Personalising ADHD Medication Treatment for Children and Young People
ConditionADHD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorUniversity of Southampton
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PETRA decision-aid tool
Other interventionThe 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 tool
Other interventionThe 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.
Treatment groups
102 Participants
are divided into 3 treatment groupsGroup A: PETRA decision-support toolExperimental treatment 1 intervention
Group B: Best-evidence decision-support toolActive comparator 1 intervention
Group C: Standard practiceNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Acceptability of PETRA decision-aid tool
measured using a qualitative interview shortly after the first medication appointment
Time frame
Enrolment to approximately 24 weeks2
Recruitment Rate
measured using trial database at the end of study
Time frame
Enrolment to approximately 24 weeks3
Withdrawal rates
Measured using trial database at the end of the study
Time frame
Enrolment to approximately 24 weeks4
Data completeness
Measured using trial database at the end of the study
Time frame
Enrolment to approximately 24 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: