Frequently Asked Questions about the STAR-CAT study for clinical services.
About STAR-CAT
What is the STAR-CAT study?
SupporTing pARents and their autistic Children through Anxiety Treatment (STAR-CAT) is a research study funded by the National Institute for Health and Care Research (NIHR). It is taking place at the University of Oxford, across the departments of Psychiatry, Experimental Psychology, and the Primary Health Care Clinical Trials Unit. You can meet the STAR-CAT team here.
What is the study trying to find out?
We are testing whether an online, parent-led intervention (called OSI-A) can make treatment for anxiety problems among autistic children more accessible without compromising children’s outcomes. Further information about OSI-A can be found in the section below. Families who take part in STAR-CAT will be randomly allocated to receive either OSI-A or treatment as usual – which is whatever treatment their services would typically offer autistic children to address anxiety problems. The STAR-CAT research team will follow up all families six months and twelve months after they have been allocated to their treatment, using online questionnaires. Some families will also be invited to take part in interviews so we can find out more about their experiences.
What is the timeline for the study?
STAR-CAT is currently in the set up phase of the study. Recruitment is due to start in January / February 2025 (subject to ethical approval) and services will be able to continue recruiting families until March 2027.
Who has approved the study?
STAR-CAT will have been reviewed and approved by the Health Research Authority (HRA) and Research Ethics Committee (REC), and will have received HRA and REC approval, prior to opening to recruitment.
Taking part in the STAR-CAT study
What type of services can be involved in the STAR-CAT study?
Any organisation that provides (free at the point of delivery) treatment to autistic (or likely to be autistic) children with anxiety problems can be involved in STAR-CAT. This could be NHS CAMHS clinics, Mental Health Support Teams (MHSTs), local authorities, charities, and third party organisations who deliver treatment on behalf of the NHS/local authorities. Please get in touch with the research team if you are unsure whether your organisation can participate.
For participating services, what would be involved?
Clinical services will be responsible for recruiting eligible families to the STAR-CAT study. Once families have consented to take part and are randomly allocated to their treatment (either OSI-A or treatment as usual), clinicians in the service will deliver this treatment. Alongside delivering the allocated treatment, clinicians will be asked to fill in a brief weekly form about the amount of time spent on treatment, supervision, admin and other related activities. We will also invite some clinicians to take part in interviews about their experiences, but these will be optional.
Who can deliver treatment as part of STAR-CAT?
For STAR-CAT, ‘clinicians’ are considered to be anyone who delivers treatment for anxiety problems to autistic (or likely to be autistic) children. In our previous projects, we had a wide range of staff delivering OSI and treatment as usual, including Children’s Wellbeing Practitioners (CWPs); Education Mental Health Practitioners (EMHPs); assistant psychologists; clinical, educational and counselling psychologists; school pastoral workers; social workers; registered nurses; mental health workers; family support workers; CBT therapists etc. Trainee CWPs and EMHPs can also be involved if they would usually provide treatment for anxiety problems to autistic (or likely to be autistic) children, but it is worth checking with their course provider whether or not delivering OSI-A will count towards their portfolio hours.
I work in a suitable service – how can I get involved?
Please contact the STAR-CAT research team via email (starcat@psy.ox.ac.uk) and we will talk you through the next steps. We are asking interested sites to complete a Feasibility Form.
Is there a deadline for interested sites to email over the Feasibility Form?
We will be accepting new sites to join the study on an ongoing basis, but the sooner you email us the form, the sooner we can get you signed up and start booking in your training.
What can treatment as usual be?
Treatment as usual is whatever treatment your service would typically offer autistic (or likely to be autistic) children with anxiety problems. This can include parent-led CBT, but cannot be the original, unadapted version of OSI. If you have any queries about this, please get in touch.
It also important to note that treatment as usual should be an active, psychological treatment – medication only or signposting to another service would not be considered treatment as usual for this study.
How long after randomisation does treatment need to start?
Once a family has been randomly allocated to either treatment as usual or OSI-A, their treatment needs to start within one month. This is to ensure that the family have received their treatment prior to their first follow up assessment for the study.
Do patient records need to stay open for the duration of the STAR-CAT trial?
No, once you have finished treatment as usual or OSI-A with your family, you can continue your usual service procedures.
Which families in our service can participate in STAR-CAT?
The key criteria for families is that the child is aged 5-12 years, and is autistic (or likely to be autistic). They should be about to receive treatment from your service for problems with anxiety. Further details about the criteria for families can be found in the ‘Inclusion and exclusion criteria for families’ section below.
Is there a minimum recruitment target for sites?
We have set a minimum recruitment target as 5 families per site, as this should be achievable for even the smaller clinics. However, we would encourage sites to recruit as many families as possible.
What support is available for services taking part in STAR-CAT?
We will provide an online training session to explain the trial procedures, and throughout your involvement in the trial we will be available via email and telephone to answer queries. A Team Handbook and our study website will contain guidance about all aspects of taking part in the trial. We will also hold twice weekly online Question & Answer (Q&A) sessions, where you can drop in and speak to a member of the trial team. To keep you updated about the study, we will email out weekly newsletters. Merchandise will also be sent out to services, to assist with recruiting families.
For the new intervention, OSI-A, clinicians will receive training in an e-learning format that will take no more than 7.5 hours to complete in total. We will have a helpdesk for OSI-A to assist with any technical queries, and we can also provide support via email, telephone and the Q&A sessions.
What is a Principal Investigator (PI)?
The Principal Investigator (PI) for a site has overall responsibility for the service(s) taking part in the study e.g., will ensure all clinicians involved have completed their study training, and will be the key point of contact for the research team throughout your involvement in the STAR-CAT study. If a site has more than one service involved, we also ask to have a key point of contact at each service.
If you work in a non-NHS service (e.g. a local authority or a charity) but are funded by the NHS, the PI should be based within your service, rather than any linked NHS services.
OSI-A
What is OSI-A?
OSI-A is an adapted version of an existing intervention, OSI (Online Support and Intervention for child anxiety). More information about the original, unadapted version of OSI can be found here.
OSI was adapted to OSI-A following an extensive co-design process with autistic children, autistic parents, non-autistic parents, academics and clinicians, in order to ensure it meets the needs of autistic children and their families. You can read more about the co-design process here. As a result of the co-design, changes have been made to the module content and the language used; new videos have been created; and two additional modules have been produced. More information about the changes made for OSI-A can be found here.
What training will clinicians receive for OSI-A?
Training for OSI-A will be in an e-learning format. It will take about half a day to complete in total but this can be completed over multiple sessions. All clinicians will also be provided with a manual and regular clinical skills sessions will be provided. There will also be ongoing support from the research team and a technical helpdesk.
What is the evidence base for OSI?
You can read about previous OSI research here.
Inclusion and exclusion criteria for families
What are the inclusion criteria for families?
Inclusion criteria – child:
– is aged 5-12 years old at the point of consent
– has a diagnosis of autism or is considered likely to be eligible for an autism diagnosis and screens positive on an autism screening questionnaire (Social Communication Questionnaire – lifetime version)
– primary problem is anxiety, and there is the intention to begin treatment within the following month
Inclusion criteria – parent/carer:
– has sufficient English language, or available assistance, to complete measures/access intervention
– has access to the internet
– is willing and able to provide consent
What are the exclusion criteria for families?
Exclusion criteria – child:
– has co-morbid conditions that mean therapeutic strategies are clinically inappropriate (diagnosed profound or severe intellectual disability, suicidal intent/ recurrent or potentially life limiting self-harm)
– is identified by social services due to child protection concerns
Exclusion criteria – parent/carer:
– diagnosed profound or severe intellectual disability or severe mental health problem that is likely to interfere with treatment delivery
Can children and/or parents with mild or moderate learning difficulties take part?
Yes, only profound/severe learning difficulties are an exclusion criterion.
If children have ADHD, in addition to autism/suspected autism, are they suitable for trial?
Yes, children with a diagnosis of ADHD are eligible for the trial.
If the child has had previous self-harm/suicidal ideation, but it is not current, would they be suitable for the trial?
Yes, as long as it is not current. The key rationale for not including children with current self-harm suicidal ideation is that if it were current it would need to be the focus of the intervention, rather than a treatment focused specifically on anxiety problems (which is what the family would get if they are randomised to the OSI-A arm).
What level of social care involvement means the family cannot take part in the trial?
The family will not be able to take part if there is a child protection plan, but the family can take part if there are lower levels of social care involvement.
Is there any support available to families who have limited access to the internet?
Yes, we can provide access to devices and help with the costs of mobile data if this is a barrier for families.
What is the screening questionnaire that families complete?
If the child does not have a diagnosis of autism but it is considered that the child would likely to eligible for an autism diagnosis, their parent/carer will complete the Social Communication Questionnaire (SCQ) prior to completing their main consent form. It will be important that the clinical team have discussed the fact that autism being considered with the family prior to introducing the study to them (as study materials refer to autism throughout). In these cases, a positive screen for autism on the SCQ will be required for the families to take part in the STAR-CAT study. If the child’s SCQ score means that they ineligible for the STAR-CAT study, alternative treatment should be arranged as soon as possible. It is important to note that the SCQ is not a perfect measure so if a child screens positive it doesn’t mean they would definitely get an autism diagnosis; similarly if a child does not screen positive it doesn’t mean they would not get an autism diagnosis if formally assessed.