NCT06141382

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

November 9, 2023

Last Update Submit

November 15, 2023

Conditions

Keywords

Autism Spectrum disorderLanguage disorders in childrenNarrative therapy

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (6)

English Language-Sensory based narrative intervention

EXPERIMENTAL

This experimental group participants will receive sensory based intervention in English language.

Other: English Langugae-Sensory based narrative intervention

English Language-Narrative intervention

ACTIVE COMPARATOR

This Control group participants will receive narrative intervention in English language.

Other: English Language-Narrative intervention

Urdu Language-Sensory based narrative intervention

EXPERIMENTAL

This experimental group participants will receive sensory based narrative intervention in Urdu language.

Other: Urdu Langusge-Sensory based narrative intervention

Urdu Language-Narrative intervention

ACTIVE COMPARATOR

This control group participants will receive narrative intervention in Urdu language.

Other: Urdu Language-Narrative intervention

Bilingual-Sensory based narrative intervention

EXPERIMENTAL

This experimental group participants will receive sensory based narrative intervention in both English and Urdu language.

Other: Bilingual-Sensory based narrative intervention

Bilingual-Narrative intervention

ACTIVE COMPARATOR

This control group participants will receive narrative intervention in both English and Urdu language.

Other: Bilingual-Narrative intervention

Interventions

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-Sensory based 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.

English Language-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-Sensory based 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.

Urdu Language-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-Sensory based 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.

Bilingual-Narrative intervention

Eligibility Criteria

Age6 Years - 11 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profiles Speech & Language Therapy Clinic

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Related Publications (8)

  • 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.

    PMID: 26806602BACKGROUND
  • 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.

    PMID: 22042307BACKGROUND
  • 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.

    PMID: 29971024BACKGROUND
  • 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.

    PMID: 26935766BACKGROUND
  • 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.

    PMID: 33281259BACKGROUND
  • 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.

    PMID: 34368487BACKGROUND
  • 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.

    PMID: 32084324BACKGROUND
  • 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.

    PMID: 32073376BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Rabia Zubair, MS-SLP/T

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabia Zubair, MS-SLP/T

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 21, 2023

Study Start

November 10, 2023

Primary Completion

December 22, 2023

Study Completion

December 22, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations