Evaluate scales for RRB, digital biomarkers in participants with ASD
Research type
Research Study
Full title
Study to evaluate and explore scales for Repetitive and Restricted Behaviors and Digital Biomarkers in children, adolescents and adults with Autism Spectrum Disorder (ASD)
IRAS ID
251572
Contact name
Declan Murphy
Contact email
Sponsor organisation
Roche Pharma Research & Early Development
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
Research Summary
Autism Spectrum Disorder (ASD) is characterised by persistent deficits in social communication and the presence of repetitive and restricted behaviours (RRBs), interests, or activities. RRBs comprise a diverse collection of behaviours, ranging from ‘lower level’ stereotypical movements, such as hand flapping, to the insistence on very specific routines and rituals (e.g., only taking a particular route to school). Failure to adhere to these routines can result in extreme distress, anger or temper tantrums. Other aspects of RRBs are often reported as enjoyable, e.g. intense preoccupation with particular activities or ‘special interests’ (e.g. in trains). However, these intense interests may also interfere with the family’s daily living and social interactions.
Currently, no drugs have been approved to treat RRBs. A major barrier to our ability to test new treatments is the lack of sensitive measures to quantify improvement in RRBs over a short period of time typical for clinical trials.
The goal of this study is to evaluate and explore a range of clinical measures of RRBs. In addition, the feasibility of using digital devices (smartphones, smartwatches and Bluetooth transmitters) to measure ASD symptoms, including RRBs, will be investigated.
This is a multi-site study sponsored by Roche, in approximately 15 sites in the US, Canada and UK. It will involve 105 participants (90 with ASD and 15 typically developing children), of which approximately 20 participants are expected to be recruited in the UK. The duration of the study for each participant will be approximately 15 weeks (up to 4 clinic visits and 2 phone contacts). Each participant with ASD will be assessed using several questionnaires at each visit. Typically developing children will be enrolled for validation of digital biomarkers only. No drug will be administered and participants with ASD will not be requested to change their therapy if they receive any.Summary of Results
Please see https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdj8o1FpylFwbn362DUDJ-2Fz2RQasSwIAp7FF-2Fz-2FbdhUS52IpT3t7Iy0Ntf2R4iPUYE-3DEK82_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLLsbje7C-2BxApJMmGhSl4S2OMoxBWxWX7Wf3xHI6Gq4nP3yV-2FeBYws1MW1bG53Lnp-2B9f6JmWTaxxidpvwOmYiER5AjxDRcadTSdFPaP-2B8nuhU03Yhn-2FoGuIdTv8wiHH6dlnJ2hvsWKXyyuR9RzNq5FF3U6r6eoF5WheFIQg9aCDJg-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cf484e5dc000e445c774808da7188647b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637947127855498410%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=m%2Fz61BkC0UEFjed3CRHVu0CzPuP1ujhjpDGquZT7Ig8%3D&reserved=0
REC name
Wales REC 5
REC reference
18/WA/0270
Date of REC Opinion
26 Sep 2018
REC opinion
Further Information Favourable Opinion