Trial document




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  DRKS00024353

Trial Description

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Title


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)

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Trial Acronym

Projekt FOCUS

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URL of the Trial

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

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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.

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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

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

to be continued

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Organizational Data

  •   DRKS00024353
  •   2021/04/26
  •   [---]*
  •   yes
  •   Approved
  •   BASEC- Nr. 2021-00021, Ethikkommission Zürich Stampfenbachstrasse 121 8090 Zürich Schweiz https://www.zh.ch/de/gesundheitsdirektion/ethikkommission.html
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F80 -  Specific developmental disorders of speech and language
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Interventions/Observational Groups

  •   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
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Communicative participation: total score FOCUS © -G (only T1 and T4) or FOCUS-34 © -G (T0 to T5, Thomas-Stonell et al., 2012)

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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 //

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2021/04/26
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   24   Months
  •   56   Months
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Additional Inclusion Criteria

Suspected development language disorder (DLD, T0)
Diagnosis of DLD (T1-T5)

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Praxis für Logopädie Steinmaur
    • Ms.  Svenja  Zauke 
    • Burgweg 4B
    • 8162  Steinmaur
    • Switzerland
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    • Professur für Inklusive Bildungsprozesse bei Beeinträchtigungen von Sprache und KommunikationFachgebiet Sonder- und SozialpädagogikErziehungswissenschaftliche FakultätUniversität Erfurt
    • Ms.  Prof. Dr.  Sandra  Neumann 
    • Nordhäuser Str. 63
    • 99089  Erfurt
    • Germany
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    • Praxis für Logopädie Steinmaur
    • Ms.  Svenja  Zauke 
    • Burgweg 4B
    • 8162  Steinmaur
    • Switzerland
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    • Praxis für Logopädie Steinmaur
    • Ms.  Svenja  Zauke 
    • Burgweg 4B
    • 8162  Steinmaur
    • Switzerland
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Sources of Monetary or Material Support

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    • Praxis für Logopädie Steinmaur
    • Ms.  Svenja  Zauke 
    • Burgweg 4B
    • 8162  Steinmaur
    • Switzerland
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.