Acquired Brain InjuryABIabcNCT04280978
Pragmatic Abilities in Children With Acquired Brain Injury
An observational study of Acquired Brain Injury and Pragmatic Communication Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Acquired Brain Injury, Pragmatic Communication Disorder
- What is being tested?
- ABI ABC
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 6 Apr 2020to 30 Dec 2024
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Child
Study population: Acquired Brain Injury
Who may be able to join
- italian
- 6 to 11 years old
- at least 6 months after ABI onset
Who cannot join
- diagnosis of aphasia, dysarthria, apraxia, and/or sensorial difficulties (visual and hearing)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS E. Medea
Bosisio Parini, Lecco, 23842
Sandra Strazzer, MD, 031877111 ext. +39, Sandra.Strazzer@lanostrafamiglia.it
About this study
Official title: Pragmatic Abilities in Children With Acquired Brain Injury: Assessment and Analysis With the ABaCo Test
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.
Read more
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.
Read the 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".
- Being tested
- ABI ABC
- Medical subject headings
- Brain Injuries, Social Communication Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI ABCDiagnostic test
Also called ABaCo test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ABI ABC |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABaCo
ABaCo test
Measured: 3 years after ABI
Secondary outcomes (3)
BVL 4-12
Italian neuropsychological test "BVL 4-12"
Measured: 3 years after ABI
BVN 5-11
Italian neuropsychological test "BVN 5-11"
Measured: 3 years after ABI
QI
non-verbal Intelligence Quotient
Measured: 3 years after ABI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start6 Apr 2020
- Primary completion20 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280978
- Sponsor's protocol ID
- 01.2020 Oss.
- Acronym
- ABIabc
- Status last verified
- Mar 2024
- First submitted
- 18 Feb 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Abilities in Children With Acquired Brain Injury: Assessment and Analysis With the ABaCo Test
- ClinicalTrials.gov ID
- NCT04280978
- Acronym / sponsor ID
- ABIabc / 01.2020 Oss.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquired Brain Injury | – | Diagnostic Test: ABI ABCSuitable 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Age groups
- Child
- Study population
- Acquired Brain Injury
Key inclusion criteria (3 listed)
- italian
- 6 to 11 years old
- at least 6 months after ABI onset
Key exclusion criteria (1 listed)
- diagnosis of aphasia, dysarthria, apraxia, and/or sensorial difficulties (visual and hearing)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI ABCAlso: ABaCo testThe 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. | Diagnostic test | Aquired Brain Injury |
Primary outcome
ABaCo
Time frame: 3 years after ABI
ABaCo test
3 secondary outcomes
BVL 4-12
Time frame: 3 years after ABI
BVN 5-11
Time frame: 3 years after ABI
QI
Time frame: 3 years after ABI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Brain Injury and Pragmatic Communication Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Strazzer, MD (031877854 ext. +39, sandra.strazzer@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABaCo (time frame: 3 years after ABI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.