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Clinical Trial 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.

Clinical Trial Description

This is a randomised, double-blind, placebo-controlled, two-period crossover proof-of-concept trial of methylphenidate (MPH) for children with childhood apraxia of speech (CAS). 24 children aged 6 to 12 years with CAS will be recruited. If children pass the screening procedure, which includes a physical exam conducted by a medical officer at the Melbourne Children's Campus, children will be enrolled into the 8 weeks + 2-day trial (includes 2-day washout). Participants will be randomly assigned to sequence A (4 weeks of MPH, followed by 4 weeks of placebo) or sequence B (4 weeks of placebo, followed by 4 weeks of MPH). After 4 weeks in period 1, a two-day washout period will occur before participants crossover to period 2 for 4 weeks. Pre- and post-treatment speech outcomes will be measured. The investigators' primary objective is to provide proof-of-concept that speech intelligibility could demonstrate greater improvements from baseline to 4 weeks following a 4-week period of MPH use compared with placebo in children with CAS. The secondary objectives are to describe feasibility, tolerability and change from baseline in: connected speech intelligibility, quality of language production, speech quality, functional speech intelligibility, phonological working memory, attentional and hyperactive behaviour. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05185583
Study type Interventional
Source Murdoch Childrens Research Institute
Contact Angela Morgan, PhD
Phone +613 8341 6458
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date January 2022
Completion date December 2023

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04832503 - Childhood Apraxia of Speech: Experience Dependent Changes Induced by Treatment
Recruiting NCT04642053 - A Randomized Control Trial of Motor-based Intervention for CAS N/A
Recruiting NCT03238677 - Treating Childhood Apraxia of Speech N/A
Recruiting NCT03903120 - ASSIST: Treatment for Childhood Apraxia of Speech Phase 1