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Online Screening and Empowerment Program for Children With SLD

Primary Purpose

Learning Disorder

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Online enhancement training
Sponsored by
IRCCS Burlo Garofolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Learning Disorder focused on measuring Specific Learning Disorders, Screening, Online enhancement

Eligibility Criteria

7 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children attending the second year of the primary school (about 7-8 years of age) Exclusion Criteria: Presence of biological problems associated to school difficulties Low cognitive level

Sites / Locations

  • IRCCS Burlo Garofolo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children positive to screening test

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
March 24, 2023
Last Updated
April 6, 2023
Sponsor
IRCCS Burlo Garofolo
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1. Study Identification

Unique Protocol Identification Number
NCT05803278
Brief Title
Online Screening and Empowerment Program for Children With SLD
Official Title
Application of an Online Screening and Empowerment Program Carried Out at Schools to Identify Children With Specific Learning Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Burlo Garofolo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Learning Disorder
Keywords
Specific Learning Disorders, Screening, Online enhancement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1548 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children positive to screening test
Arm Type
Experimental
Arm Description
Children positive to the online test "InTempo", which includes standardized and scientifically validated tests in the following areas: Metaphonology, Reading and Writing
Intervention Type
Other
Intervention Name(s)
Online enhancement training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of SLD
Description
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 Outcome Measure Information:
Title
To evaluate the prevalence of school difficulties
Description
Defined by positivity at the first screening test and by negativity at the second, carried out after the enhancement intervention
Time Frame
6 months
Title
To compare the Strengths and Difficulties Questionnaire scores recorded during the study
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children attending the second year of the primary school (about 7-8 years of age) Exclusion Criteria: Presence of biological problems associated to school difficulties Low cognitive level
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Lonciari, MSC
Organizational Affiliation
IRCCS materno infantile Burlo Garofolo
Official's Role
Study Director
Facility Information:
Facility Name
IRCCS Burlo Garofolo
City
Trieste
ZIP/Postal Code
34137
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Online Screening and Empowerment Program for Children With SLD

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