Information about the ADEPT-2 study
ADEPT-2 is a multi-centre, randomised controlled trial for autistic adults comparing Guided Self-Help with NHS support for depression.
Depression is a common mental health problem that affects many people, including autistic people.
Guided Self-Help (GSH) for low mood/depression is a psychological intervention based on the principles of Cognitive Behaviour Therapy (CBT). Guided Self-Help means that someone is provided with written materials and sessions with a therapist to ‘guide’ their use of those materials. We have developed written materials especially for autistic people and their therapist guide.
Results from our previous study showed that autistic people and therapist guides found the materials acceptable. We would now like to find out how effective these materials are and how useful people find them compared to the support that is usually available. We would also like to find out whether GSH represents good value for money for clinical services.
We would also like to invite carers of autistic adults who wish to take part to join the study. This is so we can understand the impact on carers.
Can I take part?
To be eligible to participate, you need to:
• be aged 18 or over;
• have received a diagnosis of autism from a healthcare professional(s);
• experience low mood or depression;
• be able to complete forms with questions online or on paper;
• be able to give informed consent to take part.
What is involved if I take part?
If you decide to take part:
- The first step is to complete the Expression of Interest Form.
If your responses to the Expression of Interest form show that the study is not suitable for you at this time, we will let you know as soon as possible and thank you for your interest. We will then remove all identifiable information that we have about you.
If your Expression of Interest form is incomplete or we require more information to know if the study is possibly suitable for you, a member of the study team will contact you using your preferred method to ask some additional questions.
- If your responses to the Expression of Interest form show that the study is potentially suitable for you:
A member of the study team will contact you using your preferred method to let you know that you are potentially eligible to take part in the study. The researcher will then arrange a time to go through the eligibility assessment in more detail and answer any questions you may have. This is called the ADEPT-2 initial appointment.
- During the ADEPT-2 initial appointment, with the support of a researcher you will:
- Discuss the study and ask any questions.
- Provide any necessary further information so that the study team can complete eligibility checks (e.g.. a medical letter confirming your Autism diagnosis, if you are not currently under the direct care of Autism services). The researcher will then reconfirm it is still suitable for you to take part in the study.
- Complete the consent form.
- Complete the study questionnaires (e.g. about your low mood, medications and other symptoms). We will offer you a £10 voucher upon completion of this appointment.
- Be randomly allocated to receive either Guided Self-Help (GSH) or NHS support for depression (usual care). Please note that sometimes this happens after the initial appointment.
- In addition to the questionnaires you complete during the initial ADEPT-2 appointment, you will be asked to complete follow-up questionnaires at 16, 32 and 52 weeks after your initial ADEPT-2 appointment.
These can be completed online, via post (a pre-paid envelope will be provided); or with a researcher via video call or telephone. On each occasion you will receive a £10 gift voucher to thank you for your time spent completing the questionnaires. If you need help to complete the questionnaires, the research team will make all reasonable adjustments to assist with this. Similarly, a carer/family member or friend can provide support, but they will be advised not to answer any questions on your behalf.
I want to express an interest in taking part.
Once you have read the information above, as well as the Participant Information Leaflet, and discussed the study with family/friends/carers/others if you wish, please express an interest in taking part by completing this form, which will help us understand if this study is suitable for you.
If you would prefer to complete the Expression of Interest form on paper, or over the phone with a member of the team, please contact us to request a posted paper copy: email@example.com or phone 07855 973171.
Please contact the ADEPT study team by email: firstname.lastname@example.org or phone 07855 973171 if there are any parts of the study information that you do not understand, you have any questions, or you would like further information.
We want to make sure that all participants are comfortable during research meetings and interactions with our staff. You can talk to a member of our team about reasonable adjustments at any time during the study. If you would like to tell us about reasonable adjustments you require before an appointment, please email us: email@example.com, or phone 07855 973171. We understand that the support you may need can change on a day-to-day basis. Therefore, please also let our staff know about any reasonable adjustments you find helpful when you need them.
To find out more about reasonable adjustments please visit The National Autistic Society website Asking for reasonable adjustments (autism.org.uk)
Can I stop taking part?
Taking part is voluntary. If you decide you no longer wish to take part, you are free to leave the study at any time during the 52 weeks.
You do not have to give a reason and your medical care and legal rights will not be affected. If you do withdraw from the study we would confidentially keep the information we had already collected about you, for the purposes of the study only. We may ask if you would be willing to discuss your reasons for leaving the study with a researcher, but this is optional.