Effectiveness of methylphenidate in children with co-occurring attention-deficit/hyperactivity disorder (ADHD) and autism - MICAA Trial

Professor Katrina Williams0 sites40 target enrollmentNovember 6, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 6, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Professor Katrina Williams

•Each participant (child) must meet all the following criteria to be enrolled in this trial:
•\- Is between the ages of 6 \- 15 years at the time of enrolment.
•\- Has a clinical diagnosis of ADHD and of ASD.
•\- Has been taking a stable dose of MPH\-IR (i.e. Ritalin 10\) for one month prior to trial enrollment.
•\- Parent has signed and dated an informed consent form.

•Exclusion criteria will include any of the following:
•\- Inability to read or speak sufficient English for parent/guardian to complete assessment tasks.
•\- Is currently taking a medication other than MPH\-IR (i.e. Ritalin 10\) for the purpose of treating ADHD symptoms.
•\- Unable to swallow capsules.
•\- Has major illness or disability, including but not limited to: epilepsy, major head injury, Fragile X Syndrome or Williams Syndrome, Foetal Alcohol Spectrum Disorder (FASD) or Neonatal abstinence syndrome.
•\- Is known to be pregnant.
•\- Research team is not confident the child has both an ADHD and ASD diagnosis.
•\- Parent/guardian does not consent to contact with the clinician and school.
•\- Is deemed by their treating clinician (psychiatrist/paediatrician/GP) to be medically unfit for trial participation.
•\- Child’s school is unwilling to participate in outcome assessments.