Clinical trial NCT06141382: Development of Sensory Based Narrative Intervention
Official title: Development of Sensory Based Narrative Intervention and the Effect of Treatment on Vocabulary Development in Children - Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum disorder
Language disorders in children
Narrative therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Attention span
timeFrame: 18 days
measure: Sequencing skill
timeFrame: 18 days
measure: Vocabulary development
timeFrame: 18 days
measure: Initiation for expression
timeFrame: 18 days
measure: Non verbal communication
timeFrame: 18 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Profiles Speech & Language Therapy Clinic
state: Punjab
Study officials:
affiliation: Riphah International University
name: Rabia Zubair, MS-SLP/T
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Barnes 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.
citation: Ferretti 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.
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citation: Beytollahi 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.
citation: Venkatraman 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.
citation: Abdalla 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.
citation: Bowles 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.