Transdiagnostic Dimensional Profiling of Neurodevelopmental Disorders

NCT07544199 | Not Yet Recruiting

• 2 other identifiers: 316-255*1000
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

In recent years, the growing awareness of the multifactorial nature of neurodevelopmental disorders has stimulated interest in transdiagnostic approaches aimed at investigating underlying etiological mechanisms beyond traditional diagnostic categories. In this context, the present study seeks to provide a transdiagnostic profiling of both domain-general cognitive functions (attention, working memory, executive control) and domain-specific functions (phonological awareness, rapid naming, vocabulary, reading) underlying the main neurodevelopmental disorders in a large sample of preschool and school-age children (3-11 years), through the use of CRAB (Computerized Reading-related Assessment Battery). CRAB is a digital platform specifically developed by SUPSI and the Université de Genève to integrate, within a single testing environment, the assessment of the main domain-general and domain-specific cognitive functions underlying neurodevelopmental disorders. In particular, participating families will receive an email containing a link to access the CRAB platform, which will not include their personal data but rather a code provided by the staff of IRCCS Medea. A screen will open displaying several game-like tasks designed to measure both domain-general and domain-specific cognitive functions, which must be completed by the participating subject. The main objective is to obtain a fine-grained and multidimensional mapping of cognitive profiles prior to the standard diagnostic process, in order to identify early patterns of (a)typical or at-risk functioning.

Conditions

Neurodevelopmental Disorder (Diagnosis)

Keywords

NDD, CRAB, transdiagnostical profiles, prospective study

Outcome Measures

Primary Outcomes (8)

• READING DECODING

  the ability to read single words (pseudowords) fluently and accurately as ad hoc developed within CRAB;

  6 months

• RECEPTIVE VOCABULARY

  the ability to select the picture that corresponds to a verbally presented target word (accuracy) as ad hoc developed within CRAB

  6 MONTHS

• PHONEME DELETION

  the ability to repeat a (pseudo)word after cutting its first phoneme (accuracy) as ad hoc developed within CRAB

  6 MONTHS

• VISUAL ORTHOGRAPHIC

  the ability to visually process both orthographic (letter-based) and non-orthographic (symbol-based) stimuli (accuracy) as ad hoc developed within CRAB

  6 MONTHS

• Rapid Automatized Naming (RAN) - Color

  the ability to access lexical information from visual targets (time and accuracy) as ad hoc developed within CRAB;

  6 MONTHS

• BARRAGE

  visuo-spatial attention and search strategies by asking children to identify targets among distractors (accuracy) as ad hoc developed within CRAB

  6 MONTHS

• CORSI

  visuo-spatial working memory by asking children to recall sequences of illuminated bloks in a 3D space (accuracy) as ad hoc developed within CRAB

  6 MONTHS

• Multiple Objects Tracking - MOT

  sustained attention and working memory updating by asking children to follow moving target among distractors (accuracy) as ad hoc developed within CRAB.

  6 MONTHS

Secondary Outcomes (1)

• identification of transdiagnostic cognitive clusters

  6 months

Study Arms (1)

NDD

Subjects with a diagnosis of neurodevelopmental disorder.

Diagnostic Test: Neuropsychological assessment

Interventions

Neuropsychological assessment DIAGNOSTIC_TEST

CRAB (Computerized Reading-related Assessment Battery). CRAB is a digital platform specifically developed by SUPSI and the Université de Genève to integrate, within a single testing environment, the assessment of the main domain-general and domain-specific cognitive functions underlying neurodevelopmental disorders

NDD

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children referred for the first time to the Territorial Unit of Child and Adolescent Neuropsychiatry (NPIA) at IRCCS Eugenio Medea - Associazione "La Nostra Famiglia", Bosisio Parini (LC), for suspected neurodevelopmental or psychopathological disorders. The project will be proposed to all children aged 3 to 11 years (from the first year of preschool to the fifth year of primary school). This is a heterogeneous population reflecting the variety of profiles typically seen in neuropsychiatric services, including suspected neurodevelopmental disorders (e.g., reading disorders, ADHD, language disorders, developmental coordination disorder), learning difficulties, or other clinical concerns. The study does not involve interventions or group allocation, but only a single digital data collection via CRAB prior to the standard diagnostic process.

You may qualify if:

• Age between 3 and 11 years;
• First access to the NPIA service at IRCCS Eugenio Medea (Bosisio Parini);
• Suspected neurodevelopmental or psychopathological disorder;
• Completion of the standard clinical diagnostic pathway;
• Availability of a compatible device (tablet or computer) for remote administration, if applicable.

You may not qualify if:

• Age outside the specified range;
• Failure to complete the diagnostic pathway;
• Lack of access to a compatible device (for remote administration);
• Severe sensory impairments (uncorrected blindness or deafness);
• Motor impairments preventing use of digital devices;
• Significant lack of understanding of the Italian language affecting task comprehension.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Scuola Universitaria Professionale della Svizzera Italiana (SUPSI): collaborator
• University of Geneva, Switzerland: collaborator

Related Publications (7)

• Pennington BF. From single to multiple deficit models of developmental disorders. Cognition. 2006 Sep;101(2):385-413. doi: 10.1016/j.cognition.2006.04.008. Epub 2006 Jul 17.

  PMID: 16844106 BACKGROUND

• Parsons T, Duffield T. Paradigm Shift Toward Digital Neuropsychology and High-Dimensional Neuropsychological Assessments: Review. J Med Internet Res. 2020 Dec 16;22(12):e23777. doi: 10.2196/23777.

  PMID: 33325829 BACKGROUND

• Morris SE, Sanislow CA, Pacheco J, Vaidyanathan U, Gordon JA, Cuthbert BN. Revisiting the seven pillars of RDoC. BMC Med. 2022 Jun 30;20(1):220. doi: 10.1186/s12916-022-02414-0.

  PMID: 35768815 BACKGROUND

• Lumsden J, Edwards EA, Lawrence NS, Coyle D, Munafo MR. Gamification of Cognitive Assessment and Cognitive Training: A Systematic Review of Applications and Efficacy. JMIR Serious Games. 2016 Jul 15;4(2):e11. doi: 10.2196/games.5888.

  PMID: 27421244 BACKGROUND

• Germine L, Reinecke K, Chaytor NS. Digital neuropsychology: Challenges and opportunities at the intersection of science and software. Clin Neuropsychol. 2019 Feb;33(2):271-286. doi: 10.1080/13854046.2018.1535662. Epub 2019 Jan 6.

  PMID: 30614374 BACKGROUND

• Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.

  PMID: 23020641 BACKGROUND

• Astle DE, Fletcher-Watson S. Beyond the Core-Deficit Hypothesis in Developmental Disorders. Curr Dir Psychol Sci. 2020 Oct;29(5):431-437. doi: 10.1177/0963721420925518. Epub 2020 Jul 15.

  PMID: 33071483 BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders; Disease

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sara Mascheretti, PhD

CONTACT

+39031877985; sara.mascheretti@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): January 30, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share