Brief description of trial (Data source: BASEC)
Eine Rechenstörung bzw. eine Dyskalkulie kann für die betroffenen Personen mit grossen Einschränkungen verbunden sein: Schwierigkeiten im Umgang mit grossen Zahlen, Mathematikangst, Stress in der Schule usw. Für Jugendliche und junge Erwachsene mit einer Rechenstörung fehlen Förderangebote. Deshalb bieten wir für diese eine Förderung an und möchten untersuchen, ob und wie fehlende mathematische Grundlagen erfolgreich aufgearbeitet werden können und ob dadurch Prozesse im Gehirn verändert werden.
Health conditions investigated(Data source: BASEC)
Dyskalkulie/Rechenstörung/mathematische Lernstörung
Health conditions
(Data source: WHO)
F81.2;Specific disorder of arithmetical skills;F81.2
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Teilnehmende Personen mit einer Rechenstörung/Dyskalkulie erhalten eine individuell abgestimmte Förderung (14 Termine à eine Stunde). Sie werden zusammen mit einer Fachperson in Einzelsitzungen Lücken im mathematischen Verständnis aufarbeiten. Zudem erhalten sie Übungsmaterialien, die sie zuhause (am Handy, Computer, Tablet) durchführen können. Um die Wirksamkeit der Förderung überprüfen zu können, werden verschiedene Tests und Magnetresonanztomographie-Messungen (MRI) durchgeführt.
Interventions
(Data source: WHO)
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
Criteria for participation in trial
(Data source: BASEC)
- Alter zwischen 14 und 27 Jahren
- Dyskalkulie-Gruppe: Dyskalkulie Diagnose/ Kontrollgruppe: keine Dyskalkulie
- Normale kognitive Entwicklung
Exclusion criteria
(Data source: BASEC)
- Neurologische Störungen
- Kontraindikationen gemäss MRI-Sicherheitskriterien (zum Beispiel Metallteile im Körper, Schwangerschaft etc.)
- Medikation, welche die neuronale Aktivität beeinflusst (zum Beispiel Ritalin)
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: 27 Years
Minimum age: 14 Years
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
Exclusion criteria: - Neurological disorders
- Contraindication according to MR-safety guidelines of the Center for MR-Research of the University Children?s Hospital Zurich
- Pregnancy
- Medication that might have an impact on neuronal activity (e.g. Ritalin)
- Intellectual disability (IQ < 70)
-
Further information on trial
Date trial registered
Dec 7, 2023
Incorporation of the first participant
Jan 24, 2024
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Development and Evaluation of an Intervention for Adolescents and Adults with Dyscalculia - SMILE
Type of trial
(Data source: WHO)
interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized controlled study; Masking: Open (masking not used); Control: No treatment / Standard of care; Assignment: crossover; Study design purpose: treatment
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
- 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
Secundary end point
(Data source: WHO)
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
Contact information
(Data source: WHO)
Palatin Stiftung;URPP Adaptive Brain Circuits in Development and Learning (AdaBD), Universit?t Z?rich;Fondation Dora;Kanton Z?rich Gemeinn?tziger Fonds;UZH Foundation;Universit?ts-Kinderspital Z?rich - Eleonorenstiftung;Institut f?r Erziehungswissenschaft, Universit?t Z?rich;Erika Schwarz Stiftung
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
Yes
coded data might be used for further analyses to answer additional open research questions if participants have given consent.
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Zurich
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Caroline Biegel
+41 76 838 77 08
smile@ife.uzh.ch
Contact for general information
(Data source: WHO)
Caroline
Biegel
Lenggstrasse 30
Universit?ts-Kinderspital Z?rich - Eleonorenstiftung
+41 44 249 77 08
smile@ife.uzh.ch
Contact for scientific information
(Data source: WHO)
Caroline
Biegel
Lenggstrasse 30
Universit?ts-Kinderspital Z?rich - Eleonorenstiftung
+41 44 249 77 08
smile@ife.uzh.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
14.11.2023
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2023-01592
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