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Rehabilitation of Narrative Language in Children With Hearing Impairment and Developmental Language Disorder

Primary Purpose

Hearing Impaired Children, Developmental Language Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Narrative language intervention program
Conventional language intervention
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Impaired Children focused on measuring Hearing impairment, Developmental language disorder, Narrative language, Language rehabilitation

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Alexandria UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Hearing Impairment cases

Hearing Impairment control

Developmental language disorder cases

Developmental language disorder control

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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
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).

Secondary Outcome Measures

change in comprehensive Arabic language test scores
Quantitative tool that evaluates language skills, raw scores are converted into language age equivalent scores
Change in values of Stanford Binet scale
Quantitative tool that evaluates verbal Intelligence, abstract intelligence and short term memory

Full Information

First Posted
June 30, 2022
Last Updated
July 18, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05445687
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
April 19, 2024 (Anticipated)
Study Completion Date
April 19, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impaired Children, Developmental Language Disorder
Keywords
Hearing impairment, Developmental language disorder, Narrative language, Language rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
The participants and the outcome assessors will be blinded to the type of intervention given.
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hearing Impairment cases
Arm Type
Experimental
Arm Description
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.
Arm Title
Hearing Impairment control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Developmental language disorder cases
Arm Type
Experimental
Arm Description
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.
Arm Title
Developmental language disorder control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Narrative language intervention program
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Conventional language intervention
Intervention Description
Language rehabilitation targets improving semantics, syntax, pragmatics and phonology.
Primary Outcome Measure Information:
Title
Change in Test on Narrative language- second edition comprehension sub-test
Description
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.
Time Frame
baseline and 3 months
Title
Change in Test on Narrative language- second edition production sub-test
Description
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
Time Frame
baseline and 3 months
Title
Change in Test on Narrative language- second edition narrative language ability index
Description
The comprehension and production subtests are combined to form a composite (narrative language ability index).
Time Frame
baseline and 3 months
Secondary Outcome Measure Information:
Title
change in comprehensive Arabic language test scores
Description
Quantitative tool that evaluates language skills, raw scores are converted into language age equivalent scores
Time Frame
baseline and 3 months
Title
Change in values of Stanford Binet scale
Description
Quantitative tool that evaluates verbal Intelligence, abstract intelligence and short term memory
Time Frame
baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara M Ibrahim, Master
Phone
+201222866742
Email
s_ibrahim16@alexmed.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Nesrine H Hammouda, PhD
Phone
+201222362880
Email
nesrinehazem@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara M Ibrahim, Master
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ossama A Sobhy, PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Riham M ElMaghraby, PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nesrine H Hammouda, PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Alexandria University
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara M Ibrahim, Master
Phone
+201222866742
Email
s_ibrahim16@alexmed.edu.eg
First Name & Middle Initial & Last Name & Degree
Ossama A Sobhy, Phd
Phone
+20122402475
Email
o.sobhy@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Rehabilitation of Narrative Language in Children With Hearing Impairment and Developmental Language Disorder

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