ABIabc: Pragmatic Abilities in Children With Acquired Brain Injury

Sponsor
IRCCS Eugenio Medea (Other)
Overall Status
Recruiting
CT.gov ID
NCT04280978
Collaborator
(none)
30
1
38.8
0.8

Study Details

Study Description

Brief Summary

Although neuroplasticity of the brain is high in childhood, some neuropsychological sequelae could persist over the long term in children with Acquired Brain Injury (ABI). Many children with TBI, show deficits in pragmatic abilities that usually persist. Pragmatic difficulties have been observed also in children with sequelae of brain neoplasms .

The lack of validated assessment tools for this population is described in literature. This limit is also valid for the tests that assess pragmatic abilities. The tests that SLPs usually administer investigate only the comprehension of verbal pragmatic and, sometimes the comprehension of linguistic and emotional prosody as well. This could lead to the risk that, sometimes, some pragmatic abilities might not be included in the evaluation. Moreover, it leads to a harder definition of the treatment aims and a harder objective demonstration of treatment outcomes.

For these reasons, it is important to use an assessment tool that provides information on all the pragmatic abilities, not only in input but also in output. Some Italian researchers, recently, developed a test that investigates all these areas. It is called "ABaCo", and it is based on the Cognitive Pragmatics Theory. This theory is focused on cognitive processes underlying human communication.

This test is standardized on a normative group of 300 adults. It was developed with the aim of assessing pragmatic abilities in adults with brain injuries. The assessor shows short videos to the patient, and he/her has to complete or understand the interaction transmitted through different communication channels. The authors also created an adaptation of this test for children aged 5 to 8.6 years old, modifying some items. After that, they administered this adaptation of the test to 390 healthy children. In another study, the authors administered this version of the batteries to children with autism spectrum disorders and to a control group of healthy children, matched by age and sex.

Considering all the studies that already exist for the application of this assessment tool in childhood and adolescence, and the perspective of a standardization for developmental ages, this study aims to investigate whether this test could be useful to detect pragmatic difficulties also in children with ABI.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ABI ABC

Detailed Description

This project involved two different experimental populations: children with Acquired Brain Injury. Moreover, it includes a wider investigation; in fact, it involves the assessment, not only of linguistic and pragmatic abilities but also of neuropsychological abilities and the theory of mind.

Approximately 30 children with Acquired Brain Injury will be involved in the study.

The data will be collected through the administration of the adapted version of ABaCo test, individually, to each subject involved in the study. The assessment will be conducted in the IRCCS Eugenio Medea. The assessor will administer ABaCo test through a computer device and she will marked the responses on a paper sheet. Video recordings are needed only to allow an impartial scoring. In fact, an external trained judge will do the scoring. The researchers will complete the scoring process within two weeks from the acquisition of the recordings, after that they will destroy the videos.

Furthermore the linguistic abilities will be assessed through the administration of some subtests of the Italian battery "BVL 4-12". In particular, the researcher will administer the following subtests: "naming", "lexical comprehension" and "grammatical comprehension".

Moreover, some neuropsychological abilities will be analysed using the test "BVN 5-11". In addition, the theory of mind and the non-verbal IQ will be assessed.

The Socio-Economic-Status of the family involved in the research will also be investigated, considering its importance on the rehabilitation outcomes , using a questionnaire realized, based on the "Four Factor Index of Social Status".

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pragmatic Abilities in Children With Acquired Brain Injury: Assessment and Analysis With the ABaCo Test
Actual Study Start Date :
Apr 6, 2020
Anticipated Primary Completion Date :
Feb 20, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Aquired Brain Injury

Suitable potential participants would be children with ABI, at least 6 months post onset, from 6 to 11 years old, without diagnosis of aphasia, dysarthria, apraxia, and/or sensorial difficulties (visual and hearing), with Italian as a first language.

Diagnostic Test: ABI ABC
The assessor will administer ABaCo test through a computer device and she will marked the responses on a paper sheet. Video recordings are needed only to allow an impartial scoring. In fact, an external trained judge will do the scoring. Furthermore the linguistic abilities will be assessed through the administration of some subtests of the Italian battery "BVL 4-12". In particular, the researcher will administer the following subtests: "naming", "lexical comprehension" and "grammatical comprehension". Moreover, some neuropsychological abilities will be analysed using the test "BVN 5-11". In addition, the theory of mind and the non-verbal IQ will be assessed. The Socio-Economic-Status of the family involved in the research will also be investigated, considering its importance on the rehabilitation outcomes.
Other Names:
  • ABaCo test
  • Outcome Measures

    Primary Outcome Measures

    1. ABaCo [3 years after ABI]

      ABaCo test

    Secondary Outcome Measures

    1. BVL 4-12 [3 years after ABI]

      Italian neuropsychological test "BVL 4-12"

    2. BVN 5-11 [3 years after ABI]

      Italian neuropsychological test "BVN 5-11"

    3. QI [3 years after ABI]

      non-verbal Intelligence Quotient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 11 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • italian

    • 6 to 11 years old

    • at least 6 months after ABI onset

    Exclusion Criteria:
    • diagnosis of aphasia, dysarthria, apraxia, and/or sensorial difficulties (visual and hearing)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IRCCS E. Medea Bosisio Parini Lecco Italy 23842

    Sponsors and Collaborators

    • IRCCS Eugenio Medea

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IRCCS Eugenio Medea
    ClinicalTrials.gov Identifier:
    NCT04280978
    Other Study ID Numbers:
    • 01.2020 Oss.
    First Posted:
    Feb 21, 2020
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 5, 2022