Improving speech, language and communication in pre-school children: implementation and effectiveness of the Sign 4 Programme, Luton, UK

ISRCTN ISRCTN42025531
DOI https://doi.org/10.1186/ISRCTN42025531
Secondary identifying numbers FS_Sign4_LT_BF
Submission date
15/02/2018
Registration date
21/02/2018
Last edited
23/05/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Not Applicable
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
The Sign 4 Programme uses sign language to support understanding and language development in hearing pre-school children. Nursery staff and parents read to children using Sign 4 story books and dolls to reinforce key words with sign language to facilitate story telling. Repeated use may help to improve children's comprehension, use of linking words, help with pronunciation and use of more complex words, as well as helping children to identify different emotions which allows them to 'name and tame' more challenging behaviours (such as 'frustrated' and 'angry'). The aim of this study is to find out whether the Sign 4 Programme improves language, speech and communication in pre-school children.

Who can participate?
Children aged under 5

What does the study involve?
Pre-school children take part in story time sessions in their nurseries as part of usual day-to-day activities. Children are assessed by nursery staff in four areas: listening and attention; understanding; speaking; and managing feelings and behaviour. These are part of standard assessments and are largely made through daily observation and activities. These assessments allow the tracking of progress over a period of months to assess the effectiveness of Sign 4 compared with a database of children who have not been part of the programme.

What are the possible benefits and risks of participating?
Early results suggest that children make better than expected progress in communication skills when attending Sign 4 story sessions. There are no anticipated risks.

Where is the study run from?
1. University of Bedfordshire (UK)
2. Flying Start Luton (UK)

When is the study starting and how long is it expected to run for?
February 2016 to November 2018

Who is funding the study?
1. University of Bedfordshire (UK)
2. Flying Start Luton (UK)

Who is the main contact?
Dr Rosemary Davidson
rosemary.davidson@beds.ac.uk

Contact information

Dr Rosemary Davidson
Scientific

Institute for Health Research
University of Bedfordshire
University Square
Luton
LU1 3JU
United Kingdom

ORCiD logoORCID ID 0000-0002-0010-4809
Phone +44 (0)796 667 6974
Email rosemary.davidson@beds.ac.uk
Prof Gurch Randhawa
Scientific

Institute for Health Research
University of Bedfordshire
Putteridge Bury Campus
Hitchin Road
Luton
LU2 8LE
United Kingdom

ORCiD logoORCID ID 0000-0002-2289-5859
Email gurch.randhawa@beds.ac.uk

Study information

Study designSingle-centre non-randomised study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)School
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleImproving speech, language and communication in pre-school children: a process and outcome evaluation of the Sign 4 Programme, Luton, UK
Study acronymSign 4 Little Talkers (S4LT) and Sign 4 Big Feelings (S4BF)
Study hypothesisThe Sign 4 Programme improves language, speech and communication in pre-school children when compared with a matched control group as measured by Early Years Outcomes (EYO).
Ethics approval(s)University Research Ethics Committee, University of Bedfordshire, 10/04/2017, ref: UREC104
ConditionDevelopment of speech, language and communication in pre-school children, with particular focus on children who are not showing expected levels of development
InterventionTargeted intervention in early years settings versus statutorily collected Early Years Outcome (EYO) control data

The Sign 4 Programme uses British Sign Language to support understanding and language development in hearing children.

Approach 1: Designated Safeguarding Officers led, Luton wide
Approach 1 aims to implement Sign 4 Big Feelings across Luton to children assessed as having lower levels of expected development as efficiently as possible given limited resources. The intervention will be incorporated into existing safeguarding processes across the town in 50-60 schools, registered child minders, and private, voluntary or independent (PVI) nursery settings. Designated Safeguarding Officers (DSOs) will follow agreed protocols to identify and monitor a minimum of two children per setting who are below expected levels in communication and language development (and may show signs of emotional distress) as part of the evaluation, although many more children in each setting will use Sign 4. DSOs will attend a briefing session where they will learn about the intervention and receive the Sign 4 Big Feelings book and dolls. A ‘light touch’ ensures as great a reach as possible with early years professionals who already work with children judged to be at risk. Practitioners are asked to incorporate the story books and signing into daily routines with children, with data collected at baseline and follow-up at three months (one school term).

Approach 2: Targeted, 8 Early Years settings
Eight settings have been identified for a comprehensive roll out of the Sign 4 approach. These settings have reported lower than expected progress and attainment in communication and language as demonstrated by the Early Years Foundation Stage Outcomes data routinely collected and inputted into the Luton Borough Council Tracking System (LATS database). Children from these settings also do less well than Luton and National levels in Communication and Language and Managing Feelings and Behaviour when they are assessed using the EYFS Profile at aged 5. Head teachers and senior staff in each setting must be committed to implementing Sign 4 Little Talkers and be able to incorporate the intervention by embedding the approach into daily routines such as story time. All children in the specified age ranges appropriate for Sign 4 can access materials combining Little Talkers and Big Feelings materials, however, practitioners are led by stage of development of each child rather than chronological age. In addition, settings will identify approximately 10 children who need additional support and invite their families along for Sign 4 Little Talkers sessions so they can learn how to use the materials with their children. Practitioners are asked to incorporate the story books and signing into daily routines with children, with data collected at baseline and follow-up at six months (two school terms).
Intervention typeBehavioural
Primary outcome measureListening and attention, speaking, managing feelings and behaviour, and understanding are measured using Early Years Outcomes at baseline and 6 month follow-up
Secondary outcome measuresChildren’s well-being is measured using Leuven Well-being scales at baseline and 6 month follow-up
Overall study start date01/02/2016
Overall study end date01/11/2018

Eligibility

Participant type(s)Mixed
Age groupChild
Upper age limit5 Years
SexBoth
Target number of participants1000
Total final enrolment111
Participant inclusion criteria1. Children under 5 years
2. Early years practitioners
3. Head Teachers/Managers of pre-schools
4. Sign 4 Trainers
5. Sign 4 Managers
6. Local Authority commissioners
Participant exclusion criteria1. Persons with no experience of Sign 4
2. Persons with no experience of working in the early years sector
Recruitment start date01/05/2017
Recruitment end date01/12/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

University of Bedfordshire
Institute for Health Research
University Square
Luton
LU1 3JU
United Kingdom
Flying Start Luton
The TOKKO Building
7 Gordon Street
Luton
LU1 2QP
United Kingdom

Sponsor information

University of Bedfordshire
University/education

Institute for Health Research
University Square
Luton
LU1 3JU
England
United Kingdom

Website https://www.beds.ac.uk/research-ref/ihr
ROR logo "ROR" https://ror.org/0400avk24
Flying Start Luton
Government

The TOKKO Building
7 Gordon Street
Luton
LU1 2QP
United Kingdom

Website https://www.flyingstartluton.com

Funders

Funder type

University/education

University of Bedfordshire
Private sector organisation / Universities (academic only)
Location
United Kingdom
Flying Start Luton

No information available

Results and Publications

Intention to publish date15/03/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planStudy protocol is available on request and is to be submitted for publication. Participant information sheets and topic guides are available on request.

Two outcome articles and one process evaluation article. The outcome articles will report on data analysed from eight targeted settings and from childminders and Designated Safeguarding Officers. The process evaluation article will report on implementation and progress of the Sign 4 Programme.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 20/05/2022 23/05/2022 Yes No

Editorial Notes

23/05/2022: Publication reference and total final enrolment added.
07/06/2018: Prof Gurch Randhawa has been added as a scientific contact

Springer Nature