Language ImpairmentSSVC-PILOTNCT07786545
Pilot Evaluation of the Developed Syntactic-Semantic Visual Configuration Intervention for Children With Language Impairment
A study testing Syntactic-Semantic Visual Configuration Intervention (SSVCI) in people with Language Impairment and Autism, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Language Impairment, Autism, Hearing Impaired Children
- What is being tested?
- Syntactic-Semantic Visual Configuration Intervention (SSVCI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2026to 23 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Child Development Center
Rawalpindi, Federal, 44000
Humaira Shamim Kiyani, Phd, 03005471389, humaira.shamim@riphah.edu.pk
Naima Farooq, Phd, 03005082849, naima.farooq@riphah.edu.pk
About this study
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.
Read more
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.
- Conditions
- Language Impairment, Autism, Hearing Impaired Children, Down Syndrome
- Being tested
- Syntactic-Semantic Visual Configuration Intervention (SSVCI)
- Keywords
- Urdu Language intervention, Syntactic-Semantic Visual Configuration Intervention (SSVCI)
- Medical subject headings
- Language Disorders, Autistic Disorder, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntactic-Semantic Visual Configuration Intervention (SSVCI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Syntactic-Semantic Visual Configuration Intervention (SSVCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and immediately after completion of the 16 intervention sessions (approximately 8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion23 Sep 2026 (estimated)
- Study completion23 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language ImpairmentStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Humaira Shamim Kiyani, Phd, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786545
- Sponsor's protocol ID
- REC/014187 Naima Farooq
- Acronym
- SSVC-PILOT
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the Developed Syntactic-Semantic Visual Configuration Intervention for Children With Language Impairment
- ClinicalTrials.gov ID
- NCT07786545
- Acronym / sponsor ID
- SSVC-PILOT / REC/014187 Naima Farooq
- Conditions
- Language Impairment, Autism, Hearing Impaired Children, Down Syndrome
- Keywords
- Urdu Language intervention, Syntactic-Semantic Visual Configuration Intervention (SSVCI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 23 Sep 2026 (estimated)
- Study completion
- 23 Sep 2026 (estimated)
- First posted
- 26 Aug 2026 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Syntactic-Semantic Visual Configuration Intervention (SSVCI) | Experimental | Behavioral: Syntactic-Semantic Visual Configuration Intervention (SSVCI)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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Syntactic-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. | Behavioural | Experimental: Syntactic-Semantic Visual Configuration Intervention (SSVCI) |
Primary outcome
Outcome 1: Change in Narrative Performance (MAIN)
Time frame: Baseline and immediately after completion of the 16 intervention sessions (approximately 8 weeks).
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.
Outcome Measure 2 Title: Change in Mean Length of Utterance in Words Derived from the Narrative Language Sam
Time frame: Baseline and immediately after completion of the 16 intervention sessions (approximately 8 weeks).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: 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.
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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.
Humaira Shamim Kiyani, Phd study chair
Riphah International 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 Syntactic-Semantic Visual Configuration Intervention (SSVCI) in people with Language Impairment and Autism, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 26 Aug 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naima Farooq, Phd (03005082849, naima.farooq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome 1: Change in Narrative Performance (MAIN) (time frame: Baseline and immediately after completion of the 16 intervention sessions (approximately 8 weeks).). The study lists 2 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 26 Aug 2026.