Since the beginning of this study, over 700 families in England, Germany, the Netherlands, Sweden, and Italy have participated in the Longitudinal European Autism Project (LEAP).  

This study is currently the largest study in the world to identify variability in autism in terms of behaviour, cognition, co-occurring conditions, outcomes, brain structure/function, and genetics.  

Through an improved understanding of the variability between autistic people, our goal is to identify ‘subgroups’ of individuals with similar characteristics and needs who may benefit most from particular support strategies (e.g., for sensory sensitivities, epilepsy, anxiety), rather than taking a ‘one size fits all’ approach. 

In the LEAP study, we ‘deeply phenotyped’ participants according to their clinical/behavioural features, cognition, eye-tracking, neurophysiology/neuroimaging (EEG and MRI), and genetics, and biochemical markers.

An overview of the LEAP study and the measures collected can be found in our LEAP leaflet

Please note that at this stage, we are only able to share processed LEAP data from timepoints 1 and 2.

See more information of the protocols here: https://osf.io/mxnf8/files/yafc7

We are planning to make processed LEAP data from timepoint 3 (and our other AIMS-2-TRIALS cohort studies) available at a later date.

AIMS-2-TRIALS is funded by the Innovative Medicines Initiative (grant agreement No. 777394) until 30th November 2026. In-kind contributions (such as time and resources) have also been given by pharmaceutical companies (Hoffmann La Roche, Janssen) and charities (Simons Foundation for Autism Research, Autism Speaks, Autistica) to support this research programme.

The external database of AIMS-2-TRIALS data will be supported by ELIXIR for a minimum period of 15 years. The consortium are currently seeking funding to support ongoing data sustainability beyond the current AIMS-2-TRIALS grant such as supporting internal hosting, data processing and funding the review committee.

You must log in to the ELIXIR Luxembourg platform. Each Investigator in your project team must read and acknowledge our Data Access Policy and Consortium Principles.

You will need to complete a project proposal and submit this, with proof of ethics approval/code of conduct for secondary data analysis, as part of your data access request via ELIXIR.

Your application will be reviewed by ELIXIR Luxembourg (initial credential check) and the LEAP Project Review Committee. We aim to review and confirm the outcome of your data access request within one month. We may ask you to provide more information in your project proposal to make a final decision.

If your project proposal is approved by ELIXIR and the LEAP PRC, your Institution(s) must sign the official Data Transfer Agreement provided (GDPR compliant). 

After you have access to the data that you require for your project, we ask that you update us on your project progress, and reupload your analysis pipeline/metadata at the end of your project (e.g., to OSF/Github).

Project proposals are reviewed by the AIMS-2-TRIALS LEAP Project Review Committee (LEAP PRC). The LEAP PRC includes representatives of the autistic community (including autistic people, parents, and carers), AIMS-2-TRIALS project leads, and analysis experts relevant to the project proposal submitted.

We review proposals against the following checklist:

1. Must comply with participant informed consent wording
2. Must comply with each of our Consortium Principles (Beneficence, Inclusion/Engagement, Culture/Language, Minimising Risk) and language guidelines
3. Must have submitted proof of ethics approvals/code of conduct
4. Must have submitted a data management plan (how data will be stored/used)
5. Must have clear and specific aims
6. Must detail analysis plan clearly
7. Must be within the scope of approximately one scientific paper
8. Must make a unique contribution to science

At this stage, there is no fee for AIMS-2-TRIALS data access. 

However, please note that this point is under continued review to ensure the sustainability of the database and review process, as supporting external data access was not included in the original AIMS grant funding and incurs administrative costs linked to data extraction, and database maintenance and curation.

The review panel has up to 30 days to review each proposal. There are further administrative steps in the process including those taken by the ELIXIR team and the review and signing of the data use agreement by your institution followed by the final legal and data protection sign off by ELIXIR. We suggest allowing up to 3 months in total to access the data from the time of submission, if your application is successful.

To align with our consortium ethical principal of ‘respect, trust-building and community inclusion’ you will be asked to outline efforts you will have made (or will make) to engage or include relevant stakeholder communities as part of your research process. 

Please provide specific details of your community engagement activities and the outcomes of these on your research plans. If you have not yet commenced community engagement for your project a clear plan should be given and a link to any existing work that outlines your stance where available. Community engagement should be proportionate to the scale and complexity of a planned project. Examples of our own community engagement can be seen here.

We also require that all projects (hypothesis, and data driven) are pre-registered and that details of this are shared in the data access application (e.g. OSF). This is to ensure transparency and that researchers are accountable for carrying out projects in the way they have been proposed at the data application stage.  

As a guide, applications should be roughly equivalent to one research paper. Applications asking for the whole dataset (i.e., all data modalities) are unlikely to be approved, unless there is an extremely strong case for doing so. Requests for each data type needs to be well justified within the data access application. If you are planning to combine data with other datasets it is important that this is specified in the application. If researchers are interested to carry out larger projects beyond this scope, they are welcome to contact members of the consortium to enquire about data analysis collaborations. If you are unsure of who to contact, please email communication@aims2trials.eu in the first instance. Please see details above regarding data driven projects and further guidance in our data access policy. 

Summary level data on questionnaires and assessments, for example total/scale scores for each participant. For other data types, such as EEG and MRI, pre-processed data is available. The data dictionary provided on ELIXIR outlines the sample composition and measures available within each modality, along with information about preprocessing steps implemented. A summary of numbers of available participants per data modality is also available in this FAQ, and see our data dictionary for detailed information.  Raw data is not available for any of the data modalities.  Data does not contain any personal details or identifiers. MRI scans have had any face data removed to further protect the identity of participants. Further details on each data type are available on the ELIXIR platform.  

If you’re using AI approaches, we require the project to follow the EU Artificial Intelligence Act guidelines to ensure safe and ethical AI usage. Please visit the official guidelines here: https://artificialintelligenceact.eu/. A summary is available here: https://artificialintelligenceact.eu/high-level-summary/  

Key considerations include: 
Human Oversight: AI should not be used to analyse sensitive data, such as health-related information, without human interpretation or validation of the results. We strongly recommend that autistic representatives are involved in all stages of the research, including the design phase to mitigate against potential harms of unexpected outcomes of data-driven approaches, and the interpretation phase to ensure that claims of the research outcomes are not overstated. 

Data Security: Avoid uploading data to cloud platforms for AI analysis, unless the platform is secure and fully compliant with data protection regulations. You must share this information with us at the data access proposal stage. 

Please see the PDF link below for all demographic and clinical information:

What demographic and clinical measures were collected at LEAP