Development of Sensory Based Narrative Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: English Langugae-Sensory based narrative intervention; Other: English Language-Narrative intervention; Other: Urdu Langusge-Sensory based narrative intervention; Other: Urdu Language-Narrative intervention; Other: Bilingual-Sensory based narrative intervention; Other: Bilingual-Narrative intervention

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 Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Amjad, PhD; Phone Number: 03324390125; Email: imran.amjad@riphah.edu.pk
• Study Contact Backup: Name: Rabia Zubair, MS-SLP/T; Phone Number: 03365581583; Email: rabia.zubair@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Recruiting
      • Profiles Speech & Language Therapy Clinic
      • Contact: Rabia Zubair, MS-SP/T; Phone Number: 03365581583; Email: rabia.zubair@riphah.edu.pk
      • Principal Investigator: Rabia Zubair, MS-SLP/T

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: English Language-Sensory based narrative intervention; This experimental group participants will receive sensory based intervention in English language.	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.
Active Comparator: English Language-Narrative intervention; This Control group participants will receive narrative intervention in English language.	Other: 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.
Experimental: Urdu Language-Sensory based narrative intervention; This experimental group participants will receive sensory based narrative intervention in Urdu language.	Other: 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.
Active Comparator: Urdu Language-Narrative intervention; This control group participants will receive narrative intervention in Urdu language.	Other: 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.
Experimental: Bilingual-Sensory based narrative intervention; This experimental group participants will receive sensory based narrative intervention in both English and Urdu language.	Other: 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.
Active Comparator: Bilingual-Narrative intervention; This control group participants will receive narrative intervention in both English and Urdu language.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention span	Changes from baseline, change in attention span will be measured in time in seconds pre and post intervention.	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.	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.	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.	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.	18 days

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Rabia Zubair, MS-SLP/T, Riphah International University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): December 22, 2023
• Study Completion (Estimated): December 22, 2023

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Estimated): November 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Narrative therapy; Autism Spectrum disorder; Language disorders in children
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: RIPHAH/RCRS/REC/Letter-01202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No