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The use of the 'focus on the outcome of communication under six' (FOCUS © -G & FOCUS © -34-G) - investigating the communicative participation in preschool-children with development language disorders (DLD)

Organizational Data

DRKS-ID:
DRKS00024353
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2021-04-26
Last update in DRKS:
2021-04-26
Registration type:
Prospective

Acronym/abbreviation of the study

Projekt FOCUS

URL of the study

https://www.uni-erfurt.de/erziehungswissenschaftliche-fakultaet/fakultaet/profil/fachgebiete-und-professuren/sonder-und-sozialpaedagogik/professuren-und-arbeitsbereiche/professur-fuer-inklusive-bildungsprozesse-bei-beeintraechtigungen-in-sprache-und-kommunikation/forschung-und-projekte/forschungsprojekte/focusc-34-g

Brief summary in lay language

Parents observe their young children every day in a wide variety of communicative situations (= communicative participation). Their evaluation is therefore particularly suitable for assessing successes, difficulties and changes in everyday communication. The questionnaire FOCUS © (Thomas-Stonell, Oddson, Robertson, Walker, & Rosenbaum, 2012) was developed by speech-language pathologists in order to capture such evaluations by parents and to map changes in communicative participation. In our project we take a closer look at the questionnaire in the long (FOCUS © -G) and short version (FOCUS © -34-G) and investigate the use in preschool-children with developmental language disorders (DLD). We want to find out - whether parents find the questionnaire useful and practicable - whether the questionnaire differs between children with and without DLD - whether changes in communicative participation occur in the further development - and if so, what factors (e.g. speech therapy service or language productive skills) influence these changes With our project, we want to go new, ICF-oriented ways in order to optimize the care of children with DLD and to be able to prove, for example, therapy outcomes relevant to everyday life. In our longitudinal study, 50 preschool-children with DLD are accompanied: from the first point in time when parents start to worry and register with an institution for advice, through the diagnosis to various times during which the children receive speech-language therapy (« treatment-as-usual ”, as customary in the canton of Zurich), up to mandatory kindergarten at the age of 5.

Brief summary in scientific language

Our project contributes to research on developmental language disorders and the effects of DLD on the communicative participation of the affected preschool-children are examined. We investigate whether the FOCUS © questionnaire is suitable for use in young children with DLD so that it can then be established for clinical use (e.g. speech therapists, psychologists). In our project, the long (FOCUS © -G) and short version (FOCUS © -34-G) questionnaires are used and validated in relation to preschool-children with developmental language disorders (DLD). Our project aims: 1. Validation of the short version FOCUS © -34-G in comparison to the original version 2. Collection of reference data on communicative participation with FOCUS © -G / FOCUS © -34-G from children with DLD 3. Evaluation of the FOCUS © -G / FOCUS © -34-G as a Therapy Outcome measure (TOM) 4. Determination of predictors for communicative participation in children with DLD 5. Optimization of future speech-language services for children with DLD regarding to improve their communicative participation

Health condition or problem studied

ICD10:
F80 - Specific developmental disorders of speech and language
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
The FOCUS©-G questionnaire is used in 50 children with development language disorders between the ages of 2;0 to 6;5 years 1. We validate the short version FOCUS ©-34-G in comparison to the original version 2. We collect reference data on communicative participation with FOCUS©-G / FOCUS©-34-G for children with DLD 3. We evaluate the FOCUS©-G / FOCUS©-34-G as a Therapy Outcome Measure (TOM) 4. We determine predictors for communicative participation in children with DLD 5. We optimize the future speech-language service for children with DLD regarding to improve their communicative participation

Endpoints

Primary outcome:
Communicative participation: total score FOCUS © -G (only T1 and T4) or FOCUS-34 © -G (T0 to T5, Thomas-Stonell et al., 2012)
Secondary outcome:
Desires and goals regarding therapy success: values ​​of the visual analog scale (VAS) // Communicative-pragmatic competence: total score Beobachtungsrasters zur Erfassung der kommunikativ-pragmatischen Kompetenz von ein- bis fünfjährigen Kindern (BpkK, Vischer, 2016) and total score Beobachtungsbogen für pragmatische Fähigkeiten (BFI, Shelten-Cornish, Hofbauer, & Wirts, oJ) / / Practical-gnostic, symbolic, linguistic and social-communicative competence: scores ​​Entwicklungsprofil (EP, Zollinger, 2015) // Grammatical competence: Mean Length of Utterance (MLU), percent of 2-word combination (% 2-Wo), percent of multiple word utterances (% MeWo), percent of correct verb second placement in main clause (% V2), percent of correct subject-verb congruence (% SVK): Percentage of correct verb marking of the 1st person singular (I) or plural (we,% 1.P.), the 3rd person singular (he / she / it) or plural (they;% 3.P.) .) and the verb marking of the 2nd person singular (you) or plural (you,% 2.P): scores ​​language sample analysis // Articulation competence: Percentage Consonant Correct (PCC), Percentage Vowels Correct (PVC): Scores ​​​language sample analysis // Semantic-lexical competence: Total Number of Words (TNW), Total Number of Different Words (TDW): Scores ​​​language sample analysis // Pragmatic competence:% incomprehensible: Scores ​​​language sample analysis // Receptive competence:% correct reaction: Scores ​​​language sample analysis //

Study Design

Purpose:
Diagnostic
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Switzerland
Number of study centers:
Monocenter study
Recruitment location(s):
  • Medical center Fachstelle Sonderpädagogik Zürich & Winterthur

Recruitment period and number of participants

Planned study start date:
2021-04-26
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
50
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
24 Months
Maximum Age:
56 Months
Additional Inclusion Criteria:
Suspected development language disorder (DLD, T0) Diagnosis of DLD (T1-T5)

Exclusion Criteria

no DLD diagnosis (after T0) other developmental disorder (diagnosis when clarified by the special education department) Parents do not understand enough German to fill out project documents

Addresses

Primary Sponsor

Praxis für Logopädie Steinmaur
Svenja Zauke
Burgweg 4B
8162 Steinmaur
Switzerland
Telephone:
0041764516312
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Praxis für Logopädie Steinmaur
Svenja Zauke
Burgweg 4B
8162 Steinmaur
Switzerland
Telephone:
0041764516312
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Praxis für Logopädie Steinmaur
Svenja Zauke
Burgweg 4B
8162 Steinmaur
Switzerland
Telephone:
0041764516312
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Praxis für Logopädie Steinmaur
Svenja Zauke
Burgweg 4B
8162 Steinmaur
Switzerland
Telephone:
0041764516312
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Praxis für Logopädie Steinmaur
Burgweg 4B
8162 Steinmaur
Switzerland
Telephone:
0041764516312
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission Zürich [Ethikkommission Zürich Stampfenbachstrasse 121 8090 Zürich Schweiz https://www.zh.ch/de/gesundheitsdirektion/ethikkommission.html]
Stampfenbachstrasse 121
8090 Zürich
Switzerland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://www.zh.ch/de/gesundheitsdirektion/ethikkommission.html

Vote of leading Ethics Committee

Date of ethics committee application:
2021-01-27
Ethics committee number:
BASEC- Nr. 2021-00021
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-04-13

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
to be continued

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry