Personalising ADHD Medication Treatment for Children and Young People

N/ANot Yet RecruitingNCT07812948

University of Southampton102 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

102

Conditions

ADHD

Interventions

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Acceptability of PETRA decision-aid tool

measured using a qualitative interview shortly after the first medication appointment

Time frame: Enrolment to approximately 24 weeks

Recruitment Rate

measured using trial database at the end of study

Time frame: Enrolment to approximately 24 weeks

Withdrawal rates

Measured using trial database at the end of the study

Time frame: Enrolment to approximately 24 weeks

Data completeness

Measured using trial database at the end of the study

Time frame: Enrolment to approximately 24 weeks