Psychological and Quality of Life Impact of Brain in Hand

NCT05468541 | Completed

• 1 other identifier: Version 4 25.10.21
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Autism

Outcome Measures

Primary Outcomes (11)

• 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

  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

  3 months

• Level of acceptability (drop-out rates)

  Drop out rates will be recorded

  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

  3 months

• Understand how BiH impacts on coping skills

  Short semi structured interviews with ten end users to understand usage and acceptability

  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

  3 months

• Does BiH App help autistic people feel safe?

  Short semi structured interviews with ten end users to understand usage and acceptability

  3 months

• Does the BiH help autistic people feel more independent?

  Short semi structured interviews with ten end users to understand usage and acceptability

  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

  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

  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

  3 months

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. Not willing to engage with smart device/internet. 7. Insufficient English language to understand and complete questionnaires.

Sponsors & Collaborators

• Cornwall Partnership NHS Foundation Trust: lead
• braininhand.co.uk: collaborator

Study Sites (1)

Cornwall Partnership NHS Foundation Trust

Bodmin, Cornwall, PL31 2QN, United Kingdom

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 21, 2022
• Study Start: July 30, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)