Developmental Language DisorderNCT05242575
The Influence of Immersive Virtual Field Trips on Academic Vocabulary
A study of Developmental Language Disorder and Language Disorders in Children, run by Salus University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorder, Language Disorders in Children
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 6 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.)
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Immersive Virtual Field Trips on Academic Vocabulary for Early Elementary Students With Developmental Language Disorder
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.
Read the detailed description
The purpose of this randomized control study is to investigate an immersive virtual field trip (iVFT) for learning academic vocabulary for students with developmental language disorder (DLD).
The primary objective is to compare gains in topic specific vocabulary measures between a traditional book condition and an iVFT learning condition. Also, this study will compare perceptions of the study experience between the control and experimental groups.
At study entry, 24 children between the ages of 6:0 to 8:12 years old with a developmental language disorder (DLD) will be randomized to equal groups of control book and experimental iVFT conditions.
If satisfy the inclusion and exclusion criteria, a three-phase pre-enrollment process will ensue. In the first phase, the Student Language Scale (SLS) and Shaywitz Dyslexia screeners will be administered to determine likelihood of presence of a language disorder and functional impact on academic and social growth. In the second phase, the CELF-5 diagnostic language assessment will determine the presence of a DLD if a standard score equal or less than 75 is obtained. In the third phase, the PPVT-5 vocabulary assessment will be administered to provide additional information about general receptive vocabulary knowledge. Lastly, four topic specific vocabulary measures will provide a measure of baseline topic vocabulary knowledge.
Consented and enrolled participants will be randomized into equal groups of control and experimental conditions. The control group will receive a pre-read book and the experimental group will be exposed to an immersive virtual field trip using 3D cardboard goggles and a smart phone. The content in the book and iVFT parallel one another. In both groups, audio and visual stimuli are presented. For all participants, a total of three 15-minute exposures will occur.
Following the condition, the four-topic specific vocabulary measures will be repeated to report on vocabulary growth. The measures include:
- Divergent Naming (expressive): "Tell me the names of as many [topic] as you can think of, as quickly as possible, in one minute."
- Word Naming (expressive confrontational naming): State name of target image presented in isolation.
- Picture Identification (receptive): Identify target picture in field of ten.
- Word meaning recognition: Match the word with the written meaning. Lastly, all participants will rate experience their experience using an Intrinsic Motivation Inventory (IMI) with a 5-point Smile Likert Scale.
The data analysis will include descriptive and inferential statistics to report within and between group gains in the four-topic specific vocabulary measures.
- Being tested
- The information provided in the iVFT and control book parallel one another.
- Keywords
- Developmental Language Disorder (DLD), Specific Language Impairment (SLI), Vocabulary
- Medical subject headings
- Language Development Disorders, Specific Language Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The information provided in the iVFT and control book parallel one another.Behavioural
Also called Virtual Reality (VR)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The information provided in the iVFT and control book parallel one another. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
- Word Naming (expressive confrontational naming): State name of target image presented in isolation. One point earned for each correct response.
- Picture Identification (receptive): Identify target picture in field of ten. One point earned for each correct response.
- Word meaning recognition: Match the word with the written meaning. One point earned for each correct response.
Measured: 1 week: pretest, three 15-minute intervention sessions, posttest
Secondary outcomes (2)
Vocabulary growth following an iVFT condition
To determine if an iVFT is effective for improving topic-specific vocabulary four omnibus vocabulary measures will be conducted pre-treatment and re-administered post-treatment.
omnibus vocabulary measures include:
- 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.
- Word Naming (expressive confrontational naming): State name of target image presented in isolation. One point earned for each correct response.
- Picture Identification (receptive): Identify target picture in field of ten. One point earned for each correct response.
- Word meaning recognition: Match the word with the written meaning. One point earned for each correct response.
Measured: 1 week: pretest target vocabulary, three 15-minute intervention sessions, posttest target vocabulary
Compare group perceptions of the study experience.
Following post vocabulary testing, participants will rate their experience by responding to a 15 question Intrinsic Motivation Inventory (IMI) with a 5-point Smile Likert Scale.
Measured: 1 week: following three 15-minute intervention sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start7 Oct 2021
- Primary completion1 Mar 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Scheiman, PhD, DO, Study chair, Dean of ResearchAmy Lustig, PhD,SLP,MPH, Study chair, Salus UniveristyYvonne D'Uva Howard, PhD, MS SLP, Principal investigator, Salus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242575
- Sponsor's protocol ID
- Salus University
- Status last verified
- Feb 2022
- First submitted
- 23 Jan 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Immersive Virtual Field Trips on Academic Vocabulary for Early Elementary Students With Developmental Language Disorder
- ClinicalTrials.gov ID
- NCT05242575
- Acronym / sponsor ID
- Salus University
- Keywords
- Developmental Language Disorder (DLD), Specific Language Impairment (SLI), Vocabulary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Salus UniversityUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this randomized control study is to investigate an immersive virtual field trip (iVFT) for learning academic vocabulary for students with developmental language disorder (DLD).
The primary objective is to compare gains in topic specific vocabulary measures between a traditional book condition and an iVFT learning condition. Also, this study will compare perceptions of the study experience between the control and experimental groups.
At study entry, 24 children between the ages of 6:0 to 8:12 years old with a developmental language disorder (DLD) will be randomized to equal groups of control book and experimental iVFT conditions.
If satisfy the inclusion and exclusion criteria, a three-phase pre-enrollment process will ensue. In the first phase, the Student Language Scale (SLS) and Shaywitz Dyslexia screeners will be administered to determine likelihood of presence of a language disorder and functional impact on academic and social growth. In the second phase, the CELF-5 diagnostic language assessment will determine the presence of a DLD if a standard score equal or less than 75 is obtained. In the third phase, the PPVT-5 vocabulary assessment will be administered to provide additional information about general receptive vocabulary knowledge. Lastly, four topic specific vocabulary measures will provide a measure of baseline topic vocabulary knowledge.
Consented and enrolled participants will be randomized into equal groups of control and experimental conditions. The control group will receive a pre-read book and the experimental group will be exposed to an immersive virtual field trip using 3D cardboard goggles and a smart phone. The content in the book and iVFT parallel one another. In both groups, audio and visual stimuli are presented. For all participants, a total of three 15-minute exposures will occur.
Following the condition, the four-topic specific vocabulary measures will be repeated to report on vocabulary growth. The measures include:
- Divergent Naming (expressive): "Tell me the names of as many [topic] as you can think of, as quickly as possible, in one minute."
- Word Naming (expressive confrontational naming): State name of target image presented in isolation.
- Picture Identification (receptive): Identify target picture in field of ten.
- Word meaning recognition: Match the word with the written meaning. Lastly, all participants will rate experience their experience using an Intrinsic Motivation Inventory (IMI) with a 5-point Smile Likert Scale.
The data analysis will include descriptive and inferential statistics to report within and between group gains in the four-topic specific vocabulary measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: The information provided in the iVFT and control book parallel one another.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. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- History of the following medical conditions
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The information provided in the iVFT and control book parallel one another.Also: Virtual Reality (VR)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. | Behavioural | Immersive virtual field trip (iVFT) |
Primary outcome
Compare vocabulary gains between the book and iVFT conditions
Time frame: 1 week: pretest, three 15-minute intervention sessions, posttest
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.
2 secondary outcomes
Vocabulary growth following an iVFT condition
Time frame: 1 week: pretest target vocabulary, three 15-minute intervention sessions, posttest target vocabulary
Compare group perceptions of the study experience.
Time frame: 1 week: following three 15-minute intervention sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No. IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Scheiman, PhD, DO study chair
Dean of Research
Amy Lustig, PhD,SLP,MPH study chair
Salus Univeristy
Yvonne D'Uva Howard, PhD, MS SLP principal investigator
Salus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Developmental Language Disorder and Language Disorders in Children, run by Salus University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare vocabulary gains between the book and iVFT conditions (time frame: 1 week: pretest, three 15-minute intervention sessions, posttest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.