NCT06250218

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

January 18, 2024

Last Update Submit

February 6, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    5 weeks

  • 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.

    5 weeks

  • 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.

    5 weeks

  • 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.

    5 weeks

  • 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.

    5 weeks

  • 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.

    5 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL

The group will receive the intervention Video Interaction Guidance.

Other: Video Interactive Guidance (VIG)

Interventions

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.

Intervention Group

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • No identified language delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Educational Visitor (Dumfries and Galloway Council). Student (University of Sheffield).

Study Record Dates

First Submitted

January 18, 2024

First Posted

February 9, 2024

Study Start

February 1, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

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.