Other Developmental Disorders of Speech and LanguageNCT02313025
A Speech Sound and Phonemic Awareness Intervention in Flemish Early Childhood Education
A study testing speech sound intervention and World-project in people with Other Developmental Disorders of Speech and Language, run by KU Leuven at 1 site in Belgium.
Trial summary
The language intervention 'Kaatje Klank' is designed for stimulating the speech production and speech perception skills of 4-year-olds in an early childhood educational setting, in order to stimulate early literacy skills. These skills are crucial skills for technical reading in later ages. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Other Developmental Disorders of Speech and Language
- What is being tested?
- speech sound intervention and World-project
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Dec 2015
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In eary childhood education in Flanders (2de kleuterklas)
Who cannot join
- Language or speech disorder
- Less than 1 year acquiring Dutch
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Odisee
Aalst, Oost-Vlaanderen, 9320
Lieve Van Severen, Dr, +32 (0)53 72 71 70, lieve.vanseveren@odisee.be
About this study
Official title: Spreken Verfijnen in de Kleuterklas: De Ontwikkeling Van Een Spraakdidactiek Als Uitbreiding op de Gangbare Taaldidactiek in Het Kleuteronderwijs
The language intervention 'Kaatje Klank' is designed for stimulating the speech production and speech perception skills of 4-year-olds in an early childhood educational setting, in order to stimulate early literacy skills. These skills are crucial skills for technical reading in later ages. Good reading skills are an important condition for academic success.
To measure the effect of the language intervention 'Kaatje Klank', the intervention will be applied in six Dutch preschool classes (n = 100 children, 50% native speakers of Dutch, 50% non-native speakers) during 12 weeks (daily). Teachers will be trained and observed using a coaching trajectory.To measure the effect on speech production and perception skills, a pre- and posttest and a comparison with a matched control group (n = 100 children, 50% native speakers of Dutch, 50% non-native speakers) will be used. The control group will receive a different language intervention which focuses on vocabulary development (World-project).
- Being tested
- speech sound intervention, World-project
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speech sound interventionOther
Also called Kaatje Klank
An intervention that stimulates speech sound perception and production in four-year-olds.
Each day at preschool the children receive a 15 to 20 minutes intervention, for 12 weeks
World-projectOther
Also called Wereldwoorden
An intervention that stimulates vocabulary development in four-year-olds. Each day at preschool the children receive a 120 minutes intervention, for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Speech sound intervention | Experimental | This group receives a speech sound and phonemic awareness intervention for four months. Receives: Other: speech sound intervention |
| World-project | Active comparator | This group receives the WORLD intervention for four months. Receives: Other: World-project |
What is being measured
The primary outcome is the main question the study is designed to answer.
test battery: speech articulation test + phonemic awareness
Measured: Participants will be tested after an intervention of 12 weeks. The expected average test duration is 16 minutes
Secondary outcomes (1)
vocabulary test (Wereldwoorden project)
Measured: Participants will be tested after an intervention of 12 weeks. The expected average test duration is 4 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Developmental Disorders of Speech and LanguageStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lieve Van Severen, KU Leuven
- Investigators
- Lieve Van Severen, Dr, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313025
- Sponsor's protocol ID
- CatholicULeuven
- Status last verified
- Dec 2014
- First submitted
- 4 Dec 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spreken Verfijnen in de Kleuterklas: De Ontwikkeling Van Een Spraakdidactiek Als Uitbreiding op de Gangbare Taaldidactiek in Het Kleuteronderwijs
- ClinicalTrials.gov ID
- NCT02313025
- Acronym / sponsor ID
- CatholicULeuven
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Dec 2014 (estimated)
- 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.
The language intervention 'Kaatje Klank' is designed for stimulating the speech production and speech perception skills of 4-year-olds in an early childhood educational setting, in order to stimulate early literacy skills. These skills are crucial skills for technical reading in later ages. Good reading skills are an important condition for academic success.
To measure the effect of the language intervention 'Kaatje Klank', the intervention will be applied in six Dutch preschool classes (n = 100 children, 50% native speakers of Dutch, 50% non-native speakers) during 12 weeks (daily). Teachers will be trained and observed using a coaching trajectory.To measure the effect on speech production and perception skills, a pre- and posttest and a comparison with a matched control group (n = 100 children, 50% native speakers of Dutch, 50% non-native speakers) will be used. The control group will receive a different language intervention which focuses on vocabulary development (World-project).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speech sound intervention | Experimental | Other: speech sound interventionThis group receives a speech sound and phonemic awareness intervention for four months. |
| World-project | Active comparator | Other: World-projectThis group receives the WORLD intervention for four months. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- In eary childhood education in Flanders (2de kleuterklas)
Key exclusion criteria (2 listed)
- Language or speech disorder
- Less than 1 year acquiring Dutch
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 |
|---|---|---|
| speech sound interventionAlso: Kaatje KlankAn intervention that stimulates speech sound perception and production in four-year-olds. Each day at preschool the children receive a 15 to 20 minutes intervention, for 12 weeks | Other | Speech sound intervention |
| World-projectAlso: WereldwoordenAn intervention that stimulates vocabulary development in four-year-olds. Each day at preschool the children receive a 120 minutes intervention, for 10 weeks | Other | World-project |
Primary outcome
test battery: speech articulation test + phonemic awareness
Time frame: Participants will be tested after an intervention of 12 weeks. The expected average test duration is 16 minutes
1 secondary outcome
vocabulary test (Wereldwoorden project)
Time frame: Participants will be tested after an intervention of 12 weeks. The expected average test duration is 4 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Information on the speech sound interventionLink provided by the sponsor.
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. This study is not recruiting at the moment.
Lieve Van Severen, Dr principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing speech sound intervention and World-project in people with Other Developmental Disorders of Speech and Language, run by KU Leuven 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 1 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: status not confirmed, as of the sponsor's last update on 9 Dec 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lieve Van Severen, Dr (+32 (0)53 72 71 70, lieve.vanseveren@odisee.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
test battery: speech articulation test + phonemic awareness (time frame: Participants will be tested after an intervention of 12 weeks. The expected average test duration is 16 minutes). 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 Dec 2014.