Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT06250218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Video Interaction Guidance (VIG) With Children Who Have Language Delays.
Sponsor:
University of Sheffield
Organization:
Study Overview
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?
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: