Treatment of Cantonese Speakers With Childhood Apraxia of Speech

April 22, 2024 updated by: Dr Min Wong, The Hong Kong Polytechnic University
The proposed study aims to investigate the efficacy of the Dynamic Temporal and Tactile Cueing treatment in Cantonese-English bilingual speakers with childhood apraxia of speech.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Four CE children with CAS will be recruited and receive two versions of the DTTC treatment (i.e., DTTC in English [DTTC-E] and DTTC in Cantonese [DTTC-C]). After the initial assessment and baseline probe sessions, all the participants will be randomly assigned to receive either DTTC-E or DTTC-C in the first 6-week treatment phase. Then, the between-treatment probe sessions will be conducted during a 2-week washout period. This will be followed by the second 6-week treatment phase, which will be the other version of DTTC. Post-treatment probe sessions will be conducted one week and one month after completion of the second treatment.

Participants' speech productions will be transcribed and evaluated based on their accuracy in phonemes, stress, and tone. Growth curve analysis (Mirman, 2014) will be conducted to examine the group differences in the outcome measures across the treatment sessions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • Recruiting
        • The Hong Kong Polytechnic University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) 3;0 - 11;11 (years;months) years of age at treatment commencement;
  • (2) speak both Cantonese and English: One caregiver one language for at least one year; speaking different languages at home versus school; and/or speak different languages at different times of day;
  • (3) no concomitant developmental disorders including autism spectrum disorder;
  • (4) no structural abnormalities that affect speech, such as cleft lip and/or palate;
  • (5) no uncorrected vision impairment; and
  • (6) no hearing loss;
  • (7) CAS diagnosis confirmed by the research team based on the available diagnostic criteria in Cantonese speakers, which will be described in the next section

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DTTC treatment
Four Cantonese-English bilingual children with be randomly assigned to receive either one of the two versions of DTTC (i.e., DTTC in Cantonese [DTTC-C] and DTTC in English [DTTC-E]) in the first 6-week treatment phase. Then, there will be a 2-week washout period followed by the second 6-week treatment phase with another version of DTTC.
Behavioral: Dynamic Temporal and Tactile Cueing treatment

DTTC is a motor-based treatment designed for children with CAS who may have limited verbal output. It applies the principles of motor learning and focuses on speech movement gestures in the context of functional words and phrases.

The participants will receive two versions of the DTTC treatment (i.e., DTTC in English [DTTC-E] and DTTC in Cantonese [DTTC-C]), where probe data will be collected before, during, between and after the treatment intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phonemes accuracy
Time Frame: Change Before, Between, 1-week and 5-week post DTTC treatment
Participants' performance is probe sessions will be transcribed and analysed by an independent research assistant who has experience with Cantonese and English disordered speech will undergo training in phonetic transcription. The training will include practicing transcription of Cantonese and English speech of preschool children on standardized articulation tests. The accuracy of phonemes and the following aspects will be judged by the research assistant.
Change Before, Between, 1-week and 5-week post DTTC treatment
Stress accuracy
Time Frame: Change Before, Between, 1-week and 5-week post DTTC treatment
Participants' performance is probe sessions will be transcribed and analysed by an independent research assistant who has experience with Cantonese and English disordered speech will undergo training in phonetic transcription. The training will include practicing transcription of Cantonese and English speech of preschool children on standardized articulation tests. The accuracy of phonemes and the following aspects will be judged by the research assistant.
Change Before, Between, 1-week and 5-week post DTTC treatment
Tone accuracy
Time Frame: Change Before, Between, 1-week and 5-week post DTTC treatment
Participants' performance is probe sessions will be transcribed and analysed by an independent research assistant who has experience with Cantonese and English disordered speech will undergo training in phonetic transcription. The training will include practicing transcription of Cantonese and English speech of preschool children on standardized articulation tests. The accuracy of phonemes and the following aspects will be judged by the research assistant.
Change Before, Between, 1-week and 5-week post DTTC treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The University of Hong Kong
University of Vermont

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Min Ney Wong, PhD, study principal investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20231112001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data sets generated and analyzed during this study are not publicly available due to study institutional review board data security requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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