ADHDPETRANCT07812948
Personalising ADHD Medication Treatment for Children and Young People
A study testing PETRA decision-aid tool and Best-evidence decision-support tool in people with ADHD, run by University of Southampton.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- PETRA decision-aid tool and Best-evidence decision-support tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children/adolescents:
- Aged 6-17 years
- With a clinical diagnosis of ADHD by a clinical team (using either DSM-5-TR or ICD-11 criteria)
- On the waiting list for the pharmacological treatment of ADHD
- Parental responsibility
- Knowledge of child's medical history sufficient to complete assessments.
Show all 9Show fewer
- Access to internet and email
- Able to give valid informed consent
- Sufficient understanding of English to allow access/understanding of the PETRA decision support system and study documentation
Who cannot join
- 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
- Immediate risk to self or others
About this study
Official title: PErsonalising the Pharmacological TReatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children
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.
- Conditions
- ADHD
- Being tested
- PETRA decision-aid tool, Best-evidence decision-support tool
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETRA decision-aid toolOther
The PETRA decision-aid tool will use personalised data as well as data from meta-analysis to provide three best choices of ADHD medication. This will aid shared decision-making between clinician and patient.
Best-evidence decision-support toolOther
The output for this arm will look the same as the PETRA tool, providing three top choices of medication, each with respective pros and cons and margin of statistical uncertainty. However, the output of this tool will instead indicate the side effects that any medication is likely to cause, or not cause, based on population average data, regardless of the patients' individual characteristics.
| Study group | Role | What they receive |
|---|---|---|
| PETRA decision-support tool | Experimental | Not described Receives: Other: PETRA decision-aid tool |
| Best-evidence decision-support tool | Active comparator | Not described Receives: Other: Best-evidence decision-support tool |
| Standard practice | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of PETRA decision-aid tool
measured using a qualitative interview shortly after the first medication appointment
Measured: Enrolment to approximately 24 weeks
Recruitment Rate
measured using trial database at the end of study
Measured: Enrolment to approximately 24 weeks
Withdrawal rates
Measured using trial database at the end of the study
Measured: Enrolment to approximately 24 weeks
Data completeness
Measured using trial database at the end of the study
Measured: Enrolment to approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812948
- Sponsor's protocol ID
- 110433
- Acronym
- PETRA
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PErsonalising the Pharmacological TReatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children
- ClinicalTrials.gov ID
- NCT07812948
- Acronym / sponsor ID
- PETRA / 110433
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PETRA decision-support tool | Experimental | Other: PETRA decision-aid tool |
| Best-evidence decision-support tool | Active comparator | Other: Best-evidence decision-support tool |
| Standard practice | No intervention | – |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Aged 6-17 years
- With a clinical diagnosis of ADHD by a clinical team (using either DSM-5-TR or ICD-11 criteria)
- On the waiting list for the pharmacological treatment of ADHD
- Parental responsibility
- Knowledge of child's medical history sufficient to complete assessments.
Key exclusion criteria (2 listed)
- 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
- Immediate risk to self or others
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PETRA decision-aid toolThe PETRA decision-aid tool will use personalised data as well as data from meta-analysis to provide three best choices of ADHD medication. This will aid shared decision-making between clinician and patient. | Other | PETRA decision-support tool |
| Best-evidence decision-support toolThe output for this arm will look the same as the PETRA tool, providing three top choices of medication, each with respective pros and cons and margin of statistical uncertainty. However, the output of this tool will instead indicate the side effects that any medication is likely to cause, or not cause, based on population average data, regardless of the patients' individual characteristics. | Other | Best-evidence decision-support tool |
Primary outcome
Acceptability of PETRA decision-aid tool
Time frame: Enrolment to approximately 24 weeks
measured using a qualitative interview shortly after the first medication appointment
Recruitment Rate
Time frame: Enrolment to approximately 24 weeks
measured using trial database at the end of study
Withdrawal rates
Time frame: Enrolment to approximately 24 weeks
Measured using trial database at the end of the study
Data completeness
Time frame: Enrolment to approximately 24 weeks
Measured using trial database at the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Related trials for ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PETRA decision-aid tool and Best-evidence decision-support tool in people with ADHD, run by University of Southampton.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of PETRA decision-aid tool (time frame: Enrolment to approximately 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.