Pragmatic Abilities in Children With Acquired Brain Injury (ABIabc)

March 20, 2024 updated by: IRCCS Eugenio Medea

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Acquired Brain Injury

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ABaCo
Time Frame: 3 years after ABI
ABaCo test
3 years after ABI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BVL 4-12
Time Frame: 3 years after ABI
Italian neuropsychological test "BVL 4-12"
3 years after ABI
BVN 5-11
Time Frame: 3 years after ABI
Italian neuropsychological test "BVN 5-11"
3 years after ABI
QI
Time Frame: 3 years after ABI
non-verbal Intelligence Quotient
3 years after ABI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Eugenio Medea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01.2020 Oss.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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