NCT05445687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

June 30, 2022

Last Update Submit

July 29, 2024

Conditions

Keywords

Hearing impairmentDevelopmental language disorderNarrative languageLanguage rehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • change in comprehensive Arabic language test scores

    baseline and 3 months

  • Change in values of Stanford Binet scale

    baseline and 3 months

Study Arms (4)

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.

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.

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.

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.

Behavioral: Conventional language intervention

Interventions

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

Developmental language disorder casesHearing Impairment cases

Language rehabilitation targets improving semantics, syntax, pragmatics and phonology.

Developmental language disorder controlHearing Impairment control

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Children with intellectual disability.
  • Children with neurodevelopmental disorders (example; ASD).
  • Children with additional sensory deprivation (impaired vision).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, 21131, Egypt

Location

MeSH Terms

Conditions

Language Development DisordersHearing Loss

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation Disorders

Study Officials

  • Sara M Ibrahim, Master

    Alexandria University

    PRINCIPAL INVESTIGATOR
  • Ossama A Sobhy, PhD

    Alexandria University

    STUDY CHAIR
  • Riham M ElMaghraby, PhD

    Alexandria University

    STUDY CHAIR
  • Nesrine H Hammouda, PhD

    Alexandria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participants and the outcome assessors will be blinded to the type of intervention given.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Phoniatrics

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 6, 2022

Study Start

April 19, 2022

Primary Completion

May 19, 2024

Study Completion

May 19, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations