Development of Sensory Based Narrative Intervention

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06141382

Collaborator

(none)

Enrollment

Location

Arms

1.4

Anticipated Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	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	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 10, 2023

Anticipated Primary Completion Date :

Dec 22, 2023

Anticipated Study Completion Date :

Dec 22, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Attention span [18 days]
Changes from baseline, change in attention span will be measured in time in seconds pre and post intervention.
Sequencing skill [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Profiles Speech & Language Therapy Clinic	Rawalpindi	Punjab	Pakistan	46000

Sponsors and Collaborators

Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT06141382

Other Study ID Numbers:

RIPHAH/RCRS/REC/Letter-01202

First Posted:

Nov 21, 2023

Last Update Posted:

Nov 21, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Autism Spectrum disorder

Language disorders in children

Narrative therapy

Additional relevant MeSH terms:

Autism Spectrum Disorder

Study Results

No Results Posted as of Nov 21, 2023