Methylphenidate in children with attention-deficit/hyperactivity disorder (ADHD) and autism (MICAA) trial

Phase 4

• Conditions: Attention-deficit/hyperactivity disorder; Autism Spectrum Disorder; Mental Health - Other mental health disorders; Mental Health - Autistic spectrum disorders

• Registration Number: ACTRN12623001147673
• Lead Sponsor: Professor Katrina Williams

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-06
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant ADHD traits, at an individual level, assessed using the teacher-rated Swanson, Nolan, and Pelham (SNAP-IV) questionnaire, a 26-item measure of inattention, hyperactivity/impulsivity and oppositional/defiant traits.[ This outcome will be assessed weekly (each Friday) during the 12-week trial. Primary timepoint = comparison of MPH-IR week to placebo week ratings.];Participant ADHD traits, at an individual level, assessed using the parent-rated Swanson, Nolan, and Pelham (SNAP-IV) questionnaire, a 26-item measure of inattention, hyperactivity/impulsivity and oppositional/defiant traits.[ This outcome will be assessed weekly (each Friday) during the 12-week trial. Primary timepoint = comparison of MPH-IR week to placebo week ratings.]