Sensory Integration Education

A Pragmatic Randomised Controlled Trial of Sensory Integration Therapy vs usual care for sensory processing difficulties in Autism Spectrum Disorder in children - SenITA

Sue Delport shares an update on the progress of this research study currently underway.

Background

The National Institute for Health Research (NIHR) - Health Technology Assessment programme commission research on specific questions identified and prioritised for their importance to the National Health Service (NHS) and patients. Research suggests Sensory Integration Therapy (SIT) might be helpful for some children with Autism Spectrum Disorder (ASD) and Sensory Processing (SP) difficulties. NIHR wanted to be able to answer the question: ‘what is the clinical and cost-effectiveness of sensory integration therapy for children with Autism Spectrum Disorder (ASD)?

We were successful in our grant application of £1.2 million to investigate whether, compared to treatment normally offered to families (‘usual care’), SIT improves the child’s behaviour, socialisation and daily functioning.

The SenITA intervention

Children were randomisation on a 1:1 ratio to Usual Care or SIT. The intervention consisted of 2 assessment sessions followed by 24 face-to-face 1 hour intervention sessions (2 x a week for 2 ½ months, 2 x a month for 2 months). Participants in the intervention arm also received 2 follow-up telephone calls once a month for two months, following on from the face-to-face sessions. Those in the Usual Care arm just carried on seeing their usual practitioners. Carers of children in both groups were asked to complete a diary to document activities that were recommended by a professional for the participating child. 

Where consent was given, intervention sessions were recorded in order to carry out assessments of fidelity to SIT. Intervention therapists were also assigned a Mentor to provide support and feedback to their delivery of SIT.

The primary objective of the trial is to determine the impact of SIT on irritability and agitation, as measured by the corresponding sub-scale of the Aberrant Behaviour Checklist (ABC).

Secondary outcomes being measured were:

• Problem behaviours: Other problem behaviours (remaining four ABC sub-scales).
• Adaptive behaviours, socialisation and functional change (VABS-II).
• Carer stress: Autism Parenting Stress Index (APSI).
• Quality of Life: Carer QoL will be measured using the EQ5D 5L and CarerQol.
• Cost-effectiveness outcomes (CSRI).
• Mediators: Scores on the Sensory Processing Measure are also assessed at six months (in addition to screening) in order to determine whether any effects of the intervention on the primary outcome at 12 months (if observed) are mediated by severity of SP difficulty post-intervention.

Process Evaluation

We also carried out a process evaluation, the aim of which was to measure: Recruitment, Fidelity to the intervention, Retention, Adherence/Acceptability, Contamination. The process evaluation used a mixed methods approach. Quantitative methods were used to assess recruitment rates/patterns, attendance and intervention fidelity. Qualitative interviews with intervention delivery staff and parents/carers explored factors such as barriers/facilitators, adherence, delivery of the intervention.

Progress

The trial has now closed to recruitment and follow-up after reaching its target of 138 children along with their parent or carer. We had 14 SIT therapists delivering the intervention to children at seven different sites in three regions (South Wales, Cornwall and Buckinghamshire). There were an additional four SIT trained therapists acting as Mentors to the intervention therapists and four who completed Fidelity assessments of the delivered intervention.

Conclusion

The final results are currently being analysed. This includes all quantitative results as well as qualitative interviews and data. A final report will be written up and submitted to the funder in June 2021. It is anticipated that this report will be published and available towards the end of 2021. We will also be publishing separate papers focusing on various aspects of the trial. 

Funding Acknowledgement: This project was funded by the National Institute for Health Research HTA programme (project number 15/106/04) 

Department of Health Disclaimer: The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or Department of Health.