Trial name: SenITA. A pragmatic randomised controlled trial of sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children: impact on behavioural difficulties, adaptive skills and socialisation.
ISRCTN Trial registration number: 14716440
Grant value (£): 1,193,553
Funding end date: 31 March 2020
Background
Autism spectrum disorder (ASD) is a common lifelong condition affecting 1 in 100 people. ASD affects how a person relates to others and the world around them. Difficulty responding to sensory information (noise, touch, movement, taste, sight) is common in ASD. This might include feeling overwhelmed or distressed by loud or constant low-level noise eg in the classroom.
Affected children may also show little or no response to these sensory cues. These sensory processing difficulties are associated with behaviour and socialisation problems, and affect education, relationships, and participation in daily life.
Sensory integration therapy
Sensory integration therapy (SIT) is a type of face-to-face therapy or treatment provided by trained occupational therapists (OT) who use play-based sensory-motor activities to influence the way the child responds to sensation, reducing distress and improving concentration and interaction with others.
Research suggests SIT might be helpful for some children. In this study we are interested in whether, compared to treatment normally offered to families (‘usual care’), SIT improves the child’s behaviour socialisation and daily functioning. Usual care could involve some contact with an occupational therapist, who might give parents or carers strategies to practice at home with their child. It is much less common though to be offered the kind of structured one-to-one regular contact involved in SIT (24 face-to-face sessions, 2 telephone sessions over 26 weeks in this study). We will compare SIT to usual care in a sample of 216 children and will assess behaviour, daily functioning, socialisation, and parent/carer stress at 6 and 12 months using questionnaires. Those who agree to take part will be allocated at random to either SIT or usual care by an online programme. Discussion groups for therapists and carers will be organised before approaching people to take part, so that what people normally receive as ‘usual care’ can be mapped out. Carers will be given diaries (paper-based or electronic) to record their contact with NHS and other services (e.g. social care).
Recruitment
We are recruiting children and their parents in Hywel Dda, Cardiff and Vale, Cwm Taf and Aneurin Bevan Health Boards. Children are eligible if they have confirmed or likely ASD; are in mainstream primary education for the duration of the trial (so aged 4-11 yrs); have definite/probable sensory processing difficulties (SPM); provide carer consent/child assent. Exclusion criteria are those who have had current/previous SIT; or current Applied Behaviour Analysis therapy.
Study design
A sample of carers will be interviewed at six months to gain their views and experiences of taking part and of their child’s sensory problems.
Therapists will also be interviewed to get a sense of what intervention was actually provided. The cost of providing this type of treatment, compared to usual care will be assessed. Once approximately 10% of study participants have completed the six-month assessment, a sample of carer diaries will be examined to see whether SIT is different (in content or amount of contact) to usual care.
The study will only continue if this is confirmed. We will also look at the number of people willing to take part and whether they continue to participate in all sessions and assessments.
We are also currently interested in parents experience of usual care for their child and have a survey open for those who have 10 minutes to complete it.
https://cardiff.onlinesurveys.ac.uk/senita-parent-survey
Results
At the end of the trial, an event for affected families will be organised to publicise the results. A summary will also be made available to organisations like The National Autistic Society (NAS) to include on their websites and for dissemination via social media.
