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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02313025
Other study ID # CatholicULeuven
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 4, 2014
Last updated December 8, 2014
Start date January 2015
Est. completion date December 2015

Study information

Verified date December 2014
Source Katholieke Universiteit Leuven
Contact Lieve Van Severen, Dr
Phone +32 (0)53 72 71 70
Email lieve.vanseveren@odisee.be
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria:

- In eary childhood education in Flanders (2de kleuterklas)

Exclusion Criteria:

- Language or speech disorder

- Less than 1 year acquiring Dutch

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
speech sound intervention
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-project
An intervention that stimulates vocabulary development in four-year-olds. Each day at preschool the children receive a 120 minutes intervention, for 10 weeks

Locations

Country Name City State
Belgium Odisee Aalst Oost-Vlaanderen

Sponsors (1)

Lead Sponsor Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary test battery: speech articulation test + phonemic awareness Participants will be tested after an intervention of 12 weeks. The expected average test duration is 16 minutes No
Secondary vocabulary test (Wereldwoorden project) Participants will be tested after an intervention of 12 weeks. The expected average test duration is 4 minutes No