Brain stimulation device cleared for ADHD in the US is safe but not effective

Brain stimulation device cleared for ADHD in the US is safe but not effective

Brain stimulation device cleared for ADHD in the US is overall safe but ineffective

A large multicentre clinical trial led by King’s College London with 150 children and adolescents has shown that a device cleared by the USA FDA to treat ADHD is not effective in reducing symptoms.

The device – which uses an approach called trigeminal nerve stimulation (TNS) – was cleared for use by the US Food and Drugs Administration (FDA) to treat ADHD in 2019 based on a small study. These new findings from a larger multicentre trial, published in the journal Nature Medicine, suggest authorities should revisit the original evidence that supported the FDA clearance. Notably, TNS is currently not recommended for use in the UK by NICE guidelines.

The trial was run in collaboration with University of Southampton and funded by a partnership between the National Institute for Health and Care Research (NIHR) and Medical Research Council (MRC) with further support from the NIHR Maudsley Biomedical Research Centre.

Attention-Deficit/Hyperactivity Disorder (ADHD) affects 5-8 per cent of school-age children worldwide and is associated with age-inappropriate problems with attention and/or hyperactivity and impulsivity that can impair everyday functioning. Stimulant medications improve symptoms in 70 % of those who take them in the short term but there is less evidence of their long-term effects.

To provide an alternative to medication researchers have developed and trialled approaches that use non-invasive stimulation of the brain, working on the regions that have been identified as influential in ADHD.

One of these approaches involves stimulating the trigeminal nerve (TNS), targeting a branch of this facial nerve which is thought to activate the brainstem and from there other brain regions that may be relevant to ADHD, in particular the locus coeruleus, which plays a role in arousal which is typically diminished in people with ADHD. TNS is thought to stimulate other brain regions associated with attention such as frontal and thalamic areas via the brainstem in a bottom-up manner.

A previous small trial in the US with 62 children diagnosed with ADHD has shown that when TNS is applied every night for 8 hours for one month it is effective in reducing symptoms – this research led to its clearance by the FDA for use in the US. However, the control condition involved no stimulation and blinding was not tested after one month, raising questions about a potential placebo effect.

This new UK clinical trial across two sites in London and Southampton tested TNS in a wider range of 150 children and adolescents diagnosed with ADHD aged between 8 and 18 years old and applied a more rigorous placebo condition. Half of the sample received real TNS for about 9 hours every night for 4 weeks through battery-powered electrodes applied to the forehead. The other half of the sample received the ‘sham’ condition where electrodes were still applied to the forehead every night for 4 weeks but participants only received 30 seconds of stimulation every hour at a lower frequency and pulse width, which are thought to be non-effective and hence act as a “control” condition.

Professor Katya Rubia, Professor of Cognitive Neuroscience at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King’s College London and senior author of the study said: “Our study shows how important it is to design an appropriate placebo condition in clinical trials of brain therapies. There is a large placebo effect with high-tech brain therapies, in particular for patients and families that have an expectation that they can adjust brain differences associated with ADHD. It is hence paramount to control for placebo effects in modern brain therapies to avoid false hopes.”

Dr Aldo Conti, postdoctoral researcher at IoPPN and at Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King’s College London and first author on the study said: “This multicentre trial was designed to address key limitations of the previous pilot study that informed FDA clearance of TNS for ADHD, particularly by using a rigorously controlled sham condition that supported successful blinding across the treatment period. Unlike the earlier study, which was limited to younger children, we also included adolescents, a clinically important group given well-documented challenges with long-term medication adherence. These design choices enabled a more robust and clinically relevant evaluation of TNS.”

By comparing the groups researchers evaluated effectiveness of TNS by assessing the symptoms of ADHD as reported by parents, alongside other outcomes such as mind-wandering and attention, depression and anxiety, and sleep.

The trial showed that TNS was safe with no serious adverse events and most participants considered it a mild or no burden to use. However, the results showed no significant change in ADHD symptoms, objective measures of hyperactivity, attention and associated behaviours around mood and sleep.

Professor Samuele Cortese, NIHR Research Professor at University of Southampton and study lead for the Southampton site, stated: “Rigorous evidence, such as that generated by this study, is essential for supporting shared decision-making regarding interventions for ADHD. It empowers individuals with ADHD and their families to make informed choices about the treatment of ADHD. Clinicians, individuals with ADHD, and their families need to know which treatments work, and which do not based on the best evidence.”

This project was funded by the Efficacy and Mechanism Evaluation (EME) Programme which is a partnership of the Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR). The trial was run by the King’s Clinical Trials Unit and recruitment involved the Child and Adolescent Mental Health Services (CAMHS) clinics within the following NHS trusts: South London and Maudsley NHS Foundation Trust, Hampshire and Isle of Wight Healthcare (previously known as SOLENT NHS Trust), Central and North-West London NHS Foundation Trust, Oxleas NHS Foundation Trust and South-West London and St. George’s Mental Health NHS Trust.

External trigeminal nerve stimulation in youth with ADHD: a randomized, sham-controlled, phase 2b trial by Conti, A.A. et al was published in Nature Medicine. https://doi.org/10.1038/s41591-025-04075-x

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RE-STAR Team & Dr Gonzalo Salazar de Pablo win at Association for Child and Adolescent Mental Health Awards

RE-STAR Team & Dr Gonzalo Salazar de Pablo win at Association for Child and Adolescent Mental Health Awards

RE-STAR Team & Dr Gonzalo Salazar de Pablo win at Association for Child and Adolescent Mental Health Awards

RE-STAR Team

Held annually, the Association for Child and Adolescent Mental Health (ACAMH) Awards aim to recognise high quality work in evidence based science, both in publication and practice, in the field of child and adolescent mental health. Receiving a nomination is prestigious recognition of work that is at the forefront of the advancement of child and adolescent mental health research, and clinical practice. 

Dr Gonzalo Salazar De Pablo wins Kathy Sylva ‘Rising Star’ Award

The Kathy Sylva ‘Rising Star’ Award is presented to someone who has made a significant scientific contribution to child and adolescent mental health literature, within 10 years of their first peer reviewed journal publication.

The 2025 Award was presented to Dr Gonzalo Salazar de Pablo, Senior Clinical Lecturer in the Department of Child & Adolescent Psychiatry, honorary Consultant Child & Adolescent Psychiatrist at the South London and Maudsley NHS Foundation Trust and part of the King’s Maudsley Partnership for Children & Young People. It was presented in recognition of his outstanding scientific contributions to child and adolescent mental health.

I am deeply honoured to receive the Kathy Sylva Rising Star Award. This recognition means a great deal to me, and it is only possible thanks to the young people, families, and colleagues I have had the privilege of working with. I am really grateful to ACAMH for this award, and to my collaborators across King’s, South London and Maudsley, and our international partners for their support and inspiration.

Dr Gonzalo Salazar de Pablo

Dr Gonzalo Salazar de Pablo’s research focuses on the early identification and prediction of bipolar disorder and psychosis in young people, advancing the field through high-impact publications.

The nomination highlighted his exceptional productivity, international collaborations, and leadership. A defining feature of Dr Salazar de Pablo’s work is his commitment to co-production with young people, families, and clinicians, ensuring that research questions and interventions are grounded in lived experience and real-world clinical needs. Receiving this award is a meaningful recognition of his work and his contributions to child and adolescent mental health.

Looking ahead, he hopes to continue developing equitable, accessible, and youth-informed approaches that improve early intervention and long-term outcomes for children and adolescents worldwide.

Lionel Hersov Memorial Award presented to RE-STAR

The Lionel Hersov Memorial Award is given to a practice or research team that has either demonstrated the translation of an evidence base into clinical practice with measurable clinical impact, or demonstrated quality improvement within either clinical or research practice.

This year, it was presented to RE-STAR Academic Researchers (Ars) and its Youth Researcher Panel (Y-RP), a four-year interdisciplinary programme led by researchers from the Department of Child & Adolescent Psychiatry, and part of the King’s Maudsley Partnership at King’s College London with UCL, Anna Freud and Centre.

We are thrilled that the work of the RE-STAR Team – both the academics and the youth researchers – has been recognised in this way. This collaborative process has been transformative on so many levels, both for those involved and the science we’ve been focused on. Ultimately, we hope this will help us find new ways to promote the mental health of neurodivergent young people.

Dr Susie Chandler

RE-STAR Programme Manager, Department of Child & Adolescent Psychiatry, IoPPN

RE-STAR, led by Professor Edmund Sonunga-Barke, explores the interplay between autism and/or ADHD traits, exposure to environmental stressors, and emotional responding in neurodivergent young people, in driving developmental pathways to depression.

Who are the RE-STARs? To me we are a band of neurodiverse adventurer scientists coming together, at a particular moment in time, to explore new ways of doing child and adolescent mental health research by stretching the boundaries of participatory and inter-disciplinary practice. I believe our last four years of work illustrates the creative energy that can be released when researchers from radically different backgrounds come together with young autistic young people and those with ADHD to produce real progress in ideas new, methods, interpretations and interventions.

Professor Edmund Sonuga-Barke

RE-STAR Chief Investigator, Department of Child & Adolescent Psychiatry, IoPPN

The programme works closely with its Youth Researcher Panel, who play an integral role in the planning and delivery of RE-STAR, and contribute to the project in a wide variety of ways, working alongside the academic researchers as ‘co-researchers’, co-analysing and collecting data, and helping to share and communicate the work of RE-STAR to a wider audience.

RE-STAR is funded by UKRI Medical Research Council.

Celebrating the award wins, Head of Department for Child & Adolescent Psychiatry, Professor Philip Shaw, said, “I know that all in the King’s Maudsley Partnership join me in congratulating the award winners and those nominated, and a shout out also to others at KMP who were nominated, the awardees showcase how King’s Maudsley Partnership strives to infuse research into clinical care, and will enrich our research through clinical insights and experience.”

Dr Gonzalo Salazar de Pablo, the Rising Star, has provided consistently highly impactful reviews of studies that centre on key clinical questions.  His achievement is all the more impressive as he is very active in CAMHS, both working with families and developing care pathways.  The RE-STAR team, led by Professor Sonuga-Barke, gain their award in part for placing neurodivergent young people at the core of all of stages of their research.  In RE-STAR, experts by lived experience and experts by academic training have together provided rich insights into why depression is so often experienced by neurodivergent youth.  

Professor Philip Shaw

Director of the King’s Maudsley Partnership and Head of Department of Child & Adolescent Psychiatry, IoPPN

Alongside these wins, we’re delighted to recognise Dr. Josefien Breedvelt who was also nominated for the Rising Star award, and Mr Sangwoo Richard Jung, shortlisted for Clinical Trainee of the Year.

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Prestigious Academy of Medical Sciences Professorship awarded to Professor Philip Shaw

Prestigious Academy of Medical Sciences Professorship awarded to Professor Philip Shaw

Prestigious Academy of Medical Sciences Professorship awarded to Professor Philip Shaw

A photo of Philip Shaw stood in front of the Pears Maudsley Centre for children and young people

Professor Philip Shaw, Head of Child and Adolescent Psychiatry at King’s College London and Director of the King’s Maudsley Partnership for Children and Young People, has been awarded a prestigious Professorship by the Academy of Medical Sciences (AMS).

Philip joined King’s from the US National Institutes of Health in 2024 to become Head of Child and Adolescent Psychiatry at King’s College London and take up the position of Director of the King’s Maudsley Partnership for Children and Young People.

Philip’s research focuses on understanding the life course of symptoms of Attention Deficit Hyperactivity Disorder (ADHD) and related conditions. Working alongside those living with ADHD, he looks at how differences in the brain, alongside the genetic and the environmental factors together impact on symptoms as children grow into adulthood. The AMS professorship will help Philip and his team use ‘Big Data’ to gain further insights into the reasons why some children ‘grow out’ of ADHD, whereas others have persistent challenges. The award will also help his team build links with local communities, ensuring that clinical research both reflects the voice of those with lived experience and captures the rich diversity of its south London home. His ultimate aim is to translate these discoveries into new tools to help better target existing treatments and as the foundation of new interventions. His clinical work as a consultant psychiatrist in specialist NHS child and adolescent mental health services, both inspires and shapes his research.

I’m honoured to be recognised by the Academy of Medical Sciences through this Professorship. The award will enable my team to use large-scale data to understand why some children ‘grow out’ of ADHD while others continue to face challenges into adulthood, and to translate those insights into more precise, effective interventions. Having recently joined the UK research community, I’m excited to be part of such a collaborative and internationally connected environment that values global perspectives in improving children’s and young people’s mental health.

Professor Philip Shaw

The Academy of Medical Sciences Professorship scheme is designed to attract and retain outstanding emerging leaders from around the world, strengthening the UK’s biomedical research landscape. Supported by the Department for Science, Innovation and Technology, the initiative provides flexible funding to individuals either newly appointed to or about to begin full Professorships.

The Academy of Medical Sciences (AMS) Professorship is a highly prestigious award and undergoes a rigorous selection process. I am delighted Philip has received this award, which is a reflection of his international standing in children and young people’s mental health research and will allow him to expand his research and its impact, through the King’s Maudsley Partnership.

Professor Matthew Hotopf, Executive Dean, IoPPN

 

 

“I congratulate Professor Philip Shaw on receiving this prestigious award. His work is already driving forward discoveries and innovation in children’s mental health and neurodivergence, and we’re excited to see how this recognition will further support his innovative research and its real-world applications including through the delivery of services in South London.”

David Bradley, Chief Executive South London and Maudsley NHS Trust

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King’s Maudsley Partnership welcomes the ADHD Taskforce final report

King’s Maudsley Partnership welcomes the ADHD Taskforce final report

King’s Maudsley Partnership welcomes the ADHD Taskforce final report

Close up self-portrait picture of happy young Hispanic mom and small teen biracial daughter have fun together. Smiling Latino mother and little girl child make selfie relax at home on weekend.

“The ADHD Taskforce report is a call to action to provide better support and treatmentDelivering this for children and young people with ADHD is central to King’s Maudsley Partnership’s mission. We are proud to have contributed to the evidence base and are committed to driving forward many of its recommendations – ensuring timely, effective, and inclusive support for all.” 

Professor Philip Shaw

Director, King’s Maudsley Partnership

We welcome the publication of the ADHD Taskforce’s final report—a landmark step toward improving support for individuals with ADHD across the UK. The report rightly emphasises early intervention, whole-school approaches, better training for health professionals, and digital innovation as ways to improve care for those living with ADHD. These priorities align closely with much of the work of King’s Maudsley Partnership for Children and Young People.

We are proud that work that has taken place across the Partnership has contributed to the evidence base underpinning the report and are actively working already on many of its recommendations. Work cited in the report included Professor Edmund Sonuga-Barke’s work evaluating the New Forest Parenting Programme, a parent-led intervention for children with ADHD. As well as Dr Nicoletta Adamo’s meta-analysis into the efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults.

The King’s Maudsley Partnership is home to the world’s largest group of academics and clinicians focused on ADHD in children and young people. We are working to understand ADHD better, but also to co-design more and better treatment options for children and young people with ADHD.

Work is already underway or planned that will drive many of the Taskforce’s recommendations forward:

1.Early Intervention

The report highlights the importance of early intervention. Our Empowering Parents, Empowering Communities (EPEC) programme complements school-based approaches by supporting school readiness through reaching families before formal schooling begins. EPEC has developed neurodivergence-specific modules, including for children with ADHD, having reflected on the need for early support. We now need rigorous evaluation of these interventions to understand the potential for wider scale application.

2.Whole-School Approach

We welcome the Taskforce’s recommendations to both move towards a whole school approach and to move away from requiring a diagnosis to access interventions. This would create more inclusive environments and remove the unnecessary delays to support.  The Regulating Emotions – Strengthening Adolescent Resilience (RE-STAR) programme, led by Professor Edmund Songa-Barke exemplifies this. RE-STAR is working to create school environments which are inclusive for children with ADHD and autism. The study is aiming to improving the experiences of children with ADHD and autism in school and reduce their chance of experiencing depression.

Through the Schools Mental Health Innovation Network we are also looking to develop teaching resources for schools in south London to learn about brain health and contribute to creating neuro-affirmative and de-stigmatising school environments.

3.Assessment and Treatment Innovation

We’re rethinking how assessment and treatment can work for every child and young person with ADHD. We’re focusing on three key areas, which reflect recommendations within the taskforce. First, we’re expanding training for professionals who support this group, offering webinars and plan a new on-line course focused on neurodevelopmental conditions including ADHD.   At the same time, our CAMHS Digital Lab is leading digital transformation – exploring how digital tech and AI can support diagnosis and treatment monitoring. We’re also committed to improving access for those waiting for care and are conducting trials into digital support for young people on waiting lists. We’re also beginning a new study to investigate if we can combine online cognitive data with reports of ADHD symptoms to predict who is most likely to receive a clinical diagnosis of ADHD. These initiatives reflect our commitment to using technology and research to deliver timely, effective care.

This report is a milestone for ADHD care, responding to the clinical realities of today.   At King’s Maudsley Partners, we equally focus on transforming care for the future.  We have listened to those living with ADHD who ask for new effective, safe non-drug treatment options.  We will build this next generation of treatments on science, by unravelling the differences in the genetic code, the brain and thinking that underpin ADHD and using these features as the foundation for innovative new ways of helping.

We will continue to lead research, innovation, and collaboration to make its vision a reality—improving outcomes for children, families, and communities.

If you want to keep up to date with our work on ADHD please sign up to our newsletter. Or emails us at helen.honstvet@slam.nhs.uk for any more information about our work in this area.

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Parents Supported to Navigate Early Years Misinformation Online in New Government Campaign

Parents Supported to Navigate Early Years Misinformation Online in New Government Campaign

Parents Supported to Navigate Early Years Misinformation Online in New Government Campaign

From Instagram gurus to TikTok tips, turning to online communities is an understandable trend among parents of young children – with new research revealing a third (33%) now scrolling social media for support.

However, the vast majority (68%) are battling with conflicting advice that they struggle to trust, causing 7 in 10 (69%) to feel overwhelmed by the amount of information available. Contributing to this confusion are viral posts that push unverified ‘miracle’ fixes or hacks, with short-form videos from sources offering no evidence to back their claims often doing more harm than good.

As part of its Plan for Change, the government is driving national renewal by tackling inequality and unlocking opportunity across the country.

Following the rollout of 30 hours government-funded childcare last month, over half a million children are now benefitting from the expertise of this country’s early years professionals, and now, the new Best Start in Life campaign will build on this progress by bringing together trusted NHS and government-backed guidance to help parents with everything from feeding time and sleeping to speech and language, child development, and finding local childcare and family support.

This comes alongside investment to ensure every family can access in-person support too, as 65 previously unfunded local areas from Devon to Stockton-on-Tees have this week received their share of a £12 million development grant to begin building their Best Start Family Hub offer – ahead of rollout beginning next year.

Professor Stephen Scott, Professor Emeritus at King’s College London, part of the King’s Maudsley Partnership said:

“A new evidence review conducted and published by King’s College London, part of the King’s Maudsley Partnership for Children and Young People, has found that analysis from shows that many parents are negatively impacted by the breadth of information available and the weak credibility of some sources can affect their confidence and even prevent them from making key parenting decisions.

“To help tackle the consequences of ‘information overwhelm’, it’s important for parents to have easily accessible, trusted resources to help cut through online noise and misinformation.”

As part of its Plan for Change commitment to get tens of thousands more children school ready each year, the government has vowed to join-up and roll out vital services.

That includes thousands of school-based nurseries, Best Start Family Hubs in every local area, free breakfast clubs in every school and backing for the Holiday Activities and Food Programme for another three years.

The £12 million Best Start Family Hubs development grant distributed this week builds on existing efforts to break down barriers, supporting areas to identify an appropriate site to reach disadvantaged families and prepare to deliver evidence-based programmes and support.

The grant comes on top of an over £500 million investment to create up to 1,000 hubs across the country, rolling out from April 2026.

Health and Social Care Secretary Wes Streeting said, “In between sleepless nights, potty training and weaning their children, it’s no wonder so many knackered parents feel they need to turn to unverified social media posts for advice about their child’s health and development.

“But it’s vital they get reliable information – and that’s why this Best Start in Life campaign is so important, and the health benefits are so clear. When parents get the right advice on things like nutrition, sleep and development, children arrive at school ready to learn, with stronger immune systems and better mental health that can last a lifetime.”

Hazards of Online Advice for Parents of Young Children: A Scoping Review is available to read here.

A copy of the attitudinal survey of parents and expectant parents, commissioned by the Department of Health & Social Care and Department for Education, can be found here.

This press release can also be found on KCL website.

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Experts come together to discuss social media use in children and young people

Experts come together to discuss social media use in children and young people

Experts come together to discuss social media use in children and young people

The “Teens, Screens & Social Media” webinar, held on Thursday 18 September, brought together clinicians, researchers and educators to critically examine both the opportunities and challenges posed by digital technologies in the lives of children and young people.  

In November 2024, the Australian Government passed a new law which introduces a mandatory minimum age of 16 for accounts on certain social media platforms. These regulations will come into place by December 2025 and will ensure platforms take reasonable steps to verify users’ ages. 

During the webinar, experts from the UK and Australia discussed this timely and globally relevant topic through a series of talks and panel discussion which examined how social media use intersects with mental health and wellbeing.  

Professor Philip Shaw, Director of the King’s Maudsley Partnership for Children and Young People and Professor at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London opened the webinar.

“By understanding the harms and benefits of social media use in children and young people, we hope to identify small but strategic changes to have the potential to make a lasting difference and support young people, their families, clinicians and educators.”

Professor Philip Shaw

Director King's Maudsley Partnership

Learning from Australia: digital technology and mental health 

Dr Danielle Einstein, Clinical Psychologist and Adjunct Fellow at Macquarie University in Sydney, Australia, discussed the relationship between social media use and the mental health of children and young people. She highlighted the growing concern around the psychological impact of online engagement, noting in one study that 58 per cent of students reported their self-esteem is influenced by the number of likes, comments and shares they receive.

Dr Einstein emphasised that the instant reassurance provided by social media may be undermining young people’s ability to tolerate uncertainty and develop healthy coping mechanisms. She concluded by stressing the importance of “device discipline”, encouraging families, schools and social media companies to reflect on how addictive design features and constant connectivity can decrease resilience.

More information can be read in Dr Einstein’s substack https://theeinsteinreport.substack.com/

Are smartphones addictive?  

Dr Nicola Kalk, Adjunct Senior Lecturer at the IoPPN and Consultant Addiction Psychiatrist at South London & Maudsley NHS Foundation Trust, discussed problematic smartphone use is not simply about screentime. Drawing on previous research from over 40,000 young people, primarily in Southeast Asia, 23 per cent reported smartphone use patterns consistent with behavioural addiction, which were associated with stress, anxiety, depression and poor sleep.

Building on this, Dr Kalk shared findings from more recent UK-based research, which found problematic smartphone use is not culturally bound. She highlighted a study in the United States, involving over 4,000 students, which identified persistent and increasing patterns of addictive smartphone use—both of which were associated with suicidal ideation and behaviour.

She ended with a thought-provoking question “is it the phone itself that’s addictive, or the content it delivers?”.

Panel discussion 

The webinar concluded with a panel discussion chaired by Professor Ben Carter, Professor of Medical Statistics at the IoPPN.

The panel featured experts from London and Sydney, including Dr Nicola Kalk, Dr Danielle Einstein, Professor Rina Dutta (Professor in Psychiatry and Academic Capacity Development at King’s College London and Consultant Psychiatrist at South London and Maudsley NHS Foundation Trust) and Professor Nick Titov AM (Macquarie University, Australia and Executive Director of MindSpot).

Watch below:

The webinar coincided closely with today’s Youth Mental Health Day, which is celebrated annually on 19 September. The awareness day was founded by UK charity stem4 to improve young people’s mental wellbeing.

It was an opportunity to engage with key themes that will be explored in greater depth at a future conference at King’s College London on Thursday 26 February 2026, encouraging dialogue and collaboration across disciplines.

For more information, please contact Anisa Haque (School of Mental Health & Psychological Sciences Communications Assistant).

This blog is also available to read on the IoPPN website.

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