Allgemeine Informationen
  • Krankheitskategorie Geistes- und Verhaltenskrankheiten , Andere (BASEC)
  • Studienphase N/A (ICTRP)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Zürich
    (BASEC)
  • Studienverantwortliche Caroline Biegel smile@ife.uzh.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 24.06.2025 ICTRP: Import vom 12.04.2025
  • Letzte Aktualisierung 24.06.2025 11:36
HumRes63366 | SNCTP000005698 | BASEC2023-01592 | DRKS00033068

SMILE - Difficulties in Learning Mathematics: Intervention Opportunities for Young People

  • Krankheitskategorie Geistes- und Verhaltenskrankheiten , Andere (BASEC)
  • Studienphase N/A (ICTRP)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Zürich
    (BASEC)
  • Studienverantwortliche Caroline Biegel smile@ife.uzh.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 24.06.2025 ICTRP: Import vom 12.04.2025
  • Letzte Aktualisierung 24.06.2025 11:36

Zusammenfassung der Studie

A calculation disorder or dyscalculia can be associated with significant limitations for affected individuals: difficulties with large numbers, math anxiety, stress in school, etc. Young people and young adults with a calculation disorder lack support offerings. Therefore, we provide support for them and want to investigate whether and how missing mathematical foundations can be successfully addressed and whether this can change processes in the brain.

(BASEC)

Untersuchte Intervention

Participants with a calculation disorder/dyscalculia receive individually tailored support (14 sessions of one hour each). They will work together with a professional in individual sessions to address gaps in mathematical understanding. Additionally, they will receive practice materials that they can use at home (on their phone, computer, tablet). To assess the effectiveness of the support, various tests and magnetic resonance imaging (MRI) measurements will be conducted.

(BASEC)

Untersuchte Krankheit(en)

Dyscalculia/calculation disorder/mathematical learning disorder

(BASEC)

Kriterien zur Teilnahme
- Age between 14 and 27 years - Dyscalculia group: dyscalculia diagnosis / control group: no dyscalculia - Normal cognitive development (BASEC)

Ausschlusskriterien
- Neurological disorders - Contraindications according to MRI safety criteria (e.g., metal parts in the body, pregnancy, etc.) - Medication that affects neuronal activity (e.g., Ritalin) (BASEC)

Studienstandort

Zürich

(BASEC)

Switzerland (ICTRP)

Sponsor

PD Dr. sc. nat. Karin Kucian

(BASEC)

Kontakt für weitere Auskünfte zur Studie

Kontaktperson Schweiz

Caroline Biegel

+41 44 249 77 08

smile@ife.uzh.ch

Universitäts-Kinderspital Zürich Zentrum für MR-Forschung Lenggstrasse 30 CH-8008 Zürich

(BASEC)

Allgemeine Auskünfte

Universitts-Kinderspital Zrich - Eleonorenstiftung

+41 44 249 77 08

smile@ife.uzh.ch

(ICTRP)

Wissenschaftliche Auskünfte

Universit?ts-Kinderspital Z?rich - Eleonorenstiftung

+41 44 249 77 08

smile@ife.uzh.ch

(ICTRP)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

14.11.2023

(BASEC)


ICTRP Studien-ID
DRKS00033068 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Development and Evaluation of an Intervention for Adolescents and Adults with Dyscalculia (BASEC)

Wissenschaftlicher Titel
Development and Evaluation of an Intervention for Adolescents and Adults with Dyscalculia - SMILE (ICTRP)

Öffentlicher Titel
Development and Evaluation of an Intervention for Adolescents and Adults with Dyscalculia (ICTRP)

Untersuchte Krankheit(en)

F81.2Specific disorder of arithmetical skillsF81.2 (ICTRP)

Untersuchte Intervention
Group 1: Dyscalculics, group 1: receive the support program after a waiting period of 14 to 28 weeks.
- The support program consists of 14 intervention units of one hour as well as exercise material for home over a period of about 14 to 28 weeks
- Participation in four diagnostic appointments: before the waiting period, before the intervention, after the intervention, and 14 to 28 weeks after the intervention
Group 2: Dyscalculics, group 2: receive the support program immediately.
- The support program consists of 14 intervention units of one hour as well as exercise material for home over a period of about 14 to 28 weeks
- Participation in three diagnostic appointments: before the intervention, after the intervention, and 14 to 28 weeks after the intervention
Group 3: Control group without dyscalculia and not participating in the intervention.
- Participation in two diagnostic appointments at intervals of 14 to 28 weeks (ICTRP)

Studientyp
interventional (ICTRP)

Studiendesign
Allocation: Randomized controlled study; Masking: Open (masking not used); Control: No treatment / Standard of care; Assignment: crossover; Study design purpose: treatment (ICTRP)

Ein-/Ausschlusskriterien
Inclusion criteria: - Signed informed consent

Dyscalculia group:
- Diagnosis of dyscalculia
- Time and willingness to participate in the intervention (14 sessions 1 hour)
- A score below 73 points in the Basis-Math 4-8 test

Control group:
- No dyscalculia (ICTRP)

Exclusion criteria: - Neurological disorders
- Contraindication according to MR-safety guidelines of the Center for MR-Research of the University Childrens Hospital Zurich
- Pregnancy
- Medication that might have an impact on neuronal activity (e.g. Ritalin)
- Intellectual disability (IQ < 70)

Primäre und sekundäre Endpunkte
- Improved performance after completing the support program, assessed by means of tests in the field of maths, assessed at all diagnostic appointments as well as at the first and the last intervention unit
- Evaluation of changes in brain activity and structure induced by the support program, assessed by means of magnetic resonance imaging, assessed at all diagnostic appointments (ICTRP)

Evaluation of:
- Neuronal differences between adolescents and adults with dyscalculia and without dyscalculia
- Long term neuronal and behavioural effects of the support program
- Selected learning biography interviews (ICTRP)

Registrierungsdatum
07.12.2023 (ICTRP)

Einschluss des ersten Teilnehmers
24.01.2024 (ICTRP)

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
Caroline Biegel, smile@ife.uzh.ch, +41 44 249 77 08, Universitts-Kinderspital Zrich - Eleonorenstiftung (ICTRP)

Sekundäre IDs
nicht verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
Yescoded data might be used for further analyses to answer additional open research questions if participants have given consent. (ICTRP)

Weitere Informationen zur Studie
http://drks.de/search/en/trial/DRKS00033068 (ICTRP)

Ergebnisse der Studie

Zusammenfassung der Ergebnisse

nicht verfügbar

Link zu den Ergebnissen im Primärregister

nicht verfügbar