ClinicalTrials.gg
CompletedNCT05803278Updated Apr 7, 2023

Online Screening and Empowerment Program for Children With SLD

An interventional study of Online enhancement training in Learning Disorder, sponsored by IRCCS Burlo Garofolo. Completed at 1 site in Italy. Open to participants aged 7 Years to 8 Years. Per ClinicalTrials.gov, last updated 2023-04-07.

Primary conditionSpecific Learning DisorderRegistry: Learning DisabilitiesReclassifiedWhy we changed it
Registry
Learning Disabilities — the first condition term the registry derived for this study.
ClinicalTrials.gg
Specific Learning Disorder
Why
  1. The study's title name Specific Learning Disorder, a narrower term within Learning Disabilities.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by IRCCS Burlo Garofolo · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Feb 2021, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
1,548
Allocation
Not applicable
Ages
7 Years to 8 Years
Sex
All
01

Study summary

One of the problems faced by health services that deals with the diagnosis and treatment of Specific Learning Disorders (SLD), like Dyslexia, Dysgraphia, Dysorthography and Dyscalculia, is the long waiting lists for first visits to possible confirm the diagnosis. One of the reasons explaining the long waiting times is that the school refers a large number of children to the hospital services who do not actually have SLD but a simple school difficulty. These two are very different conditions:

  • SLD is a neurobiological and genetic-based disorder that, with various degrees of severity, lasts a lifetime. Epidemiological data of the FVG region report a prevalence of dyslexia of 3.1%. Therefore, a prevalence of SLD between 4 and 5% can be assumed. This is a condition whose expressiveness cannot be modified by an enhancement intervention;
  • The school difficulties are not innate and are characterized by an initial slowdown in bed-writing learning. The prevalence of low-performance school difficulties is between 10 and 15%. This type of problem improves significantly following specific enhancement.

Resistance to enhancement intervention is precisely one of the criteria that is still used to distinguish a school difficulty from a SLD: students with SLD would be those who show resistance to specific educational interventions. This criterion is based on the assumption that SLD has a precise neurofunctional basis in contrast to school difficulties. These are a transitional condition, which can be modified by didactic adaptations and enhancement activities (Law 170/2010; regional resolution 933/2014 FVG).

The application of enhancement tools in the school environment would therefore make it possible to distinguish, on the basis of the response, subjects with simple school difficulties from those with suspected SLD and, therefore, to report just those one, to the health services for diagnostic confirmation, contributing to the reduction of the workload of the hospital services and the reduction of waiting lists. These results are very important for children with SLD who could be identified and treated in an early and timely manner. The aim of this project is to apply an online screening and further school enhancement process using the "InTempo software" to distinguish children with SLD from those with school difficulties, thus also obtaining data on the real incidence of SLD and school difficulties in The Friuli Venezia Giulia Region.

02

Conditions studied

  • Learning Disorder

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Keywords

  • Specific Learning Disorders
  • Screening
  • Online enhancement
03

In context

Specific Learning Disorder Reclassified

24 studies on the registry are indexed under Specific Learning Disorder; 4 are open to participants now.

This study's enrollment of 1,548 is above the median of 153 across 16 interventional studies indexed under Specific Learning Disorder.

Browse Specific Learning Disorder studies →

Lead sponsor

IRCCS Burlo Garofolo is the lead sponsor of 89 studies on the registry; 32 are open to participants now.

Compared within Specific Learning Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Learning Disabilities. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
7 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children attending the second year of the primary school (about 7-8 years of age)

Exclusion criteria

Exclusion Criteria:

  • Presence of biological problems associated to school difficulties
  • Low cognitive level
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,548 participants (actual)

Study arms

  • Experimental
    Children positive to screening test

    Children positive to the online test "InTempo", which includes standardized and scientifically validated tests in the following areas: Metaphonology, Reading and Writing

    Other: Online enhancement training

Interventions

  • OtherOnline enhancement training

    Online enhancement training lasting 3 months, using the "InTempo" app system (Gea-Metaphonology-Athena-reading/Ermes-writing) three times a week for twenty minutes. The training will include: Metaphonological Enhancement; Reading Enhancement; Writing Enhancement.

06

What researchers measure

Primary outcomes

  1. Prevalence of SLD

    The first screening test and the subsequent enhancement training for positive will be carried out on-line in school children aged 7-8 years. Children without improvement after enhancement training (second screening test) will be considered positive (presence of SLD) and sent to the health services for a specific diagnostic evaluation.

    Time frame: 6 months

Secondary outcomes

  1. To evaluate the prevalence of school difficulties

    Defined by positivity at the first screening test and by negativity at the second, carried out after the enhancement intervention

    Time frame: 6 months

  2. To compare the Strengths and Difficulties Questionnaire scores recorded during the study

    The Strengths and Difficulties Questionnaire (italian version) will be administered to parents of the children involved in the study pre and post intervention to evaluate emotional and behavioural characteristics of the children and to assess how they change during the enhancement process.

    Time frame: 6 months

07

Study locations

1 site
  • IRCCS Burlo Garofolo
    Trieste, 34137, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05803278
Lead sponsor
IRCCS Burlo Garofolo
Responsible party
Sponsor
First posted
Apr 7, 2023
Start date
Feb 9, 2021
Primary completion
Dec 16, 2022
Completion
Dec 16, 2022
Last update
Apr 7, 2023

Study contacts

Isabella Lonciari, MSC
study director · IRCCS materno infantile Burlo Garofolo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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