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Childhood Apraxia of SpeechReST-SSDNCT07636031

Rapid Syllable Transition (ReST) Interventions for Speech Sound Disorders in Children

A study testing Rapid Syllable Transition Treatment (ReST) in people with Childhood Apraxia of Speech, run by Aline Mara de Oliveira at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will investigate the feasibility of applying the Rapid Syllable Transition Treatment (ReST) protocol in children with Childhood Apraxia of Speech, considering the scarcity of evidence in the context of Brazilian Portuguese and the need to implement evidence-based interventions in clinical practice. Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
Childhood Apraxia of Speech
What is being tested?
Rapid Syllable Transition Treatment (ReST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteBrazil
Study dates
1 Apr 2026to 20 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Signed informed consent form provided by the child's legal guardians
  • Native speakers of Brazilian Portuguese
  • Absence of associated comorbidities, verified through detailed clinical history and parent-reported information
  • Receptive language abilities superior to expressive language abilities, confirmed through clinical observation and simple comprehension tasks
  • Hearing thresholds within normal limits
  • Preserved visual acuity
  • Age between five and eight years

Who cannot join

  • Significant cognitive impairments;
  • Severe comprehension difficulties that prevent participation in the proposed activities.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • UFSC

    Florianópolis, Santa Catarina, 88085-174

Other trials in Brazil

About this study

Official title: Rapid Syllable Transition (ReST) and Related Interventions for Speech Sound Disorders in Children: A Master Protocol Investigating Treatment Approaches, Dose Frequency, and Delivery Modality

This study will investigate the feasibility of applying the Rapid Syllable Transition Treatment (ReST) protocol in children with Childhood Apraxia of Speech, considering the scarcity of evidence in the context of Brazilian Portuguese and the need to implement evidence-based interventions in clinical practice. The objective is to evaluate the feasibility of the protocol and estimate preliminary effects on articulatory accuracy, prosody, and speech motor planning. This is a randomized clinical trial with a quantitative and qualitative approach. Participants will be children between five and twelve years old, diagnosed with Childhood Apraxia of Speech. The intervention will be carried out over six weeks, with two weekly sessions, using pseudowords structured according to the ReST protocol. After an initial assessment, participants will be randomized to an intervention group or a control group on a waiting list. Pre- and post-intervention assessments and a one-month follow-up will be conducted. Data analysis will be exploratory, focusing on evaluating the feasibility of the procedures and estimating parameters for future studies. Primary outcomes will include feasibility indicators such as recruitment rate, adherence, therapeutic fidelity, acceptability, and retention. Secondary outcomes will include preliminary measures of speech performance and effect size estimation. The results are expected to provide preliminary effect estimates and inform the design of a definitive randomized clinical trial.

Read the detailed description

This research corresponds to the comparison between the group submitted to the intervention with the ReST method and the control group, maintaining the methodological rigor of the experimental design. The interventions will be conducted by different master's students, each responsible for one of the therapeutic approaches, while the doctoral student will be responsible for randomization, evaluations, and methodological supervision. The study design will follow the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) recommendations, and the results will be reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines, in their most recent versions, including a checklist and participant flowchart. In addition, as this is a pilot randomized clinical trial, the study will also follow recommendations for pilot and feasibility studies, focusing not only on preliminary effects of the intervention, but also on assessing the feasibility of the procedures and generating parameters for a future confirmatory trial.

All participants and their guardians will receive information about the research and, after agreeing to participate, will sign the Informed Consent Form (ICF), the Assent Form, with the study having been previously submitted to and approved by the Research Ethics Committee. Considering recommendations for pilot studies and the rarity and clinical heterogeneity of the population, the inclusion of approximately 12 to 20 participants is expected. These will be Brazilian, monolingual individuals, aged between five and twelve years, all diagnosed with Childhood Apraxia of Speech (CAS). The sample size will be defined based on methodological justification specific to randomized pilot studies, and not on power calculations for confirmatory efficacy testing.

The inclusion criteria adopted will be: signed informed consent form by the guardians; patients who are native speakers of Brazilian Portuguese; absence of associated comorbidities, verified from a detailed clinical history and information provided by the parents; superior receptive language performance compared to expressive performance, confirmed by clinical observation and simple comprehension tasks; hearing thresholds within normal limits; preserved visual acuity; and age between five and eight years.

Children with significant cognitive impairments or severe comprehension difficulties that prevent participation in the proposed activities will be excluded.

In addition to the eligibility criteria, the diagnosis of AFI will be established by clinical consensus among experienced evaluators, based on multiple diagnostic sources and the presence of the clinical markers described for the disorder, including inconsistency in productions, prolonged and/or interrupted coarticulatory transitions, and prosodic alterations. Complementary instruments will be used to increase diagnostic accuracy and reduce clinical heterogeneity in the sample.

After screening, confirmation of eligibility criteria, and completion of the initial assessment, participants will be randomized, using a computerized procedure conducted by an independent researcher, into one of three clinical trial groups: intervention with ReST, or a control group on a waiting list, ensuring random allocation and reduction of biases. For the purposes of this research, data from participants allocated to the ReST group and the control group will be analyzed.

Participants allocated to the control group on the waiting list will not receive intervention during the experimental period and will subsequently be referred for therapeutic intervention at the end of data collection.

Data collection for this study will be organized into three main stages. The first will include anamnesis and speech-language pathology assessment, performed using the Orofacial Praxis Skills Assessment (The Orofacial Praxis Test) and the ABFW assessment. Following this, a diagnostic speech motor assessment will be conducted, involving the Speech Inconsistency Test The Multisyllabic Word Repetition Test and the Lexical Phrase Test. The third stage consists of therapeutic intervention with the ReST method, post-intervention evaluation, with the possibility of follow-up to analyze the maintenance of therapeutic gains .

For the intervention, four vowels and four consonants will be selected, which serve as the basis for the construction of a list of 20 pseudowords. These pseudowords, disyllabic or trisyllabic, should be elaborated according to the level of difficulty of each child, following the protocol of Oliveira and Oliveira (2023), which provides for variation in the position of the lexical accent. It is noteworthy that the choice of pseudowords will follow linguistic criteria (control of structure and accentual pattern), as recommended by the ReST protocol, favoring interpretation and replicability. Therapeutic dose parameters will be monitored, including the number of attempts per session, the expected number of correct productions, criteria for stimulus progression, and the frequency and type of feedback offered. The fidelity of the intervention will be monitored using a structured checklist and procedures inspired by the TIDieR checklist, ensuring standardization, replicability, and consistency in the application of the protocol. The principal investigator will receive prior training and ongoing supervision to maintain therapeutic fidelity.

The intervention will be conducted in person, with a frequency of two sessions per week over six weeks, totaling 12 sessions, according to protocols previously described in the literature for the ReST method, considered adequate to promote measurable changes in initial studies. Each session will be structured in two stages: a pre-practice phase, characterized by greater support from the therapist, including modeling and explicit instructions, and a structured practice phase, consisting of intensive repetition of stimuli, with progressive reduction of feedback, favoring motor learning and participant autonomy, with an estimated 100 to 150 productions per session, in order to guarantee adequate intensity of motor practice. The intervention will be conducted by the researcher responsible for this study.

Due to the nature of the interventions, therapists and participants cannot be blinded to the treatment received. However, the initial and post-intervention assessments will be conducted by the doctoral candidate, who will not act as a therapist for the participants. When operationally feasible, the analysis of part of the samples will be performed with blinding regarding the allocation group.

In addition, independent judges blinded to the allocation of participants may analyze speech samples for certain perceptual measures, with inter-rater reliability estimated to reinforce the robustness of the analyses and reduce measurement biases.

The intervention sessions will be structured in two phases: a pre-practice phase, in which the therapist offers greater support with immediate feedback and modeling, and a practice phase, in which the pseudowords will be repeated in blocks, with non-immediate and random outcome feedback, interspersed with two-minute rest intervals .

As outcomes, preliminary measures related to articulatory precision, prosodic accuracy, generalization to untrained items, and maintenance of gains in follow-up will be analyzed.

The fidelity of the intervention will be ensured through the standardized application of the ReST protocol, controlling the number of trials per session, organization of practice, type and frequency of feedback, as well as criteria for stimulus progression. Sessions may be recorded for monitoring and later analysis, ensuring consistency in the application of the method.

Being tested
Rapid Syllable Transition Treatment (ReST)
Keywords
Rapid Sylablle Transition (ReST);, Motor Speech Disorders, Speech Motor Therapy, Childhood apraxia of speech, Speech therapy.
Medical subject headings
Apraxias, Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rapid Syllable Transition Treatment (ReST)Behavioural

    Speech-motor therapy based on the Rapid Syllable Transition Treatment (ReST) method, rigorously followed. Its objective is to improve speech motor planning and programming through intensive practice of pseudowords that vary in stress patterns and structure, facilitating training in rapid and precise transitions between syllables.

Study groups in NCT07636031
Study groupRoleWhat they receive
Rapid Syllable Transition Treatment (ReST) InterventionExperimentalSpeech therapy using the Rapid Syllable Transition Treatment (ReST) intervention method. Indicated for children with Childhood Apraxia of Speech (CAS). Sessions take place twice a week for six weeks (total of 12 sessions), focusing on speech planning and accuracy, using motor learning principles.
Receives: Behavioral: Rapid Syllable Transition Treatment (ReST)
control groupNo interventionWaiting list, without active intervention during the research, subject to intervention after the research is completed in accordance with ethical terms.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of correct consonants (PCC)

    Percentage of correctly produced consonants (PCC) for treated and untreated stimuli: Generalization to new words, phrases, sentence contexts, and spontaneous speech; Maintenance of gains in follow-up.

    Measured: Assessment performed during follow-up, 4 weeks after the last therapy session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start1 Apr 2026
  3. Primary completionOct 2027 (estimated)
  4. Study completion20 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07636031
Sponsor's protocol ID
09476918.5.0000.0122
Acronym
ReST-SSD
Status last verified
Jun 2026
First submitted
5 May 2026
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Rapid Syllable Transition Treatment (ReST) in people with Childhood Apraxia of Speech, run by Aline Mara de Oliveira at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of correct consonants (PCC) (time frame: Assessment performed during follow-up, 4 weeks after the last therapy session.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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