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Not yet recruitingNCT06250218Updated Feb 9, 2024

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

An interventional study of Video Interactive Guidance (VIG) in Language Development Disorders, sponsored by University of Sheffield. Not yet recruiting. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by University of Sheffield · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
2 Years to 5 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Language Development Disorders
03

In context

Language Development Disorders

121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.

This study's planned enrollment of 4 is below the median of 74 across 106 interventional studies indexed under Language Development Disorders.

Browse Language Development Disorders studies →

Lead sponsor

University of Sheffield is the lead sponsor of 75 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No identified language delay
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    The group will receive the intervention Video Interaction Guidance.

    Other: Video Interactive Guidance (VIG)

Interventions

  • OtherVideo Interactive Guidance (VIG)

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 5 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2024; primary completion for Aug 2024, 6 months later.

Of 72 non-industry interventional studies with no phase under Language Development Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 6 months is below that.

Counting every sponsor, half of 72 studies reached it within 30 months; a quarter within 19 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2024
First posted
Feb 9, 2024
StartEst.
Feb 2024
Primary completionEst.
Aug 2024
CompletionEst.
Aug 2024
Last update
Feb 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06250218
Lead sponsor
University of Sheffield
Responsible party
Emma J Harvey (Educational Visitor (Dumfries and Galloway Council). Student (University of Sheffield)., University of Sheffield) — Principal investigator
First posted
Feb 9, 2024
Start date
Feb 2024 (estimated)
Primary completion
Aug 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Feb 9, 2024

Study contacts

Emma Harvey
Contact
emma.harvey@live.co.uk
+44 (0)7920528260

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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