- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05445687
Rehabilitation of Narrative Language in Children With Hearing Impairment and Developmental Language Disorder
Assessment and Rehabilitation of Narrative Language in Children With Hearing Impairment and Developmental Language Disorder
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Alexandria, Egypt, 21131
- Alexandria University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children with developmental language disorder of both sexes in the age group (5 to 12 years).
- 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).
- 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.
- Children with expressive language skills of at least 3 word length sentences.
Exclusion Criteria:
- Children with intellectual disability.
- Children with neurodevelopmental disorders (example; ASD).
- Children with additional sensory deprivation (impaired vision).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hearing Impairment cases
Hearing impaired children who will receive the proposed narrative intervention program. 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.The narrative intervention program will be applied on the cases groups by a phoniatrician in 24 sessions, 60 minutes in duration, one session per week, for 3 months. |
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 |
|
Active Comparator: Hearing Impairment control
The Hearing impairment control group will receive the conventional language rehabilitation sessions in 30 minute sessions twice a week, for 3 months.
Conventional language therapy targets semantics, syntax, prosody, pragmatics, and phonology.
|
Language rehabilitation targets improving semantics, syntax, pragmatics and phonology.
|
|
Experimental: Developmental language disorder cases
Developmental language disorder children who will receive the proposed narrative intervention program.
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.The narrative intervention program will be applied on the cases groups by a phoniatrician in 24 sessions, 60 minutes in duration, one session per week, for 3 months.
|
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 |
|
Active Comparator: Developmental language disorder control
The developmental language disorder control group will receive the conventional language rehabilitation sessions in 30 minute sessions twice a week, for 3 months.
Conventional language therapy targets semantics, syntax, prosody, pragmatics, and phonology.
|
Language rehabilitation targets improving semantics, syntax, pragmatics and phonology.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Test on Narrative language- second edition comprehension sub-test
Time Frame: baseline and 3 months
|
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
|
|
Change in Test on Narrative language- second edition production sub-test
Time Frame: baseline and 3 months
|
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
|
|
Change in Test on Narrative language- second edition narrative language ability index
Time Frame: baseline and 3 months
|
The comprehension and production subtests are combined to form a composite (narrative language ability index).
|
baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in comprehensive Arabic language test scores
Time Frame: baseline and 3 months
|
Quantitative tool that evaluates language skills, raw scores are converted into language age equivalent scores
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baseline and 3 months
|
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Change in values of Stanford Binet scale
Time Frame: baseline and 3 months
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Quantitative tool that evaluates verbal Intelligence, abstract intelligence and short term memory
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baseline and 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara M Ibrahim, Master, Alexandria University
- Study Chair: Ossama A Sobhy, PhD, Alexandria University
- Study Chair: Riham M ElMaghraby, PhD, Alexandria University
- Study Director: Nesrine H Hammouda, PhD, Alexandria University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0201642
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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