Personalising ADHD medication treatment for children and young people

ISRCTN	ISRCTN17600162
DOI	https://doi.org/10.1186/ISRCTN17600162
Integrated Research Application System (IRAS)	369722
Central Portfolio Management System (CPMS)	73351
National Institute for Health and Care Research (NIHR)	303122
Sponsor	University of Southampton
Funder	National Institute for Health and Care Research

Submission date: 31/07/2026
Registration date: 14/08/2026
Last edited: 14/08/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Attention deficit hyperactivity disorder (ADHD) is a common condition that affects children's behaviour, attention and activity levels. Medicines can be an effective treatment for ADHD, but it is often difficult to know which medicine will work best for a particular child. As a result, some children may need to try several medicines before finding one that is effective and well tolerated.
This study aims to test a new online decision-support system called PETRA. The system is designed to help children, parents or carers, and doctors make shared decisions about ADHD medication. The study will assess whether it is practical and acceptable to run a larger clinical trial comparing this personalised approach with standard care.

Who can participate?
Children and young people aged 6 to 17 years with a clinical diagnosis of ADHD who are waiting to start medication treatment may be eligible to take part. A parent or carer with parental responsibility must also participate, be able to give informed consent, have access to the internet and email, and be able to understand English well enough to use the study materials.

What does the study involve?
Parents or carers will be invited to visit the study website, where they will complete screening questions and provide consent if they wish to take part. They will also provide information about their child's health and complete questionnaires about quality of life, ADHD symptoms, side effects and related conditions.
Participants will be randomly allocated to one of three groups. One group will use the personalised PETRA decision-support system, one group will use a best-evidence version of the system without personalisation, and one group will receive usual care without a decision-support tool.
Participants will attend their normal medication appointment, where routine clinical information such as height, weight, blood pressure and pulse will be collected. The doctor will then prescribe ADHD medication.
After starting treatment, parents or carers will complete a short daily online question about medication use. They will also receive telephone calls from a research assistant approximately every four weeks to discuss medication use, adherence and any side effects.
Follow-up assessments will take place at approximately 12 weeks and 24 weeks. These will include routine clinical measurements, medication reviews and questionnaires about quality of life, ADHD symptoms and medication side effects. Some participants may also be invited to take part in an interview about their experiences of the study.

What are the possible benefits and risks of participating?
Participants allocated to one of the decision-support groups may benefit from using a tool designed to help identify the most suitable ADHD medication. This may help reduce the need to switch medications and may reduce unwanted side effects. All participants will also receive a detailed assessment of possible additional mental health conditions through study questionnaires.
The study is considered low risk. The main burden is the time required to complete questionnaires, answer a daily adherence question and take part in telephone follow-up calls, which are expected to last about 15 minutes every four weeks.

Where is the study run from?
The study is run from the University of Southampton Clinical Trials Unit and will recruit participants through one NHS Trust with two participating hospitals in England.

When is the study starting and how long is it expected to run for?
September 2026 to November 2028.

Who is funding the study?
The study is funded by the National Institute for Health and Care Research (NIHR).

Who is the main contact?
petra@soton.ac.uk

Contact information

Dr Samuele Cortese
Principal investigator, Scientific, Public

School of Psychology, Building 44 (Shackleton Building), Highfield Campus, University of Southampton
Southampton
SO17 1BJ
United Kingdom

ORCID ID	0000-0001-5877-8075
Email	Samuele.Cortese@soton.ac.uk

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Single
Purpose	Treatment
Scientific title	PErsonalising the pharmacological TReatment of Attention deficit hyperactivity disorder (ADHD) in children
Study acronym	PETRA
Study objectives	Primary objective: To determine the feasibility of running a randomised controlled trial comparing a decision-support system to usual care Secondary objectives: 1. To assess acceptability of using a tool to support medication choices 2. To review contamination between trial arms
Ethics approval(s)	Submitted 30/07/2026, London – Fulham Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; fulham.rec@hra.nhs.uk), ref: 26/LO/0599
Health condition(s) or problem(s) studied	Attention deficit hyperactivity disorder (ADHD)
Intervention	There will be one participating NHS Trust, with two different hospitals recruiting suitable patients into the study. Potentially suitable patients will be identified from the ADHD medication waiting list. Primary caregivers of children aged 6 to 17 years will be invited to take part by clinicians and research assistants. They will be sent a summary information sheet that will direct them to the study website, where they can read a full patient information sheet and learn more about what the study involves. Participants will have the contact details of a research team member to ask any questions they might have before consenting. Caregivers will complete initial screening questions on the study website. They will then complete informed consent on the study website and add information about their child's medical history and demographics. This is followed by a quality of life questionnaire for themselves (EQ-5D-5L), and two quality of life questionnaires for the child (EQ-5D-5L and CHU9D). They will also complete the ADHD rating scale on the website, the Hill and Taylor Side Effects Scale, and the DAWBA to assess comorbidities. They will then be split into three groups: 34 will use the personalised internet-based system to inform ADHD medication discussions (PETRA), 34 will use the best-evidence website, and 34 will discuss medication with their doctor without the use of a decision support system, as is standard practice. The groups using the PETRA website or the best-evidence website will be blinded to the exact group they are in. They will be aware that they are in the intervention group, but the website will look the same for each group. This design has been deemed necessary to: • Help ensure the positive effects of the tool are from personalisation and not derived simply from using a decision support tool for shared decision-making • Limit the possibility of contamination of the prescriber, who may observe different recommendations for patients with similar clinical profiles, as one may be assigned to the personalised arm and another to the best-evidence arm They will then attend their medication appointment, where they will complete their baseline investigations and receive their prescription for ADHD medication. At this appointment, the following activities will occur: • Confirm the child is eligible • Measure height, weight, blood pressure, and pulse • Collect information on any other medications the participant is taking • Complete the ADHD rating scale again with the researcher if required, or the researcher will check the responses to the parent-completed scale • Collect information regarding health, social care, and community services used by the participant • Prescribe the child's medication, either using a decision support system or not Qualitative interviews will take place shortly after the first appointment, if the participant chooses to take part. Once the participant has collected their prescription and their child has started taking their medication, they will need to complete a daily adherence question online. For the full duration of the study, the participant will also receive regular four-weekly calls from the research assistant to discuss their child's ADHD medication and provide any adjustments, as well as collect adherence and side effect data. The participant will attend the hospital for a follow-up visit as part of standard care, and the following will be conducted as close to 12 weeks as possible. The data collected will include: • Height, weight, blood pressure, and pulse • Other regular medications • How much of the prescribed medication has been taken At 12 weeks, participants will complete the following online questionnaires: • Quality of life questionnaires (two for the child and one for the parent/carer) • Hill and Taylor Side Effects Scale During the four-weekly calls, close to 12 weeks: • Collect information regarding health, social care, and community services used by the participant • Complete the ADHD symptom rating scale Between the 12-week and 24-week visits, the researcher will contact the participant at four-weekly intervals to collect information on any changes to the medication prescription and to discuss medication adherence and side effects. The participant will attend the hospital for a follow-up visit as part of standard care, and the following will be conducted as close to 24 weeks as possible. The data collected will include: • Height, weight, blood pressure, and pulse • Other regular medications • How much of the prescribed medication has been taken At 24 weeks, participants will complete the following online questionnaires: • Quality of life questionnaires (two for the child and one for the parent/carer) • Hill and Taylor Side Effects Scale During the four-weekly calls, close to 24 weeks: • Collect information regarding health, social care, and community services used by the participant • Complete the ADHD symptom rating scale
Intervention type	Other
Primary outcome measure(s)	Feasibility assessed by: 1. Acceptability and experience of ADHD medication decision-making and study participation measured using a qualitative interview shortly after the first medication appointment 2. Recruitment rate (randomised out of those approached) measured using trial database at the end of study 3. Withdrawal rates measured using trial database at the end of study 4. Data completeness of the outcomes below measured using trial database at end of study
Key secondary outcome measure(s)	1. Medication adherence measured using a daily online adherence question daily from initiation of ADHD medication until 24 weeks 2. Medication adherence measured using research assistant four-weekly telephone follow-up calls at 4, 8, 12, 16, 20 and 24 weeks 3. ADHD medication side effects measured using research assistant four-weekly telephone follow-up calls at 4, 8, 12, 16, 20 and 24 weeks 4. Height measured using hospital clinic assessment at 12 and 24 weeks 5. Weight measured using hospital clinic assessment at 12 and 24 weeks 6. Blood pressure measured using hospital clinic assessment at 12 and 24 weeks 7. Pulse measured using hospital clinic assessment at 12 and 24 weeks 8. Concomitant medication use measured using medication review at hospital follow-up visits at 12 and 24 weeks 9. Prescribed ADHD medication taken measured using medication adherence assessment at hospital follow-up visits at 12 and 24 weeks 10. Child health-related quality of life measured using the EQ-5D-5L questionnaire at 12 and 24 weeks 11. Child health-related quality of life measured using the CHU9D questionnaire at 12 and 24 weeks 12. Parent/carer health-related quality of life measured using the EQ-5D-5L questionnaire at 12 and 24 weeks 13. ADHD medication side effects measured using the Hill and Taylor Side Effects Scale at 12 and 24 weeks 14. Health, social care and community service use measured using research assistant four-weekly telephone follow-up calls at 12 and 24 weeks 15. ADHD symptom severity measured using the ADHD symptom rating scale at 12 and 24 weeks 16. Changes to ADHD medication prescription measured using research assistant four-weekly telephone follow-up calls at 16, 20 and 24 weeks
Completion date	30/11/2028

Eligibility

Participant type(s)
Age group	Child
Lower age limit	6 Years
Upper age limit	17 Years
Sex	All
Target sample size at registration	102
Key inclusion criteria	Children/adolescents: 1. Aged 6-17 years 2. With a clinical diagnosis of ADHD by a clinical team (using either DSM-5-TR or ICD-11 criteria) 3. On the waiting list for the pharmacological treatement of ADHD Inclusion criteria for parent/carer: 4. Parental responsibility 5. Knowledge of child’s medical history sufficient to complete assessments. 6. Access to internet and email 7. Able to give valid informed consent 8. Sufficient understanding of English to allow access/understanding of the PETRA decision-support system and study documentation
Key exclusion criteria	1. Based on the clinical judgement of the prescribing clinician, any current condition that would be a contraindication for ADHD medication, including abnormal cardiovascular examination (i.e., BP>95th percentile (for stimulants) and low blood pressure for guanfacine/clonidine as well as tachycardia ) or any conditions that should be treated before starting pharmacological treatment for ADHD such as alcohol/substance dependence, active psychosis, and active mania 2. Immediate risk to self or others
Date of first enrolment	01/09/2026
Date of final enrolment	30/11/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

-
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England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

31/07/2026: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).