Clinical trial NCT05445687: Rehabilitation of Narrative Language in Children With Hearing Impairment and Developmental Language Disorder
Official title: Assessment and Rehabilitation of Narrative Language in Children With Hearing Impairment and Developmental Language Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impaired Children
Developmental Language Disorder
Keywords: Hearing impairment
Developmental language disorder
Narrative language
Language rehabilitation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 88
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A comparative intervention study comparing the effect of narrative language intervention on narrative language skills in children with hearing impairment and children with developmental language disorder in comparison to conventional language intervention.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Test on Narrative language- second edition comprehension sub-test
timeFrame: baseline and 3 months
measure: Change in Test on Narrative language- second edition production sub-test
timeFrame: baseline and 3 months
measure: Change in Test on Narrative language- second edition narrative language ability index
timeFrame: baseline and 3 months
Secondary outcomes:
measure: change in comprehensive Arabic language test scores
timeFrame: baseline and 3 months
measure: Change in values of Stanford Binet scale
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Alexandria University
name: Sara M Ibrahim, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Ossama A Sobhy, PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Riham M ElMaghraby, PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Nesrine H Hammouda, PhD
role: STUDY_DIRECTOR
References: