Evidencing the need for routine sensory-motor assessment and support for autistic adults
| ISRCTN | ISRCTN81585166 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81585166 |
| IRAS number | 330960 |
| Secondary identifying numbers | X730, IRAS 330960, NIHR206138, CPMS 57232 |
- Submission date
- 06/08/2024
- Registration date
- 15/08/2024
- Last edited
- 10/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Autism is a naturally occurring, largely genetic condition that affects how that person understands their environment and interacts with other people, with around 1-1.5% of people diagnosed in the UK. Sensory and motor difficulties (SMD), such as hypersensitivity to sound and light, and difficulties with carrying out physical movements, occur in ~80% of autistic people. SMD can cause significant problems with day-to-day tasks, such as getting dressed, eating and maintaining employment – often leading to anxiety, depression, fatigue, a restricted lifestyle and reduced quality of life. Despite the serious impact of SMD, autistic adults do not receive routine assessment and support for their SMD unless they also have a diagnosed Learning Disability (LD), which is usually picked up in early childhood and supported accordingly. This study aims to show the need for routine SMD assessments and treatment for autistic people without LD and what kinds of support would help, leading towards an innovative new SMD pathway. The study will start by showing what proportion of autistic adults that do not have a LD need SMD support and how many are likely to take this up.
Who can participate?
Autistic adults aged 18 years old and over
What does the study involve?
Participants will be recruited via autism diagnostic clinics to receive an SMD assessment (involving tasks such as positioning one’s own body) and a follow-up appointment with a specialist clinician. These will show how many patients offered the assessment wanted to be assessed, the range of their SMD and what types of support were useful. Second, information will be collected on what the volunteers thought about the assessment and how they benefitted, this will help plan how to test the new pathway. Third, workshops with the research team and a survey of clinicians will identify which of the assessments and support options should be included in the pathway.
Patient and Public Involvement and sharing our findings
Previous work with autistic people confirmed the importance of but lack of SMD assessment and support and guided our decisions around recruitment and assessment to maximise benefit for volunteers. This project will be co-produced with two autistic team members who will attend team meetings and workshops. Advice will also be sought from ~15 members of the Autism@Manchester Expert by Experience advisory group and implemented where practicable. Participants will benefit immediately by acquiring greater personal awareness and understanding, together with recommendations to help manage their SMD. The longer-term goal of introducing an SMD pathway is to improve the quality of life for autistic people. Blogs and presentations about the findings will be shared with autistic people and clinicians through Autism@Manchester, support groups, charities, NHS trusts and related social media. The study team will reach professionals via conferences and publications.
What are the possible benefits and risks of participating?
Where is the study run from?
Autism clinics at Greater Manchester Mental Health (GMMH) and Merseycare NHS trusts
When is the study starting and how long is it expected to run for?
April 2024 to March 2026
Who is funding the study?
The National Institute for Health and Care Research (NIHR) Research for Patient Benefit (RfPB) programme
Who is the main contact?
Dr Emma Gowen, emma.gowen@manchester.ac.uk
Contact information
Public, Scientific, Principal Investigator
Carys Bannister Building
Dover Street
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)1613064548 |
|---|---|
| emma.gowen@manchester.ac.uk |
Study information
| Study design | Non-randomized cross-sectional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Diagnostic, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evidencing the need for routine sensory-motor assessment and support for autistic adults and identifying appropriate intervention pathways |
| Study objectives | To provide evidence for the need and acceptability of routine sensory motor assessments and treatment for autistic adults and to identify and map existing intervention pathways |
| Ethics approval(s) |
Approved 06/08/2024, North West - Greater Manchester Central Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; gmcentral.rec@hra.nhs.uk), ref: 24/NW/0157 |
| Health condition(s) or problem(s) studied | Sensory motor conditions in autistic people |
| Intervention | For phase 1, consented autistic participants will be offered the Evaluation in Ayres Sensory Integration (EASI) assessment. Study OTs will collect demographics, perform the EASI, the Occupational Circumstances Interview and complete assessment reports detailing any need for sensory motor support (Objective 1) and specific support recommendations. Participants will receive a report detailing any sensory-motor difficulties and any support recommendations. Within 2 weeks of this first visit, participants will be sent an online survey asking about their experience of the assessment, using an acceptability survey and bespoke questions. This has the benefit of (a) participants being more likely to remember the assessment and (b) maintaining engagement in the study. Participants will have a 1-hour follow-up appointment ~6 weeks after receiving the report for the clinician to provide further advice and collect proof of concept and feasibility data (Objective 2). This will consist of data to determine participant views around the acceptability of the report and perceived impacts of open-ended qualitative survey items. Feasibility data will be collected to test whether it is possible to collect reliable outcome measures for future economic evaluation (validated QoL questionnaires recommended for use in economic evaluation: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) and to identify additional outcome measures from the participants’ comments for evaluation in future studies. Phase 2: Workshops and survey During phase 2, the assessment and support recommendations extracted from the EASI reports in phase 1, will be presented at a stakeholder workshop involving the multidisciplinary research team to generate a list of additional assessments and existing support options. These lists will be circulated via a survey to a wider group of clinicians (~100 OTs and physiotherapists, recruited via our networks) to identify their preferred options and any additional assessments and interventions. A second workshop with the research team will involve a discussion of the survey findings and agreement on recommendations for assessment and support pathways, based on clinical and scientific evidence. Workshops will employ a Nominal Group Technique to refine the content of the toolkit and assess the level of consensus around assessment and support. This technique follows set stages of silent idea generation, ‘round robin’, clarifications and scoring enabling workshop participants time to think in silence and all to contribute. This is important as we wish to obtain information as well as develop guidance and the group is comprised of a mix of autistic people, clinicians and researchers so will allow everyone to raise issues. The scoring stage will only be conducted after workshop 2 using an online private Likert scale form for each individual. |
| Intervention type | Behavioural |
| Primary outcome measure | Evidence on the level of need for sensory and motor difficulties (SMD) assessment in autistic adults without LD will be measured using the % of autistic adults without LD who are willing to take up an SMD assessment and the % of these that are identified as needing support following assessment recorded in study data at one time point |
| Secondary outcome measures | 1. Proof of concept and feasibility measured using open-ended qualitative survey items and Quality of life (European Quality of Life 5 Dimensions 5 Level Version) to facilitate future development and evaluation of the toolkit and pathway at one time point 2. A prototype SMD toolkit providing an itemised list of resources, detailing when they could be used (based on patient presentation), what they measure or support, available evidence base and what training might be required enabled and measured using study data at one time point |
| Overall study start date | 01/04/2024 |
| Completion date | 31/03/2026 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Phase 1: 110; Phase 2: 100 |
| Key inclusion criteria | Phase 1: 1. Diagnosis of an Autism Spectrum condition without a Learning Disability (LD) 2. >18 years without LD 3. Presenting at participating adult autism diagnostic clinics (GMMH and Merseycare) Phase 2: 1. Clinicians who assess and support autistic adults with sensory motor needs 2. Able to understand written English and access the internet 3. >18 years of age |
| Key exclusion criteria | Phase 1: 1. Outside of stated age range. 2. Diagnosis of a Learning Disability 3. Unable to understand verbal and written English as they will need to respond to both verbal and written questions 4. Outside-stated diagnostic clinics. Phase 2: Clinicians who do not assess and support autistic adults for sensory motor needs |
| Date of first enrolment | 01/10/2024 |
| Date of final enrolment | 30/11/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Kings Business Park
Prescot
L34 1PJ
United Kingdom
Sponsor information
Hospital/treatment centre
Harrop House Bury New Road
Prestwich
Manchester
M25 3BL
England
United Kingdom
| Phone | +44 (0)161 271 0722 |
|---|---|
| researchoffice@gmmh.nhs.uk | |
| Website | https://www.gmmh.nhs.uk// |
"ROR" |
https://ror.org/05sb89p83 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | 1. The data is owned by the study sponsor – GMMH (on a non-restrictive licence). On completion of the study, the data will be analysed and tabulated and a Final Study Report prepared. NIHR RfPB will be acknowledged in publications/presentations. Relevant summaries and publications will be added to the study website. 2. The project is relevant for autistic individuals and their family members and clinicians and researchers involved in diagnosing and supporting autistic people. This includes OTs, Clinical Psychologists, Psychiatrists, Nurses, Physiotherapists and Speech and Language Therapists. 3. Findings will be disseminated via mailing lists and social media channels (e.g. Autism@Manchester, Salfordautism support group, UK charity Autistica) reaching clinicians, researchers and autistic individuals. The results will be discussed with the Autism@Manchester Expert by Experience group who will advise on the impact to the autistic community, dissemination strategies and implementation of the next stage. For phase 2, a lay summary will be sent round the clinical mailing lists. 4. The project will be presented to the involved Trusts and the Northwest Neurodiversity network consisting of clinicians working with autistic adults and disseminated to the Chartered Society of Physiotherapy and clinical mailing lists within the research team. Findings will also be presented at autism and clinical conferences (e.g. National Autistic Society, Autism Today, Royal College of OTs/Psychiatrists annual conference, Translation@Manchester) as well as submitted for publication (e.g. Autism in Adulthood, Autism or British Journal of OT). 5. We envisage that some OTs may use the toolkit and can begin providing us with informal feedback via a survey on the toolkit website so we can continue to refine the toolkit. 6. NHS England are investing in developing consultants in LD and/or autism and we will present at the NHS England Centre for Advancing Practice conference to access all the consultants. We will also promote our results through our NIHR Applied Research Collaborations Greater Manchester to reach a broader range of academics, patient groups and health professionals. 7. During recruitment in phase 1, participants can optionally consent to receiving a lay summary of the research findings at the end of the study which will also contain links to any publications. In addition, they will be provided with a debrief document containing details about Autism@Manchester and how to join the mailing list and social media channels. If they choose to join these, they will receive the biannual Autism@Manchester newsletter which will also contain a summary of the study and will be kept informed of wider autism research, events and further involvement opportunities at The University of Manchester and affiliated Universities. 8. The study report, anonymised participant level data set and any statistical code will be made openly available using Open Science Framework once the results have been published. |
| IPD sharing plan | The study report, anonymised participant-level data set and any statistical code will be made openly available using Open Science Framework (https://osf.io/) once the results have been published. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 04/04/2024 | 08/08/2024 | No | No |
Additional files
Editorial Notes
10/09/2024: The recruitment start date was changed from 01/09/2024 to 01/10/2024.
07/08/2024: Study's existence confirmed by the Research for Patient Benefit (RfPB) Programme, National Institute for Health and Care Research (NIHR).
