Feasibility trial to assess Attention Deficit Hyperactivity Disorder (ADHD) in the Criminal Justice System by using QbTest (a computer task)
| ISRCTN | ISRCTN17402196 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17402196 |
| Secondary identifying numbers | 40004 |
- Submission date
- 09/01/2019
- Registration date
- 08/02/2019
- Last edited
- 10/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Young people in prison are more likely to have Attention Deficit Hyperactivity Disorder (ADHD). To help decide if a young person has ADHD information from parents/teachers is helpful. Often this information is not available for young people in prison and therefore they miss getting the help they need. This means that some young people can be aggressive or experience a greater number of physical and mental health problems later in life. This study will try to identify young people with ADHD using a computer task called QbTest which does not need information from parents/teachers. This has not been tried before in prison with young people and we need to test out how we will go about using it by doing a small trial.
Who can participate?
Young people at HMPYOI Wetherby with ADHD symptoms
What does the study involve?
Part 1 of the study involves 60 young people from one prison. Half (30) are randomly selected to take the QbTest in addition to normal care, and 30 receive normal care alone. This will help to show if the larger trial can be done, how willing young people are to take part and how they feel about the study. In Part 2 young people and health professionals are interviewed to see what they think about QbTest and how it might be used in the real world. The researchers will work alongside patients and members of the public in the study to help decide how the study will be done and make sure the views of young people are fully included.
What are the possible benefits and risks of participating?
At the end of the study the researchers will write up their findings and decide if a large trial can be done. The larger trial could lead to better ways prisons can identify young people with ADHD and this could help more young people get the help they need. By participating, young people are helping to find out whether QbTest can reduce time to diagnosis for ADHD and they will also gain some experience of how psychological research studies are carried out. Participating involves talking about health issues and some may find this upsetting. Some young people may find the QbTest procedure a bit uncomfortable as they have to wear a sensor on their head to track their head movements.
Where is the study run from?
HMPYOI Wetherby (UK)
When is the study starting and how long is it expected to run for?
November 2018 to November 2020
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Charlotte Lennox
Charlotte.lennox@manchester.ac.uk
Contact information
Scientific
2.315 Jean McFarlane Building
The University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0001-9014-9965 |
|---|---|
| Phone | +44 (0)161 306 8014 |
| charlotte.lennox@manchester.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Screening, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Using an objective computer task (QbTest) to aid the identification of Attention Deficit Hyperactivity Disorder (ADHD) in young people in the criminal justice secure estate: a feasibility randomised controlled trial |
| Study acronym | FACT |
| Study hypothesis | To descriptively assess the feasibility and acceptability of the trial protocol. |
| Ethics approval(s) | Wales REC 3, Health and Care Research Wales Castlebridge 4, 15 – 19 Cowbridge Road East, Cardiff CF11 9AB , Tel: 029 2078 5735, Email: corinne.scott@wales.nhs.uk, 02/12/2018, ref: 18/WA/0347 |
| Condition | Learning disorders - ADHD |
| Intervention | QbTest (QbTech Ltd) is a computer task that measures three core aspects of ADHD: attention, impulsivity and motor activity. Performance on the task provides information (via an immediate report) on the three symptom domains of ADHD and a ‘summary score’ based on deviation from a normative data set based on age group and gender. QbTest can be used with individuals with mild to moderate learning disabilities as instructions on how to complete the task are visual. Practitioners use the information from the QbTest report in conjunction with the clinical information (patient history, observation and ADHD symptom questionnaire) to inform their decision whether the young person has ADHD or not. The QbTest takes approximately 20 minutes to complete and the results will be discussed with the psychiatrist, this will take approximately 5 minutes. Part 1 of the study will involve 60 young people from one prison. Half (30) will be randomly selected to QbTest in addition to normal care, and 30 to normal care alone. This will help the researchers to understand if the larger trial can be done, how willing young people are to take part and how they feel about the study. In Part 2 the researchers will interview young people and health professionals to see what they think about QbTest and how it might be used in the real world. They will work alongside patients and members of the public in the study. They will help to decide how the study will be done and make sure the views of young people are fully included. |
| Intervention type | Other |
| Primary outcome measure | 1. Eligibility rate recorded as the number of eligible young people against the total number of young people identified with ADHD needs 2. Recruitment rate recorded as the number of eligible young people who consent to participate 3. Acceptability of randomisation recorded as the number of young people randomised 4. Attrition rate recorded as the number of young people who consent to participate that remain in the study until the end of follow up at 6 months |
| Secondary outcome measures | 1. Behaviour is measured using the Strengths and Difficulties Questionnaire (SDQ) at baseline, 3 and 6 months 2. ADHD symptoms are measured using the Barkley ADHD Rating Scale- IV Brief Screen (BAARS-IV Brief Screen) at baseline, 3 and 6 months 3. Health-related quality of life is measured using the Child Health Utility Instrument (CHU-9D) at baseline, 3 and 6 months 4. Objective rating of symptoms and functioning is measured by the Swanson, Nolan and Pelham Questionnaire (SNAP-IV) and Children's Global Assessment Scale (C-GAS) at baseline, 3 and 6 months 5. Number and duration of (in minutes) consultations/appointments until confirmed ADHD diagnosis as recorded on a pro-forma completed by clinicians after each consultation with the young person 6. Number of days until a confirmed diagnosis is reached using file information 7. Contact with services is measured using the modified Client Service Receipt Inventory (CSRI) ) at baseline, 3 and 6 months 8. Number of reordered behavioural incidents and adjudications are collecting using prison file information at baseline, 3 and 6 months |
| Overall study start date | 12/11/2018 |
| Overall study end date | 11/11/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Total final enrolment | 60 |
| Participant inclusion criteria | Young people at HMPYOI Wetherby identified as presenting with ADHD symptoms via the CHAT e.g. any CHAT ADHD symptom read codes via SystmOne |
| Participant exclusion criteria | 1. On remand (uncertain/sudden release) 2. Non English speaking 3. Previous or current confirmed diagnosis of ADHD 4. Currently receiving ADHD medication 5. Deemed to present too high a risk to either the researcher or the staff 6. Unable to provide informed consent (over 16) 7. Parental/legal guardian consent not received (under 16) |
| Recruitment start date | 11/02/2019 |
| Recruitment end date | 02/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wetherby
LS22 5ED
United Kingdom
Sponsor information
Hospital/treatment centre
225 Old Street
Ashton-under-Lyne
OL6 7SR
England
United Kingdom
| Phone | +44 (0)161 716 3080 |
|---|---|
| reagan.blyth@nhs.net | |
| Website | https://www.penninecare.nhs.uk/research-projects/ |
"ROR" |
https://ror.org/03t59pc95 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 11/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The trialists are planning on submitting the protocol for publication after registration. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study is not expected to be made available due to the study involving prisoners. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/01/2020 | 10/11/2020 | Yes | No |
| Results article | 16/12/2022 | 22/03/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/11/2020: Publication reference added.
13/03/2020: The following changes have been made:
1. The recruitment end date has been changed from 10/02/2020 to 02/03/2020.
2. The total final enrolment number has been added.
01/04/2019: The sponsor website was added.
