scholarly journals Multicentre, randomised waitlist control trial investigating a parent-assisted social skills group programme for adolescents with brain injuries: protocol for the friends project

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029587 ◽  
Author(s):  
Rose Gilmore ◽  
Leanne Sakzewski ◽  
Jenny Ziviani ◽  
Sarah Mcintyre ◽  
Hayley Smithers Sheedy ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Social Skills ◽  
Brain Injury ◽  
Social Competence ◽  
Research Ethics ◽  
Autism Spectrum ◽  
Ethics Committee ◽  
Waitlist Control ◽  
Research Ethics Committee

IntroductionAdolescents with brain injury frequently have difficulties with social competence, which persist into adulthood affecting their participation in daily life. To date, there has been limited research into the efficacy of social competence interventions in this population. Research from the Program for the Education and Enrichment of Relational Skills (PEERS) has demonstrated significant improvements in social competence skills, maintained at 1-year to 5-year follow-up, for adolescents with autism spectrum disorder. PEERS has not yet been tested among adolescents with brain injury. This protocol describes a pragmatic, parallel two-group pre-test post-test randomised waitlist control trial across two sites in Australia, which aims to evaluate the feasibility, acceptability and efficacy of PEERS in adolescents with brain injury compared with usual care.Methods and analysisForty adolescents with an acquired brain injury or cerebral palsy will be randomly assigned to either the 14-week PEERS group or waitlist care as usual group. The waitlist group will then receive PEERS following the 26-week retention time point. Outcomes will be assessed at baseline, 14 weeks (immediately postintervention) and 26 weeks follow-up (retention). The primary outcomes are self-report and parent report on the Social Skills Improvement System Rating Scales immediately post PEERS at 14 weeks. Secondary outcomes include increased frequency of get-togethers with peers with reduced conflict and increased adolescent self-reported knowledge of social skills. Acceptability and feasibility will be examined through qualitative analysis of focus group data collected after the completion of each group.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/17/QRCH/87), The University of Queensland (2017000864) and the Cerebral Palsy Alliance Ethics Committee (20170802/HREC:EC00402). The findings will be disseminated in peer-reviewed journals, by conference presentation and newsletters to consumers.Trial registration numberACTRN12617000723381.

Role of a research ethics committee in follow-up and publication of results11Edited by Hans E. Grossniklaus, MD

2003 ◽  
Vol 136 (4) ◽  
pp. 785
Author(s):  
J Piche ◽  
X Carné ◽  
J.A Arnaiz ◽  
B Gomez ◽  
A Trilla ◽  
...  
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Research Ethics Committee

Role of a research ethics committee in follow-up and publication of results

The Lancet ◽  
2003 ◽  
Vol 361 (9376) ◽  
pp. 2246 ◽  
Author(s):  
Nello Martini ◽  
Carlo Tomino ◽  
Alessandro Liberati
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Research Ethics Committee

scholarly journals An Evaluation of Individually Delivered Secret Agent Society Social Skills Program for Children with High-Functioning Autism Spectrum Disorders: A Pilot Study

2015 ◽  
Vol 32 (3) ◽  
pp. 159-174 ◽  
Author(s):  
Yunxi Lynette Tan ◽  
Trevor G. Mazzucchelli ◽  
Renae Beaumont
Keyword(s):  
Autism Spectrum Disorders ◽  
Social Skills ◽  
Pilot Study ◽  
Social Competence ◽  
Autism Spectrum ◽  
Post Intervention ◽  
High Functioning ◽  
Spectrum Disorders ◽  
Secret Agent

High-functioning children with autism spectrum disorders display social skill deficits that can have a debilitating impact on their daily lives. The Secret Agent Society (SAS) program has been shown to be effective in improving the social skills of these children when delivered in a group setting. This pilot study evaluated whether individually delivered SAS would yield similar outcomes. Three participants were recruited for the 9-week intervention. Measures of social competence were administered at four points: pretest 1, pretest 2, post-intervention, and 6-week follow-up. Participants showed significant improvement in half of the measures assessing social competence. On a third of these measures, two participants demonstrated improvements to within the range of their typically developing peers. Follow-up results suggested that improvements were maintained at 6 weeks’ post-intervention. Limitations of this study and directions for future research are discussed.

Role of a research ethics committee in follow-up and publication of results

The Lancet ◽  
2003 ◽  
Vol 361 (9376) ◽  
pp. 2245-2246 ◽  
Author(s):  
P Suñe-Martin ◽  
JB Montoro-Ronsano
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Research Ethics Committee

Role of a research ethics committee in follow-up and publication of results

The Lancet ◽  
2003 ◽  
Vol 361 (9362) ◽  
pp. 1015-1016 ◽  
Author(s):  
Judit Pich ◽  
Xavier Carné ◽  
Joan-Albert Arnaiz ◽  
Begoña Gómez ◽  
Antoni Trilla ◽  
...  
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Research Ethics Committee

scholarly journals Citizens, Research Ethics Committee Members and Researchers’ Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems

2021 ◽  
pp. 155626462199221
Author(s):  
Annabelle Cumyn ◽  
Roxanne Dault ◽  
Adrien Barton ◽  
Anne-Marie Cloutier ◽  
Jean-François Ethier
Keyword(s):  
Research Ethics ◽  
Health Systems ◽  
Ethics Committee ◽  
Health Data ◽  
Data Reuse ◽  
Fundamental Importance ◽  
Research Ethics Committee ◽  
Secondary Use ◽  
Public Perspectives ◽  
Advance Knowledge

A survey was conducted to assess citizens, research ethics committee members, and researchers’ attitude toward information and consent for the secondary use of health data for research within learning health systems (LHSs). Results show that the reuse of health data for research to advance knowledge and improve care is valued by all parties; consent regarding health data reuse for research has fundamental importance particularly to citizens; and all respondents deemed important the existence of a secure website to support the information and consent processes. This survey was part of a larger project that aims at exploring public perspectives on alternate approaches to the current consent models for health data reuse to take into consideration the unique features of LHSs. The revised model will need to ensure that citizens are given the opportunity to be better informed about upcoming research and have their say, when possible, in the use of their data.

scholarly journals Developing a policy to reduce the salt content of food consumed outside the home in Malaysia: protocol of a qualitative study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044628
Author(s):  
Mhairi Karen Brown ◽  
Suzana Shahar ◽  
Yee Xing You ◽  
Viola Michael ◽  
Hazreen Abdul Majid ◽  
...  
Keyword(s):  
Medical Research ◽  
Research Ethics ◽  
Salt Intake ◽  
Salt Content ◽  
Ethics Committee ◽  
Salt Reduction ◽  
Reduction Strategy ◽  
Research Ethics Committee ◽  
School Canteen ◽  
Medical Research Ethics

IntroductionCurrent salt intake in Malaysia is high. The existing national salt reduction policy has faced slow progress and does not yet include measures to address the out of home sector. Dishes consumed in the out of home sector are a known leading contributor to daily salt intake. This study aims to develop a salt reduction strategy, tailored to the out of home sector in Malaysia.Methods and analysisThis study is a qualitative analysis of stakeholder views towards salt reduction. Participants will be recruited from five zones of Malaysia (Western, Northern, Eastern and Southern regions and East Malaysia), including policy-makers, non-governmental organisations, food industries, school canteen operators, street food vendors and consumers, to participate in focus group discussions or in-depth interviews. Interviews will be transcribed and analysed using thematic analysis. Barriers will be identified and used to develop a tailored salt reduction strategy.Ethics and disseminationEthical approval has been obtained from the Universiti Kebangsaan Malaysia Medical Research Ethics Committee (UKM PPI/1118/JEP-2020–524), the Malaysian National Medical Research Ethics Committee (NMRR-20-1387-55481 (IIR)) and Queen Mary University of London Research Ethics Committee (QMERC2020/37) . Results will be presented orally and in report form and made available to the relevant ministries for example, Ministry of Health, Ministry of Education and Ministry of Trade to encourage adoption of strategy as policy. The findings of this study will be disseminated through conference presentations, peer-reviewed publications and webinars.

scholarly journals Early Moves: a protocol for a population-based prospective cohort study to establish general movements as an early biomarker of cognitive impairment in infants

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e041695
Author(s):  
Catherine Elliott ◽  
Caroline Alexander ◽  
Alison Salt ◽  
Alicia J Spittle ◽  
Roslyn N Boyd ◽  
...  
Keyword(s):  
At Risk ◽  
Cohort Study ◽  
Cognitive Impairment ◽  
Research Ethics ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Ethics Committee ◽  
Research Ethics Committee ◽  
National Implementation ◽  
General Movements

IntroductionThe current diagnostic pathways for cognitive impairment rarely identify babies at risk before 2 years of age. Very early detection and timely targeted intervention has potential to improve outcomes for these children and support them to reach their full life potential. Early Moves aims to identify early biomarkers, including general movements (GMs), for babies at risk of cognitive impairment, allowing early intervention within critical developmental windows to enable these children to have the best possible start to life.Method and analysisEarly Moves is a double-masked prospective cohort study that will recruit 3000 term and preterm babies from a secondary care setting. Early Moves will determine the diagnostic value of abnormal GMs (at writhing and fidgety age) for mild, moderate and severe cognitive delay at 2 years measured by the Bayley-4. Parents will use the Baby Moves smartphone application to video their babies’ GMs. Trained GMs assessors will be masked to any risk factors and assessors of the primary outcome will be masked to the GMs result. Automated scoring of GMs will be developed through applying machine-based learning to the data and the predictive value for an abnormal GM will be investigated. Screening algorithms for identification of children at risk of cognitive impairment, using the GM assessment (GMA), and routinely collected social and environmental profile data will be developed to allow more accurate prediction of cognitive outcome at 2 years. A cost evaluation for GMA implementation in preparation for national implementation will be undertaken including exploring the relationship between cognitive status and healthcare utilisation, medical costs, health-related quality of life and caregiver burden.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Joondalup Health Services and the Health Service Human Research Ethics Committee (1902) of Curtin University (HRE2019-0739).Trial registration numberACTRN12619001422112.

scholarly journals A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid‐19 Era

2021 ◽  
Vol 43 (5) ◽  
pp. 42-44
Author(s):  
Leonardo Tamariz ◽  
Fred J. Hendler ◽  
John M. Wells ◽  
Annette Anderson ◽  
Stephen Bartlett
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Research Ethics Committee
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