ADHD
Conditions
Brief 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. 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.
Interventions
OTHERPETRA decision-aid tool
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.
OTHERBest-evidence decision-support tool
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.
Sponsors
University of Southampton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
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 Inclusion criteria for parent/carer: * Parental responsibility * Knowledge of child's medical history sufficient to complete assessments. * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of PETRA decision-aid tool | Enrolment to approximately 24 weeks | measured using a qualitative interview shortly after the first medication appointment |
| Recruitment Rate | Enrolment to approximately 24 weeks | measured using trial database at the end of study |
| Withdrawal rates | Enrolment to approximately 24 weeks | Measured using trial database at the end of the study |
| Data completeness | Enrolment to approximately 24 weeks | Measured using trial database at the end of the study |
Outcome results
None listed