A trial of sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children
| ISRCTN | ISRCTN14716440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14716440 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 15/106/04 |
| Sponsor | Cardiff University |
| Funder | Health Technology Assessment Programme |
- Submission date
- 08/11/2016
- Registration date
- 08/11/2016
- Last edited
- 19/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 sessions over 26 weeks. The first 24 sessions will be face-to-face while the final two will be phone calls. 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 Centre for Trials Research 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 November 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)
McNamara@cardiff.ac.uk
2. Ms Elizabeth Randell (public)
randelle@cardiff.ac.uk
Contact information
Scientific
Centre for Trials Research
4th Floor Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
 ORCID ID |
0000-0002-7280-1611 |
|---|---|
| Phone | +44 2920 687614 |
| McNamara@cardiff.ac.uk |
Public
Centre for Trials Research
4th Floor Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
| ORCID ID |
0000-0002-1606-3175 |
|---|---|
| Phone | +44 2920 687608 |
| randelle@cardiff.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pragmatic randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study acronym | SenITA |
| Study objectives | The aim of this study is to determine the impact of SIT on irritability and agitation, as measured by the corresponding sub-scale of the Aberrant Behaviour Checklist (ABC). |
| Ethics approval(s) | Wales REC 3, 23/02/2017, ref: 17/WA/0031 |
| Health condition(s) or problem(s) studied | Autism Spectrum Disorder in children aged 4-11 years with sensory processing difficulties. |
| Intervention | Following screening, consent and collection of baseline data, participants will be randomly allocated to usual care or SIT in a 1:1 ratio. Online randomisation will utilise random permuted blocks stratified by region and severity of sensory processing difficulty. Intervention arm: Participants will receive 24 one-hour sessions of SIT (Ayres Sensory Integration® Therapy) and 2 follow up phone calls, delivered over 26 weeks: two sessions per week for 10 weeks (intensive phase), followed by two sessions per month for two months, then one phone call per month for two months (tailoring phase). The intervention will be delivered by occupational therapists (typically NHS Band 7) trained in SIT meeting fidelity criteria. Comparator arm: Participants will receive usual care (UC) which is defined as awaiting services or sensory based intervention not meeting SIT fidelity criteria (e.g. 1 face-to-face session per week or less). Focus groups will map the provision of UC. Follow up assessments will take place at 6 and 12 months post randomisation. |
| Intervention type | Other |
| Primary outcome measure(s) |
Irritability/agitation is measured using the Aberrant Behaviour Checklist (ABC) at baseline, 6 and 12 months. |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 14/01/2019: |
| Completion date | 17/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 11 Years |
| Sex | All |
| Target sample size at registration | 216 |
| Total final enrolment | 138 |
| Key inclusion criteria | Current inclusion criteria as of 14/01/2019: 1. Children aged between 4 and 11 years with ASD/related disorder 2. In mainstream primary education until the primary outcome timepoint 3. Definite/probable SP difficulties 4. Carer consent/child assent Previous inclusion criteria: 1. Children aged between 4 and 11 years with ASD/related disorder 2. In mainstream primary education for the duration of the trial 3. Definite/probable SP difficulties 4. Carer consent/child assent |
| Key exclusion criteria | 1. Current/previous SIT 2. Current Applied Behaviour Analysis therapy |
| Date of first enrolment | 01/04/2017 |
| Date of final enrolment | 30/11/2019 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
4th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2022 | 30/06/2022 | Yes | No | |
| Protocol article | protocol | 11/02/2019 | 08/12/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Process evaluation | 17/02/2024 | 19/02/2024 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/02/2024: Publication reference added.
30/06/2022: Publication reference added.
06/05/2022: The intention to publish date has been changed from 31/05/2022 to 07/09/2022.
02/11/2021: The intention to publish date has been changed from 14/05/2021 to 31/05/2022.
02/09/2021: The intention to publish date has been changed from 30/09/2021 to 14/05/2021.
25/01/2021: The overall trial end date has been changed from 30/11/2020 to 17/12/2020.
08/12/2020: Publication reference added.
03/09/2020: The overall trial end date was changed from 30/09/2020 to 30/11/2020.
06/12/2019: The total final enrolment number has been added.
14/11/2019: The recruitment end date has been changed from 31/10/2019 to 30/11/2019.
17/09/2019: The following changes were made:
1. The recruitment end date was changed from 01/08/2019 to 31/10/2019.
2. The overall trial end date was changed from 31/03/2020 to 30/09/2020.
3. The intention to publish date was changed from 31/03/2021 to 30/09/2021.
14/01/2019: The following changes were made to the trial record:
1. The secondary outcome measures and inclusion criteria were updated.
2. The recruitment end date was changed from 31/12/2018 to 01/08/2019.
02/10/2017: Internal review.
31/08/2017: Ethics approval information has been added.
