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Speech Sound DisorderNCT03700151

Efficacy of an Intervention for the Children With Severe Speech Sounds Disorders

A study testing Treatment for Children with Severe Speech Sound Disorders in people with Speech Sound Disorder and Apraxia of Speech, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Speech sound disorders (SSDs) is one type of communication problems in children. It is a board term describing different difficulties that impact speech intelligibility. There are different types of SSDs, including motor-based disorders (e.g., dysarthria and childhood apraxia of speech [CAS]), structurally based… Read more about this study

Who is it for?
Ages 3 to 18 years
What is being tested?
Treatment for Children with Severe Speech Sound Disorders
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteHong Kong
Study dates
1 Oct 2018to 30 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

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 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Aged between 3 to 18 Cantonese as the main language input No oral structural abnormality No hearing loss No diagnosis of Autism Spectrum Disorders No major behavioural problem

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Eddy CH WONG, MPhil contact

852 39435905

eddychwong@ent.cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • Department of Otorhinolaryngology, Head and Neck Surgery, the Chinese University of Hong Kong

    Hong Kong

    Eddy CH WONG, MPhil, 39435905, eddychwong@ent.cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Speech sound disorders (SSDs) is one type of communication problems in children. It is a board term describing different difficulties that impact speech intelligibility. There are different types of SSDs, including motor-based disorders (e.g., dysarthria and childhood apraxia of speech [CAS]), structurally based disorders (e.g., cleft-palate), syndrome/condition-related disorders (e.g., Down), sensory-based conditions (e.g., hearing loss), and idiopathic in nature.

Among different types of SSDs in children, childhood apraxia of speech (CAS) is a type of motor speech disorders with symptom complex, and is always considered as severe SSDs if objective measurement of severity, percentage of consonant correct (PCC) is applied.

Read more

Evidence of different intervention approaches of CAS and SSDs have been obtained from English-speaking children. This is unknown if these approaches can be applied to languages which are different from English in terms of the sound inventory and prosody.

A treatment program for Cantonese-speaking children with childhood apraxia of speech was studied. Preliminary positive findings were obtained from two participants in an ABA single-case study. With the preliminary positive data, a higher level of evidence could be obtained from group study. The purpose of this study is to determine the efficacy of the proposed intervention for children with severe SSDs by quasi-experimental design.

Read the detailed description

A treatment program for children with severe SSDs, especially childhood apraxia of speech (CAS), a type of motor speech disorders in children was proposed. The program includes syllable repetition tasks and training of core vocabularies. In the syllable repetition tasks, children are required to repeat nonsense syllables three to five times according to their sequencing abilities. This flexibility training of syllables was believed to address the underlying speech motor deficits of children with severe SSDs. The level of difficulty is increased in a systematic way to help progression of children speech skills. In the training of core vocabulary, ten vocabularies which have high functional values in children's daily communication were proposed by parents. Speech therapists are instructed to prioritize the vocabularies and practice the children with the application of Principle of Motor Learning (PML) and Dynamic Temporal and Tactile Cueing (DTTC).

Preliminary positive findings were obtained from two participants in an single-case study. The results showed that the treatment program was able to increase the number of syllable per words, increase the speech sound accuracy, increase the complexity of syllable structure, and increase speech intelligibility.

A quasi-experimental one-group pre- and post-test design will be conducted to study the efficacy of the proposed treatment. A power calculation has been used to determine the number of participants to be recruited. Preliminary findings of the proposed treatment program was obtained. One of the two participants demonstrated statistically significant differences with medium effect size. Based on this, with the estimated medium effect size (d =0.6) with .05 alpha error probability and 0.8 power (1-beta error probability), a total of 19 participants are required.

Twenty children aged between 3 to 18 will be recruited. The specific inclusion criteria of the participants are set as follow:

  1. Cantonese as the main language input
  2. No oral structural abnormality
  3. No hearing loss
  4. No diagnosis of Autism Spectrum Disorders
  5. No major behavioral problem

Pre-treatment assessment and baseline probes:

Pre-treatment assessment will be implemented to all participants. The assessment protocol proposed by Wong (2017) will be used. The assessment protocol consists of case history taking, collecting speech sample, standardized language assessment, standardized speech screening, non-standardized motor speech assessment, hearing screening, tone identification test, and observation of suprasegmental features.

A specially designed word list will be used to take the baseline data for all children about their number of syllable in words, speech sound accuracy, complexity of phonotactic structure. Speech intelligibility will be measured by percentage of consonant correct (PCC) in the children's 15-minutes speech sample.

CAS diagnosis:

After the assessment, the speech therapists will make a diagnosis of CAS if applicable and plan the treatment goals for the children. The speech therapists will make a CAS diagnosis if the children show all 29 diagnostic clinical features of CAS proposed by Wong (2017). For planning treatment, the speech therapists will select stimuli for the syllable repetition task and discuss the core vocabularies with the parents for training.

Intervention:

Each participant will be allocated one or two trained speech therapists for all treatment sessions. All participants will receive the 45-minute sessions, twice a week for six weeks for a total of 12 treatment sessions. All the sessions will be video-recorded for measurement of treatment fidelity. The detail of the treatment protocol was documented in Wong (2017).

In-session probes:

Speech therapists will require the children to produce the word lists at the end of every six sessions of treatment. Two probe sessions will be taken after the practice at 6th and 12th session.

Post-treatment evaluation:

All children will be required to produce the specially designed words lists and be collected a 15-minute speech sample by speech therapists one week after the end of 12th treatment session to document the post-treatment performances in term of the number of syllable in words, speech sound accuracy, phonotactic complexity and speech intelligibility.

Data Analysis:

The pre- and post-treatment differences of the percent correct of the speech sound accuracy and speech intelligibility will be compared by the Wilcoxon Signed-Rank Test. It is hypothesized that the treatment group will show significant improvement on the two outcome measures after intervention.

The inter-rater and intra-rater reliability of the judgement on CAS diagnosis will be analysed by Cohen's kappa. The assessor and the video-viewer will re-view 20% of the videos that were viewed for CAS diagnosis one month later to determine the intra-rater reliability. Another 20% of the rated data will be randomly selected to compare and determine the inter-rater reliability.

A training workshop will be given to the speech therapists who will provide intervention for the children prior to the start of intervention. A checklist will be used to measure the fidelity of the intervention. The measures consist of 1) application of the program structure, including, timing, sequences and content of the tasks, and 2) application of the cueing hierarchy, provision of feedback and the proposed practice amount. Two independent speech therapists will randomly view 20% of all treatment sessions and rate the fidelity by the checklist. The intra-rater and inter-rater reliability of the rating will be measured by Cohen's kappa.

Being tested
Treatment for Children with Severe Speech Sound Disorders
Medical subject headings
Speech Sound Disorder, Apraxias

What participants receive

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

  • Treatment for Children with Severe Speech Sound DisordersBehavioural

    The intervention has two tasks, including syllable repetition tasks which requires participants to repeat nonsense syllables, and training of vocabulary or phrase with the application of Principle of Motor Learning.

Study groups in NCT03700151
Study groupRoleWhat they receive
Children with SSDExperimentalParticipants will receive a piloted treatment programme for children with severe speech sound disorders, especially childhood apraxia of speech.
Receives: Behavioral: Treatment for Children with Severe Speech Sound Disorders

What is being measured

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

  1. Percent correct for target speech sounds

    Measured: 6 weeks treatment

Secondary outcomes (1)
  1. Speech intelligibility

    5-point Likert scale

    Measured: 6 weeks treatment

Timeline

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

  1. First posted9 Oct 2018
  2. Study start1 Oct 2018
  3. Primary completion31 Dec 2018
  4. Study completion30 Oct 2019 (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
Not applicable
Intervention model
Single group
Model description
A group of 20 participants with severe speech sound disorders will receive the proposed intervention. Pre- and post-test data will be collected to study the treatment efficacy
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03700151
Sponsor's protocol ID
KPF18HLF26
Status last verified
Jun 2019
First submitted
22 Sep 2018
Last updated
26 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Treatment for Children with Severe Speech Sound Disorders in people with Speech Sound Disorder and Apraxia of Speech, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jun 2019. 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 Hong Kong. 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?

Results are not available in the source record.

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

Contact Eddy CH WONG, MPhil (852 39435905, eddychwong@ent.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent correct for target speech sounds (time frame: 6 weeks treatment). 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 26 Jun 2019.

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