Development of Sensory Based Narrative Intervention

Autism Spectrum Disorder Clinical Trial

Official title:

Development of Sensory Based Narrative Intervention and the Effect of Treatment on Vocabulary Development in Children - Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141382
• Other study ID #: RIPHAH/RCRS/REC/Letter-01202
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: December 22, 2023

Study information

• Verified date: November 2023
• Source: Riphah International University
• Contact: Imran Amjad, PhD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Control group participants will be given only narrative intervention. Vocabulary improvement will be documented pre-post testing in both groups.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Other:
• English Langugae-Sensory based narrative intervention
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 intervention
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 intervention
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 intervention
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 intervention
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 intervention
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.

Locations

Country	Name	City	State
Pakistan	Profiles Speech & Language Therapy Clinic	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Ketelaars 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention span	Changes from baseline, change in attention span will be measured in time in seconds pre and post intervention.	18 days
Primary	Sequencing skill	Change from baseline, sequencing skill will be measured as an ability to to place correct 3 part sequence picture of the story.	18 days
Primary	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.	18 days
Primary	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.	18 days
Primary	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.	18 days