A Phase 2 interventional study of Methylphenidate Hydrochloride and Placebo in Childhood Apraxia of Speech, sponsored by Murdoch Childrens Research Institute. Completed at 1 site in Australia. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Murdoch Childrens Research Institute · Phase 2, Interventional, and Treatment
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.
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.
65 studies on the registry are indexed under Apraxias; 21 are open to participants now.
This study's enrollment of 18 is below the median of 32 across 50 interventional studies indexed under Apraxias.
Browse Apraxias studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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.
Drug: Methylphenidate Hydrochloride · Drug: Placebo
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.
Drug: Methylphenidate Hydrochloride · Drug: Placebo
Participants will receive twice daily doses of Methylphenidate Hydrochloride four hours apart. There will be three dosage schedules, determined based on three weight ranges (20-30kg; 30-40kg; ≥40kg). For children weighing 20-30kg, the maximum daily dose will be 20mg. For children weighing 30-40kg, the maximum daily dose will be 30mg. For children weighing ≥40kg, the maximum daily dose will be 40mg.
Also known as: Ritalin 10
Participants will receive twice daily doses of placebo capsules. Gelatine placebo capsules will contain hypromellose, an inert substance.
Change From Baseline in Preschool Speech Intelligibility Measure Score at 4 weeks
Single word speech intelligibility will be measured using the Preschool Speech Intelligibility Measure (PSIM). Twenty (20) items from the PSIM will be administered at each testing time point. Participants are required to repeat each test word after the researcher. Higher scores are indicative of greater unintelligibility (range 0-80). Mean change from baseline will be reported at the group level.
Time frame: Baseline and 4 weeks
Change From Baseline in Assessment of the Intelligibility of Dysarthric Speech-II (ASSIDS-II) Score at 4 weeks
The Assessment of the Intelligibility of Dysarthric Speech-II (ASSIDS-II) will be used to measure sentence level speech intelligibility. Five (5) 5-word sentences will be administered at each assessment time point. A phonemic accuracy score will be calculated by determining the percentage of correct phonemes across the 5 sentences at each timepoint. Mean change from baseline will be reported at the group level.
Time frame: Baseline and 4 weeks
Number of children at screening who refuse, are eligible, or are ineligible (and reason).
The frequency of children at screening who refuse, are eligible, or are ineligible (and reason).
Time frame: At study recruitment, up to 4 weeks before starting treatment.
Number of children who withdraw, discontinue, and/or experience 1 or more protocol violations.
Number of children in either sequence A or B who: 1. withdraw 2. discontinue the treatment prior to 4 weeks 3. experience 1 or more protocol violations.
Time frame: During the 4 week treatment phase.
Adherence to dose regimen during each 4 week treatment period
Adherence will be determined by calculating the percentage of prescribed doses achieved based on the medication diary entries and reconciling against returned dispensed medication. A participant will be considered adherent during a 4-week period if 80% of the prescribed doses are achieved. Data will be aggregated such that the proportion of children who adhere to the dosing regimen in each 4-week period will be reported.
Time frame: 4 weeks
Parent/caregiver experience of tolerability and utility
Measured using the investigators' parent/caregiver tolerability and utility survey which is a dedicated electronic Case Report Form. This provides data on caregiver(s)'s views of usability (e.g., "It was convenient to give my child the capsules"), tolerability (e.g., "It was not a burden to participate in this trial") and experience of the trial (Vogel, 2016) (e.g., "I am glad my child participated in this trial"), and whether speech was improved (e.g., "I think the capsule improved my child's speech"). Items will be rated 1-5 where a score of 1 indicates the parent/caregiver strongly disagrees and a score of 5 indicates the parent/caregiver strongly agrees. One item related to school can be rated as 0 if the child is on holidays or in a COVID-19 lockdown for the trial duration. Total scores range from 20-105, where a higher score indicates a greater tolerability/utility of the trial as rated by the parent. Mean change from baseline will be reported at the group level.
Time frame: Baseline and 4 weeks
Paediatric patient experience of tolerability and utility
Measured using the investigators' patient tolerability and utility survey which is a dedicated electronic Case Report Form (eCRF). This provides data on participants' views of usability (e.g., "It was easy to take the capsules"), tolerability/burden (e.g., "I had enough energy to play when taking the capsules") and experience of the trial (Vogel, 2016) (e.g., "I would do this trial again"), and whether speech was improved (e.g.,"I think my speech is better after taking the capsules"). Items will be rated 1-5 where a score of 1 indicates the participant strongly disagrees with the statement and a score of 5 indicates the participant strongly agrees. One item related to school can be rated as 0 if the child is on holidays or in a COVID-19 lockdown for the duration of the trial. Total scores range from 20-105, where, a higher score indicates a greater tolerability/utility of the trial as rated by the child participant. Mean change from baseline will be reported at the group level.
Time frame: Baseline and 4 weeks
Change From Baseline in syllable repetition at 4 weeks
Syllable repetition will be measured by analysing the average number of syllables produced, average period or duration between consonant-vowel syllable voicing offsets (milliseconds) and variance of the diadochokinetic period (percentage reported). Mean change from baseline will be reported at the group level, and will be compared between Sequence A and Sequence B.
Time frame: Baseline and 4 weeks
Change From Baseline in Intelligibility in Context Scale Score at 4 weeks
The Intelligibility in Context Scale (ICS) will measure functional speech intelligibility using parent/caregiver ratings across 7 items, where high scores are indicative of poor intelligibility of speech (range 7-35). Mean change from baseline will be reported at the group level.
Time frame: Baseline and 4 weeks
Change From Baseline in Children's Non-word Repetition (CNRep) Test Score at 4 weeks
The Children's Non-word Repetition (CNRep) Test will measure phonological working memory. Ten CNRep items will be administered at each of the four assessment timepoints to control for learning effects. The percentage of correct responses will be calculated by syllable (i.e., 2, 3, 4 and 5 syllable words) and for the total list of words. Mean change from baseline will be reported at the group level.
Time frame: Baseline and 4 weeks
Change From Baseline in Swanson, Nolan, and Pelham (SNAP-IV) Parent 18-Item Rating Scale (SNAP-IV) Score at 4 weeks
The Swanson, Nolan, and Pelham (SNAP-IV) Questionnaire is a measure of Attention Deficit Hyperactivity Disorder (ADHD) symptoms using ADHD diagnostic criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Parent ratings on the Attention and Hyperactivity subscales will be used to measure attention deficit and hyperactivity symptoms. Higher scores indicate greater inattentive and/or hyperactive behaviours. Scores on each subscale range from 0-27. A score below 13 is indicative of symptoms not being clinically significant. A score of 13-17 indicates mild symptoms; a score of 18-22 indicates moderate symptoms and a score of 22-27 indicates severe symptoms. Mean change from baseline will be reported at the group level.
Time frame: Baseline and 4 weeks
Change From Baseline in maximum phonation time at 4 weeks
Maximum phonation time will be measured by determining the maximum length of a continuous vowel phonation on one breath to indicate airflow sufficiency and adequacy of vocal folds closure. Mean change from baseline will be reported at the group level, and will be compared between Sequence A and Sequence B.
Time frame: Baseline and 4 weeks
Change from Baseline in vowel space of speech at 4 weeks
Vowel space measurements can provide objective information on formant distribution and act as a proxy for vowel production. Vowel space will be quantified by using the vowel articulation index (see Sapir et al. (2009) for more information). Mean change from baseline will be reported at the group level, and compared between Sequence A and Sequence B.
Time frame: Baseline and 4 weeks
Change from Baseline in the Mel-frequency cepstral coefficient (MFCC) at 4 weeks
Mel-frequency cepstral coefficient (MFCC) measures subtle changes in the motion of the articulators (jaw, tongue, lips). The MFCC coefficient represents the vocal tract transfer function, indicating potential problems in the articulators. The MFCC was designed to represent overall stability of individual vocal tract elements. The MFCC parameter is defined as the mean of the standard deviations of the 1st-12th MFCCs. See Fraile et al. (2009) for further description. Mean change from baseline will be reported at the group level, and compared between Sequence A and Sequence B.
Time frame: Baseline and 4 weeks
Change from Baseline in mean of pause length of speech at 4 weeks
The mean of pause length of speech measures the average length of silence in a speech sample. The mean of pause length will be analysed by determining the number of silences divided by the total silence duration (msec). Mean change from baseline will be reported at the group level, and will be compared between Sequence A and Sequence B.
Time frame: Baseline and 4 weeks
Change from Baseline in standard deviation of pauses of speech at 4 weeks
The standard deviation of pauses of speech measures the variability in pause length. Mean change from baseline will be reported at the group level, and will be compared between Sequence A and Sequence B.
Time frame: Baseline and 4 weeks
Change from Baseline in percentage of silence at 4 weeks
The percentage of silence of speech measures the proportion of silence derived from total pause duration divided by total signal time. Mean change from baseline will be reported at the group level, and will be compared between Sequence A and Sequence B.
Time frame: Baseline and 4 weeks
Change from Baseline in rate of speech at 4 weeks
The rate of speech is derived from number of syllables spoken per second. The rate of speech will be analysed by determining the number of syllables spoken in a duration of a speech sample. Mean change from baseline will be reported at the group level, and will be compared between Sequence A and Sequence B.
Time frame: Baseline and 4 weeks
Change from Baseline in pairwise variability index at 4 weeks
The Pairwise Variability Index (PVI) is a measure of relative vowel duration across adjacent syllables in a word or sentence that is normalised to allow comparison across different speech rates (Vergis et al., 2014). PVI is calculated by determining the difference in duration for two adjacent syllables and then dividing the difference by an average of the two values. Higher PVI values indicate greater contrastiveness, while values close to zero indicate equal stress. Mean change from baseline will be reported at the group level, and will be compared between Sequence A and Sequence B.
Time frame: Baseline and 4 weeks
Plan to share: Yes — The de-identified data set collected for this analysis of the trial will be available six months after publication of the primary outcome. The study protocol may be obtained from the Murdoch Children's Research Institute. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the trial investigators must see and approve the analysis plan describing how the data will be analyzed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered. Should the study investigators be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognized research institute which has approved the proposed analysis plan.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 6 months after publication of primary outcome
Access criteria: Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the trial investigators must see and approve the analysis plan describing how the data will be analyzed, there must be an agreement around appropriate acknowledgment and any additional costs involved must be covered.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylphenidate
Murdoch Childrens Research Institute