Cleft Palate ChildrenNCT06381713
Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate
A study testing High intensive combined phonetic-phonological intervention and Low intensive combined phonetic-phonological intervention in people with Cleft Palate Children and Speech Therapy, run by University Ghent at 1 site in Belgium.
Trial summary
Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cleft Palate Children, Speech Therapy, Speech Disorders in Children
- What is being tested?
- High intensive combined phonetic-phonological intervention and Low intensive combined phonetic-phonological intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Nov 2024to Dec 2027
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
- Aged between 4 and 12 years,
- Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist
Who cannot join
- Children with syndromic clefts
- Oronasal fistula
- Velopharyngeal insufficiency
- Hearing disabilities based on pure tone audiometry (>25 dB HL)
- Cognitive and/or related learning disabilities or neuromuscular disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, 9000
Kristiane Van Lierde, +3293320530, hiruz.ctu@uzgent.be
About this study
Official title: Short and Long Term Effect and Cost-utility of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate
Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice.
Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders.
Read the detailed description
Objective 1: Conduct a large-scale randomized controlled trial to compare the short- and long-term sustainable effects of two different speech intervention intensities (i.e. high intensity speech intervention: 5x30 min/week during 2x4 weeks (2x10 hours) and low intensity speech intervention: 2x30 min/week during 20 weeks (20 hours)) on the speech and quality of life in Belgian Dutch-speaking children with a cleft palate with or without a cleft lip. Speech intervention will be provided by first-line speech language pathologists in private practices who will receive thorough training before the onset of the trial.
Hypothesis 1: Based on the state-of-the-art and our proof-of-concept, it is assumed that 20 hours of high intensity speech intervention will lead to superior speech outcomes and health-related quality of life compared to 20 hours of low intensity speech intervention.
Objective 2: To compare the cost-utility in quality-adjusted life years of two different speech intervention intensities (i.e. high intensity speech intervention: 5x30 min/week during 2x4 weeks (2x10 hours) and low intensity speech intervention: 2x30 min/week during 20 weeks (20 hours)) in Belgian Dutch-speaking children with a cleft palate with or without a cleft lip. Demonstrating the cost-effectiveness of high intensity speech intervention will facilitate implementation and utilization of this protocol in clinical practice as less money has to be spent in order to gain one life year in full health (QALY) when providing high intensity speech intervention compared to low intensity speech intervention.
Hypothesis 2: Besides the superior speech outcomes and health related quality of life in a shorter intervention time (cfr. hypothesis 1), it is hypothesized that less money has to be spent in order to gain one life year in full health (QALY) in the high intensity intervention group. In other words, it is hypothesized that high intensity intervention will be more cost-effective compared to low intensity speech intervention.
- Being tested
- High intensive combined phonetic-phonological intervention, Low intensive combined phonetic-phonological intervention
- Keywords
- Randomized controlled trial, Speech therapy, Cleft lip and palate
- Medical subject headings
- Communication Disorders, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensive combined phonetic-phonological interventionBehavioural
Children will receive phonetic articulation therapy supplemented by phonological principles. Consonants will be treated with emphasis on phonetic placement and shaping techniques. Phonetic articulation therapy includes five different steps:(1) identification of the target consonant using visual, tactile, and auditory feedback techniques,(2) discrimination between the used and targeted consonant, (3) variation and correction, (4) stabilize the target, and (5) maintenance of the target. A next level will be introduced when the child is able to correctly produce the sound in 80% of the time with minimal cues from the therapist. Multiple errors will be targeted simultaneously by focusing on a process. Child-friendly games will be played to illustrate the contrast between concepts, for example glottal 'throat' sounds and oral 'mouth' sounds. Exercises will be embedded in meaningful language contexts such as minimal pairs.
Therapy will be provided 5 times 30' per week for 2 times 4 weeks.
Low intensive combined phonetic-phonological interventionBehavioural
Children will receive phonetic articulation therapy supplemented by phonological principles. Consonants will be treated with emphasis on phonetic placement and shaping techniques. Phonetic articulation therapy includes five different steps:(1) identification of the target consonant using visual, tactile, and auditory feedback techniques,(2) discrimination between the used and targeted consonant, (3) variation and correction, (4) stabilize the target, and (5) maintenance of the target. A next level will be introduced when the child is able to correctly produce the sound in 80% of the time with minimal cues from the therapist. Multiple errors will be targeted simultaneously by focusing on a process. Child-friendly games will be played to illustrate the contrast between concepts, for example glottal 'throat' sounds and oral 'mouth' sounds. Exercises will be embedded in meaningful language contexts such as minimal pairs.
Therapy will be provided 2 times 30' per week for 20 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High intensive speech therapy | Experimental | To investigate the (cost-)effectiveness of speech therapy for children with a cleft palate (with of without a cleft lip), we will provide a high-intensive speech intervention. Receives: Behavioral: High intensive combined phonetic-phonological intervention |
| Low intensive speech therapy | Active comparator | To investigate the (cost-)effectiveness of speech therapy for children with a cleft palate (with of without a cleft lip), we will provide a low-intensive speech intervention. Receives: Behavioral: Low intensive combined phonetic-phonological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Measured: Assessment 2 weeks pre-intervention, immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 1 week post-intervention, at 2 weeks post-intervention, at 3 months post-intervention
Incremental cost-utility ratio
The cost-utility of the high intensity speech intervention compared to the low intensity speech intervention will be examined by calculating the ratio of the incremental costs to the incremental health effects (QALYs) called the incremental cost-utility ratio (ICUR), calculated as Cost intervention - Cost control / Effect intervention - Effect control.
The EQ-5D-Youth version will be used for children aged 8-12 years and the EQ-5D proxy version for children aged 4-7 years to collect information on HRQoL ("utilities").
Cost information will be obtained using a self-reported questionnaire on health care use.
Measured: After a 12-week rest period (high intensity arm), at 3 months post-intervention
Incremental cost-effectiveness ratio
The cost-effectiveness of the high intensity speech intervention compared to the low intensity speech intervention will be examined by calculating the ratio of the incremental costs to the incremental health effects (percentage correctly produced consonants) called the incremental cost-effectiveness ratio (ICER), calculated as Cost intervention - Cost control / Effect intervention - Effect control.
The effectiveness will be estimated using the primary outcome (percentage correctly produced consonants) obtained from the randomized controlled trial.
Cost information will be obtained using a self-reported questionnaire on health care use.
Measured: After a 12-week rest period (high intensity arm), at 3 months post-intervention
Secondary outcomes (6)
Intelligibility in Context
To assess possible transfer of learned speech skills to contexts outside the therapy setting, the Intelligibility in Context Scale (ICS) will be administered. The ICS rates the degree to which children's speech is understood by different partners (caregivers, immediate and extended family, friends, acquaintances, teachers, and strangers) on a 5-point scale (1 - never intelligible to 5 - always intelligible)
Measured: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Health-related quality of life
To evaluate the psychosocial impact of the interventions, the Velopharyngeal insufficiency Effects on Life outcomes (VELO) questionnaire will be administered. This tool consists of a caregiver and child report (for children older than 8 years) addressing different domains: speech limitation, swallowing problems, situational difficulty, emotional impact, perception by others, and caregiver impact. The higher the score, the better the health related quality of life.
Measured: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Speech Function
The subscale "Speech Function" from the Dutch CLEFT-Q will be administered to measure how often someone has trouble speaking. This scale consists of 10 questions. Scores range from 0 to 100. Higher scores indicate less trouble speaking. This scale was developed and validated for children with CP±L between 8 and 29 years of age. Consequently, this scale will only be administered to children aged 8 years and older.
Measured: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Speech Distress
The subscale "Speech Distress" from the Dutch CLEFT-Q will be administered to assess in more detail the feelings someone has regarding speaking. This scale consists of 10 questions. Scores range from 0 to 100. Higher scores indicate less negative feelings. This scale was developed and validated for children with CP±L between 8 and 29 years of age. Consequently, this questionnaire will only be administered to children aged 8 years and older.
Measured: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Communication attitudes of children aged 4 and 5 years
To evaluate the change in communication attitudes of children aged 4 and 5 years during the intervention, the KiddyCAT will be administered before, during and after the intervention. This questionnaire evaluates the extent to which the child has a negative attitude toward speaking.
The higher the score, the more negative the attitude toward speaking. the scores range from 0 (no negative communication attitudes) to 14 (negative communication attitudes only).
Measured: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Communication attitudes of children aged 6 years and older
To evaluate the change in communication attitudes of children aged 6 years and older during the intervention, the Communication Attitudes Test (CAT) will be administered before, during and after the intervention. This questionnaire evaluate the extent to which the child has a negative attitude toward speaking.
The higher the score, the more negative the attitude toward speaking. the scores range from 0 (no negative communication attitudes) to 33 (negative communication attitudes only).
Measured: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start26 Nov 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Palate ChildrenStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Kristiane Van Lierde, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381713
- Sponsor's protocol ID
- ONZ-2024-0158
- Status last verified
- Jan 2025
- First submitted
- 8 Apr 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Effect and Cost-utility of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate
- ClinicalTrials.gov ID
- NCT06381713
- Acronym / sponsor ID
- ONZ-2024-0158
- Keywords
- Randomized controlled trial, Speech therapy, Cleft lip and palate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice.
Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders.
Detailed description
Objective 1: Conduct a large-scale randomized controlled trial to compare the short- and long-term sustainable effects of two different speech intervention intensities (i.e. high intensity speech intervention: 5x30 min/week during 2x4 weeks (2x10 hours) and low intensity speech intervention: 2x30 min/week during 20 weeks (20 hours)) on the speech and quality of life in Belgian Dutch-speaking children with a cleft palate with or without a cleft lip. Speech intervention will be provided by first-line speech language pathologists in private practices who will receive thorough training before the onset of the trial.
Hypothesis 1: Based on the state-of-the-art and our proof-of-concept, it is assumed that 20 hours of high intensity speech intervention will lead to superior speech outcomes and health-related quality of life compared to 20 hours of low intensity speech intervention.
Objective 2: To compare the cost-utility in quality-adjusted life years of two different speech intervention intensities (i.e. high intensity speech intervention: 5x30 min/week during 2x4 weeks (2x10 hours) and low intensity speech intervention: 2x30 min/week during 20 weeks (20 hours)) in Belgian Dutch-speaking children with a cleft palate with or without a cleft lip. Demonstrating the cost-effectiveness of high intensity speech intervention will facilitate implementation and utilization of this protocol in clinical practice as less money has to be spent in order to gain one life year in full health (QALY) when providing high intensity speech intervention compared to low intensity speech intervention.
Hypothesis 2: Besides the superior speech outcomes and health related quality of life in a shorter intervention time (cfr. hypothesis 1), it is hypothesized that less money has to be spent in order to gain one life year in full health (QALY) in the high intensity intervention group. In other words, it is hypothesized that high intensity intervention will be more cost-effective compared to low intensity speech intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensive speech therapy | Experimental | Behavioral: High intensive combined phonetic-phonological interventionTo investigate the (cost-)effectiveness of speech therapy for children with a cleft palate (with of without a cleft lip), we will provide a high-intensive speech intervention. |
| Low intensive speech therapy | Active comparator | Behavioral: Low intensive combined phonetic-phonological interventionTo investigate the (cost-)effectiveness of speech therapy for children with a cleft palate (with of without a cleft lip), we will provide a low-intensive speech intervention. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
- Aged between 4 and 12 years,
- Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist
Key exclusion criteria (5 listed)
- Children with syndromic clefts
- Oronasal fistula
- Velopharyngeal insufficiency
- Hearing disabilities based on pure tone audiometry (>25 dB HL)
- Cognitive and/or related learning disabilities or neuromuscular disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensive combined phonetic-phonological interventionChildren will receive phonetic articulation therapy supplemented by phonological principles. Consonants will be treated with emphasis on phonetic placement and shaping techniques. Phonetic articulation therapy includes five different steps:(1) identification of the target consonant using visual, tactile, and auditory feedback techniques,(2) discrimination between the used and targeted consonant, (3) variation and correction, (4) stabilize the target, and (5) maintenance of the target. A next level will be introduced when the child is able to correctly produce the sound in 80% of the time with minimal cues from the therapist. Multiple errors will be targeted simultaneously by focusing on a process. Child-friendly games will be played to illustrate the contrast between concepts, for example glottal 'throat' sounds and oral 'mouth' sounds. Exercises will be embedded in meaningful language contexts such as minimal pairs. Therapy will be provided 5 times 30' per week for 2 times 4 weeks. | Behavioural | High intensive speech therapy |
| Low intensive combined phonetic-phonological interventionChildren will receive phonetic articulation therapy supplemented by phonological principles. Consonants will be treated with emphasis on phonetic placement and shaping techniques. Phonetic articulation therapy includes five different steps:(1) identification of the target consonant using visual, tactile, and auditory feedback techniques,(2) discrimination between the used and targeted consonant, (3) variation and correction, (4) stabilize the target, and (5) maintenance of the target. A next level will be introduced when the child is able to correctly produce the sound in 80% of the time with minimal cues from the therapist. Multiple errors will be targeted simultaneously by focusing on a process. Child-friendly games will be played to illustrate the contrast between concepts, for example glottal 'throat' sounds and oral 'mouth' sounds. Exercises will be embedded in meaningful language contexts such as minimal pairs. Therapy will be provided 2 times 30' per week for 20 weeks. | Behavioural | Low intensive speech therapy |
Primary outcome
Consonant proficiency
Time frame: Assessment 2 weeks pre-intervention, immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 1 week post-intervention, at 2 weeks post-intervention, at 3 months post-intervention
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Incremental cost-utility ratio
Time frame: After a 12-week rest period (high intensity arm), at 3 months post-intervention
The cost-utility of the high intensity speech intervention compared to the low intensity speech intervention will be examined by calculating the ratio of the incremental costs to the incremental health effects (QALYs) called the incremental cost-utility ratio (ICUR), calculated as Cost intervention - Cost control / Effect intervention - Effect control. The EQ-5D-Youth version will be used for children aged 8-12 years and the EQ-5D proxy version for children aged 4-7 years to collect information on HRQoL ("utilities"). Cost information will be obtained using a self-reported questionnaire on health care use.
Incremental cost-effectiveness ratio
Time frame: After a 12-week rest period (high intensity arm), at 3 months post-intervention
The cost-effectiveness of the high intensity speech intervention compared to the low intensity speech intervention will be examined by calculating the ratio of the incremental costs to the incremental health effects (percentage correctly produced consonants) called the incremental cost-effectiveness ratio (ICER), calculated as Cost intervention - Cost control / Effect intervention - Effect control. The effectiveness will be estimated using the primary outcome (percentage correctly produced consonants) obtained from the randomized controlled trial. Cost information will be obtained using a self-reported questionnaire on health care use.
6 secondary outcomes
Intelligibility in Context
Time frame: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Health-related quality of life
Time frame: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Speech Function
Time frame: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Speech Distress
Time frame: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Communication attitudes of children aged 4 and 5 years
Time frame: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Communication attitudes of children aged 6 years and older
Time frame: Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristiane Van Lierde, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensive combined phonetic-phonological intervention and Low intensive combined phonetic-phonological intervention in people with Cleft Palate Children and Speech Therapy, run by University Ghent at 1 site in Belgium.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Jan 2025. 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 Belgium. 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?
Contact Fien Allemeersch (+32474128135, Fien.Allemeersch@UGent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consonant proficiency (time frame: Assessment 2 weeks pre-intervention, immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 1 week post-intervention, at 2 weeks post-intervention, at 3 months post-intervention). The study lists 3 primary outcomes in all. 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 13 Jan 2025.