Matteo Bottai

Most young people with autism have comorbid mental disorders, such as obsessive-compulsive disorder (OCD), which can be impairing and difficult to treat. However, the necessary treatments are rarely available because they require access to highly specialised clinics. The families of autistic children demand more access to treatment for OCD. We aim to evaluate a novel digital intervention for OCD in autistic youth aged 7-17. We have previously co-developed and successfully piloted the intervention together with young people with lived experience, their families, and clinicians. We will now evaluate its efficacy and cost-effectiveness in a multicentre randomised controlled trial (N=220) comparing the intervention with an ecologically valid control (stress management training). The primary outcome is OCD symptom severity at the 3-month follow-up (primary endpoint). Secondary outcomes include other clinical symptoms (e.g., mood) and general functioning. Intention-to-treat, mixed-effect regression models will be used for analysis. Costs will be analysed from various perspectives. A subset of participants, therapists, and stakeholders will participate in a process evaluation. The last participant will reach the primary endpoint by the end of 2028. If proven effective, the intervention will be implemented nationally within 2 years after the end of the study. The project is already partially funded

we seek additional funding to increase national coverage and recruitment pace.

Cardiovascular and metabolic diseases (CMD) remain the leading cause of morbidity and mortality globally, including myocardial infarction, stroke and type 2 diabetes. Although young people are not typically affected by CMD, the risk factors for these conditions are present during the early years of life, affecting long-term disease risk and the disease burden in the adulthood. Air pollution, transportation noise, and greenness are among the modifiable risk factors that may influence cardiometabolic health. Previous research on causes of CVD often focuses on single risk factors while effects from multiple environmental exposures in young adults are understudied. This project aims to investigate how air pollution, transportation noise and neighborhood greenness contribute to the development of a wide range of early markers of CMD and to elucidate characteristics that may modify the relation between environmental exposures and CMD traits. The project will be based on the prospective population-based birth cohort BAMSE comprising 4000 individuals followed from birth up to young adulthood with repeated questionnaires and extensive clinical investigations. Exposure to environmental factors is estimated based on residential address history. The results of the project will serve as a basis for policy makers in decision making processes, particularly related to environmental policies and urban planning as well as for individual risk assessment and prevention in clinical practice.

Research problem / specific questions Autism Spectrum Disorders (ASD) are neurodevelopmental disorders associated with life-long struggles and high societal costs affecting about 2% of all children and adults. A large majority of young people with autism have comorbid mental disorders, such as obsessive-compulsive disorder (OCD), which are potentially treatable. However, these treatments are rarely available because they require access to highly specialised clinics. The families of children with ASD demand more access to treatment for these comorbidities. Access to specialist treatment could be improved dramatically if routine aspects of treatment could be digitalised. The overarching purpose of this project is to co-develop and evaluate the efficacy and cost-effectiveness of a novel digital intervention for OCD in young people with autism, and to follow through with a nationwide implementation of the intervention.  Data and method We propose to partner with patients, families, and clinicians to develop a novel digital intervention and evaluate its efficacy and cost-effectiveness in a fully powered multicentric (Stockholm, Lund, Gothenburg) randomised controlled trial (N=220), comparing our novel digital intervention with an active comparator. Next, we will implement the intervention in the national Stöd och Behandling digital platform and will conduct a real-world evaluation of the intervention in the same three clinics.  Plan for project realisation The project brings together a multidisciplinary team of researchers with a track record in child and adolescent psychiatry, clinical trials, digital interventions, biostatistics, health economics, and implementation science. The team also includes service users and patient organisations that will contribute with their lived experience, as well as health professionals.  RelevanceThis project originated as a direct response to a demand from families who have children with ASD. This will be the first properly powered trial of a digital intervention for a comorbid psychiatric disorder in autistic children anywhere, and the first to conduct a health economic evaluation. This will also be a rare example of national implementation of a digital intervention for youth with mental health problems and of a formal evaluation of the implementation. If successful, this project could represent a new model for the development and implementation of digital interventions for a broader range of comorbidities in youth with ASD.