Work Package 4 - Randomised Controlled Trial
In this pragmatic, multi-centre, cluster randomised controlled trial we are interested in comparing the clinical and cost effectiveness of aDIALOG+ with usual care in reducing behaviours that challenge and improving quality of life, compared to usual care only.
Clinicians will be randomised to either deliver aDIALOG+ with usual care or usual care only, and each arm/group will have 42 clinicians and 210 service users with mild or moderate learning disability.
There will be 20 sites (15 in England; 5 in Northern Ireland), and outcome measures will be assessed at baseline, 6 and 12 months post randomisation.
The primary outcome will be changes in behaviour that challenges, measured by the Aberrant behaviour Checklist- Irritability subscale (ABC-I) at 6 months.
What will happen?
For service users that agree to take part and provide consent, their clinician will either to be randomised to deliver aDIALOG+ with usual care or usual care only over a period of 6 months.
Clinicians randomised to aDIALOG+ will administer the intervention using the app during a face-to-face session at least once a month. The intervention will take about 30 minutes but it might take less time or more time depending on the needs of the person. Participant carers may be asked to support the service user to their appointments with the clinician and may be asked to help with implementing some of the actions.
Service users will complete questionnaires at baseline, 6 and 12 months, and clinicians and participant carers will also be asked to complete some questionnaires about themselves and the service user. After the 6-month follow-up assessment we will conduct semi-structured qualitative interviews with service users, clinicians and participant carers (20 in each stakeholder group; 60 in total), who will be selected purposively across all the sites.
Who can take part?
Service users will be eligible to take part if they are aged 18 or over, have mild or moderate learning disability based on service records / clinical notes, have a current history of behaviour that challenges (at least one incident of self-injurious behaviour, physical or verbal aggression, anger / frustration outbursts, or damage to property in the last 3 months), and can provide informed verbal or written consent.
Clinicians will be eligible to take part if they are aged 18 or over, are currently working within a community learning disability service, intensive support team or in a local authority or social care organisation for people with learning disability, are from any profession (e.g. psychology, nursing, speech and language therapy, psychiatry, social work) with a minimum of six months experience working with people with learning disability, have a caseload of at least five potential participants who are likely to be eligible to take part, and consent to participate.
Participant carers will be eligible to take part if they are aged 18 or over, are a paid or family carer of participant enrolled into the study, know the person well and have supported/worked with the person for at least six months, and consent to participate.
When is it running?
The randomised controlled trial is starting in January 2027 and is expected to run for 30 months.