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Language Development DisordersNCT06250218

Using Video Interaction Guidance (VIG) With Children Who Have Language Delays.

A study testing Video Interactive Guidance (VIG) in people with Language Development Disorders, run by University of Sheffield.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study aims to explore whether the intervention Video Interactive Guidance (VIG) has an impact on the development of the language and sociocognitive skills of children aged between 2 and 5 with identified language delays. Read more about this study

Who is it for?
Ages 2 to 5 years
Conditions the study is for
Language Development Disorders
What is being tested?
Video Interactive Guidance (VIG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
No sites listed yet
Study dates
Feb 2024to Aug 2024
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 2 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Identified language delay (identified by participants Health Visitor through ASQ-3 assessment.

Who cannot join

  • No identified language delay

Trial locations and contacts

No sites are listed yet.

About this study

Official title: Does the Intervention Video Interactive Guidance (VIG) Have an Impact on the Development of the Language and Sociocognitive Skills of Children Aged Between 2 and 5 With Identified Language Delays?

The study aims to explore whether the intervention Video Interactive Guidance (VIG) has an impact on the development of the language and sociocognitive skills of children aged between 2 and 5 with identified language delays. The study is expected to take the form of a small mixed methods case study of AB design and is anticipated to involve 4 participants.

Read the detailed description

The study will take the form of a small mixed methods case study of AB design and is expected to involve 4 participants. These participants are children aged between 2 and 4 who have all been referred to the Educational Visiting Service, a specialist branch of Early Years Education in Dumfries and Galloway local authority, within which the researcher currently works as an Educational Visitor. The children's key workers at nursery will be involved in the delivery of this video-based intervention and it is from both the child's parents/carers and them that informed consent to participate will be sought. Any identifying text based personal information and gathered assessment data will be coded to preserve the anonymity of the participants. Consent to store and share original, unaltered audio-visual recordings with research supervisors will be gained from the participant's parents and key workers. These recordings will be thematically analysed and coded before they are included in the final project, again to preserve the anonymity of the participants. Any original recordings made will be securely stored on the researcher's university managed Google Drive until the project is complete and then deleted. As the researcher is currently working towards full accreditation from aVIGUK, they have been appointed an aVIGUK accredited supervisor for the duration of this project. Alongside the University research supervisors, they will be responsible for overseeing the project and will carry out regular supervision meetings with the researcher. This will involve the reviewing of the researchers filmed intervention sessions to ensure that the researcher adheres to the aVIGUK approved method of delivering the intervention, as well as corroborating and cross-checking the researcher's collected data.

Each of the participants will receive the intervention Video Interaction Guidance (VIG) with their key worker at nursery. Three norm-referenced standardised tests will be carried out at T1 (pre-intervention stage, 6 weeks before the intervention takes place), T2 (immediately prior to the intervention taking place) and T3 (immediately after the intervention takes place). The tests that will be carried out are the Renfrewshire Action Picture test (measuring expressive language, specifically information and grammar), the Renfrewshire Expressive Vocabulary test (measuring expressive vocabulary, specifically the extent to which objects can be named verbally from their picture) and the Hogrefe Early Sociocognitive Battery (measuring early sociocognitive skills, (specifically their social responsiveness, joint attention and symbolic comprehension). These assessments will be scored by the researcher but will also be filmed to allow for an independent evaluation to be carried out by an aVIGUK appointed supervisor. This will be done by sampling the videos at random, a second scoring being carried out by the aVIG UK approved supervisor and the scores compared. The purpose of this is to limit the impact of researcher bias and improve the internal validity of the study. MORS (see Appendix A) and Belfast (see Appendix B) assessments will also be carried out for each of the children at T1, T2 and T3. These assessments are not standardised but will provide data similar in style to the qualitative data provided by semi-structured interviews and will be analysed thematically. The final method of data collection will be an analysis of the first and final sessions of each of the participants. These will be coded in the same way as the Early Sociocognitive Battery with an emphasis on social responsiveness, joint attention and symbolic comprehension. As previously, samples of this analysis will be cross-evaluated by an aVIGUK appointed supervisor to improve the internal validity of the study.

Being tested
Video Interactive Guidance (VIG)
Medical subject headings
Language Development Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video Interactive Guidance (VIG)Other

    Video interaction guidance (VIG) is a video feedback intervention through which a "guider" helps a client to enhance communication within relationships. The client is guided to analyse and reflect on video clips of their own interactions.

Study groups in NCT06250218
Study groupRoleWhat they receive
Intervention GroupExperimentalThe group will receive the intervention Video Interaction Guidance.
Receives: Other: Video Interactive Guidance (VIG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Social Responsiveness

    A subtest of the Early Sociocognitive Battery Assessment will be used to determine whether there was a change in the participant's social responsiveness after the intervention.

    Measured: 5 weeks

  2. Joint Attention

    A subtest of the Early Sociocognitive Battery Assessment will be used to determine whether there was a change in the participant's joint attention after the intervention.

    Measured: 5 weeks

  3. Symbolic Comprehension

    A subtest of the Early Sociocognitive Battery Assessment will be used to determine whether there was a change in the participant's symbolic comprehension after the intervention.

    Measured: 5 weeks

  4. Expressive Language - Information

    A subtest of the Renfrew Action Picture Test will be used to determine whether there was a change in the participant's expressive language (information) after the intervention.

    Measured: 5 weeks

  5. Expressive Language - Grammar

    A subtest of the Renfrew Action Picture Test will be used to determine whether there was a change in the participant's expressive language (grammar) after the intervention.

    Measured: 5 weeks

  6. Expressive Vocabulary

    A subtest of the Renfrewshire Expressive Vocabulary Test will be used to determine whether there was a change in the participant's expressive vocabulary after the intervention.

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2024
  2. Study startFeb 2024 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06250218
Sponsor's protocol ID
001
Status last verified
Feb 2024
First submitted
18 Jan 2024
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Any identifying text based personal information and gathered assessment data will be coded to preserve the anonymity of the participants. Consent to store and share original, unaltered audio-visual recordings with research supervisors will be gained from the participant's parents and key workers. These recordings will be thematically analysed and coded before they are included in the final project, again to preserve the anonymity of the participants.

Questions about this trial

What is this clinical trial studying?

A study testing Video Interactive Guidance (VIG) in people with Language Development Disorders, run by University of Sheffield.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Emma Harvey (+44 (0)7920528260, emma.harvey@live.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Responsiveness (time frame: 5 weeks). The study lists 6 primary outcomes in all. 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 9 Feb 2024; AzTrials last refreshed its copy on 2 Nov 2026.

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