No two people with autism are the same. And of course we wouldn’t want them to be. But people with autism often have behaviors that they repeat and which can be limited. These are known as repetitive and restricted behaviors, or RRBs.
Different scales have been developed to help measure RRBs in autism, and we want to understand these scales better.
That’s why we are conducting the oRBiting study. We want to improve the way we assess and monitor autism, in order to help us learn, in later studies, if investigational drugs could help make life with autism a little easier.
Scales and questionnaires are very useful, but wearable technologies could also give us important insights into daily behaviors.
For example, digital monitoring has already helped researchers to learn more about daily life for people with multiple sclerosis. So as well as learning more about the assessments that are used in autism, we also want to explore the use of wearable technologies such as a smartphone app, or a wrist-worn gadget.
Clinical studies (also known as ‘clinical trials’) are carefully controlled scientific investigations. Most clinical studies are designed to find out about the safety and efficacy of an investigational drug; however, there are also studies known as ‘non-drug’ studies.
One type of non-drug study is an ‘observational study.’ In a non-drug observational study, no investigational drug is given, but certain factors are measured; for example, the participants’ behaviors.
The oRBiting study is a non-drug observational study enrolling people with autism.
We are looking for 90 people who have been diagnosed with autism who:
Anyone who is interested in joining the oRBiting study will be carefully assessed first to make sure that they are suitable for the study, and they/their study partner will sign an informed consent form.
We need people like you to be a part of this study because you know someone with autism very well, who you see on a very regular basis. Not only would we need you to attend all clinic visits with the person you care for with autism; you would also be actively involved in completing some questionnaires and helping the clinicians, with your observations, to complete scales, as well as ensure that the wearable technologies are used correctly.
The study is expected to last for approximately 15 weeks, as shown below. As the study partner, we would ask you to attend all of these appointments with the person you care for with autism:
Screening period (approximately 3 weeks)
During this time, you and the person you care for with autism would attend a clinic visit where we would tell you about the study in detail and conduct some assessments to see if the study is right for both of you.
Observation period (12 weeks)
You and the person you care for with autism would attend 3 further clinic visits and have 2 phone interviews. During the observation period, the study team would complete various questionnaires and scales with you and the person you care for with autism, as well as collect data from the wearable technologies and check on their wellbeing.
There are no costs involved in taking part and – depending on local regulations – expenses may be provided for study-related travel and meals. If you decide to take part, you and the person you care for with autism will be asked to sign an informed consent form, which will have more details.
Participation is voluntary and you and the person you care for with autism can leave the study at any time without penalty. If they do decide to leave, or if they are under 18 and you withdraw consent on their behalf, we may ask you both if you can come to the clinic one final time to complete the study assessments.
Thank you for your time and interest in the oRBiting study. If you think you and the person you care for with autism may be interested in taking part in the study, please contact us using the number at the top of this page. Visit our Find My Trial Page to locate study sites nearest you and use the link below for information about this study that you can share with your healthcare provider.