Extract

Background and study aims Autism Spectrum Disorder (ASD) is a common lifelong condition affecting 1 in 100 people, which affects how a person relates to others and the world around them. Difficulty responding to sensory information (noise, touch, movement, taste and sight) is common in ASD. This might include feeling overwhelmed or distressed by loud or constant low-level noise, such as that 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 (SIT) is a type of face-to-face therapy or treatment, provided by trained occupational therapists. The therapist uses 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. The aim of this study is to find out whether SIT improves the child’s behaviour socialisation and daily functioning more than the treatment normally offered to families (usual care). Who can participate? Children aged between 4 and 11 years with ASD or a related disorder, who also has sensory processing difficulties. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group continue to receive usual care. This could involve some contact with an occupational therapist, who might give parents strategies to practice at home with their child. Those in the second group receive SIT. This involves taking part in 26 face-to-face sessions over 26 weeks. At the start of the study and then again after 6 and 12 months, children’s behaviour, daily functioning, socialisation, and parent/carer stress are assessed using questionnaires. A sample of carers is interviewed at six months to gain their views and experiences of taking part in the study and of their child’s sensory problems. Therapists are also interviewed in order to get a sense of what participants actually receive in the study. The cost of providing this type of treatment, compared to usual care is also assessed. Once approximately 10% of study participants have completed the 6-month assessment, a sample of carer diaries is examined to see whether SIT is different (in content or amount of contact) to usual care. The study only continues if this is confirmed. Finally, the study team also looks at the number of people willing to take part and whether they continue to participate in all sessions and assessments. What are the possible benefits and risks of participating? Participants benefit from receiving treatment which could imporve their behaviour, social functioning, and well-being. There are no known risks involved with participating. Where is the study run from? The study is run from the South East Wales Trials Unit at Cardiff University and takes place in secondary care NHS and private occupational therapy treatment settings across South Wales and in South West England (UK) When is the study starting and how long is it expected to run for? October 2016 to March 2020 Who is funding the study? National Institute for Health Research, Health Technology Assessment Programme (UK) Who is the main contact? 1. Dr Rachel McNamara (scientific) [email protected] 2. Ms Elizabeth Randell (public) [email protected]

Inclusion criteria

• Autism Spectrum Disorder in children aged 4-11 years with sensory processing difficulties

Links

• isrctn