ClinicalTrials.gg
CompletedNCT07786545Updated Nov 5, 2026

Pilot Evaluation of the Developed Syntactic-Semantic Visual Configuration Intervention for Children With Language Impairment

An interventional study of Syntactic-Semantic Visual Configuration Intervention (SSVCI) in Language Impairment, Autism and Hearing Impaired Children, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Updated Nov 5, 2026Now CompletedStart date moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the detailed description

Language impairment affects a child's ability to understand and use spoken language, particularly the development of phrases and sentences. Urdu-speaking children with conditions like autism, hearing impairment , down syndrome and cerebral palsy , often experience difficulties with syntactic and semantic language skills; however, there is currently no standardized, culturally appropriate intervention developed specifically for the Urdu language. The Syntactic-Semantic Visual Configuration Intervention (SSVCI) was developed to address this gap by providing a structured, visually supported language intervention based on the linguistic characteristics of Urdu.

The intervention was developed through a systematic review of evidence and literature on language intervention approaches, followed by the identification of foundational syntactic and semantic domains relevant to Urdu-speaking children. Intervention materials were designed , with reference to different domains using visual configuration cues to facilitate language comprehension and expression. Before pilot implementation, the content underwent expert review to evaluate its relevance, representativeness, technical quality, and cultural appropriateness. Feedback from SLPs and Urdu linguistic experts and representatives of the target population was incorporated to refine the intervention materials.

The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary clinical utility of the SSVCI in Urdu-speaking children with language impairment. The study will also determine whether the intervention procedures, session structure, assessment methods, and treatment materials are suitable for implementation in a larger clinical trial.

All enrolled participants will receive the SSVCI. This pilot study uses a single-group, quasi-experimental pretest-posttest design, and no control group or randomization will be used during this phase.

Participants will complete baseline language assessments before beginning the intervention. Following baseline assessment, participants will receive 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 is organized into progressive stages. The initial sessions focus on baseline assessment of language abilities. The second stage introduces children to the visual configuration system and its symbolic cues that support comprehension and production of language. Therapy activities target foundational syntactic and semantic concepts, including understanding and answering questions . The final stage targets early grammatical structures, , through structured visual supports and functional language activities designed to promote phrase and sentence development.

Participant progress will be monitored throughout the intervention using standardized probe activities and language assessments administered before and after treatment. Measures of participant engagement, treatment adherence, intervention delivery, and language performance will also be collected to evaluate the practicality and acceptability of the intervention.

The findings of this pilot study will be used to refine the intervention protocol, improve treatment materials and procedures, and establish the feasibility of conducting a future randomized controlled trial to evaluate the effectiveness of the Syntactic-Semantic Visual Configuration Intervention in Urdu-speaking children with language impairment.

02

Conditions studied

  • Language Impairment
  • Autism
  • Hearing Impaired Children
  • Down Syndrome

Keywords

  • Urdu Language intervention
  • Syntactic-Semantic Visual Configuration Intervention (SSVCI)
03

In context

Language Disorders

84 studies on the registry are indexed under Language Disorders; 18 are open to participants now.

This study's enrollment of 20 is below the median of 51 across 66 interventional studies indexed under Language Disorders.

Browse Language Disorders studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Experimental: Syntactic-Semantic Visual Configuration Intervention (SSVCI)

    Participants received 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

  • BehavioralSyntactic-Semantic Visual Configuration Intervention (SSVCI)

    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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

07

Study locations

1 site
  • Child Development Center
    Rawalpindi, Federal 44000, Pakistan
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2026 to primary completion in Oct 2026, 2 months.

Of 35 non-industry interventional studies with no phase under Language Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 56. This study's 2 months is below that.

Counting every sponsor, half of 36 studies reached it within 27 months; a quarter within 9 and three quarters within 54.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start Sep 2026 → Aug 2026, primary completion Sep 2026 → Oct 2026 and completion Sep 2026 → Oct 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2026
First posted
Aug 26, 2026
StartActual
Aug 1, 2026was Sep 2026
Primary completionActual
Oct 6, 2026was Sep 2026
CompletionActual
Oct 8, 2026was Sep 2026
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Completed
changed Nov 5, 2026
Start date
Sep 1, 2026→Aug 1, 2026 (actual)
Nov 5, 2026
Primary completion
Sep 23, 2026→Oct 6, 2026 (actual)
Nov 5, 2026
Study completion
Sep 23, 2026→Oct 8, 2026 (actual)
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Not yet recruiting→Completed
    Start date Sep 1, 2026→Aug 1, 2026 (now actual)
    Primary completion Sep 23, 2026→Oct 6, 2026 (now actual)
    Study completion Sep 23, 2026→Oct 8, 2026 (now actual)
    + 5 other changes: identifiers, verification date, design details, arm descriptions and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07786545
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Aug 1, 2026
Primary completion
Oct 6, 2026
Completion
Oct 8, 2026
Last update
Nov 5, 2026

Study contacts

Humaira Shamim Kiyani, Phd
study chair · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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