NCT07786545

Brief Summary

This study will pilot a newly developed Syntactic-Semantic Visual Configuration Intervention (SSVCI) designed to help Urdu-speaking children with language impairment improve their ability to understand and produce phrases and sentences. The intervention was developed through extensive literature review, expert recommendations, and the structure of the Urdu language to ensure that it is appropriate for children in Pakistan. Before pilot testing, experts in speech-language pathology and Urdu linguist according to the inclusion criteria reviewed the intervention material to evaluate whether the activities are relevant, culturally appropriate, and representative of the language skills being taught. Feedback from children and caregivers was also be used to in the first phase of need assessment, before the intervention material was finalized. The pilot study will include 20 children aged 6 to 12 years, including 10 children with language impairment and 10 children with typical language development. Participants will be recruited from selected schools, hospitals, and special education centers in Islamabad. Children with language impairment conditions , with primary diagnosis of autism spectrum disorder, hearing impairment, cerebral palsy, or Down syndrome, provided they meet the study eligibility criteria will be included. Participants will complete language assessments before taking part in the intervention activities. These assessments will measure language skills such as sentence formation, understanding of spoken language, and narrative abilities. Information collected during the pilot study will help researchers determine whether the intervention materials are clear, practical, culturally appropriate, and suitable for use in a larger clinical trial. Findings from this study will also be used to refine the intervention by identifying activities or items that require modification or removal before final implementation.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 27, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2026

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

22 days

First QC Date

July 27, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Urdu Language interventionSyntactic-Semantic Visual Configuration Intervention (SSVCI)

Outcome Measures

Primary Outcomes (2)

  • Outcome 1: Change in Narrative Performance (MAIN)

    Description: Narrative language performance will be assessed using the Urdu version of the Multilingual Assessment Instrument for Narratives (MAIN). At baseline and post-intervention, each participant will be presented with a standardized six-picture narrative sequence and will be asked to produce the corresponding story. Narrative production will be scored according to the standardized MAIN Urdu scoring criteria, including story structure and structural complexity. Narrative comprehension will be assessed using the standardized MAIN comprehension questions administered following the narrative task. For each participant, the MAIN narrative production score and narrative comprehension score will be calculated according to the instrument's predefined scoring criteria. Higher scores indicate better narrative production and/or comprehension performance. The outcome will be evaluated as the change in MAIN scores from baseline to immediately after completion of the intervention.

    Baseline and immediately after completion of the 16 intervention sessions (approximately 8 weeks).

  • Outcome Measure 2 Title: Change in Mean Length of Utterance in Words Derived from the Narrative Language Sam

    Description Description: Mean Length of Utterance in words (MLU-w) will be calculated from each participant's recorded narrative language sample obtained during the story-production task at baseline and after completion of the intervention. The participant's narrative will be audio-recorded and transcribed verbatim. The transcript will be segmented into utterances using predefined language-sample segmentation rules. MLU-w will be calculated as: MLU-w = Total number of words produced ÷ Total number of utterances A separate MLU-w value will be calculated for each participant at baseline and post-intervention. The outcome will be the change in MLU-w from baseline to post-intervention, with a higher MLU-w indicating production of longer utterances and greater expressive syntactic complexity.

    Baseline and immediately after completion of the 16 intervention sessions (approximately 8 weeks).

Study Arms (1)

Experimental: Syntactic-Semantic Visual Configuration Intervention (SSVCI)

EXPERIMENTAL

Participants will receive the Syntactic-Semantic Visual Configuration Intervention (SSVCI), a structured, visually supported Urdu language intervention designed to improve syntactic and semantic language skills in children with language impairment. The intervention consists of 16 individual therapy sessions delivered by a qualified speech-language pathologist, two to three times per week, with each session lasting approximately 30 minutes. The intervention progresses from foundational language concepts to early grammatical structures using visual configuration cues and structured language activities.

Behavioral: Syntactic-Semantic Visual Configuration Intervention (SSVCI)

Interventions

The Syntactic-Semantic Visual Configuration Intervention (SSVCI) is a structured, therapist-delivered language intervention developed specifically for Urdu-speaking children with language impairment. The intervention integrates syntactic and semantic language instruction with a visual configuration system that uses standardized visual cues to facilitate language comprehension and expressive language production. Therapy progresses systematically from foundational language concepts to early grammatical structures, including question forms, descriptive language, location concepts, negation, and plural forms. The intervention is culturally and linguistically tailored to Urdu and is delivered individually by a qualified speech-language pathologist in sixteen 30-minute sessions conducted two to three times per week.

Experimental: Syntactic-Semantic Visual Configuration Intervention (SSVCI)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Both genders will be included
  • Children of age range 6-12 years.
  • Children whose primary Language is Urdu.
  • Children who have the concept of noun, verbs, adjectives and prepositional concepts.
  • Children who are unable to join them to form phrases and sentences.
  • Diagnosed cases of ASD, hearing impairments, Cerebral Palsy and Down syndrome.

You may not qualify if:

  • Children with any co morbid conditions.
  • Children with Behavioral issues.
  • Children with attention deficit hyper activity.
  • Hearing impaired children not using amplifying and assistive devices.
  • Children with impaired vision.
  • Children not able to perform on ICW level 1 and blank level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Development Center

Rawalpindi, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Language DisordersAutistic DisorderDown Syndrome

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAutism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersIntellectual DisabilityAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Humaira Shamim Kiyani, Phd

    Riphah International University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-group, quasi-experimental pilot study using a pretest-posttest design. All participants will receive the Syntactic-Semantic Visual Configuration Intervention (SSVCI). No control group or random allocation will be used during this pilot phase. Participants' language performance will be assessed before and after the intervention to evaluate feasibility, acceptability, and preliminary changes in syntactic and semantic language skills.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2026

First Posted

August 26, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 23, 2026

Study Completion (Estimated)

September 23, 2026

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study involves a small sample of children, and sharing individual-level data may increase the risk of participant identification. Results will be reported in aggregate form to protect participant confidentiality and privacy. There are no current plans to share individual participant data. Study findings will be published in aggregate form, and participant confidentiality will be maintained in accordance with institutional ethics requirements.

Locations