Methylphenidate in Childhood Apraxia of Speech

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to describe the possible effects of methylphenidate (MPH) on speech intelligibility in children with childhood apraxia of speech (CAS) aged 6-12 years. This outcome will be compared between MPH intake and placebo intake.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Murdoch Childrens Research Institute
• Treatments: Methylphenidate

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 100 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, autism spectrum disorder, 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 100 kilometres from the study site

• Unable to swallow a capsule