scholarly journals Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e044669
Author(s):  
Lucie Jurek ◽  
Pauline Occelli ◽  
Angelique Denis ◽  
Anouck Amestoy ◽  
Thierry Maffre ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Urban Areas ◽  
Fixed Effects ◽  
Controlled Trial ◽  
Random Effect ◽  
Autism Spectrum ◽  
Health Priorities ◽  
Preschool Period ◽  
Randomised Controlled

IntroductionIntervention in the preschool period is currently recommended for autism spectrum disorder. Therapies delivered by parents are particularly suitable for young children. Preschool Autism Communication Trial (PACT) is a parent-mediated therapy that has shown a significant and sustained impact on autism symptom reduction. However, access to such evidence-based therapies for families is limited due to autism centres located in large urban areas. Using videoconferencing to deliver PACT training to parents may improve accessibility for families living in underserved areas.Methods and analysisThis single-blind randomised controlled trial, involving six sites in France, will investigate the efficacy of a telehealth, videoconferencing-based, parent-mediated PACT therapy on autism symptoms, over a 12-month period. It will compare PACT plus treatment as usual (TAU) against TAU only in a cohort of 238 toddlers (119 per group) aged 18–36 months at inclusion and living with their families more than 40 min away from the specialist centres for autism. Primary outcome will include change of overall autism score on the Autism Diagnostic Observation Scale (ADOS) at 12 months. Secondary outcomes will measure change in child skills, child functioning, impact on parents (stress, health, priorities) and implementation characteristics. Repeated measures analyses will be used to test the effect of PACT intervention on the overall ADOS module 1 score over the 12-month study period. Linear mixed models will be used with time, treatment allocation and the interaction between treatment and time as fixed effects and individual variation as random effect.Ethics and disseminationThis protocol (V.5, date: 25 October 2019) is approved by the French National Review Board (reference no 2018-A02516-49). The results will be disseminated via peer-reviewed journalsTrial registration numberNCT04244721.

scholarly journals Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e039981
Author(s):  
Maleea Denise Holbert ◽  
Roy M Kimble ◽  
Mark Chatfield ◽  
Bronwyn R Griffin
Keyword(s):  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Geometric Mean ◽  
First Aid ◽  
Self Report ◽  
Thermal Burn ◽  
Pain Scores ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).

scholarly journals Vitamin D intake, serum 25-hydroxyvitamin D status and response to moderate vitamin D3 supplementation: a randomised controlled trial in East African and Finnish women

2018 ◽  
Vol 119 (4) ◽  
pp. 431-441 ◽  
Author(s):  
Folasade A. Adebayo ◽  
Suvi T. Itkonen ◽  
Taina Öhman ◽  
Essi Skaffari ◽  
Elisa M. Saarnio ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomised Controlled Trial ◽  
Ethnic Differences ◽  
Repeated Measures ◽  
Controlled Trial ◽  
East African ◽  
Hydroxyvitamin D ◽  
Vitamin D Intake ◽  
25 Hydroxyvitamin D ◽  
Randomised Controlled

AbstractInsufficient vitamin D status (serum 25-hydroxyvitamin D (S-25(OH)D)<50 nmol/l) is common among immigrants living at the northern latitudes. We investigated ethnic differences in response of S-25(OH)D to vitamin D3 supplementation, through a 5-month randomised controlled trial, in East African and Finnish women in Southern Finland (60°N) from December 2014 to May 2015. Vitamin D intakes (dietary and supplemental) were also examined. Altogether, 191 subjects were screened and 147 women (East Africans n 72, Finns n 75) aged 21–64 years were randomised to receive placebo or 10 or 20 µg of vitamin D3/d. S-25(OH)D concentrations were assessed by liquid chromatography–tandem MS. At screening, 56 % of East Africans and 9 % of Finns had S-25(OH)D<50 nmol/l. Total vitamin D intake was higher in East Africans than in Finns (24·2 (sd 14·3) v. 15·2 (sd 13·4) µg/d, P<0·001). Baseline mean S-25(OH)D concentrations were higher in Finns (60·5 (sd=16·3) nmol/l) than in East Africans (51·5 (sd 15·4) nmol/l) (P=0·001). In repeated-measures ANCOVA (adjusted for baseline S-25(OH)D), mean S-25(OH)D increased by 8·5 and 10·0 nmol/l with a 10-µg dose and by 10·7 and 17·1 nmol/l with a 20-µg dose for Finns and East Africans, respectively (P>0·05 for differences between ethnic groups). In conclusion, high prevalence of vitamin D insufficiency existed among East African women living in Finland, despite higher vitamin D intake than their Finnish peers. Moderate vitamin D3 supplementation was effective in increasing S-25(OH)D in both groups of women, and no ethnic differences existed in the response to supplementation.

scholarly journals A novel group parenting intervention to reduce emotional and behavioural difficulties in young autistic children: protocol for the Autism Spectrum Treatment and Resilience pilot randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e029959 ◽  
Author(s):  
Melanie Palmer ◽  
Joanne Tarver ◽  
Juan Paris Perez ◽  
Thomas Cawthorne ◽  
Renee Romeo ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Parenting Intervention ◽  
Autism Spectrum ◽  
Attention Control ◽  
Autistic Children ◽  
Pilot Randomised Controlled Trial ◽  
Behavioural Difficulties ◽  
Randomised Controlled ◽  
Emotional And Behavioural Difficulties

IntroductionThe majority of young autistic children display impairing emotional and behavioural difficulties that contribute to family stress. There is some evidence that behavioural parenting interventions are effective for reducing behavioural difficulties in autistic children, with less evidence assessing change in emotional difficulties. Previous trials have tended to use unblinded parent-report measures as primary outcomes and many do not employ an active control, limiting the conclusions that can be drawn.Methods and analysisThe Autism Spectrum Treatment and Resilience study is a pilot randomised controlled trial (RCT) testing the specific effect of a 12-week group parenting intervention (Predictive Parenting) on primary and secondary outcomes, in comparison to an attention control condition consisting of psychoeducation parent groups. Following a feasibility study to test research procedures and the interventions, the pilot RCT participants include 60 parents of autistic children aged 4–8 years who are randomised to Predictive Parenting versus the attention control. Measures are administered at baseline and post intervention to assess group differences in child and parent outcomes, costs and service use and adverse events. The primary outcome is an objective measure of child behaviours that challenge during interactions with their parent and a researcher. The trial aims to provide data on recruitment, retention, completion of measures and acceptability of the intervention and research protocol, in addition to providing a preliminary indication of potential efficacy and establishing an effect size that could be used to power a larger-scale efficacy trial. We will also provide preliminary estimates of the cost-effectiveness of the interventions.Ethics and disseminationEthical approval was granted from NHS Camden and Kings Cross Research Ethics Committee (ref: 16/LO/1769) along with NHS R&D approval from South London and Maudsley, Guy’s and St Thomas', and Croydon Health Services NHS Trusts. The findings will be disseminated through publication in peer-reviewed journals and presentations at conferences.Trial registration numberISRCTN91411078

A randomised controlled trial comparing the effectiveness of different electric breast pumps (Preprint)

2020 ◽  
Author(s):  
Mabel Qi He Leow ◽  
Peter Kay Chai Tay ◽  
Azaizah Binte Mohamed Afif ◽  
Boh Boi Wong ◽  
Lester Chee Hao Leong
Keyword(s):  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Estimating Equation ◽  
Medium Effect ◽  
Medium Effect Size ◽  
Breast Pump ◽  
Randomised Controlled ◽  
The Impact

BACKGROUND Electric breast pump could be more effective than manual pumps or hand expression of milk. OBJECTIVE This study aims to evaluate the effectiveness of current electric breast pumps, which have additional functions such as massage and ability to vary the rate and pressure. The study will also evaluate the impact of electric pump on breast engorgement, which is a common postpartum complication. METHODS A three-group randomised controlled trial (RCT) will be conducted on Mothers who are breastfeeding and using breast pumps. Adult Mothers who are 21-39 years old will be included. We propose a medium effect size of 0.40 for the study. Taking into account of about 20% dropout rate, 180 participants will be recruited (60 in each group). In addition, 120 control participants who are not using breast pump or not breastfeeding will be recruited. Data collection will include baseline maternal data and clinical data, quantity of expressed milk and duration taken, complications of breast pumping/feeding, and psychosocial data. Quantitative outcomes will be analysed using STATA, using univariate analyses, Pearson’s correlations, generalised estimating equation and two-way ANOVA repeated measures. RESULTS Na CONCLUSIONS Na CLINICALTRIAL Not required

scholarly journals A randomised controlled trial of an iPad-based application to complement early behavioural intervention in Autism Spectrum Disorder

2017 ◽  
Vol 58 (9) ◽  
pp. 1042-1052 ◽  
Author(s):  
Andrew J.O. Whitehouse ◽  
Joanna Granich ◽  
Gail Alvares ◽  
Margherita Busacca ◽  
Matthew N. Cooper ◽  
...  
Keyword(s):  
Autism Spectrum Disorder ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Autism Spectrum ◽  
Spectrum Disorder ◽  
Behavioural Intervention ◽  
Randomised Controlled
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