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Development of Sensory Based Narrative Intervention

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ClinicalTrials.gov Identifier: NCT06141382
Recruitment Status : Recruiting
First Posted : November 21, 2023
Last Update Posted : November 21, 2023
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 10, 2023
Estimated Primary Completion Date : December 22, 2023
Estimated Study Completion Date : December 22, 2023

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Attention span [ Time Frame: 18 days ]
    Changes from baseline, change in attention span will be measured in time in seconds pre and post intervention.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06141382


Contacts
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Contact: Imran Amjad, PhD 03324390125 imran.amjad@riphah.edu.pk
Contact: Rabia Zubair, MS-SLP/T 03365581583 rabia.zubair@riphah.edu.pk

Locations
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Pakistan
Profiles Speech & Language Therapy Clinic Recruiting
Rawalpindi, Punjab, Pakistan, 46000
Contact: Rabia Zubair, MS-SP/T    03365581583    rabia.zubair@riphah.edu.pk   
Principal Investigator: Rabia Zubair, MS-SLP/T         
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Rabia Zubair, MS-SLP/T Riphah International University
More Information
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Publications:

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT06141382    
Other Study ID Numbers: RIPHAH/RCRS/REC/Letter-01202
First Posted: November 21, 2023    Key Record Dates
Last Update Posted: November 21, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Autism Spectrum disorder
Language disorders in children
Narrative therapy
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders