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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05445687
Other study ID # 0201642
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 19, 2022
Est. completion date April 19, 2024

Study information

Verified date July 2023
Source Alexandria University
Contact Sara M Ibrahim, Master
Phone +201222866742
Email s_ibrahim16@alexmed.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The importance of narrative skills is evident in their role in language development and their relation to important academic skills namely reading, comprehension, and writing. Narratives are also essential for competent social skills, and children with delayed language development are usually found to have less proficient social communication skills. Research demonstrates the effects of narrative language intervention on improved narrative structure and complexity in addition to improved receptive and expressive use of syntax, morphology and general language use in children with narrative language impairment in various types of communication disorders. Given the importance of narrative language abilities in language development and due to lack of research targeting the assessment and intervention of narrative language skills of Arabic speaking children with language impairments, this study is dedicated towards the assessment of narrative language in Arabic speaking children and the development of a comprehensive intervention program targeting narrative language skills and its application on children with hearing impairment and developmental language disorder.


Description:

A narrative refers to the ability to produce a fictional or real account of temporally sequenced meaningful occurrences and experiences. Studies have shown that narrative competence increases with age alongside language, cognitive and social skills. Development of narrative abilities starts during the preschool years, expands during the school age years, and continues to develop through adolescence and even adulthood. Children with developmental language disorder (DLD) are known to have impaired narrative skills. Narratives of children with DLD are characterized by incomplete episodes, poor coherence, less expression of cognitive states, less complex sentences with fewer dependent clauses, and less complex morpho-syntax when compared to their peers. Research has also shown that hearing impairment is another communication disorder in which narrative skills are particularly vulnerable. Narratives of children with hearing loss demonstrate comprehension and production deficits and they have a statistically significant lower performance in tests assessing narrative structure. The aim of this work is to develop a narrative language intervention program and to apply it on children with developmental language disorder and children with hearing impairment to detect its efficacy on improving their narrative and language skills. This study will be conducted on 44 children with hearing impairment, and 44 children with developmental language disorder attending the Unit of Phoniatrics, in the outpatient clinic of Alexandria Main University hospital. Sample size was calculated to achieve 80% power with a target significance level at 5% to detect the efficacy of the proposed narrative intervention program in improvement of narrative language skills of Egyptian children with hearing impairment and developmental language disorder. The narrative intervention program will include an introductory section on the elements of story grammar to introduce the children to narratives and give them explicit instructions about the concepts of narrative macrostructure. The program will include 24 illustrated story sequences with a minimum of 5 sequences representing the main story elements: characters and setting; problems; internal response; actions; and consequence. Story icons will be designed to represent the main 5 elements to accompany storytelling and act as visual prompts. Each story will reflect specific content with several target vocabulary words and complex morphosyntax. The following procedure will be implemented with each story: Modeling, answering comprehension questions, retelling with icons and colored illustrations, retelling with icons only, and retelling without icons. All subjects meeting the specified inclusion and exclusion criteria will be assessed by the specified protocol of assessment to evaluate narrative skills, language skills and cognitive abilities before and after intervention. The results of this study will be tabulated and analyzed with the use of appropriate statistical methods and appropriate figures and diagrams.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date April 19, 2024
Est. primary completion date April 19, 2024
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria: 1. Children with developmental language disorder of both sexes in the age group (5 to 12 years). 2. Hearing-impaired children of both sexes with sensorineural hearing loss using auditory verbal communication in the age group (5 to 12) years with a minimum 2 years of experience with their hearing aids or cochlear implants with good benefit (hearing threshold less than 40 dB across all frequencies). 3. Hearing impaired children using hearing aids with pure tone average thresholds at 500, 1000, and 2000 Hz between 50 and 75 dB in unaided conditions. 4. Children with expressive language skills of at least 3 word length sentences. Exclusion Criteria: 1. Children with intellectual disability. 2. Children with neurodevelopmental disorders (example; ASD). 3. Children with additional sensory deprivation (impaired vision).

Study Design


Intervention

Behavioral:
Narrative language intervention program
Narrative language targets improving narrative macrostructure and microstructure. The program will include 24 illustrated story sequences with a minimum of 5 sequences representing the main story elements: characters and setting; problems; internal response; actions; and consequence. Story icons will be designed to represent the main 5 elements to accompany storytelling and act as visual prompts. Each story will reflect specific content with several target vocabulary words and complex morphosyntax. Each story will be followed by comprehension questions to facilitate understanding and answering question about stories. The following procedure will be implemented with each story: Modeling, answering comprehension questions, retelling with icons and colored illustrations, retelling with icons only, and retelling without icons. This procedure is adapted from story champs intervention program
Conventional language intervention
Language rehabilitation targets improving semantics, syntax, pragmatics and phonology.

Locations

Country Name City State
Egypt Alexandria University Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Test on Narrative language- second edition comprehension sub-test The comprehension sub-test of the test of narrative language is a quantitative tol that assesses the ability to answer comprehension questions about 3 stories with a total maximum score of 47. baseline and 3 months
Primary Change in Test on Narrative language- second edition production sub-test The production sub-test of the test of narrative language is a quantitative tool that assesses the ability to tell 3 stories with a total maximum score of 88 baseline and 3 months
Primary Change in Test on Narrative language- second edition narrative language ability index The comprehension and production subtests are combined to form a composite (narrative language ability index). baseline and 3 months
Secondary change in comprehensive Arabic language test scores Quantitative tool that evaluates language skills, raw scores are converted into language age equivalent scores baseline and 3 months
Secondary Change in values of Stanford Binet scale Quantitative tool that evaluates verbal Intelligence, abstract intelligence and short term memory baseline and 3 months
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