Authors
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Cortese, Samuele -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2026
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 th CONDITION: Attention deficit hyperactivity disorder (ADHD) ; Mental and Behavioural Disorders PRIMARY OUTCOME: 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 SECONDARY OUTCOME: 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 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
Epistemonikos ID: ef32d213dc5fd9774634f6cb32b2ad89ef0eaed3
First added on: Aug 15, 2026