NCT05242575

Brief Summary

The purpose of this study is to investigate an immersive virtual field trip (iVFT) on topic specific academic vocabulary for students with developmental language disorder (DLD). DLD is the most common childhood learning disorder with a prevalence of 7.4%(1) and occurs in the absence of a known biomedical condition (e.g., hearing loss, autism, stroke, intellectual disability). DLD affects a person's academic and social function due to difficulty with using and understanding language.(2,3) Approximately half of students with DLD have a deficit in vocabulary that persists through highschool.(4) Once children fall behind in their language and vocabulary development, it is very difficult to catch up generally resulting in a wider gap as they progress through their school years. This deficit can have cascading social, mental health, occupational and financial consequences.(5) There is preliminary evidence that a virtual reality experience such as an immersive virtual field trip (iVFT) was beneficial for facilitating vocabulary and comprehension in general education(6-8) and within targeted populations of students including second language learners(9) and those with learning differences (e.g., autism,(10) attention deficit hyperactivity,(11,12) and dyslexia(13). The term "immersive" refers to a state of heightened sensation when viewing a simulated environment that is superimposed onto a screen with embedded multisensory input (e.g., visual, auditory, proprioceptive).(14) The viewer looks through 3D goggles to block out the present environment resulting in a feeling of presence. These simulated experiences or destinations (e.g., space) are a type of VR referred to as an immersive virtual field trip (iVFT). To date, there is a lack of empirical evidence, explicitly targeting academic vocabulary growth for early grade school students with DLD. In addition, no study has reported on learning outcomes of students with DLD following a VR condition. Therefore, the primary study objective was to compare gains in academic vocabulary measures between a traditional book condition and an iVFT learning condition for young students with DLD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2022

Completed
Last Updated

April 12, 2023

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

January 23, 2022

Last Update Submit

April 11, 2023

Conditions

Keywords

Developmental Language Disorder (DLD)Specific Language Impairment (SLI)Vocabulary

Outcome Measures

Primary Outcomes (1)

  • Compare vocabulary gains between the book and iVFT conditions

    Change in target vocabulary words from pre to post intervention between the control book condition and the iVFT learning condition. Four-topic specific omnibus vocabulary measures include: 1. Divergent Naming (expressive): "Tell me the names of as many \[topic\] as you can think of, as quickly as possible, in one minute." One point earned for each named word. 2. Word Naming (expressive confrontational naming): State name of target image presented in isolation. One point earned for each correct response. 3. Picture Identification (receptive): Identify target picture in field of ten. One point earned for each correct response. 4. Word meaning recognition: Match the word with the written meaning. One point earned for each correct response.

    1 week: pretest, three 15-minute intervention sessions, posttest

Secondary Outcomes (2)

  • Vocabulary growth following an iVFT condition

    1 week: pretest target vocabulary, three 15-minute intervention sessions, posttest target vocabulary

  • Compare group perceptions of the study experience.

    1 week: following three 15-minute intervention sessions

Study Arms (2)

Book condition

NO INTERVENTION

Participants in the control condition will be receive a pre-recorded audio-visual book presentation. The purpose of pre-reading is to provide consistency in the examiner's affect and presentation, thereby controlling for potential examiner effects on study outcomes. Participants in the control group will receive three interventions each lasting 15-minutes. The number of sessions and intervention time is equal for both the control and experimental groups. The information provided in the control book and experimental iVFT parallel one another.

Immersive virtual field trip (iVFT)

EXPERIMENTAL

The study intervention is a multisensory immersive virtual reality trip to the moon. Participants will use 3D cardboard goggles and a smart phone. No additional interventions will occur. Participants in the iVFT experimental group will receive three interventions each lasting 15-minutes. The number of sessions and intervention time is equal for both the control and experimental groups. Participants will explore the moon through a virtual reality scene by moving their body and head, which creates a 360º view. When hovering over items, participants are presented with several key elements related to word learning (e.g., written and spoken words/narrative). Multiple items are given extra emphasis through hotspots that provide audiovisual content in the form of brief videos and spoken scripts. The information provided in the iVFT and control book parallel one another.

Behavioral: The information provided in the iVFT and control book parallel one another.

Interventions

An immersive virtual fled trip (iVFT) is a form of virtual reality (VR). The term immersive refers to an experience where the senses become heightened through multisensory input (e.g., visual, auditory, proprioceptive). When adding peripherals such as a head-mounted device (HMD) (e.g., goggles with 3D-lenses), a mobile phone becomes a pseudo-theater providing a 360-degree view that mimics the real world. For example, one can experience a simulated rollercoaster or visit the moon that may otherwise be inaccessible in day-to-day life. Also, a VFT provides for context and aids in background knowledge that is a crucial aspect of learning. Participants will receive three interventions sessions each last 15-minutes.

Also known as: Virtual Reality (VR)
Immersive virtual field trip (iVFT)

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 6.0- 8.12 years.
  • English language proficiency determined by examiner screening.
  • Spoken language is readily understandable by examiner.
  • Child speaks at least five-word sentences per examiner screening.
  • Child understands and can follow two-part directions per examiner screening.
  • Subject can complete all study protocol assessments.
  • Sees single image in binoculars and sees 3D images.
  • Diagnosis of developmental language disorder (DLD) (determined by ≤-1SD on the Clinical Evaluation of Language Fundamentals (CELF-5) completed within the past 12 months or examiner evaluation with the CELF-5.
  • Vocabulary deficit determined by scores equal to or less than 30% on two or more topic specific vocabulary measures.
  • Access to home Wi-Fi with sufficient connectivity to run the iVFT
  • VFT compatible smartphone to include operating systems iOS 8.0 (e.g., Apple iPhone 6 or later) or later or Android 4.1 (JellyBean) or later (e.g., Samsung Galaxy S5 or later).
  • (Note: If a participant would otherwise not be able to participate, a loaner device will be provided to the parent/guardian for study purposes.)

You may not qualify if:

  • History of the following medical conditions
  • Seizures/epilepsy
  • Moderate to severe motion sickness, cybersickness
  • Vision impairment defined as any child who has 504 plan requiring accommodations for visual impairment
  • Hearing impairment that prevents a child from hearing audio on a mobile device, a history of a failed hearing screening that has not been resolved, or a hearing impairment that results in an educational impact and requires specially designed instruction under IDEA (34 CFR § 300.8)."
  • Inability to use the smart phone application
  • Classified by school district as LEP (limited English proficient).
  • Children who are wards of the state or any other agency, institution, or entity will not be solicited for participation.
  • Intellectual disability (based on IEP/504 status).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salus University

Elkins Park, Pennsylvania, 19027, United States

Location

MeSH Terms

Conditions

Language Development DisordersSpecific Language Disorder

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLearning DisabilitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mitchell Scheiman, PhD, DO

    Dean of Research

    STUDY CHAIR
  • Amy Lustig, PhD,SLP,MPH

    Salus Univeristy

    STUDY CHAIR
  • Yvonne D'Uva Howard, PhD, MS SLP

    Salus University

    PRINCIPAL INVESTIGATOR

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

January 23, 2022

First Posted

February 16, 2022

Study Start

October 7, 2021

Primary Completion

March 1, 2022

Study Completion

June 6, 2022

Last Updated

April 12, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations