Methylphenidate in Childhood Apraxia of Speech
Childhood Apraxia of Speech
About this trial
This is an interventional treatment trial for Childhood Apraxia of Speech focused on measuring Childhood Apraxia of Speech, Methylphenidate, Ritalin, Developmental Verbal Apraxia, Apraxia, Verbal, Attention Deficit-Hyperactivity Disorder, Central Stimulants, Central Nervous System (CNS) Stimulants, Intelligibility, Speech
Eligibility Criteria
Inclusion Criteria:
- Has childhood apraxia of speech
- Aged 6-12 years
- Can perform the speech tasks for the trial (able to speak single words and short sentences)
- English as a first language
- Has adequate hearing
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on their behalf
- Passes the health and medical examination including examination of heart rate and blood pressure for age and weight norms
- Can commit to the time requirements of the trial
- Lives within 130 kilometres of the study site (MCRI)
- Able to swallow a capsule
- Scores 13 or more out of 27 on either the inattention and/or hyperactivity subscales of the SNAP-IV Parent 18-Item Rating Scale, suggesting clinically significant symptoms of inattention and/or hyperactivity
Exclusion Criteria:
- Is unable to commit to the time requirements of the trial (8 weeks + 2 days)
- Has a diagnosis of severe intellectual disability, or other significant neurodevelopmental conditions (e.g., Fragile X, Down Syndrome, etc.)
- Has epilepsy or other seizure disorders
- Is taking medication(s) for another health condition(s) that is known to interfere with MPH
- Has any contraindication to the stimulant (methylphenidate) medication, including severe anxiety, depression, severe Tourette syndrome, glaucoma, psychotic symptoms, hypertension, congenital heart disease, known past or present diagnosed substance abuse or dependence
- Has a score of moderate or high risk of suicidality, assessed with the Columbia Suicidality Severity Rating Scale (C-SSRS)
- Has used psychostimulants within the past 3 months (e.g., Ritalin, Concerta, Focalin)
- Lives more than 130 kilometres from the study site
- Unable to swallow a capsule
Sites / Locations
- Murdoch Children's Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Sequence A: Methylphenidate, Placebo
Sequence B: Placebo, Methylphenidate
Participants will first receive methylphenidate capsules twice daily for four weeks. Doses will be administered four hours apart. The maximum dose is determined based on the participant's weight. After a 2-day washout, participants then receive Placebo (matching methylphenidate capsules) twice daily for four weeks.
Participants will first receive Placebo capsules twice daily for four weeks. Doses will be administered four hours apart. After a 2-day washout, participants then receive methylphenidate capsules (matching Placebo capsules) twice daily for four weeks. The maximum dose is determined based on the participant's weight.