Assessment of the Usability/acceptability of the Little Journey App by Parents/guardians/legal Representatives and Children Aged Between 3-12 Years Old Who Have a Diagnosis of Autism Spectrum Disorder (ASD).

Introduction

500,000 children in the UK undergo outpatient surgery annually, with 1 in 10 children having a neurodiversity diagnosis. Children often find visits to hospital scary, however neurodiverse chil-dren are twice as likely to experience anxiety and poorer outcomes. Patient care does not cur-rently focus on preparing children for their hospital attendance, instead focussing on distraction, restraints, and sedatives during their hospital visits.

Little Journey's app intends to psychologically prepare children for their hospital visit, and sub-sequently aims to reduce premedication rates, on-the-day cancellations and pre-operative anxi-ety. If effective, this will bring cost-benefits for the NHS. The app provides virtual tours of the rooms, including surgical theatres, ward areas and playrooms, and age-tailored animations to describe the hospital-specific clinical pathway and procedures. The app also provides relaxation activities and games for children and information articles, fasting guidelines and checklists for their caregivers.

Little Journey are developing an additional module named 'A Little About Me'. This module has several quizzes for children to complete, including questions about how their communication preferences, what's important to them, what they like and how they feel about being in hospi-tal. This is designed to support quicker relationship building between clinical staff and patients and enable support to be provided for neurodiverse children and their parents (or carers). It's important to have real end users provide feedback during the development of this module to support its optimisation for children with ASD.

This study aims to assess the usability of the Little Journey app with 7 children and their parents (or carers) aged between 3-12 years with a diagnosis of ASD and experience of attending hospital for a procedure. Children with an ASD diagnosis will be recruited from Birmingham Children's Hospital's and their responding to recruitment flyers circulated via UHB and BCH staff channels and placed within the vicinity of Birmingham Children's Hospital. Interested and eligible indi-viduals will be invited to participate in a 60-minute session. During the session participants will use the Little Journey app, this will be recorded to film the child and parent's (or carer's) inter-action with the app. The participants will then be asked to provide verbal feedback via a semi-structured interview.

Study Rationale and Design Justification

Formative human factors/ usability testing is completed during the development of technologies to assess user interactions, identify user errors and highlight areas of improvement before wide-spread use and adoption. This study will be conducted in line with the international standard IEC/TR 62366-2:2016 (guidance on the application of usability engineering to medical devices); although the app is not a medical device the principles of usability testing are transferable to this study.

This study researching the Little Journey app is being completed to support the software's con-tinued co-development and improvement, with particular focus on children with ASD and their parents (or carers). The study will provide opportunity for children with ASD and their parents (or carers), within a safe and controlled environment, to interact with the user interface of the Little Journey app and provide qualitative feedback collected via a semi-structured interview. This will be completed in a single visit and will take approximately 1 hour.

Management of the usability/ acceptability study

The usability study conduct, data management, data analysis and study reporting will be under-taken by the NIHR HRC-DDR Team, part of University Hospitals Birmingham NHS Foundation Trust. A pseudo-anonymised report will be provided to Little Journey Ltd, the study sponsor and developer of the Little Journey app.

Participant Identification and Recruitment

The study participants will represent the intended users of the app. 7 children with a diagnosis of ASD aged between 3-12- years old with previous experience of attending hospital for a procedure will be recruited. Their parent (or carer) will be present throughout the study involvement.

There will be two methods of recruiting individuals. Firstly, staff from BCH will screen potentially eligible individuals during their pre-admission checks (children aged between 3 and 12 years old with ASD). Potentially eligible individuals will be sent both the parent PIS and child PIS by a BCH staff member which will provide an overview of the study background, their involvement, and the benefits and risks of taking part. If interest-ed in participating, individuals will be asked to email or call the NIHR HRC-DDR Team who will then answer any questions about participating, confirm eligibility and then schedule a study visit. These contact details are included in the parent PIS.

Secondly, REC-approved recruitment flyers will be placed around the Birmingham Children's Hospital site, surrounding areas, and circulated via staff channels at BCH and UHB. Advertisements will signpost individuals to emailing or calling the NIHR HRC-DDR Team. When a potential participant/ family member/ carer contacts the NIHR HRC-DDR team an electronic parent PIS and child PIS will be provided. A member of the NIHR HRC-DDR team will answer any questions about participating, confirm eligibility and then schedule a study visit.

A limited database of name, date they contacted the NIHR HRC-DDR, means of contact which the potential participant provided, and date the PIS was provided will be kept at NIHR HRC-DDR only for the purposes of contacting those individuals to provide further information. If participants respond that they would not like to participate in the study, their name and contact de-tails will be deleted.

Once an interested participant's parent has confirmed that they have read the PIS and are eligible to participate, a study visit will be scheduled to take place within the Clinical Research Facility at Birmingham Children\'s Hospital. Participants will have at least 48 hours to consider the information in the child and parent/ carer PIS before being contacted by a member of the re-search team to see if they remain interested in taking part in the study or participating in the study.

Participant Attendance

Individuals who are interested in participating in the study will contact the NIHR HRC-DDR. They may be contacted by telephone or email thereafter to confirm their interest in participa-tion. Prior to scheduling a study visit, they will be asked to confirm that their child is eligible to participate and that they have read the participant information sheet. Once confirmed, a day will be scheduled to undertake the study.

Participant Eligibility Confirmation

On attendance, participant's parents (or carers) will verbally confirm that the child being consented has an ASD diagnosis and experience of attending hospital for a procedure. Individual's medical records will not be looked at by a member of the research team to confirm this. Confirmation of eligibility will be recorded on the Eligibility Form. All eligibility will need to be fulfilled to be consented into the study.

When a subject fails to fulfil any element of the inclusion criteria, the participant will be thanked for their time but not advanced into the study. The partially completed eligibility form will be destroyed.

The inclusion/ eligibility criteria are shown below:

* A diagnosis of autism spectrum disorder (ASD) * Aged between 3-12 years old * Experience of attending hospital for a procedure * Willing and able to participate in study, including using an app and providing verbal feedback

Participant Informed Consent Process

At least 48 hours (adequate time) will be given for consideration by the participant before taking part. The CI, or an individual delegated by the CI, must record when the Participant Information Sheet (PIS) has been given to the potential participant. This provision will typically be done electronically with a hard copy at participant discretion. Participants will have at least 48 hours to consider the information before being contacted by a member of the research team to see if they remain interested in taking part in the study or before participating in the study. They will be asked if they meet the inclusion criteria and then either signposted to attend or thanked for their time and consideration. If they are not eligible then all data, including name, contact details, and date the PIS was sent, will be deleted.

Where a participant meets all elements of the inclusion criteria, they will be invited to consent.

It is the responsibility of the investigator, or a suitable person delegated by the investigator, to obtain informed consent prior to participation in the study. This will follow an adequate explanation of the aims, methods, anticipated benefits, and risk of the study to the child and the par-ent (or carer). The person taking consent will be GCP trained, suitably qualified and experienced, and have delegated authority from the CI on the delegation log. The investigator or de-signee will explain that the participants are under no obligation to enter the study and that they can withdraw at any time during the study without having to give a reason.

Parents (or carers) will confirm consent by completing the Informed Consent Form on behalf of themselves and their child. The child will not be able to participate in the study without their parent consenting to both the participation of the child and themselves. All children will be asked to complete an Assent Form with the assistance of a suitably trained member of staff following an adequate and age-appropriate explanation of the study. Where the child is willing to participate but unable to complete the assent form due to age or ability, and the parent (or carer) has completed the consent form on the child's behalf, the child can still be enrolled in the study. Their willingness to participate will be assessed verbally, i.e. answering 'Yes; when asked if they would like to take part, pointing to the 'Yes' columns on the Assent Form. This will be recorded on the Assent Form. If the child states that they would not like to take part we would not continue with their participation in the study.

A copy of the signed informed consent form and assent form will be given to the participant on request. The original signed forms will be retained by the NIHR HRC-DDR team at UHB.

When a participant consents, they will be allocated the next available study number (subject ID number). For enrolled participants, this number will consist of the prefix "LJ" followed immediately by a sequential number (001 for the first subject, 002 for the second subject and so on). This number will be the unique identifier of the child and noted on the consent form and all other documentation relating to that individual.

Timing of Recruitment

Participant recruitment will only commence when the study has been initiated by the Sponsor and Birmingham Children's Hospital has issued the 'open to recruitment' letter.

Once the participant has confirmed eligibility and been consented to participate in the study, the participant will be considered enrolled in the study.

Duration of Study

Each participant's study session is expected to take approximately 1 hour. The study is anticipated to take 4-5 separate days, and the entire duration of the study is anticipated to be 1 month.

Methods

This study is a single-arm qualitative study assessing the usability of the Little Journey app in 7 children with an ASD diagnosis aged between 3-12 years. The schedule is indicated in Table 1.

Interested participants will be provided with Participant Information Sheets (PIS) for children and parents/carers which covers the essential information in the protocol, the risks and benefits associated with ta