s exact test using intent to treat with those lost to follow-up counted as smoking. Participants were not reimbursed.Results: Re-contact rates were 50.4% at 4 weeks and 40.2% at 6 months. There was no significant difference between intervention and control arms on the primary outcome (13.5% vs 15.7%; p=0.58;RR=0.86, 95% Confidence Interval (CI)=0.54-1.36) or secondary cessation outcomes (6-month point prevalence: 14.4% vs. 17.1%, p=0.51;RR=0.85, 95%CI=0.54-1.32; 6-month sustained: 11.1% vs 13.4%, p=0.55,RR=0.83,95%CI=0.50-1.38). Bayes factors supported the null hypothesis (B[0, 0,1.0986]=.20). Usage was similar across the conditions (mean/median logins: 9.6/4 vs. 10.5/5; time spent: 401.8/202s vs. 325.8/209s).Conclusions: The addition of craving management tools did not affect cessation, and the limited engagement with the app may have contributed to this.

scholarly journals Multi-strategy intervention increases school implementation and maintenance of a mandatory physical activity policy: outcomes of a cluster randomised controlled trial

2021 ◽  
pp. bjsports-2020-103764
Author(s):  
Nicole Nathan ◽  
Alix Hall ◽  
Nicole McCarthy ◽  
Rachel Sutherland ◽  
John Wiggers ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Policy Implementation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Classroom Teachers ◽  
Cluster Randomised ◽  
Randomised Controlled

ObjectivesTo assess if a multi-strategy intervention effectively increased weekly minutes of structured physical activity (PA) implemented by classroom teachers at 12 months and 18 months.MethodsA cluster randomised controlled trial with 61 primary schools in New South Wales Australia. The 12-month multi-strategy intervention included; centralised technical assistance, ongoing consultation, principal’s mandated change, identifying and preparing school champions, development of implementation plans, educational outreach visits and provision of educational materials. Control schools received usual support (guidelines for policy development via education department website and telephone support). Weekly minutes of structured PA implemented by classroom teachers (primary outcome) was measured via teacher completion of a daily log-book at baseline (October–December 2017), 12-month (October–December 2018) and 18-month (April–June 2019). Data were analysed using linear mixed effects regression models.ResultsOverall, 400 class teachers at baseline, 403 at 12 months follow-up and 391 at 18 months follow-up provided valid primary outcome data. From baseline to 12-month follow-up, teachers at intervention schools recorded a greater increase in weekly minutes of PA implemented than teachers assigned to the control schools by approximately 44.2 min (95% CI 32.8 to 55.7; p<0.001) which remained at 18 months, however, the effect size was smaller at 27.1 min (95% CI 15.5 to 38.6; p≤0.001).ConclusionA multi-strategy intervention increased mandatory PA policy implementation. Some, but not all of this improvement was maintained after implementation support concluded. Further research should assess the impact of scale-up strategies on the sustainability of PA policy implementation over longer time periods.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001265369).

scholarly journals A randomised controlled trial of a theory-based interactive internet-based smoking cessation intervention (‘StopAdvisor’): Study protocol

2013 ◽  
Vol 8 (2) ◽  
pp. 63-70 ◽  
Author(s):  
Susan Michie ◽  
Jamie Brown ◽  
Adam W. A. Geraghty ◽  
Sascha Miller ◽  
Lucy Yardley ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Logistic Regression ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
The Social ◽  
Randomised Controlled

Background: Internet-based interventions can help smokers to quit compared with brief written materials or no intervention. However, they are not widely used, particularly by more disadvantaged smokers, and there is significant variation in their effectiveness. A new smoking cessation website (‘StopAdvisor’) has been systematically developed on the basis of PRIME theory, empirical evidence, web-design expertise and user-testing with socio-economically disadvantaged smokers. This paper reports the protocol of a randomised controlled trial to evaluate the efficacy of StopAdvisor and determine whether it translates across the social spectrum.Methods: The trial has two arms with participants randomised to the offer of the interactive ‘StopAdvisor’ website (intervention condition) or a non-interactive, static website (control condition). Participants are adults from the UK, who smoke every day and are willing to make a serious quit attempt within a month of enrolment. At least 4260 participants will be recruited with a minimum of 2130 in each of two socio-economic sub-groups. The intervention comprises a structured quit plan and a variety of theory- and evidence-based behaviour change techniques for smoking cessation. Tailored support is offered in the form of a series of tunnelled sessions and a variety of interactive menus for use up to a month before, and then for one month after quitting (http://www.lifeguideonline.org/player/play/stopadvisordemonstration). The control is a static website that presents brief and standard advice on smoking cessation. Assessments are at baseline and 2-, 4- and 7-months post-enrolment. The primary outcome measure will be Russell Standard 6-months sustained abstinence, defined as self-reported continuous abstinence verified by saliva cotinine or anabasine at 7-month follow-up. Secondary outcome measures will include 7-day point-prevalence abstinence at 7-month follow-up, self-reported abstinence at 2- and 4-month follow-ups, satisfaction ratings of the website and quantitative indices of website interaction. All analyses will be by intention to treat and the main analysis will compare the two conditions on the primary outcome measure using a logistic regression model, adjusted for baseline characteristics. The efficacy of the intervention across the social spectrum will be assessed by a logistic regression focusing on the interaction between condition and socio-economic disadvantage.Trial registration: ISRCTN99820519.

Treatment of missing data in follow-up studies of randomised controlled trials: A systematic review of the literature

2017 ◽  
Vol 14 (4) ◽  
pp. 387-395 ◽  
Author(s):  
Thomas R Sullivan ◽  
Lisa N Yelland ◽  
Katherine J Lee ◽  
Philip Ryan ◽  
Amy B Salter
Keyword(s):  
Statistical Analysis ◽  
Missing Data ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Sensitivity Analyses ◽  
Follow Up Studies ◽  
Statistical Approaches ◽  
Randomised Controlled

Background/aims: After completion of a randomised controlled trial, an extended follow-up period may be initiated to learn about longer term impacts of the intervention. Since extended follow-up studies often involve additional eligibility restrictions and consent processes for participation, and a longer duration of follow-up entails a greater risk of participant attrition, missing data can be a considerable threat in this setting. As a potential source of bias, it is critical that missing data are appropriately handled in the statistical analysis, yet little is known about the treatment of missing data in extended follow-up studies. The aims of this review were to summarise the extent of missing data in extended follow-up studies and the use of statistical approaches to address this potentially serious problem. Methods: We performed a systematic literature search in PubMed to identify extended follow-up studies published from January to June 2015. Studies were eligible for inclusion if the original randomised controlled trial results were also published and if the main objective of extended follow-up was to compare the original randomised groups. We recorded information on the extent of missing data and the approach used to treat missing data in the statistical analysis of the primary outcome of the extended follow-up study. Results: Of the 81 studies included in the review, 36 (44%) reported additional eligibility restrictions and 24 (30%) consent processes for entry into extended follow-up. Data were collected at a median of 7 years after randomisation. Excluding 28 studies with a time to event primary outcome, 51/53 studies (96%) reported missing data on the primary outcome. The median percentage of randomised participants with complete data on the primary outcome was just 66% in these studies. The most common statistical approach to address missing data was complete case analysis (51% of studies), while likelihood-based analyses were also well represented (25%). Sensitivity analyses around the missing data mechanism were rarely performed (25% of studies), and when they were, they often involved unrealistic assumptions about the mechanism. Conclusion: Despite missing data being a serious problem in extended follow-up studies, statistical approaches to addressing missing data were often inadequate. We recommend researchers clearly specify all sources of missing data in follow-up studies and use statistical methods that are valid under a plausible assumption about the missing data mechanism. Sensitivity analyses should also be undertaken to assess the robustness of findings to assumptions about the missing data mechanism.

scholarly journals Does addition of craving management tools in a stop smoking app improve quit rates among adult smokers? Results from BupaQuit pragmatic pilot randomised controlled trial

2021 ◽  
Vol 7 ◽  
pp. 205520762110589
Author(s):  
Aleksandra Herbec ◽  
Lion Shahab ◽  
Jamie Brown ◽  
Harveen Kaur Ubhi ◽  
Emma Beard ◽  
...  
Keyword(s):  
Relative Risk ◽  
Randomised Controlled Trial ◽  
Confidence Interval ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Point Prevalence ◽  
Management Tool ◽  
Management Tools ◽  
Randomised Controlled

Objectives Delivery of craving management tools via smartphone applications (apps) may improve smoking cessation rates, but research on such programmes remains limited, especially in real-world settings. This study evaluated the effectiveness of adding craving management tools in a cessation app (BupaQuit). Methods The study was a two-arm pragmatic pilot parallel randomised controlled trial, comparing a fully-automated BupaQuit app with craving management tool with a control app version without craving management tool. A total of 425 adult UK-based daily smokers were enrolled through open online recruitment (February 2015–March 2016), with no researcher involvement, and individually randomised within the app to the intervention ( n = 208) or control ( n = 217). The primary outcome was self-reported 14-day continuous abstinence assessed at 4-week follow-up. Secondary outcomes included 6-month point-prevalence and sustained abstinence, and app usage. The primary outcome was assessed with Fisher's exact test using intent to treat with those lost to follow-up counted as smoking. Participants were not reimbursed. Results Re-contact rates were 50.4% at 4 weeks and 40.2% at 6 months. There was no significant difference between intervention and control arms on the primary outcome (13.5% vs 15.7%; p = 0.58; relative risk = 0.86, 95% confidence interval = 0.54–1.36) or secondary cessation outcomes (6-month point prevalence: 14.4% vs 17.1%, p = 0.51; relative risk = 0.85, 95% confidence interval = 0.54–1.32; 6-month sustained: 11.1% vs 13.4%, p = 0.55; relative risk = 0.83, 95% confidence interval = 0.50–1.38). Bayes factors supported the null hypothesis ( B[0, 0, 1.0986] = 0.20). Usage was similar across the conditions (mean/median logins: 9.6/4 vs 10.5/5; time spent: 401.8/202 s vs 325.8/209 s). Conclusions The addition of craving management tools did not affect cessation, and the limited engagement with the app may have contributed to this.

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