Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06250218 |
| Other study ID # |
001 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2024 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
February 2024 |
| Source |
University of Sheffield |
| Contact |
Emma Harvey |
| Phone |
+44 (0)7920528260 |
| Email |
emma.harvey[@]live.co.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
