Hearing Impaired ChildrenNCT05445687
Rehabilitation of Narrative Language in Children With Hearing Impairment and Developmental Language Disorder
A study testing Narrative language intervention program and Conventional language intervention in people with Hearing Impaired Children and Developmental Language Disorder, run by Alexandria University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Hearing Impaired Children, Developmental Language Disorder
- What is being tested?
- Narrative language intervention program and Conventional language intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Apr 2022to 19 May 2024
- Phase
- Interventional
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children with intellectual disability.
- Children with neurodevelopmental disorders (example; ASD).
- Children with additional sensory deprivation (impaired vision).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment and Rehabilitation of Narrative Language in Children With Hearing Impairment and Developmental Language Disorder
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.
Read the 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.
- Being tested
- Narrative language intervention program, Conventional language intervention
- Keywords
- Hearing impairment, Developmental language disorder, Narrative language, Language rehabilitation
- Medical subject headings
- Language Development Disorders, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative language intervention programBehavioural
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 interventionBehavioural
Language rehabilitation targets improving semantics, syntax, pragmatics and phonology.
| Study group | Role | What they receive |
|---|---|---|
| Hearing Impairment cases | Experimental | 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. Receives: Behavioral: Narrative language intervention program |
| Hearing Impairment control | Active comparator | 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. Receives: Behavioral: Conventional language intervention |
| Developmental language disorder cases | Experimental | 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. Receives: Behavioral: Narrative language intervention program |
| Developmental language disorder control | Active comparator | 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. Receives: Behavioral: Conventional language intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3 months
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
Measured: baseline and 3 months
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).
Measured: baseline and 3 months
Secondary outcomes (2)
change in comprehensive Arabic language test scores
Quantitative tool that evaluates language skills, raw scores are converted into language age equivalent scores
Measured: baseline and 3 months
Change in values of Stanford Binet scale
Quantitative tool that evaluates verbal Intelligence, abstract intelligence and short term memory
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start19 Apr 2022
- Primary completion19 May 2024
- Study completion19 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Impaired ChildrenStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Magdy Ibrahim, Alexandria University
- Investigators
- Sara M Ibrahim, Master, Principal investigator, Alexandria UniversityOssama A Sobhy, PhD, Study chair, Alexandria UniversityRiham M ElMaghraby, PhD, Study chair, Alexandria UniversityNesrine H Hammouda, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445687
- Sponsor's protocol ID
- 0201642
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2022
- Last updated
- 30 Jul 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Rehabilitation of Narrative Language in Children With Hearing Impairment and Developmental Language Disorder
- ClinicalTrials.gov ID
- NCT05445687
- Acronym / sponsor ID
- 0201642
- Keywords
- Hearing impairment, Developmental language disorder, Narrative language, Language rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 19 May 2024 (actual)
- Study completion
- 19 May 2024 (actual)
- First posted
- 6 Jul 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hearing Impairment cases | Experimental | Behavioral: Narrative language intervention programHearing 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. |
| Hearing Impairment control | Active comparator | Behavioral: Conventional language interventionThe 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. |
| Developmental language disorder cases | Experimental | Behavioral: Narrative language intervention programDevelopmental 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. |
| Developmental language disorder control | Active comparator | Behavioral: Conventional language interventionThe 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Children with intellectual disability.
- Children with neurodevelopmental disorders (example; ASD).
- Children with additional sensory deprivation (impaired vision).
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 |
|---|---|---|
| Narrative language intervention programNarrative 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 | Behavioural | Developmental language disorder cases, Hearing Impairment cases |
| Conventional language interventionLanguage rehabilitation targets improving semantics, syntax, pragmatics and phonology. | Behavioural | Developmental language disorder control, Hearing Impairment control |
Primary outcome
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.
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
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).
2 secondary outcomes
change in comprehensive Arabic language test scores
Time frame: baseline and 3 months
Change in values of Stanford Binet scale
Time frame: baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 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.
Sara M Ibrahim, Master principal investigator
Alexandria University
Ossama A Sobhy, PhD study chair
Alexandria University
Riham M ElMaghraby, PhD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative language intervention program and Conventional language intervention in people with Hearing Impaired Children and Developmental Language Disorder, run by Alexandria University at 1 site in Egypt.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jul 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Test on Narrative language- second edition comprehension sub-test (time frame: baseline and 3 months). The study lists 3 primary outcomes in all. 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 30 Jul 2024.