AutismBraininHandNCT05468541
Psychological and Quality of Life Impact of Brain in Hand
An observational study of Autism, run by Cornwall Partnership NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A prospective cohort mixed study using both qualitative and quantitative elements. The quantitative component will involve tracking outcomes at baseline and at twelve weeks, using Health of the Nation Outcome Scale for People with a Learning Disability (for quality of life) and Hospital Anxiety and Depression Rating… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Autism
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Members of the participant's existing clinical care team will access their patient records and their autism waiting list to identify potential participants for the study with the participation criteria followed without deviation.
Who may be able to join
- All who have been diagnosed with Autism Spectrum Disorder (ASD) as per DSM-5 criteria level (1) or post screening by health professional such as a GP and on the confirmatory diagnostic pathway.
- Age ranges from 19 to 80.
- Participant has been screened by the Columbia Suicide Rating Scale as not having risk concerns of suicide.
- Access to smart devices with compatibility to running BiH. The Participant will require a Smart Phone and either a Laptop / Tablet / Note Book.
- Has capacity to give informed consent and can give informed consent.
- They can understand the BiH information.
Who cannot join
- Outside of stated age range within the inclusion criteria.
- Any acute or chronic condition, particularly neurodevelopmental conditions such as significant intellectual disability, Level 2/3 DSM V ASD.
- Diagnosed con-current psychological comorbidity (psychosis, severe depression etc.) that would limit the ability of the participant to take part in the study.
- Anyone who declines to give consent or are unable to give informed consent. 5. Anyone who has been screened positive with the (C-SSRS) suicide risk scale.
- 6. Not willing to engage with smart device/internet. 7. Insufficient English language to understand and complete questionnaires.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cornwall Partnership NHS Foundation Trust
Bodmin, Cornwall, PL31 2QN
About this study
A prospective cohort mixed study using both qualitative and quantitative elements. The quantitative component will involve tracking outcomes at baseline and at twelve weeks, using Health of the Nation Outcome Scale for People with a Learning Disability (for quality of life) and Hospital Anxiety and Depression Rating Scale (for anxiety and depression). The qualitative study will involve semi structured interviews with end users to understand usage and acceptability of Brain in Hand app with the added impact of the pandemic.
Read the detailed description
The Brain in Hand App (BiH) has been awarded a Small Business Research Initiatives competitive grant to develop and test new technologies for the NHS https://braininhand.co.uk/news/brain-in-hand-wins-sbri-healthcare-award/ .
A cohort study is needed to robustly test the BiH technology to evaluate the influence, understand its capabilities, users' experiences, and the effect of clinical impact by looking to align or use the NICE Evidence Framework for Health Digital Technologies, to reference the strengths, weakness, and limitations of BiH specifically around psychological wellbeing and by extension, quality of life. This is the purpose of the study.
There are more than 700,000 autistic people in the United Kingdom. Autism research has focused on causes of autism and largely missed opportunities to discover what helps autistic people. Research highlights that autistic people experience poor mental and physical health, which go unrecognised. Autistic people have very high rates of comorbid physical disabilities as well as mental health conditions that are impacted bilaterally by the social environment. ASD is unique to the person, so person centred support is needed, and a digital solution may offer the best solution in terms of privacy and cost.
NHS England recently reported autistic people have high levels of unmet needs and existing health and social services do not usually cater for this complex group, to deliver person centred support. BiH has developed remote person-centred support with self-management tools with 24/7 helpline that encompasses a wraparound healthcare service. This has recently acquired a further interesting dimension as remote interventions have facilitated enhanced accessibility to healthcare during the pandemic.
The study participants will complete two questionnaires: The self-reporting Hospital Anxiety and Depression Scale and the quality of life, Health of the Nation Scale for people with Learning Disabilities. The questionnaires will gather baseline data and then three months later the same questionnaires will be repeated to understand change. Semi-structured questions will be utilised on a randomly selected sample from the main cohort to gain a user's experience of clinical need and safety.
- Conditions
- Autism
- Medical subject headings
- Autistic Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the impact of BiH on quality of life over a three-month period?
The Health of the Nation Outcome Scales for People with Learning Disabilities is measured on a five-point scale (0-4) with 0 being no problem and 4 being very severe. It is completed at Baseline and 3 months and the scores will be compared
Measured: 3 months
What is the impact of BiH on the participant's mental health?
Hospital Anxiety and Depression Scale is measured on a four-point scale (0-3) with 0 being no problem and 4 being very severe. It is completed at Baseline and 3 months and the scores will be compared
Measured: 3 months
Level of acceptability (drop-out rates)
Drop out rates will be recorded
Measured: 3 months
Discover the participant's experience of using BiH App to measure outcomes of reliance on their care support
Short semi structured interviews with ten end users to understand usage and acceptability
Measured: 3 months
Understand how BiH impacts on coping skills
Short semi structured interviews with ten end users to understand usage and acceptability
Measured: 3 months
To gain understanding of how BIH has impacted on the autistic person's ability to manage challenging social situations
Short semi structured interviews with ten end users to understand usage and acceptability
Measured: 3 months
Does BiH App help autistic people feel safe?
Short semi structured interviews with ten end users to understand usage and acceptability
Measured: 3 months
Does the BiH help autistic people feel more independent?
Short semi structured interviews with ten end users to understand usage and acceptability
Measured: 3 months
Can access 24/7 telephone support help autistic people feel self-empowered to manage their anxiety?
Short semi structured interviews with ten end users to understand usage and acceptability
Measured: 3 months
To gain an understanding of how BiH Traffic Light system helps a person manage their anxiety, independence and support their coping skills
Short semi structured interviews with ten end users to understand usage and acceptability
Measured: 3 months
Does the participant believe remote support has improved their access to healthcare during the pandemic?
Short semi structured interviews with ten end users to understand usage and acceptability
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start30 Jul 2021
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornwall Partnership NHS Foundation Trust
- Sponsor type
- Research network
- Collaborators
- braininhand.co.uk
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468541
- Sponsor's protocol ID
- Version 4 25.10.21
- Acronym
- BraininHand
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Quality of Life Impact of Brain in Hand
- ClinicalTrials.gov ID
- NCT05468541
- Acronym / sponsor ID
- BraininHand / Version 4 25.10.21
- Conditions
- Autism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Cornwall Partnership NHS Foundation TrustResearch network
- Collaborators
- braininhand.co.uk
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective cohort mixed study using both qualitative and quantitative elements. The quantitative component will involve tracking outcomes at baseline and at twelve weeks, using Health of the Nation Outcome Scale for People with a Learning Disability (for quality of life) and Hospital Anxiety and Depression Rating Scale (for anxiety and depression). The qualitative study will involve semi structured interviews with end users to understand usage and acceptability of Brain in Hand app with the added impact of the pandemic.
Detailed description
The Brain in Hand App (BiH) has been awarded a Small Business Research Initiatives competitive grant to develop and test new technologies for the NHS https://braininhand.co.uk/news/brain-in-hand-wins-sbri-healthcare-award/ .
A cohort study is needed to robustly test the BiH technology to evaluate the influence, understand its capabilities, users' experiences, and the effect of clinical impact by looking to align or use the NICE Evidence Framework for Health Digital Technologies, to reference the strengths, weakness, and limitations of BiH specifically around psychological wellbeing and by extension, quality of life. This is the purpose of the study.
There are more than 700,000 autistic people in the United Kingdom. Autism research has focused on causes of autism and largely missed opportunities to discover what helps autistic people. Research highlights that autistic people experience poor mental and physical health, which go unrecognised. Autistic people have very high rates of comorbid physical disabilities as well as mental health conditions that are impacted bilaterally by the social environment. ASD is unique to the person, so person centred support is needed, and a digital solution may offer the best solution in terms of privacy and cost.
NHS England recently reported autistic people have high levels of unmet needs and existing health and social services do not usually cater for this complex group, to deliver person centred support. BiH has developed remote person-centred support with self-management tools with 24/7 helpline that encompasses a wraparound healthcare service. This has recently acquired a further interesting dimension as remote interventions have facilitated enhanced accessibility to healthcare during the pandemic.
The study participants will complete two questionnaires: The self-reporting Hospital Anxiety and Depression Scale and the quality of life, Health of the Nation Scale for people with Learning Disabilities. The questionnaires will gather baseline data and then three months later the same questionnaires will be repeated to understand change. Semi-structured questions will be utilised on a randomly selected sample from the main cohort to gain a user's experience of clinical need and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Members of the participant's existing clinical care team will access their patient records and their autism waiting list to identify potential participants for the study with the participation criteria followed without deviation.
Key inclusion criteria (6 listed)
- All who have been diagnosed with Autism Spectrum Disorder (ASD) as per DSM-5 criteria level (1) or post screening by health professional such as a GP and on the confirmatory diagnostic pathway.
- Age ranges from 19 to 80.
- Participant has been screened by the Columbia Suicide Rating Scale as not having risk concerns of suicide.
- Access to smart devices with compatibility to running BiH. The Participant will require a Smart Phone and either a Laptop / Tablet / Note Book.
- Has capacity to give informed consent and can give informed consent.
Key exclusion criteria (5 listed)
- Outside of stated age range within the inclusion criteria.
- Any acute or chronic condition, particularly neurodevelopmental conditions such as significant intellectual disability, Level 2/3 DSM V ASD.
- Diagnosed con-current psychological comorbidity (psychosis, severe depression etc.) that would limit the ability of the participant to take part in the study.
- Anyone who declines to give consent or are unable to give informed consent. 5. Anyone who has been screened positive with the (C-SSRS) suicide risk scale.
- 6. Not willing to engage with smart device/internet. 7. Insufficient English language to understand and complete questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
What is the impact of BiH on quality of life over a three-month period?
Time frame: 3 months
The Health of the Nation Outcome Scales for People with Learning Disabilities is measured on a five-point scale (0-4) with 0 being no problem and 4 being very severe. It is completed at Baseline and 3 months and the scores will be compared
What is the impact of BiH on the participant's mental health?
Time frame: 3 months
Hospital Anxiety and Depression Scale is measured on a four-point scale (0-3) with 0 being no problem and 4 being very severe. It is completed at Baseline and 3 months and the scores will be compared
Level of acceptability (drop-out rates)
Time frame: 3 months
Drop out rates will be recorded
Discover the participant's experience of using BiH App to measure outcomes of reliance on their care support
Time frame: 3 months
Short semi structured interviews with ten end users to understand usage and acceptability
Understand how BiH impacts on coping skills
Time frame: 3 months
Short semi structured interviews with ten end users to understand usage and acceptability
To gain understanding of how BIH has impacted on the autistic person's ability to manage challenging social situations
Time frame: 3 months
Short semi structured interviews with ten end users to understand usage and acceptability
Does BiH App help autistic people feel safe?
Time frame: 3 months
Short semi structured interviews with ten end users to understand usage and acceptability
Does the BiH help autistic people feel more independent?
Time frame: 3 months
Short semi structured interviews with ten end users to understand usage and acceptability
Can access 24/7 telephone support help autistic people feel self-empowered to manage their anxiety?
Time frame: 3 months
Short semi structured interviews with ten end users to understand usage and acceptability
To gain an understanding of how BiH Traffic Light system helps a person manage their anxiety, independence and support their coping skills
Time frame: 3 months
Short semi structured interviews with ten end users to understand usage and acceptability
Does the participant believe remote support has improved their access to healthcare during the pandemic?
Time frame: 3 months
Short semi structured interviews with ten end users to understand usage and acceptability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism, run by Cornwall Partnership NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
What is the impact of BiH on quality of life over a three-month period? (time frame: 3 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.