Condition category
Mental and Behavioural Disorders
Date applied
09/01/2019
Date assigned
08/02/2019
Last edited
08/02/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charlotte Lennox

ORCID ID

http://orcid.org/0000-0001-9014-9965

Contact details

2.315 Jean McFarlane Building
The University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 8014
charlotte.lennox@manchester.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

40004

Study information

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

Acronym

FACT

Study hypothesis

To descriptively assess the feasibility and acceptability of the trial protocol.

Ethics approval

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

Study design

Randomised; Interventional; Design type: Screening, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

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 trial start date

12/11/2018

Overall trial end date

11/11/2020

Reason abandoned (if study stopped)

Eligibility

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 type

Other

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

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

10/02/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

HMPYOI Wetherby
York Rd
Wetherby
LS22 5ED
United Kingdom

Sponsor information

Organisation

Pennine Care NHS Foundation Trust

Sponsor details

225 Old Street
Ashton-under-Lyne
OL6 7SR
United Kingdom
+44 (0)161 716 3080
reagan.blyth@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-1216-20007

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists are planning on submitting the protocol for publication after registration.

IPD sharing statement
The datasets generated during and/or analysed during the current study is not expected to be made available due to the study involving prisoners.

Intention to publish date

11/11/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes