None listed
Conditions
Brief summary
The Methylphenidate in Children with ADHD+Autism (MICAA) Trial will use N-of-1 trial methodology to individually test the effectiveness of MPH-IR in ~40 children (aged 6-15 years) with ADHD+autism. Participants will include children who have been taking a stable dose of MPH-IR for at least one month prior to trial enrollment. The children will cycle through 12 randomised weekly periods of “on” (MPH-IR) or “off” (placebo) medication, with allocation concealment. There will be weekly monitoring of primary outcomes (ADHD symptoms), and secondary outcomes, including autistic traits, functional behaviour, emotion regulation, anxiety and medication side effects. Study findings will identify those children who are not responding to their prescribed medication, prompting a review of treatment decisions.
Interventions
A series of double-blind, placebo controlled, n-of-1 trials of clinically prescribed, individualised methylphenidate immediate-release (MPH-IR) dose in children with ADHD+autism.
Interventions will include either prescribed MPH-IR (active drug) or matched placebo oral capsules, compared in six 2-week treatment blocks (each block consisting of 1 week active drug and 1 week placebo). Interventions will be administered daily from Monday-Friday during the 12-week trial. Weekends will act as washout
A series of double-blind, placebo controlled, n-of-1 trials of clinically prescribed, individualised methylphenidate immediate-release (MPH-IR) dose in children with ADHD+autism. Interventions will include either prescribed MPH-IR (active drug) or matched placebo oral capsules, compared in six 2-week treatment blocks (each block consisting of 1 week active drug and 1 week placebo). Interventions will be administered daily from Monday-Friday during the 12-week trial. Weekends will act as washouts. The dose of MPH-IR administered during active drug periods will follow the dosage schedule already prescribed by the participant's treating clinician (paediatrician or psychiatrist). It is likely for this individualised dose to be tolerated by the child, as they would have already been taking their prescribed dose prior to enrolment in the trial. Medication side-effects will be monitored weekly. Treatment adherence will be monitored via participant medication diaries (doses taken/not taken). Tablets will be returned to study staff at the end of the trial.
Sponsors
Professor Katrina Williams
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
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
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.
Outcome results
None listed