WP4 Treatment Summary
Autism Spectrum Treatment and Resilience (ASTAR)
Our previous research in the QUEST study showed that the majority of children aged 4-8 years diagnosed with autism spectrum disorder (ASD) experienced concerning emotions and behaviours. These included hyperactivity and inattention, oppositional behaviour and fears and worries. Other studies have also found that concerning emotions and behaviours are frequently displayed by children with ASD.
Parents told us these difficulties were leading to further impairment and additional family stress, therefore effective intervention is needed. There is emerging evidence that parenting interventions could be effective in reducing concerning emotions and behaviours in young children with ASD. The aim of the study is to develop and evaluate two group-based parent focused interventions that could be delivered in the NHS and private and voluntary sectors. Both interventions (ASTAR A and ASTAR B) will use recognised strategies designed to help families with children with ASD. They will extend parents’ understanding of ASD and associated difficulties but each intervention has a different focus. As part of both interventions, tailored support from trained professionals will be offered.
The study consists of two phases; a feasibility study and a pilot randomised controlled trial (RCT). During the feasibility phase, the feasibility of running the study, the appropriateness of different outcome measures and the acceptability of the interventions will be tested. Following this, the pilot RCT will compare the effects of the ASTAR A to ASTAR B. We want to test the specific effect of the interventions on reducing concerning child emotions and behaviours.
Before and after the interventions we will be looking at the child’s behavioural and emotional wellbeing, parents’ perceptions of family life and their wellbeing, and parent-child interaction. This will enable us to examine the effects of the interventions on child and parent outcomes. We will obtain parent and professional views to help us develop research procedures and interventions that are acceptable to families and therapists. The cost-effectiveness of the interventions will also be examined.
Click here for the ASTAR Newsletter Issue 1, Spring 2018
Study name: Autism Spectrum Treatment and Resilience (ASTAR)
IRAS number: 209909
New General Data Protection Regulations (GDPR) come into effect on 25 May 2018. We want to update you about what the ASTAR Study, conducted at King’s College London, are doing to keep your personal information safe.
The ASTAR Study will only use your personal data when the law allows us to. Previously the legal basis by which we held and processed your data was that you had given us consent to do so. We will continue to seek your consent and you will still have the option to withdraw your participation and your personal data from the study in the future. However, we have declared that the legal basis for holding and processing data on the ASTAR study will be because it is necessary for the performance of a public task carried out in the public interest. ASTAR is feasibility and pilot randomised control trial of parent-focused interventions. It is of great scientific value to understanding what interventions work for reducing concerning emotions and behaviours displayed by young children with autism spectrum disorders. King’s College London, the sponsor of the ASTAR research activities, is an internationally-renowned university, one of whose aims is to undertake academic research. Therefore processing of this data is necessary for the purposes of performing the public tasks of the university.
If you are happy to remain involved in our research cohort you do not need to reply to this message. If you have any questions regarding how we manage and process your data please contact us on 0207 848 5260.
How your personal data will be used in compliance with General Data Protection Regulation (GDPR)
King’s College London (KCL) is the lead sponsor for this study based in the United Kingdom. We will be using information from you and may access your child’s medical records if you have given us consent to in order to undertake this study and will act as the data controllers for this study. This means that we are responsible for looking after your information and using it properly. KCL will keep identifiable information about you and your child for 5 years. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information by contacting the Chief Investigator Professor Tony Charman on [email protected] or visiting the KCL website: https://www.kcl.ac.uk/research/support/research-ethics/kings-college-london-statement-on-use-of-personal-data-in-research.aspx.
South London and Maudsley NHS Trust and KCL will collect information from you and your child’s medical records for this research study in accordance with our instructions.
KCL and South London and Maudsley NHS Trust will use your name, NHS number and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from KCL and regulatory organisations may look at your medical and research records to check the accuracy of the research study. The only people in KCL who will have access to information that identifies you will be people who need to contact you to invite you to take part in the study or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details. KCL and the South London and Maudsley NHS Trust will keep identifiable information about you from this study for 5 years after the study has finished.
Using your data for future research
As a university we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.
If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).
Our Data Protection Officer is Mr Albert Chan and you can contact them at [email protected].
When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research.
This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.