Autism Spectrum DisorderNCT06141382
Development of Sensory Based Narrative Intervention
A study testing English Langugae-Sensory based narrative intervention, English Language-Narrative intervention and Urdu Langusge-Sensory based narrative intervention in people with Autism Spectrum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this study is to develop a sensory based narrative intervention and see its effect on vocabulary development in children with autism spectrum disorder. Sensory based narrative intervention will be developed, and participants of experimental group will be given this treatment for 6 weeks. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- English Langugae-Sensory based narrative intervention, English Language-Narrative intervention and Urdu Langusge-Sensory based narrative intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Nov 2023to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants with mild to moderate ASD aged between 6-11 years as assessed by ADOS (already diagnosed).
- CARS score 30-37 (mild to moderate)
- Both male and female participants.
- ASD participants at 2 Information Carrying word-level receptively and at Blank level 1 expressively. (will incorporate nouns, verbs and adjectives as per individual linguistic level).
- Participants with Urdu as their first language (home language) and English as a second language.
Who cannot join
- Individuals with any co-morbidity with Autism spectrum Disorder, such as hearing impairment, cleft lip and palate, visual impairment etc.
- Individuals with a mild to moderate diagnosis but severe behavioral difficulties
- Participants with any known sensory difficulties restricting use of certain sensory props.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Profiles Speech & Language Therapy Clinic
Rawalpindi, Punjab Province, 46000
Rabia Zubair, MS-SP/T, 03365581583, rabia.zubair@riphah.edu.pk
Rabia Zubair, MS-SLP/T
About this study
Official title: Development of Sensory Based Narrative Intervention and the Effect of Treatment on Vocabulary Development in Children - Pilot Study
The goal of this study is to develop a sensory based narrative intervention and see its effect on vocabulary development in children with autism spectrum disorder. Sensory based narrative intervention will be developed, and participants of experimental group will be given this treatment for 6 weeks. Control group participants will be given only narrative intervention. Vocabulary improvement will be documented pre-post testing in both groups.
Read the detailed description
The present study aims to bridge an existing gap in the literature in Pakistan, as there are no evidence based therapeutic intervention tools available for narratives in Urdu.
The study further aims to provide a interventional resource pack for bilingual population who has Urdu as their first and dominant language. There is no therapeutic tool available for intervention that has incorporated multimodal sensory input for language intervention. Since tools developed internationally and from other countries cannot be incorporated due to cultural sensitivity and linguistic complexity, therefore, the current study will be able to incorporate these limitations. This study will provide a novel resource for intervention in the context of Pakistan.
- Conditions
- Autism Spectrum Disorder
- Being tested
- English Langugae-Sensory based narrative intervention, English Language-Narrative intervention, Urdu Langusge-Sensory based narrative intervention, Urdu Language-Narrative intervention, Bilingual-Sensory based narrative intervention
- Keywords
- Autism Spectrum disorder, Language disorders in children, Narrative therapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
English Langugae-Sensory based narrative interventionOther
Sensory based narrative intervention (auditory, visual and tactile stimulations) in English language will be administered on children with autism spectrum disorder (ASD). Intervention will be administered thrice a week in 45-minute-long session for 6 weeks.
English Language-Narrative interventionOther
Narrative intervention with the help of only pictures in English language will be administered on children with autism spectrum disorder (ASD). Intervention will be administred thrice a week in 45-minute long session for 6 weeks.
Urdu Langusge-Sensory based narrative interventionOther
Sensory based narrative intervention (auditory, visual and tactile stimulations) in Urdu language will be administered on children with autism spectrum disorder (ASD). Intervention will be administered thrice a week in 45-minute-long session for 6 weeks.
Urdu Language-Narrative interventionOther
Narrative intervention with the help of only pictures in Urdu language will be administered on children with autism spectrum disorder (ASD). Intervention will be administered thrice a week in 45-minute long session for 6 weeks.
Bilingual-Sensory based narrative interventionOther
Sensory based narrative intervention (auditory, visual and tactile stimulations) in both English and Urdu language will be administered on children with autism spectrum disorder (ASD). Intervention will be administered thrice a week in 45-minute-long session for 6 weeks.
Bilingual-Narrative interventionOther
Narrative intervention with the help of only pictures in both English and Urdu language will be administered on children with autism spectrum disorder (ASD). Intervention will be administered thrice a week in 45-minute long session for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| English Language-Sensory based narrative intervention | Experimental | This experimental group participants will receive sensory based intervention in English language. Receives: Other: English Langugae-Sensory based narrative intervention |
| English Language-Narrative intervention | Active comparator | This Control group participants will receive narrative intervention in English language. Receives: Other: English Language-Narrative intervention |
| Urdu Language-Sensory based narrative intervention | Experimental | This experimental group participants will receive sensory based narrative intervention in Urdu language. Receives: Other: Urdu Langusge-Sensory based narrative intervention |
| Urdu Language-Narrative intervention | Active comparator | This control group participants will receive narrative intervention in Urdu language. Receives: Other: Urdu Language-Narrative intervention |
| Bilingual-Sensory based narrative intervention | Experimental | This experimental group participants will receive sensory based narrative intervention in both English and Urdu language. Receives: Other: Bilingual-Sensory based narrative intervention |
| Bilingual-Narrative intervention | Active comparator | This control group participants will receive narrative intervention in both English and Urdu language. Receives: Other: Bilingual-Narrative intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention span
Changes from baseline, change in attention span will be measured in time in seconds pre and post intervention.
Measured: 18 days
Sequencing skill
Change from baseline, sequencing skill will be measured as an ability to to place correct 3 part sequence picture of the story.
Measured: 18 days
Vocabulary development
Change from baseline, vocabulary development will be measured through comprehension of individual grammatical categories such as nouns, verbs, adjectives and preposition pre and post frequency will be recorded through a record form and calculated.
Measured: 18 days
Initiation for expression
change from baseline, initiation for expression will be documented in terms of time taken to initiate attempts at production level. It will be recorded on a record form with the help of stop watch on a record form.
Measured: 18 days
Non verbal communication
change from baseline, non verbal communication attempts will be documented on a record form on each enlisted vocabulary word as highlighted by the blind reviewer pre and post testing.
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start10 Nov 2023
- Primary completion22 Dec 2023 (estimated)
- Study completion22 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabia Zubair, MS-SLP/T, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141382
- Sponsor's protocol ID
- RIPHAH/RCRS/REC/Letter-01202
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beatty J. What are narratives good for? Stud Hist Philos Biol Biomed Sci. 2016 Aug;58:33-40. doi: 10.1016/j.shpsc.2015.12.016. Epub 2016 Jan 21.
PubMed 26806602Barnes JL, Baron-Cohen S. The big picture: storytelling ability in adults with autism spectrum conditions. J Autism Dev Disord. 2012 Aug;42(8):1557-65. doi: 10.1007/s10803-011-1388-5.
PubMed 22042307Ferretti F, Adornetti I, Chiera A, Nicchiarelli S, Valeri G, Magni R, Vicari S, Marini A. Time and Narrative: An Investigation of Storytelling Abilities in Children With Autism Spectrum Disorder. Front Psychol. 2018 Jun 19;9:944. doi: 10.3389/fpsyg.2018.00944. eCollection 2018.
PubMed 29971024Ketelaars MP, Jansonius K, Cuperus J, Verhoeven L. Narrative competence in children with pragmatic language impairment: a longitudinal study. Int J Lang Commun Disord. 2016 Mar;51(2):162-73. doi: 10.1111/1460-6984.12195. Epub 2015 Nov 16.
PubMed 26935766Beytollahi S, Soleymani Z, Jalaie S. The Development of a New Test for Consecutive Assessment of Narrative Skills in Iranian School-Age Children. Iran J Med Sci. 2020 Nov;45(6):425-433. doi: 10.30476/ijms.2019.81984.
PubMed 33281259Venkatraman K, Thiruvalluvan V. Development of narratives in Tamil-speaking preschool children: A task comparison study. Heliyon. 2021 Jul 21;7(7):e07641. doi: 10.1016/j.heliyon.2021.e07641. eCollection 2021 Jul.
PubMed 34368487Abdalla F, Mahfoudhi A, Alhudhainah S. Structural Development of Narratives in Arabic: Task Complexity, Age, and Cultural Factors. Lang Speech Hear Serv Sch. 2020 Apr 7;51(2):405-415. doi: 10.1044/2019_LSHSS-19-00044. Epub 2020 Feb 20.
PubMed 32084324Bowles RP, Justice LM, Khan KS, Piasta SB, Skibbe LE, Foster TD. Development of the Narrative Assessment Protocol-2: A Tool for Examining Young Children's Narrative Skill. Lang Speech Hear Serv Sch. 2020 Apr 7;51(2):390-404. doi: 10.1044/2019_LSHSS-19-00038. Epub 2020 Feb 5.
PubMed 32073376
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Sensory Based Narrative Intervention and the Effect of Treatment on Vocabulary Development in Children - Pilot Study
- ClinicalTrials.gov ID
- NCT06141382
- Acronym / sponsor ID
- RIPHAH/RCRS/REC/Letter-01202
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum disorder, Language disorders in children, Narrative therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 22 Dec 2023 (estimated)
- First posted
- 21 Nov 2023 (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.
The goal of this study is to develop a sensory based narrative intervention and see its effect on vocabulary development in children with autism spectrum disorder. Sensory based narrative intervention will be developed, and participants of experimental group will be given this treatment for 6 weeks. Control group participants will be given only narrative intervention. Vocabulary improvement will be documented pre-post testing in both groups.
Detailed description
The present study aims to bridge an existing gap in the literature in Pakistan, as there are no evidence based therapeutic intervention tools available for narratives in Urdu.
The study further aims to provide a interventional resource pack for bilingual population who has Urdu as their first and dominant language. There is no therapeutic tool available for intervention that has incorporated multimodal sensory input for language intervention. Since tools developed internationally and from other countries cannot be incorporated due to cultural sensitivity and linguistic complexity, therefore, the current study will be able to incorporate these limitations. This study will provide a novel resource for intervention in the context of Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| English Language-Sensory based narrative intervention | Experimental | Other: English Langugae-Sensory based narrative interventionThis experimental group participants will receive sensory based intervention in English language. |
| English Language-Narrative intervention | Active comparator | Other: English Language-Narrative interventionThis Control group participants will receive narrative intervention in English language. |
| Urdu Language-Sensory based narrative intervention | Experimental | Other: Urdu Langusge-Sensory based narrative interventionThis experimental group participants will receive sensory based narrative intervention in Urdu language. |
| Urdu Language-Narrative intervention | Active comparator | Other: Urdu Language-Narrative interventionThis control group participants will receive narrative intervention in Urdu language. |
| Bilingual-Sensory based narrative intervention | Experimental | Other: Bilingual-Sensory based narrative interventionThis experimental group participants will receive sensory based narrative intervention in both English and Urdu language. |
| Bilingual-Narrative intervention | Active comparator | Other: Bilingual-Narrative interventionThis control group participants will receive narrative intervention in both English and Urdu language. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participants with mild to moderate ASD aged between 6-11 years as assessed by ADOS (already diagnosed).
- CARS score 30-37 (mild to moderate)
- Both male and female participants.
- ASD participants at 2 Information Carrying word-level receptively and at Blank level 1 expressively. (will incorporate nouns, verbs and adjectives as per individual linguistic level).
- Participants with Urdu as their first language (home language) and English as a second language.
Key exclusion criteria (3 listed)
- Individuals with any co-morbidity with Autism spectrum Disorder, such as hearing impairment, cleft lip and palate, visual impairment etc.
- Individuals with a mild to moderate diagnosis but severe behavioral difficulties
- Participants with any known sensory difficulties restricting use of certain sensory props.
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 |
|---|---|---|
| English Langugae-Sensory based narrative interventionSensory based narrative intervention (auditory, visual and tactile stimulations) in English language will be administered on children with autism spectrum disorder (ASD). Intervention will be administered thrice a week in 45-minute-long session for 6 weeks. | Other | English Language-Sensory based narrative intervention |
| English Language-Narrative interventionNarrative intervention with the help of only pictures in English language will be administered on children with autism spectrum disorder (ASD). Intervention will be administred thrice a week in 45-minute long session for 6 weeks. | Other | English Language-Narrative intervention |
| Urdu Langusge-Sensory based narrative interventionSensory based narrative intervention (auditory, visual and tactile stimulations) in Urdu language will be administered on children with autism spectrum disorder (ASD). Intervention will be administered thrice a week in 45-minute-long session for 6 weeks. | Other | Urdu Language-Sensory based narrative intervention |
| Urdu Language-Narrative interventionNarrative intervention with the help of only pictures in Urdu language will be administered on children with autism spectrum disorder (ASD). Intervention will be administered thrice a week in 45-minute long session for 6 weeks. | Other | Urdu Language-Narrative intervention |
| Bilingual-Sensory based narrative interventionSensory based narrative intervention (auditory, visual and tactile stimulations) in both English and Urdu language will be administered on children with autism spectrum disorder (ASD). Intervention will be administered thrice a week in 45-minute-long session for 6 weeks. | Other | Bilingual-Sensory based narrative intervention |
| Bilingual-Narrative interventionNarrative intervention with the help of only pictures in both English and Urdu language will be administered on children with autism spectrum disorder (ASD). Intervention will be administered thrice a week in 45-minute long session for 6 weeks. | Other | Bilingual-Narrative intervention |
Primary outcome
Attention span
Time frame: 18 days
Changes from baseline, change in attention span will be measured in time in seconds pre and post intervention.
Sequencing skill
Time frame: 18 days
Change from baseline, sequencing skill will be measured as an ability to to place correct 3 part sequence picture of the story.
Vocabulary development
Time frame: 18 days
Change from baseline, vocabulary development will be measured through comprehension of individual grammatical categories such as nouns, verbs, adjectives and preposition pre and post frequency will be recorded through a record form and calculated.
Initiation for expression
Time frame: 18 days
change from baseline, initiation for expression will be documented in terms of time taken to initiate attempts at production level. It will be recorded on a record form with the help of stop watch on a record form.
Non verbal communication
Time frame: 18 days
change from baseline, non verbal communication attempts will be documented on a record form on each enlisted vocabulary word as highlighted by the blind reviewer pre and post testing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 26806602Beatty J. What are narratives good for? Stud Hist Philos Biol Biomed Sci. 2016 Aug;58:33-40. doi: 10.1016/j.shpsc.2015.12.016. Epub 2016 Jan 21.
- Background: PubMed 22042307Barnes JL, Baron-Cohen S. The big picture: storytelling ability in adults with autism spectrum conditions. J Autism Dev Disord. 2012 Aug;42(8):1557-65. doi: 10.1007/s10803-011-1388-5.
- Background: PubMed 29971024Ferretti F, Adornetti I, Chiera A, Nicchiarelli S, Valeri G, Magni R, Vicari S, Marini A. Time and Narrative: An Investigation of Storytelling Abilities in Children With Autism Spectrum Disorder. Front Psychol. 2018 Jun 19;9:944. doi: 10.3389/fpsyg.2018.00944. eCollection 2018.
- Background: PubMed 26935766Ketelaars MP, Jansonius K, Cuperus J, Verhoeven L. Narrative competence in children with pragmatic language impairment: a longitudinal study. Int J Lang Commun Disord. 2016 Mar;51(2):162-73. doi: 10.1111/1460-6984.12195. Epub 2015 Nov 16.
- Background: PubMed 33281259Beytollahi S, Soleymani Z, Jalaie S. The Development of a New Test for Consecutive Assessment of Narrative Skills in Iranian School-Age Children. Iran J Med Sci. 2020 Nov;45(6):425-433. doi: 10.30476/ijms.2019.81984.
- Background: PubMed 34368487Venkatraman K, Thiruvalluvan V. Development of narratives in Tamil-speaking preschool children: A task comparison study. Heliyon. 2021 Jul 21;7(7):e07641. doi: 10.1016/j.heliyon.2021.e07641. eCollection 2021 Jul.
- Background: PubMed 32084324Abdalla F, Mahfoudhi A, Alhudhainah S. Structural Development of Narratives in Arabic: Task Complexity, Age, and Cultural Factors. Lang Speech Hear Serv Sch. 2020 Apr 7;51(2):405-415. doi: 10.1044/2019_LSHSS-19-00044. Epub 2020 Feb 20.
- Background: PubMed 32073376Bowles RP, Justice LM, Khan KS, Piasta SB, Skibbe LE, Foster TD. Development of the Narrative Assessment Protocol-2: A Tool for Examining Young Children's Narrative Skill. Lang Speech Hear Serv Sch. 2020 Apr 7;51(2):390-404. doi: 10.1044/2019_LSHSS-19-00038. Epub 2020 Feb 5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rabia Zubair, MS-SLP/T principal investigator
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 English Langugae-Sensory based narrative intervention, English Language-Narrative intervention and Urdu Langusge-Sensory based narrative intervention in people with Autism Spectrum Disorder, 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention span (time frame: 18 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06141382, which also lists 8 linked publications.
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 21 Nov 2023.