Condition category
Mental and Behavioural Disorders
Date applied
27/08/2019
Date assigned
29/08/2019
Last edited
28/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Attention Deficit Hyperactive Disorder (ADHD) is a developmental disorder affecting up to 5% of the population. ADHD is underdiagnosed in the UK and the process of accessing care is complex and variable. The care pathway usually involves General practitioners (GPs) referring patients to secondary care for a diagnosis and treatment. It is therefore essential that GPs have a clear understanding of ADHD and associated care pathways in order to provide optimal care for patients. This study aims to evaluate the efficiency and usability of an ADHD online education program for GPs

Who can participate?
GPs and GP trainees from England can participate in this study

What does the study involve?
This study involves GPs taking part in an online education program aimed to increase their awareness and understanding of ADHD. Following a randomised parallel design, the participants will be randomised into two groups, an intervention group and a control group. The intervention group will view the online intervention shortly after consenting to take part in the study while the control group will not view the online program upon taking part but will be invited to view it at a later date. Both groups will complete the same questionnaire on ADHD awareness at three time points, baseline, straight after completion of the intervention/control and 2 weeks after

What are the possible benefits and risks of participating?
Participants will gain a greater understanding of ADHD which in turn will facilitate their practice and help their patients. No risks are anticipated from taking part in this study

Where is the study run from?
The study is run from the University of Nottingham but as this is an online program, it can be accessed from anywhere in the country. All Clinical Research Networks (CRN) in England have agreed to take part, representing a national sample

When is the study starting and how long is it expected to run for?
The recruitment for this study takes place from July 2019 until August 2019. Participants are invited to take part in the study from September 2019

Who is funding the study?
This study is funded by the Economic and Social Research Council (ESRC) as part of a DTC PhD project

Who is the main contact?
The main contact is Blandine French
blandine.french@nottingham.ac.uk

Trial website

http://adhdinfo.org.uk

Contact information

Type

Public

Primary contact

Mrs Blandine French

ORCID ID

http://orcid.org/0000-0002-9395-5919

Contact details

Room B15
Yang Fujiya building
Jubilee campus
University of Nottingham
Nottingham
NG8 1BB
United Kingdom
0115 823 0261
blandine.french@nottingham.ac.uk

Type

Scientific

Additional contact

Mrs Blandine French

ORCID ID

http://orcid.org/0000-0002-9395-5919

Contact details

Room B15
Yang Fujiya building
Jubilee campus
University of Nottingham
Nottingham
NG8 1BB
United Kingdom
0115 823 0261
blandine.french@nottingham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS number 257567

Study information

Scientific title

Assessing the effectiveness of an online ADHD awareness online resource in primary care: Pilot of a randomised control trial evaluation

Acronym

Study hypothesis

The purpose of this study is to explore the efficiency of an online ADHD awareness intervention for GPs. We hypothise that GPs will have a better awareness and understadning of ADHD after taking part in a short online psychoeducation program

Ethics approval

1. Approved 20/02/2019, HRA (Health Research Authority, 3rd Floor Barlow House, Minshull Street, Manchester, M1 3DZ; +44207 104 8193; Hra.approval@nhs.net), ref: IRAS ID 257567
2. Approved 10/04/2019, Faculty of Medicine and Health Science Research Ethics Committee from the University of Nottingham (East Atrium, Jubilee Conference Centre, Jubilee Campus, Nottingham, NG8 1DH; +44115 8467906; sponsor@nottingham.ac.uk), ref: 270-1902, RGS ref: 19002

Study design

Pilot randomised controlled trial with waitlist control

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

https://nottingham.onlinesurveys.ac.uk/information-sheet

Condition

Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

The participants will be randomly allocated to two groups: intervention or a waitlist control group (no treatment). A simple randomisation process will determine which group each participant is allocated to by generating a random number to create a random allocation sequence.

After receiving written consent from the participants, they will be invited to take part in the study. Participants will be advised that the study will last around 60 minutes. After randomisation, participants will be allocated to either the intervention or control group. Both groups will complete the same questionnaire at three time points, baseline, straight after completion of the intervention/control and 2 weeks post-intervention. The intervention group will take part in a 45-minute online psycho-education program on ADHD. The control group will be given a 25-minute video to watch and will be invited to view the intervention after completing the last questionnaire.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

ADHD awareness and knowledge measured using a questionnaire (an adapted version of the KADDS (Scuitto et al, 2000) and Adamis et al., 2019) pre and post-intervention

Secondary outcome measures

1. Perceived confidence in the knowledge of ADHD measured using a questionnaire (an adapted version of the KADDS (Scuitto et al, 2000) and Adamis et al., 2019) pre and post-intervention
2. Beliefs and attitudes towards ADHD measured using a questionnaire (an adapted version of the KADDS (Scuitto et al, 2000) and Adamis et al., 2019) pre and post-intervention

Overall trial start date

01/09/2018

Overall trial end date

01/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 or above
2. General practitioners in NHS primary care setting in England, or
3. GP trainees/ registrar in their last 3 years of training

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

10/07/2019

Recruitment end date

01/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
Nottingham
NG8 1BB
United Kingdom

Sponsor information

Organisation

Research and Innovation

Sponsor details

East Atrium
Jubilee Conference Centre
Triumph Road
Nottingham
NG8 1DH
United Kingdom
01158467103
BB-sponsor@exmail.nottingham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Economic and Social Research Council

Alternative name(s)

ESRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

This study is part of a PhD project and will be written up as a chapter of the final PhD thesis. This study will also be published on its own as an academic paper, expected submission by August 2020

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

01/09/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/08/2019: Trial’s existence confirmed by Faculty of Medicine and Health Science Research Ethics Committee from the University of Nottingham.